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.

As an Equal Opportunity Employer, we believe in each person’s potential. Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, age, national origin, sexual orientation, gender identity, disability or any other protected category including veteran status.

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 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 the commissioning and qualification of site facility spaces and utilities. Including review and approval of Change Controls, Project Validation Master Plans, Commissioning Test Plans, Qualification protocols, SOP’s and Summary Reports.
• 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
• 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
• 5+ years in a highly regulated environment such as biotechnology, pharmaceutical or related fields, including a significant exposure to regulatory requirements
• 10 + years in a highly regulated environment such as biotechnology, pharmaceutical or related fields, including a significant exposure to regulatory requirements (Senior level)
• Experience in technical writing for cGMP documents
• Prior experience in developing equipment validation, process validation, packaging qualification and cleaning validation
• 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

Summary

Center for Breakthrough Medicines is seeking a quality expert to support the organization by establishing quality systems, drive growth, and ensure quality. The Quality Assurance Manager 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 viral vector manufacturing activities and operations including oversight of the QA vector team and technical staff. This role also 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

· Ensure that the quality and compliance are integrated into long term strategies and day to day operations of the Quality Assurance (QA) department.

· Lead the QA manufacturing operations team and ensure 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.

· Act as quality representative on core team to support client programs

· Lead the Company efforts to remain “inspection ready” and represent 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, validation protocols, and all other GxP documentation.

· Oversee the review and approval of GMP impact changes to processes, product specifications equipment and facilities, including oversight of the risk assessment/management process.

· Provide 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.

· Establish objectives and schedule tasks and resources efficiently.

· Demonstrate 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 our systems support our quality mission and ensure quality products are produced for contract manufacturing clients.

· Lead the QA function and evaluate opportunities for continuous improvements.

· Lead the effort of tracking and communicating quality improvement initiatives throughout the organization and promote a working culture in the organization that is quality based.

· Communicate Quality System performance to Senior Management on a regular basis and lead 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.

· Perform other related duties as assigned

Qualifications

· Minimum 5 years’ experience in the Contract Research Organization (CRO), or biopharmaceutical industry within a GMP environment.

· 5-10 years Quality Professional in Pharmaceutical industry

· Minimum 5 years direct people management

· Possesses front-line practical experience and real time decision making with cross functional support

· 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

Summary

The Center for Breakthrough Medicines is seeking a Microbiological Quality & Sterility Assurance (MQSA) Senior Specialist to join the Quality & Compliance team. This position will be involved in programs to ensure microbiological quality and sterility assurance of sterile product at the Center for Breakthrough Medicines, while adhering to applicable regulatory requirements and industry best practices.

The Senior Specialist will ensure compliance of aseptic manufacturing, environmental monitoring, and microbiological contamination control measures. The position will collaborate with Microbiology and Manufacturing partners to support ongoing aseptic training program to including gowning, aseptic technique and cleanroom behavior. The Senior Specialist will be responsible for routine administration of the site aseptic process simulation (APS) program, in addition to supporting the site contamination control strategy (CCS).

It will be the responsibility of the Senior Specialist to build impactful relationships and collaborate across the Center for Breakthrough Medicines organization to deliver exceptional service and the highest quality product to our clients in a highly regulated environment.

If you have experience executing Sterility Assurance program elements, we encourage you to consider building your future with The Center for Breakthrough Medicines.

Responsibilities

• Supports development and lifecycle management of the contamination control governance elements, including sterilization validation, environmental monitoring, cleaning & disinfection, and utilities qualification (e.g. WFI system, compressed gases)
• Helps in the development and implementation of the site Sterility Assurance Program
• Participates in the administration of end-to-end (E2E) microbiological control strategy for production processes from incoming raw materials through final product release
• Collaborates with Manufacturing to meet US and EU aseptic processing requirements
• Adheres to industry regulations and guidance documents when assisting in the creation and implementation of standards, policies, and site procedures (e.g., ISO 14644, Sterile Drug Products produced by Aseptic Processing-GMP, EU Annex1, and EU Guideline-GMP Specific to Advanced Therapy Medicinal Products)
• Supports compliance of site manufacturing programs, processes, and facility systems
• Performs gap assessments and collaborates in the implementation of action plans to correct identified deficiencies to improve quality processes
• Provides sterility assurance expertise as author, reviewer and/or approver for cGMP documents including, but not limited to, SOPs, work instructions, and batch records
• Authors/supports APS/media fill protocols and summary reports to ensure robust and compliant documentation of processes and validation studies
• Participates in the development of cGMP and other GxP training as needed
• Provides microbiological expertise to support non-conformances, deviations, CAPAs and complaints related to sterility assurance
• Supports preparation for regulatory and client audits
• Supports sterility/microbial specification development for incoming raw materials and components.
• Collaborates with internal and external business partners, including other CBM business units or departments and external suppliers, in support of continuous improvement initiatives

Qualifications

• Collaborative nature and ability to work well in teams
• Capable of data analysis, including ability to collect and analyze data to identify trends and detect problems and key issues
• Demonstrates good judgement; able to problem solve and to define decision criteria to recommend the most appropriate course of action
• Ability to plan and organization to meet goals and objectives within defined timelines
• Possesses strong communication skills – oral and written

Education & Experience

• Bachelor’s Degree in Microbiology, Biology, Chemical Engineering, Biomedical Engineering or closely related discipline
• 5+ years of experience in pharma/biotech industry; minimum 3 years of aseptic processing experience in a GMP environment
• Demonstrated experience in Aseptic Process Simulation (APS) execution
• Cell and Gene Therapy experience a plus
• Knowledge of analytical methods relevant for microbial control
• Experience in microbiology, sterilization validation, terminal sterilization, aseptic processing and environmental controls for a pharmaceutical, medical device or related manufacturing environment
• Proven track record troubleshooting process non-conformances and out-of-specification test results
• Proficient in providing sound and compliant resolutions to issues utilizing robust CAPA processes

Summary

Center for Breakthrough Medicines is seeking an experienced Training Coordinator to support the learning, development, and qualification needs across the functional units at CBM. The Training Coordinator will play a critical role in coordinating training and compliance activities which are essential to ensure personnel are trained prior to the commencement of GMP activities and site operations. The Training Coordinator under general supervision from the Managers and Director of the Training Department, will provide Learning Management System (LMS) support and administration in accordance with requirements specified per Standard Operating Procedures (SOPs). The position provides service and support to internal customers at all levels of the organization. The training coordinator will assist managers in determining training needs and requirements. Utilizing the LMS software system, the training coordinator will identify, create, and track training for all departments. Through knowledge and commitment, the Training Coordinator will create a collaborative team environment for their colleagues.

Responsibilities

• Set up classroom training sessions, versional documents, and track in-class, on-line, onsite and offsite, vendor training within the LMS software
• Enter training attendance sheets into the LMS system as needed
• Assist departments in defining training requirements and determining timelines
• Work closely with department managers to ensure training is available when needed and completed when required
• Manage the process that assigns courses to associates
• Develop, run, and distribute reports as scheduled or upon request for management and/ or internal/ external audit purposes
• Support the process that assigns courses to associates
• Input content into LMS using pre-determined organizational structure and naming convention (i.e.- curricula)
• Communicates training needs to local training management
• Remain current on LMS software changes and developments in field(s) of expertise

Qualifications

• High School Degree or higher
• 1 year experience in GMP environment
• 1-3 years’ experience with learning management systems (LMS)
• Proficient in Microsoft Office, PowerPoint, Excel and Outlook applications and basic HTML
• Excellent organizational skills and attention to detail
• Able to accommodate a flexible work schedule to support business demands.
• Outstanding written and verbal communication skills
• Ability to handle multiple assignments and assess and analyze data

Preferred Skills

• Knowledgeable about instructional design and e-learning platforms
• Technical skills to manage and update course content, create and manage user accounts and manage the LMS system.

As an Equal Opportunity Employer, we believe in each person’s potential. Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, age, national origin, sexual orientation, gender identity, disability or any other protected category including veteran status.