Summary

In the role of Director, Demand and Supply Planning, the leader will set and execute objectives that balance supply and demand: provide critical support to the S&OP process, measure and continuously improve our demand planning accuracy, predictably meet customer (client) supply service levels, and drive accountability across the organization to meet customer needs and financial goals, including but not limited to defined inventory targets.

This leader will identify process breakdowns and inefficiencies and oversee the creation, implementation and continuous improvement of aligned demand and supply planning processes, technology tools / systems and metrics to measure efficiency and effectiveness.

Responsibilities

· Functional ownership for End-to-End Planning, full life cycle for CBM developed and manufactured client products, to assure timely development and set up, on-time supply to client, and optimized inventory management for all client and CBM materials.

· Continuously adapt, evolve and improve the business sales, inventory, and operations planning process, focused on process to create Demand aligned to CBM sales & pipeline.

· Business leadership / ownership for E2E supply chain planning processes, technology solutions, and metrics with particular focus on the demand planning module.

· Analyze Planning Results (MRP) to identify material readiness risks and opportunities resolving constraints by partnering effectively with BUs and PD organizations.

· Driving process, effective utilization of toolsets, and reporting that supports the collaborative efforts of the supply and demand planning teams.

· Leading, coaching, and mentoring team members to reach their full potential.

· Recruits, interviews, hires, and trains new staff.

· Oversees the daily workflow of the department.

· Provides constructive and timely performance evaluations.

· Support S&OP process, working cross-functionally to drive collaboration and consensus on demand, supply and capacity, incl. its future development.

· Driving measurable, improvements across demand and supply planning team

· Oversight and execution of demand and supply planning processes for all products, resulting in strategic alignment in all Business Units (BUs).

· Serve as the point person for escalation of demand and supply related issues with Business Units.

· Act as primary owner for issues related to roll-up of demand plans, analysis of CBM client pipeline and development of final demand plan.

· Developing and reviewing metrics and assessing performance against targets to identify improvement plans to close gaps.

Qualifications

· Bachelor’s Degree in Supply Chain Management, Industrial Engineering, Business, or related field.

· 8+ years of Supply Chain, Demand Planning, Supply Planning, or related experience.

· 5+ years of experience leading, especially in a matrixed organization, preferred.

· Management of an ERP system.

· Design and / or Process ownership for Planning, Inventory Management and Master Data.

· Excellent verbal and written communication skills.

· Excellent interpersonal and customer service skills.

· Excellent sales and customer service skills.

· Excellent organizational skills and attention to detail.

· Excellent time management skills with a proven ability to meet deadlines.

· Strong analytical and problem-solving skills.

· Strong supervisory and leadership skills.

· Ability to prioritize tasks and to delegate them when appropriate.

· Ability to function well in a high-paced and at times stressful environment.

· Proficient with Microsoft Office Suite or related software.

· Data-driven and highly analytical mindset.

· Solid knowledge of databases, and reporting tools.

· Ability to collaborate effectively with other technical employees and business stakeholders.

· Some travel may be required.

· Onsite with ability to accommodate limited remote work schedule if required.

Preferred qualifications:

· MBA or advanced degree

· SAP experience

· Life Sciences or Pharmaceutical experience

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

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 Vector Bioprocessing Associate I will be responsible for performing routine cGMP manufacture of viral vectors, non-viral vectors, and advanced therapeutics supporting the gene therapy asset at the Center for Breakthrough Medicines. The incumbent will be responsible for operating upstream and downstream equipment for adherent and suspension systems and performing production support activities while maintaining compliance to cGMP standards.

We are looking for individuals that are willing to work within a team, are hard-working, and highly motivated. This position requires multi-tasking and excellent peer-to-peer communication skills.

Responsibilities

• Work in a hands-on capacity within a cleanroom environment to perform the processing tasks to support both upstream and downstream manufacturing.
• Assist in maintaining the cGMP status of the manufacturing facility to always ensure inspection readiness.
• Ensures work is completed in compliance with approved SOPs, batch records, controlled documentation, and all applicable regulations, guidelines, safety policies and procedures are followed.
• Assist in the resolution of manufacturing deviations/non-conformances.
• Assist in validation activities related to the qualification of the manufacturing process, facility suites, and process equipment.

Qualifications

• High school diploma is required, but a bachelor’s degree in biological science(s) field or related engineering is preferred.
• A range of 0-2 years of experience in cGMP biological manufacturing. Vector manufacturing or other gene therapy is highly preferred.
• General knowledge of cGMP regulations.
• Experience working in a Biological Safety Cabinet (BSC).
• General knowledge of cell expansion vessels and purification equipment.
• Ability to work well independently and as part of a team.
• Exhibits attention to detail, accuracy in work, and integrity of character.
• Self-starter who shows willingness to learn and problem-solve.
• Willingness to learn and operate production equipment.
• Able to adhere to all safety and company regulations.
• Able to accommodate a flexible work schedule to support business demands.

Physical Demands

• Ability to carry up to 55 pounds.
• Ability to stand for long periods of time while wearing PPE daily.

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 Process Engineer will be heavily involved in managing the manufacturing and production systems for gene therapy operations. They are responsible for development and implementation of process platforms that are well characterized, efficient, scalable, cost-effective and that produce high-quality products in GMP and development environments. This entails requirements gathering, specifications development, validation support, troubleshooting, quality standards compliance and identification of continuous improvement projects on production products and processes. The successful candidate will be able to collaborate with Manufacturing, Process Development, Quality, Facilities, Automation, and external parties. They will provide technical and subject matter expertise in facilities readiness assessments, facilities design and renovation projects.

Responsibilities

● Engage with internal and client process development organizations to prepare and maintain detailed layouts of simple to moderately complex viral vector, cell therapy, plasmids processes and related equipment, including block flow diagrams, process flow diagrams, piping & instrumentation diagrams, and equipment specifications

● Coordinate the process and technical input on facilities readiness design projects. This requires collaboration with architecture, engineering and construction providers.

● Identify needed process improvement, facilities reconfiguration and new capabilities projects. Engage and support project engineering staff for implementation.

● Lead manufacturing support activities for multiple advanced therapy bioprocess operations to ensure efficient production methods, continuous improvement and quality results.

● Confer with management, engineering, and other staff regarding manufacturing capabilities, production schedules, and other considerations to facilitate production processes.

● Design, develop, test, and/or source and cost-justify various tools, machinery, process equipment for recommended manufacturing methods and utility equipment for facilities infrastructure needs. Confer with vendors to determine product specifications and arrange for purchase of machinery and equipment according to specifications and quality standards.

● Ensures all project documentation is accurate and up-to-date (P&lDs, mechanical system drawings, automation documentation, etc.)

● Provide technical input to manufacturing on SOP changes, Deviations, GMP Investigations and CAPAs

● Represent manufacturing/engineering on cross-functional teams of scientists, automation engineers, facilities staff, and operations experts to develop, deploy, and rapidly improve process manufacturing solutions in a fast-paced startup environment.

● Apply statistical methods and perform product/process analysis for cost reduction, quality improvement, and improved efficiency.

● Author engineering specifications, internal standards and guidelines as part of the engineering team organization readiness efforts.

● Perform other related duties and special projects as assigned.

Qualifications

● 3-5+ years experience investigating, developing, and implementing new manufacturing processes and improving existing manufacturing processes

● Familiar with design specification and operation of bioprocess equipment, clean utilities, GMP facilities, and automation.

● Owner of smaller process or portion of larger process with guidance from senior staff.

● Willing and able to execute hands-on, clean room manufacturing support where necessary.

● Working knowledge of Unicorn Software, method writing and troubleshooting is a plus.

● Demonstrated skills:

o Comprehensive understanding of cGMPs

o Extensive biopharm process knowledge in at least one area: cell culture, fermentation & cell processing

o CAD/Bluebeam or other drawing editing capabilities

o EHS and Quality Minded

o Basic knowledge of Lean Principles Ability to Learn/Adapt

o Teamwork skills

o Independent problem solving skills

o Process flow/industrial flow

o Time management skills

o Effective communication skills

Education & Experience

B.S. or M.S. in Engineering or a Life / Physical Science with relevant work experience (Chemical Engineering preferred, others considered)

Summary

The Plasmid Bioprocessing Associate will be responsible for performing routine cGMP manufacture of plasmid DNA at the Center for Breakthrough Medicines. The incumbent will be responsible for operating upstream and/or downstream unit operations such as cell expansion, fermentation, filtration, and chromatography. Additional support activities such as media preparation, document review, and component preparation will be required while maintaining compliance to cGMP standards. We are looking for individuals that are willing to work within a team, are hard-working, and highly motivated. This position requires multi-tasking and excellent peer-to-peer communication skills. The incumbent will embrace and promote right-first-time culture.

Responsibilities

• Work in a hands-on capacity within a cleanroom environment to perform bioprocessing unit operations.
• Assist in maintaining the cGMP status of the manufacturing facility to always ensure inspection readiness.
• Ensures work is completed in compliance with approved SOPs, batch records, controlled documentation, and all applicable regulations, guidelines, safety policies and procedures are followed.
• Proactively assist in the resolution of manufacturing deviations/non-conformances and troubleshooting of process and equipment problems.
• Identify opportunities for improvements in process, safety, quality, and cost.
• Provides timely technical input to support ongoing operations.

Qualifications

• High school diploma is required, but a bachelor’s degree in biological science(s) field or related engineering is preferred.
• A range of 0-2 years of experience in cGMP biological manufacturing. Previous experience in the cell/gene therapy is highly preferred but not required.
• General knowledge of cGMP regulations.
• Experience working in a Biological Safety Cabinet (BSC).
• Experience with aseptic manipulation, pumps, sterile connections, and other common bioprocessing equipment is preferred.
• Ability to work well independently and as part of a team.
• Exhibits attention to detail, accuracy in work, and integrity of character.
• Self-starter who shows willingness to learn and problem-solve.
• Willingness to learn and operate production equipment.
• Able to adhere to all safety and company regulations.
• Able to accommodate a flexible work schedule to support business demands.

Physical Demands

• Ability to carry up to 55 pounds.
• Ability to stand for long periods of time while wearing PPE daily.

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 Vector Drug Product Bioprocessing Associate II will be responsible for performing routine cGMP manufacture of viral vectors, non-viral vectors, and advanced therapeutics supporting the gene therapy asset at the Center for Breakthrough Medicines. The incumbent will be responsible for operating aseptic filling equipment and performing production support activities while maintaining compliance to cGMP standards. May be expected to support other areas of manufacturing when aseptic filling is not ongoing.

We are looking for individuals that have experience working within a team, are hard-working, and highly motivated. This position requires multi-tasking, interdepartmental coordination, and excellent peer-to-peer communication skills. This position has the potential to evolve into a senior role.

Responsibilities

• Work in a hands-on capacity within a cleanroom environment to perform aseptic filling, inspection, labeling, and packaging of Drug Product.
• Assist in maintaining the cGMP status of the manufacturing facility to always ensure inspection readiness.
• Ensures work is completed in compliance with approved SOPs, batch records, controlled documentation, and all applicable regulations, guidelines, safety policies and procedures are followed.
• Assist in the resolution of manufacturing deviations/non-conformances and troubleshooting of process and equipment problems.
• Assist in validation activities related to the qualification of the manufacturing process, facility suites, and process equipment.

Qualifications

• High school diploma is required, but a bachelor’s degree in biological science(s) field or related engineering is preferred.
• A minimum of 2 year of experience in cGMP biological manufacturing. Vector manufacturing or other gene therapy is highly preferred.
• A minimum of 2 year of experience in cGMP biological manufacturing. Vector manufacturing or other gene therapy is highly preferred.
• Working knowledge of cGMP regulations.
• Experience working in a Biological Safety Cabinet (BSC).
• Effective written and verbal communication skills, with excellent teamwork aptitudes.
• Experience working with aseptic filling equipment and isolators is preferred.
• Experience working with pipettes, and micropipettes.
• Ability to work well independently, as part of a team, and establish working interdepartmental relationships.
• Exhibits attention to detail, accuracy in work, and integrity of character.
• Self-starter who shows ability to learn and problem-solve.
• Exhibits technical aptitude to learn and operate production equipment.
• Able to adhere to all safety and company regulations.
• Able to accommodate a flexible work schedule to support business demands.

Physical Demands

• Able to carry up to 55lbs.
• Ability to stand for long periods of time while wearing PPE daily.

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

The Deviation Investigator will own and investigate all Manufacturing related deviations. The Deviation Investigator will work with cross functional stakeholders to perform simple and complex root cause analysis to root cause and identify corrective actions to close assigned investigations on time.

The role will support all aspects of the Viral Vector Philosophy, Strategy, and Execution Plan to make Center for Breakthrough Medicines (CBM) a best-in-class Contract and Development Manufacturing Organization (CDMO).

Responsibilities

• Investigation of manufacturing deviations to determine root cause and implementation of corrective actions to prevent recurrence.
• Work with cross functional teams to gather data, lead and perform Root Cause Analysis to determine the likely root cause of the event.
• Assessment of event for overall impact.
• Identification of Corrective and Preventative actions to prevent recurrence.
• Management of multiple investigations concurrently.
• Provide routine client updates to communicate status and alignment on investigation findings.
• Ability to communicate roadblocks and challenges in a timely manner that can impact task and timely delivery of investigation.

Qualifications

• BS in Life Sciences or Engineering discipline required; Master’s degree preferred
• Related pharmaceutical experience required, including relevant experience in manufacturing in a GMP environment
• Experience utilizing root causes analysis tools and identifying corrective and preventative actions is required.
• Prior experience in Manufacturing Environment or troubleshooting Manufacturing related issues preferred.
• Excellent verbal and written communication skills.
• Excellent interpersonal and customer service skills.
• Excellent organizational skills and attention to detail.
• Excellent time management skills with a proven ability to meet deadlines.
• Strong analytical and problem-solving skills.
• Ability to prioritize tasks.
• Ability to work well on a team.
• Ability to function well in a high-paced and at times stressful environment.
• Proficient with Microsoft Office Suite or related software.
• Ensures accuracy and relevance of assigned training curriculum.
• Drives timely completion of training for employees to meet regulatory requirements

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

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

This role is responsible for planning, performing, analyzing, summarizing, reporting, and presenting experimental results related to Upstream Process development and optimization. This position works closely with external contract development and manufacturing partners. The scientist will also have oversight of external manufacturing of master and working cell banks as well as viral seed stock production, viral vector production, and scale-up. This role authors and reviews technical protocols and reports, drafts batch records and SOPs. The ideal candidate should have successfully demonstrated viral vector process development, production, and analytics, as well as personal attributes including initiative, independent thinking and collaboration skills.

Responsibilities

• Designs and implements viral vector strategies for upstream and downstream process development
• Hands-on work in the developing, executing, and optimizing of upstream (cell culture, scale-up, characterization) unit operations for viral vector production
• Support technology transfer into vector manufacturing
• Works closely with external partners on appropriate viral vector process and characterization studies to enable manufacturing
• Authors and reviews viral vector development and process protocols, reports, and batch records
• Potential responsibility to lead a small team

Qualifications

• Knowledge and experience in viral vector production, purification, and analytics
• Proficient with large-scale mammalian cell culture and suspension cells
• Ability to design experiments, follow procedures with attention to detail, and successfully execute experiments at the bench
• Project-management skills and ability to work successfully with contracting laboratories and manufacturing facilities
• Comfortable in a fast-paced environment with minimal direction and able to adjust workload based upon changing priorities
• Demonstrated ability to maintain detailed execution records and perform data analysis
• Knowledge or experience with viral vector manufacturing in the biotech industry
• Expertise in virus upstream and downstream process development, such as large-scale suspension cell culture, bioreactors, tangential flow filtration (TFF), column purification
• Experience with Design of Experiment (DOE)
• Experience with virus characterization, such as replication-competent virus (RCV), infectious virus bioassays and viral particle assays
• Experience with viral vector production, purification, and characterization
• Strong communication skills (e.g., clear and concise) and a team player
• Strong time and project management skills
• Strong critical and logical thinking with ability to analyze problems, identify alternative solutions, and implement recommendations for resolution
• Self-motivated and flexible, able to prioritize, multi-task, and work in a fast-paced & demanding environment
• Takes ownership of the assigned project, consulting with management and peers
• Able to understand and interpret data/information and its practical application

Education & Experience

• PhD in virology, virus bioengineering, gene/cell therapy, or related field with 2+ years of industry-related experience; or M.S. with 10+ years of related industry experience