866-274-4009 Contact Us

Associate Director, Validation

Summary

The Associate Director of QA Validation will be responsible for. providing leadership and strategic direction to the establishment of the validation/qualification programs (including the Qualification/PM/Calibration of instruments and equipment, as well as building and facility commissioning and qualification), ensuring alignment with industry standards and regulatory guidances. The QA Validation Associate Director will support the execution of validation and qualification protocols and reports as they apply to facilities, utilities, equipment, computer systems, cleaning and processes. Additionally, the Associate Director of QA Validation will be responsible for the support of facility start-up activities, technical transfers, re-qualifications and routine activities as they pertain to Laboratories, Manufacturing, facilities, Maintenance and Warehouse functions

Responsibilities

·Manage the validation program from a Quality Assurance perspective to ensure quality and compliance requirements are met in an efficient and effective manner, in support of corporate objectives.

·Act as the quality/ validation expert supporting GMPsystems and compliance to industry regulations

·Ensure required Standard Operating Procedures and systems are implemented to support internal and external validation programs.

·Provide quality oversight and approval of software, equipment/facility qualification.

·Ensure Site Validation Master Plan is followed at site level.

·Provide guidance , oversight and approval of internal and external method qualification, method transfer and method validation project plans, protocols and reports.

·Provide leadership and guidance to staff on qualification/validation matters and compliance to industry regulations: 21 CFR Parts 11, 211, 820, 1271, 600, EU Guidance for Advanced Therapies and Medicinal Products, EU Annex’s, GAMP5 and other industry standards as applicable

·Review and revise SOPs for consistency and compliance with regulatory requirements

·Support regulatory inspections by FDA and foreign regulatory agencies

·Stay abreast of industry and affiliated publications, memberships, and technologies to ensure organizational goals are met.

·Actively seek out new, cutting edge technology to further Quality Operations initiatives and build efficiencies.

·Participate in continuous improvement efforts in quality systems through the evaluation of trends in key performance indicators, audit and stakeholder feedback, and corrective/preventative actions.

·Lead standardization and harmonization of Standard Operating Procedures.

·Partner with Research and Development and Tech Transfer groups to develop and execute product technical transfer plans to manufacturing facilities.

·Provide support to the initiation, assessment and implementation of internal change controls.

·Apply risk based methodologies in the oversight of validation efforts.

·Provide guidance and direction throughout the Change Control process supporting GxP Systems.

·Participate in cross-functional risk assessments and process parameter classification

·Provide hands-on review and subject matter expertise of Validation lifecycle documentation including Process Design Documents, Process Control Strategy, Master Plans, Protocols and Reports.

·Participate in interdepartmental project/program teams to meet site objectives.

·Provide expertise to technical teams in the implementation of strategies for validation studies.

Provide leadership to staff by directing, mentoring, coaching and developing them towards professional growth, enhanced job performance and career satisfaction

Qualifications

·Bachelor’s Degree in science or technical discipline

·A minimum of eight (8) years’ experience in Quality Assurance in the Pharmaceutical, Biotech (or related industry), or experience in related engineering areas, e.g. R&D or Manufacturing. (Advanced degrees may be used to reduce required experience.)

August 2, 2022

Director of QA Manufacturing Operations, Cell Therapy

Summary

The Center for Breakthrough Medicines is looking for a quality expert to support the organization by establishing quality operational processes, quality systems, driving growth, and ensuring quality across cell therapy manufacturing operations. The Director of QA Manufacturing Operations will be responsible for the overall management of quality operations, audit readiness, data integrity, and document control supporting Cell Therapy product release for client services.This role will provide leadership, strategic thinking, and results focus mindset to reliably meet and/or exceed the site’s performance targets and client demands while achieving high levels of quality. This position requires an individual capable of partnering across the organization to manage a fast-paced environment and deliver exceptional service to our clients.

Responsibilities

·Direct and oversee all aspects of QA manufacturing operations within the organization, including but not limited to batch record review, QA support on floor, material release, deviation investigations, CAPAs, change controls, customer quality support, SOPs.

·Foster a Quality mindset throughout the company by ensuring consistent, risk-based and innovative thought processes are employed to advise and make decisions.

·Manage problems of varied scope using a high degree of prudence and risk-based decision making.

·Develop, motivate, and lead teams of cross-functional resources in a matrixed organization with competing priorities.

·Interpret industry regulations and guidance documents for the creation and implementation of quality standards, quality operational procedures andpolicies, and site procedures

·Partner with other business units or departments in support of continuous improvement initiatives.

·Author or revise SOPs to address gaps or necessary improvements to Quality Systems.

·Develop and provide cGMP and other GxP training as needed.

·Maintain knowledge of global regulatory requirements for the Cell and Gene Therapy products.

·Responsible for authoring quality lifecycle management documents of facilities, processes and equipment and using appropriate quality systems for implementation and maintenance.

·Develop and maintain systems that insure the technical and regulatory competency of personnel within the organization.

·Interact with the quality team and internal stakeholders to support the development, manufacturing, manufacturing, packaging and release of manufacturing products as needed.

·Additional duties as assigned.

Qualifications

·Solid understanding of industry regulation 21CFR 210, 211, 11, 820 as well as EU Guideline for Advanced Therapy and Medicinal Products.

·Significant experience with both digital and paper based QMS solutions.

·Diverse Quality operations experience across functions in GMP including CRO/CDMO oversight activities.

·Regulatory experience a plus.

·Bachelor’ s Degree in a commercial or scientific field required, advanced degree MS, PhD or MBA preferred.

·Minimum of 10-15 years of progressive managerial experience within biopharmaceutical Quality Assurance.Cell and Gene Therapy industry experience is a plus.

·10 years’ in-depth experience in GMP/GXP industry.

·In-depth knowledge of risk management systems and/or computer systems validation programs strongly preferred e.g., Veeva, Labware (LIMS), SAP

·Previous experience preparing for and leading client audits and/or regulatory inspections.

·Judgment and problem-solving – able to define decision criteria and determine the most appropriate course of action.

·Planning and organizational skills – able to establish objectives and schedule tasks and resources efficiently.

·Communication skills – strong written communication skills to provide concise and clear documentation.

·Partner with other business units or departments in support of continuous improvement initiatives.

·A hands-on leader who can perform day-to-day QA activities as well as direct others to perform such work.

·Excellent verbal, written and presentation skills with the ability to deal effectively across all levels of management.

·Ability to provide solution minded approach and flexibility to emerging challenges.

·Able to appropriately balance priorities plus multitask against competing priorities.

·Certifications is an advantage including Quality Auditor, Quality Engineer, Quality Improvement Associate, Six Sigma

·Knowledge of tools, concepts and methodologies of QA

·Solid experience in effective usage of data analysis tools and statistical analysis

·Proficient in Microsoft Office (Excel, Word, Outlook).

August 1, 2022

Specialist/Senior QA Manufacturing Operations Specialist-Viral Vector

Summary

Center for Breakthrough Medicines is seeking a regulatory/quality expert to support the organization by establishing quality systems, drive growth, and ensure quality. The Senior QA Manufacturing Operation Specialist will help build scalable QA systems as the organization continues to grow. The role will be responsible for the overall management of the quality system within the organization and oversees all quality manufacturing activities and operations including oversight of technical staff. The role also leads and manages site manufacturing operations, related programs, and activities to support the contract manufacturing organization and testing operations. The Sr. QA Manufacturing Operations Specialist supports Manufacturing Operations, providing oversight, strategic thinking, and results focus to reliably meet and/or exceed the site’s production targets while achieving high levels of quality. This position requires an individual capable of partnering across the organization to manage a fast-paced production environment and deliver exceptional service to our clients. It also ensures business, quality and compliance goals are met in full compliance with all government-issued environmental, health, safety, quality, and regulatory policies and guidelines.

Responsibilities

  • Critically review various documentation types to ensure completeness, accuracy and compliance including but not limited to test methods, method validation protocols and reports and SOPs
  • Provide Quality input and guidance for deviations, technical documentation, program/process optimization projects, and audit readiness initiatives.
  • Communicate effectively with cross functional departments to ensure on time delivery of QA review and disposition responsibilities
  • Approval of Certificate of Analysis for release of manufacturing batches within assigned timelines to effectively deliver results to client
  • Ability to review data and effectively identify and trends or key issues
  • Lead all quality operations activities to drive execution and expedient delivery of program milestones
  • Ensure facility follows current GMP standards (cGMP)
  • Ensure quality and assists Quality Assurance in maintaining all technical regulatory requirements
  • Interacts and represents the Center for Breakthrough Medicines with all regulatory agency inspections and client audits
  • Support the development quality systems including a robust and on-going quality improvement system compliant with GMP
  • Maintain knowledge of global regulatory requirements
  • Responsible for authoring quality lifecycle management documents of facilities, processes and equipment and using appropriate quality systems for implementation and maintenance
  • Develop and maintain systems that insure the technical and regulatory competency of personnel within the organization
  • Oversee all aspects of QA testing operations within the organization, including but not limited to batch record review, QA support on floor, material release, deviation investigations, CAPAs, change controls, customer quality support, SOPs. Review master batch records, product labels and all product specific documents
  • Interact with the quality team and internal stakeholders to support the development, manufacturing, testing, packaging, and release of viral vector products as needed
  • Identify and participate in internal quality improvement initiatives: evaluate internal processes, suggest/design/ implement improvements, create/revise relevant SOPs
  • Foster a Quality mindset throughout the company by ensuring consistent, risk-based, and innovative thought processes are employed to advise and make decisions
  • Manage problems of varied scope using a high degree of prudence and risk-based decision making
  • Monitor, study performance via key performance indicators to maintain or improve operational efficiencies, while ensuring compliance to GMP regulations
  • Ensure test methodologies provide quality of results required and are in full compliance with regulatory requirements, standards, and protocols
  • Prepare reports and keep upper-level management informed of progress
  • Additional duties as assigned

Qualifications

  • Bachelor’ s Degree in a commercial or scientific field required
  • Minimum 5-10 years’ experience in the Contract Research Organization (CRO), or biopharmaceutical industry within a GMP environment.
  • Possesses front-line practical experience and success in implementing quality systems
  • 5-10 years Quality Professional in Pharmaceutical and Biological Manufacturing
  • Proficient in Verbal and Written communication skills
  • Proficient in Microsoft Office (Excel, Word, Outlook)
  • Excellent problem solving, risk analysis and negotiation skills
  • Ability to review data and effectively identify and trends or key issues
  • Ability to manage multiple projects simultaneously ensuring on time execution of deliverables

Physical Demands

This position may require the ability to lift 25lbs

This position may require the ability to stand for long periods of time.

June 7, 2022

QA Validation Specialist

Summary

The Center for Breakthrough Medicines QA Department is seeking a QA Validation Specialist responsible for providing quality oversight of the validation and qualification activities for manufacturing process, facility, equipment, and systems within a Cell and Gene Therapy manufacturing facility supporting both clinical and commercial programs in a sterile GMP environment. This role will be responsible for reviewing and approving validation/qualification protocols/reports, standard operating procedures, investigations, work orders, change documents, reports for projects and maintenance activities.

Responsibilities

  • Work in a collaborative team setting with quality counterparts that include Manufacturing Operations, Engineering and Validation, Quality Control, Operations Technical Support, Testing, Supply Chain, and Planning
  • Provide quality and compliance oversight for the qualification, and validation, of manufacturing, laboratory and testing processes. Including, review and approval of master and completed qualification and validation protocols, summary reports and associated data for conformance to regulations, SOPs, specifications, and other applicable acceptance criteria
  • Provide quality and compliance oversight for scheduled and periodic maintenance activities within the manufacturing and testing facility. Including, review and approval of documentation supporting Plant and Laboratory Maintenance, whose function is to perform planned (Preventative maintenance) and unplanned (work orders and change controls) maintenance for equipment and instruments
  • Review and approve Risk Assessments, Change Controls, SOPs, FMEA, Periodic Qualifications, Project Plans, Master Plans, and Annual Product Reviews
  • Ability to manage multiple and complex projects, provide status reports and coordinating with other departments and/or outside contractors/vendors to complete validation tasks
  • Judgment and problem-solving – able to define decision criteria and determine the most appropriate course of action.
  • Planning and organizational skills – able to establish objectives and schedule tasks/resources efficiently.
  • Communication skills – strong written communication skills to provide concise and clear documentation
  • Partner with a team setting to support continuous improvement initiatives. Support technical and quality investigations to resolve issues
  • Perform tasks in a manner consistent with the safety policies, quality systems and cGMP requirements
  • Require minimal direction to complete tasks, knows how to obtain resources and information from established internal contacts; consult with manager for decisions outside established processes

Qualifications

  • Bachelor of Science degree or higher education in Engineering or Science
  • 3-5 years in a highly regulated environment such as biotechnology, pharmaceutical or related fields, including a significant exposure to regulatory requirements
  • Experience in technical writing for cGMP documents
  • Prior experience in developing equipment validation, process validation, packaging qualification and cleaning validation
  • Must be highly skilled in cleaning validation including protocol and cleaning validation study generation, sample collection and testing
  • Experience in writing & reviewing SOPs and protocols for accuracy and compliance
  • Ability to work closely with multiple disciplines, including Manufacturing, Maintenance, Facilities, Quality Control, Laboratory and Quality Assurance to execute validation protocols
  • Ability to apply comprehensive knowledge of pharmaceutical cGMPs and quality system controls, procedures and records to ensure ongoing quality compliance
  • Ability to perform all requirements independently with limited managerial oversight
  • Excellent organizational abilities to meet accelerated timelines, manage multiple shifting priorities and maximize efficiencies in a dynamic customer-focused environment
  • Superior attention to detail to ensure accuracy of work product
  • Superior critical-thinking and problem-solving skills; ability to recognize and resolve discrepancies and issues
  • Advanced computer skills to increase department’s productivity, as well as broadening technical and scientific knowledge

June 3, 2022

Senior Director of Quality Operations: Viral Vector Manufacturing

Summary

Reporting to the Vice President of Quality and Compliance, the Senior Director of QA Viral Vector Manufacturing Operations will be a key member of the Quality Assurance team and is responsible for ensuring that quality and compliance are integrated into long term strategies and day to day operations. This role is instrumental in establishing, improving, and maintaining quality systems at CBM and driving functional and cross-functional projects that embed continuous improvement principles across the company. The Senior Director directs the activities of compliance within Quality Assurance for Viral Vector Manufacturing. This includes the supervision and mentoring of staff, budgeting and resource analysis. In addition, the Senior Director will provide technical, quality, and regulatory guidance in support of Viral Vector Manufacturing operations. Lastly, the Sr. Director will be responsible for ensuring all operations relating to products or services meets the established standards and client requirements.

Responsibilities

  • Responsible for leading the QA manufacturing operations and ensuring that compliance objectives are maintained in the context of overall organizational needs and objectives with oversight of QA Compliance, Document Control, and Training, and other functions assigned to QA across viral vector manufacturing.
  • Lead CBM efforts to remain “inspection ready” and represents QA during regulatory inspections and client audits.
  • Interpret industry regulations and guidance documents for the creation and implementation of quality standards, policies, and site procedures
  • Provide direction for the review of compliance procedures, Standard Operating Procedures, master batch records, specifications, validation master plans, and validation protocols and all other GxP documentation.
  • Direct the review and approval of GMP impact changes to processes, product specifications equipment and facilities, including oversight of the risk assessment/management process. Provides direction for the review of all physical plant and equipment layouts and specifications to ensure compliance with internal and regulatory requirements.
  • Support the internal and external audit programs to ensure appropriate GMP raw material and service suppliers are selected and maintained and that critical internal GMP systems are operated in a compliant manner.
  • Judgment and problem-solving – able to define decision criteria and determine the most appropriate course of action.
  • Planning and organizational skills – able to establish objectives and schedule tasks and resources efficiently.
  • Communication skills – strong written communication skills to provide concise and clear documentation.
  • Partner with other business units or departments in support of continuous improvement initiatives.
  • Provide Quality System based leadership to ensure that CBM’s systems support the CBM quality mission and ensures quality products are produced for contract manufacturing clients.
  • Leads the QA function and evaluates opportunities for continuous improvements, e.g. manufacturing process improvements, improvement to quality programs, etc…
  • Lead the effort of tracking and communicating quality improvement initiatives throughout the organization and promoting a working culture in the organization that is quality based.
  • Communicates Quality System performance to Senior Management on a regular basis and leads efforts to remediate compliance performance as required.
  • Manage product complaints, adverse events, and any market action requirements from a quality assurance point of view.
  • Manage the compliance function to ensure deviations, including reports associated with environmental monitoring, water, and cleaning excursions are effectively managed and decisions taken support the overall quality objectives, exercising direct supervision of critical compliance issues, and leadership of critical investigations where necessary.
  • Hire, manage and train staff. Plan and assign duties to meet departmental and organizational objectives. Provide guidance and direction to staff; including appropriate training and mentoring for junior staff and development of senior staff to provide appropriate and adequate backup for primary QA Director functions.
  • Develop budgets and manages resources to meet departmental and organizational objectives.

Qualifications

  • Bachelor’s Level Degree or equivalent in a scientific discipline and a minimum of 12 years of relevant experience or equivalent in Biologics and/or Cell and Gene Therapies.
  • A combination of experience and/or knowledge of and willingness to adapt to the cGMP environment of Cell and Gene Therapy producing clinical trial materials and market licensed product is required
  • Demonstration of initiative and leadership through experience
  • Relevant experience and technical knowledge in viral vector products preferred.
  • Demonstrated ability to interact with senior management and regulatory officials
  • Clear, concise, written, and verbal communication and presentation skills
  • Ability to manage risk by maintaining and applying extensive working knowledge of applicable cGMP, FDA, and EMA regulations
  • Demonstrates potential for technical proficiency, scientific creativity, productive collaboration with others, and independent thought
  • Strong organizational skills, demonstrated ability to prioritize projects, and to meet deadlines with minimal supervision are required
  • Ability to manage performance and motivate personnel to work effectively and efficiently
  • Demonstrated problem-solving skills
June 1, 2022

QA Validation Specialist – Equipment & Facilities- TEMP POSITION

Summary

The Center for Breakthrough Medicines QA Department is seeking a QA Validation Manager responsible for providing quality oversight of the validation and qualification activities for manufacturing process, facility, equipment, and systems within a Cell and Gene Therapy manufacturing facility supporting both clinical and commercial programs in a sterile GMP environment. This role will be responsible for reviewing and approving validation/qualification protocols/reports, standard operating procedures, change documents, and reports for projects and maintenance activities.

Responsibilities

·Review and approve Validation Documentation including but no limited to: Validation Master Plans, User Requirements, Functional Requirements, FATs, SATs, IQOQPQ, Trace Matrix, Validation Summary Reports and Change Controls.

·Provide quality and compliance oversight for the qualification and validation, of manufacturing, facility, and/or laboratory systems.

·Provide quality and compliance oversight for scheduled and periodic maintenance activities within the manufacturing and testing facility. Including, review and approval of documentation.

·Work in a collaborative team setting with quality counterparts that includes: Manufacturing Operations, Facilities & Engineering, Information Technology, Testing, and Supply Chain.

·Ability to manage multiple and complex projects, provide status reports and coordinating with other departments and/or outside contractors/vendors to complete validation tasks

·Judgment and problem-solving – able to define decision criteria and determine the most appropriate course of action.

·Planning and organizational skills – able to establish objectives and schedule tasks/resources efficiently.

·Communication skills – strong written communication skills to provide concise and clear documentation

·Partner with a team setting to support continuous improvement initiatives.Support technical and quality investigations to resolve issues

·Perform tasks in a manner consistent with the safety policies, quality systems and cGMP requirements

Require minimal direction to complete tasks, knows how to obtain resources and information from established internal contacts; consult with manager for decisions outside established processes

Education & Experience

·Bachelor of Science degree or higher education in Engineering or Science

·5-10 years in a highly regulated environment such as biotechnology, pharmaceutical or related fields, including a significant exposure to regulatory requirements. Two (2) years of experience in a leadership capacity.

·Prior experience in developing, reviewing, and approving validation documentation for equipment, lab systems, utilities, and manufacturing equipment.

·Experience in writing & reviewing SOPs and protocols for accuracy and compliance

·Provide guidance and oversight to Specialist level employees.

·Ability to work closely with multiple disciplines, including: Manufacturing Operations, Facilities & Engineering, Information Technology, Testing, and Supply Chain to support validation activities.

·Ability to apply comprehensive knowledge of pharmaceutical cGMPs and quality system controls, procedures, and records to ensure ongoing quality compliance.

·Ability to perform all requirements independently with limited managerial oversight.

·Organizational abilities to meet accelerated timelines, manage multiple shifting priorities and maximize efficiencies in a dynamic customer-focused environment.

·Superior attention to detail to ensure accuracy of work product.

·Critical-thinking and problem-solving skills; ability to recognize and resolve discrepancies and issues.

Advanced computer skills to increase department’s productivity, as well as broadening technical and scientific knowledge.

May 11, 2022

Quality Systems Manager

Summary

The Center for Breakthrough Medicines is on track to be the largest single-site cell and gene therapy contract development and manufacturing organization in the world. Our comprehensive service offering accelerates speed to market through supply chain disruption mitigation strategies, end-to[1]end program management expertise and unique platform technology with the ability to follow a molecule from idea to commercialization. CBM’s integrated approach provides high quality and consistent end-to-end manufacturing capability including: Process and Analytical Development; Plasmid DNA production; Viral Vector Production of Lentivirus; AAV and Adenovirus; Testing and Analytics; Autologous, Allogeneic and Gene-edited Cell Therapy Bioprocessing; and Cell banking. CBM’s horizontal and vertical integration provides one source throughout a product’s life cycle.

CBM’s mission is to accelerate the delivery and affordability of lifesaving and life-changing therapies from discovery to market by offering a complete solution for the development and commercialization of cell and gene therapies.

CBM is located just outside of Philadelphia in the Heart of Cellicon Valley on The Discovery Labs campus set on 300 acres with 2.4 million square feet of life sciences lab and manufacturing space, allowing clients to scale their development and manufacturing needs without ever having to change sites, while providing employees a true community campus experience focused exclusively on life sciences. The Discovery Labs is a Global Platform Company inclusive of CBM, The Discovery Labs Properties, UniteIQ incubator labs, and The Colony, a unique investment and resource model enabling groundbreaking therapies to be brought to life.

Responsibilities

The Discovery Labs is seeking an experienced Quality Systems Manager to play a critical role in delivering and maintaining a Quality Management System (QMS) that enables innovation, productivity, continuous improvement, and adherence to applicable regulations. The Quality Systems Manager will be responsible for building impactful relationships and collaborations across the organization while relying on practical experience to advance a proactive strategy in a fast-paced organization.

Primary Responsibilities:

  • Provide quality ownership and oversight in the day-to-day managing of all aspects of quality management system in CBM’s eQMS systems (Veeva)– change control, deviations, effectiveness checks, risk management, lab investigations, supplier complaints, findings, and CAPA.
  • Monitor the overall site quality system effectiveness – continuous improvements, trending beyond metrics, lessons learned/knowledge management, and striving for operational excellence.
  • Create and provide training in support of the QMS e.g. GMP, GDP, Root Cause Analysis, Risk analysis tools
  • Collaborate with other subject matter experts across the GMP organizations to ensure end-user satisfaction with the eQMS system.
  • Understand and initiate configuration changes and updates to the eQMS Veeva system to accommodate CBM ways of working via change control
  • Actively participate and/or lead the preparation of Quality Management Reviews and Quality Improvement plans.
  • Propose, initiate and prepare SOPs and other governance documents.
  • Participate in Regulatory Agency Inspections and Client Audits
  • Review, approve and/or administer critical compliance documents in support of GMP and GTP operations according to Center for Breakthrough Medicines’ SOPs and regulatory requirements.
  • Represent Quality at designated cross-functional project/program team meetings.

Qualifications

  • Bachelor’s Degree in Life Sciences.
  • 7-10 years of relevant Quality experience including managing GxP quality systems in the Pharma/Biotech industry.
  • Solid understanding of industry regulation 21CFR 210, 211, 11, 820 as well as EU Guideline for Advanced Therapy and Medicinal Products.
  • Significant experience with both digital and paper based QMS solutions.
  • Diverse, Quality operations experience across functions in GMP including CRO/CDMO oversight activities.
  • Regulatory experience a plus

Physical Demands

Candidate should be able to lift 25lbs

Position may require standing for periods of time.

March 3, 2022

Quality Systems Specialist/Senior Specialist

Summary

The Center for Breakthrough Medicines is on track to be the largest single-site cell and gene therapy contract development and manufacturing organization in the world. Our comprehensive service offering accelerates speed to market through supply chain disruption mitigation strategies, end-to-end program management expertise and unique platform technology with the ability to follow a molecule from idea to commercialization. CBM’s integrated approach provides high quality and consistent end-to-end manufacturing capability including the following: Process and Analytical Development; Plasmid DNA production; Viral Vector Production of Lentivirus; AAV and Adenovirus; Testing and Analytics; Autologous, Allogeneic and Gene-edited Cell Therapy Bioprocessing; and Cell banking. CBM’s horizontal and vertical integration provides one source throughout a product’s life cycle.

CBM’s mission is to accelerate the delivery and affordability of lifesaving and life-changing therapies from discovery to market by offering a complete solution for the development and commercialization of cell and gene therapies.

CBM is located just outside of Philadelphia in the Heart of Cellicon Valley on The Discovery Labs campus set on 300 acres with 2.4 million square feet of life sciences lab and manufacturing space, allowing clients to scale their development and manufacturing needs without ever having to change sites, while providing employees a true community campus experience focused exclusively on life sciences. The Discovery Labs is a Global Platform Company inclusive of CBM, The Discovery Labs Properties, UniteIQ incubator labs, and The Colony, a unique investment and resource model enabling groundbreaking therapies to be brought to life.

Responsibilities

  • Provide quality input and oversight in the day-to-day managing of all aspects of quality management system in CBM’s eQMS systems (Veeva)– change control, deviations, effectiveness checks, risk management, lab investigations, supplier complaints, findings, and CAPA.
  • Monitor the overall site quality system effectiveness – continuous improvements, trending beyond metrics, lessons learned/knowledge management, and striving for operational excellence.
  • Create and provide training in support of the QMS e.g. GMP, GDP, Root Cause Analysis, Risk analysis tools
  • Collaborate with other subject matter experts across the GMP organizations to ensure end-user satisfaction with the eQMS system.
  • Understand and initiate configuration changes and updates to the eQMS Veeva system to accommodate CBM ways of working via change control
  • Actively participate and/or lead the preparation of Quality Management Reviews and Quality Improvement plans.
  • Propose, initiate and prepare SOPs and other governance documents.
  • Participate in Regulatory Agency Inspections and Client Audits
  • Review, approve and/or administer critical compliance documents in support of GMP and GTP operations according to Center for Breakthrough Medicines’ SOPs and regulatory requirements.
  • Represent Quality at designated cross-functional project/program team meetings.

Qualifications

  • Bachelor’s Degree in Life Sciences.
  • 3-5 (specialist)/5-7 (senior specialist) years of relevant Quality experience including managing GxP quality systems in the Pharma/Biotech industry.
  • Solid understanding of industry regulation 21CFR 210, 211, 11, 820 as well as EU Guideline for Advanced Therapy and Medicinal Products.
  • Significant experience with both digital and paper based QMS solutions.
  • Diverse, Quality operations experience across functions in GMP including CRO/CDMO oversight activities.
  • Regulatory experience a plus

Physical Demands

  • Ability to lift 25lbs
  • Position may require the candidate to stand for defined periods in support of site operations.
February 7, 2022

QS Audit Program Specialist/Senior Specialist

Summary

The QS Audit Program team will have the overall responsibility to implement and sustain the CBM Quality Audit Program ensuring compliance with internal requirements and external GMP regulations. The ideal candidate will be responsible for a high level of understanding of the standards and principles of auditing and the auditing techniques of examining, questioning, evaluating, and reporting to determine a quality system’s adequacy and deficiencies. The QS Audit Program Specialist/Senior Specialist will partner with business functions to ensure the successful implementation of the Internal and External Audit Program. This role will require the strategic capability in the form of implementation and ownership (including policies, procedures, leading governance, and quality performance monitoring efforts, etc.). In addition to serving as a subject matter expert in these areas, the role will be responsible for maintaining strong, collaborative partnerships with cross-functional and cross-site team members and to implement a successful program which would include but not be limited to Internal, External (Client & Supplier), and Regulatory Body Audits.

Responsibilities

  • Responsible for implementation and maintenance of the CBM internal and external audit program.
  • Responsible for assuring consistency across the audit program.
  • Maintain the audit program using phase-appropriate Quality processes, with respect to product lifecycle stages from non-clinical development through the life of the program, including commercial launch, and post market approval.
  • Ensure Internal Quality Audits are established using a risk-based approach, scheduled, and adhered to.
  • Participate in regulatory and external audits (e.g. control room lead, scribe).
  • Implement regulatory inspection readiness activities, including training site personnel.
  • Ensure inspection readiness of all internal and external entities in preparation of competent authority inspections.
  • Collaborate with CBM Quality Operations team to assure all applicable groups are inspection ready and operate in a complaint manner with applicable regulatory guidance.
  • Responsible for the development and training of a cross functional audit cadre to execute and complete appropriate audit activities.
  • Perform periodic reviews of Audit Program documents to ensure the files remain reflective of data/trending signals and ongoing activities.
  • Support routine Quality processes such as investigating non-conformances, CAPAs, complaints, other process monitoring activities.
  • Assist in risk assessment process and preparation of audit plan that focuses on high-risk areas.
  • Establish and maintain strong and efficient communication lines to ensure audit findings are communicated, timely execution of corrective action and implementation of efficiency gains and process improvements.
  • Act as subject matter expert (SME) of Audit Program, with responsibilities that include monitoring Key Performance Indicators (KPIs), monitoring system performance, and ensuring compliance to requirements and reporting during Quality Management Review.
  • Measure and track the results of audits performed through action plan follow-up procedures.
  • Participate in the development of responses to observations for external inspections and audits.
  • Provide recommendations for continuous improvement to strengthen the internal processes and structure.
  • Lead auditor for internal audits and perform audits to ensure compliance to internal and external requirements.

Qualifications

  • Bachelor’s degree in a technical discipline (e.g., biochemistry, chemistry, engineering).
  • 7-10 years (Senior Specialist)/5-7 years (Specialist) of experience in the GMP biotechnology and/or pharmaceutical industry, (preferably both).
  • Demonstrated knowledge of Quality Audit Management, continuous improvement methodologies & in-depth understanding of site level products & related processes.
  • Experience in participating in regulatory inspections and managing Inspection process.
  • ASQ Quality Auditor Certification, preferred.
  • Experience with audit management databases/systems.
  • Strong working knowledge of regulatory requirements for major government bodies, including FDA (US), EMA (Europe) as well as WHO (World Health Organization)
  • Technical experience from working at a manufacturing facility with the ability to understand and interpret regulatory requirements.
  • Experience in compliance with quality standards in a Pharma/Biotech industry.
  • Ability to utilize Risk Based approaches to prioritize and take appropriate actions.
  • Ability to work effectively in a team environment and build strong working relationships.
  • Experience in project and/or program management leading cross-functional teams
  • Solid analytical skills with the ability to look at the big picture impact.
  • Demonstrated ability to lead, acknowledge, develop, communicate & implement a strategy under crisis situations to ensure compliance.
  • Strong organizational skills and the ability to multitask; can set priorities and follow a timeline.
  • Collaborates cross-functionally and can work independently with minimal functional oversight.
  • Ability to effectively operate across diverse cultures with strong stakeholder management and influencing skills

Travel

Travel is required to support Supplier on-site audits (25-50%, subject to change to support a growing supplier base)

January 31, 2022

Senior QA Testing Specialist

Summary

Center for Breakthrough Medicines is seeking a regulatory/quality expert to support the organization by establishing quality systems, drive growth, and ensure quality. The Senior QA Testing Specialist will help build scalable QA systems as the organization continues to grow. The role will be responsible for the overall management of the quality system within the organization and oversees all testing laboratory activities and operations including oversight of technical staff. The role also leads and manages site testing operations, related programs, and activities to support the contract manufacturing organization and manufacturing operations. The Sr. QA Testing Specialist supports Testing Operations, providing oversight, strategic thinking, and results focus to reliably meet and/or exceed the site’s production targets while achieving high levels of quality. This position requires an individual capable of partnering across the organization to manage a fast-paced production environment and deliver exceptional service to our clients. It also ensures business, quality and compliance goals are met in full compliance with all government-issued environmental, health, safety, quality, and regulatory policies and guidelines.

Responsibilities

  • Critically review various documentation types to ensure completeness, accuracy and compliance including but not limited to test methods, method validation protocols and reports and SOPs
  • Provide Quality input for the investigation of OOS results including support on determining investigative testing plans, resampling, and root cause analysis
  • Communicate effectively with cross functional departments to ensure on time delivery of QA review and disposition responsibilities
  • Approval of Certificate of Analysis for release of testing results within assigned timelines to effectively deliver results to client
  • Ability to review data and effectively identify and trends or key issues
  • Direct all laboratory activities to drive execution and expedient delivery of all testing
  • Ensure facility follows current ISO and GMP standards (cGMP)
  • Ensure quality and assists Quality Assurance in maintaining all technical regulatory requirements
  • Interacts and represents The Discovery Labs with all regulatory agencies
  • Develop quality systems including a robust and on-going quality improvement system compliant with GMP
  • Maintain knowledge of global regulatory requirements
  • Responsible for authoring quality lifecycle management documents of facilities, processes and equipment and using appropriate quality systems for implementation and maintenance
  • Develop and maintain systems that insure the technical and regulatory competency of personnel within the organization
  • Oversee all aspects of QA testing operations within the organization, including but not limited to batch record review, QA support on floor, material release, deviation investigations, CAPAs, change controls, customer quality support, SOPs. Review master batch records, product labels and all product specific documents
  • Interact with the quality team and internal stakeholders to support the development, manufacturing, testing, packaging, and release of viral vector products as needed
  • Identify and participate in internal quality improvement initiatives: evaluate internal processes, suggest/design/ implement improvements, create/revise relevant SOPs
  • Foster a Quality mindset throughout the company by ensuring consistent, risk-based, and innovative thought processes are employed to advise and make decisions
  • Manage problems of varied scope using a high degree of prudence and risk-based decision making
  • Monitor, study performance via key performance indicators to maintain or improve operational efficiencies, while ensuring compliance to GMP regulations
  • Ensure test methodologies provide quality of results required and are in full compliance with regulatory requirements, standards, and protocols
  • Prepare reports and keep upper-level management informed of progress
  • Additional duties as assigned

Qualifications

  • Bachelor’ s Degree in a commercial or scientific field required
  • Minimum 5+ years’ experience in the Contract Research Organization (CRO), or biopharmaceutical industry within a GLP or GMP environment. CRO and both GLP & GMP experience is preferred
  • Possesses front-line practical experience and success in implementing quality systems
  • 5 years Quality Professional in Pharmaceutical and Biological Manufacturing
  • Proficient in Verbal and Written communication skills
  • Proficient in Microsoft Office (Excel, Word, Outlook)
  • Excellent problem solving, risk analysis and negotiation skills
  • Ability to review data and effectively identify and trends or key issues
  • Ability to manage multiple projects simultaneously ensuring on time execution of deliverables

January 7, 2022