AstraZeneca
Executive Director Cell Culture and Fermentation Sciences
AstraZeneca, Gaithersburg, Maryland, us, 20883
The Executive Director, Cell Culture and Fermentation Sciences position will be responsible for all aspects of upstream development and strategic direction to support the advancement of AstraZeneca’s (AZ’s) biologics pipeline projects from pre-clinical to commercial stage. The successful candidate will also drive the development and implementation of next generation manufacturing platforms to increase productivity and reduce costs to make AZ’s products available to more patients. In addition, he/she will be responsible for evaluation and implementation of new technologies as well as digitalization/automation approaches to drive innovation in upstream development. The Exec. Director CCFS will define risk-based strategies and implement new systems to support flexible CMC plans and improve project execution to meet aggressive timelines for AZ’s complex and growing portfolio of biologics projects.
The position resides within the Cell Culture and Fermentation Sciences (CCFS) department in Biopharmaceutical Development (BPD) within AZ’s R&D organization. This is a highly visible and influential role in the organization. The incumbent will work collaboratively with other CCFS groups and BPD functions, MS&T, Global Technical Operations, clinical and commercial Manufacturing, external CMOs, regulatory affairs, and QA to ensure development of robust and capable manufacturing processes as well as appropriate scale up and transfer of clinical/commercial processes to manufacturing facilities.
Responsibilities:
Provides leadership and strategic guidance to a large group of engineers and scientists responsible for upstream process development activities to support early to late stage clinical and commercial manufacturing. Products include mAbs, ADCs, bi- and tri-specific antibodies, fusion proteins, vaccines, and other new biologic modalities.
Process development responsibilities include development, optimization and characterization of robust cell culture processes used in fed-batch and continuous manufacturing operations to produce clinical and commercial biological products.
Provides technical and strategic guidance and drives alignment of short-term deliverables and long-term plans for upstream development activities for portfolio projects in line with BPD’s/AZs priorities, goals, and timelines.
Responsible for developing and implementing the next generation of upstream manufacturing processes to improve productivity, increase robustness and throughput, and lower costs of manufacturing.
Leads strategy and implementation of new technologies, digitalization, and automation of upstream processes for traditional and emerging biologics modalities.
Drives development and implementation of agile and risk-based approaches to define CMC strategies for process development and characterization to support efficient and accelerated project delivery.
Senior member of the CCFS governance team that is responsible for providing leadership and decisions for the upstream process development and commercialization strategies for pipeline projects and technical development initiatives.
Supports regulatory filings by authoring, reviewing, and approving technical reports, CMC sections of clinical and registration submissions (INDs/BLAs), and responses to questions. Also supports interactions with Health Authorities and product-related inspections.
Builds strong relationships and partners with other leaders across Biopharmaceutical Development, AZ Bio-Operations, Quality, Regulatory, and external CMOs to ensure that AZ Biologics Portfolio is progressed with a sense of urgency.
As a member of the CCFS leadership team, works collaboratively with his/her peers to establish and drive strategic goals and ensures that department objectives are in alignment to overall BPD and R&D goals.
Participates and drives BPD-wide initiatives and represents CCFS in cross-functional BPD and AZ teams.
Builds and develops high performance teams. Hires, mentors, and develops team members within the organization.
Builds and sustains a culture that embraces AZ’s values and behaviors, promotes inclusion and diversity, and is committed to making CCFS and BPD a great place to work.
Required Skills:
Demonstrated experience leading cell culture process development of biologics from pre-clinical to commercial launch/post-launch and life-cycle management, including phase-appropriate approaches for process development, process characterization , and process validation. Must have experience with multiple product modalities such as mAbs, bi/tri-specifics, fusion proteins, etc.
Advanced education (Ph.D or equivalent) in biology, chemical engineering, biochemical engineering or related scientific discipline is required.
Candidate must have 15+ years of industrial experience in cell culture development and commercialization of biologics with people leadership accountabilities.
Extensive experience leading technical line functions and working with cross-functional matrix teams in the biotech and/or pharma industry.
Proven track record of success in developing, optimizing, and transferring cell culture processes to clinical and commercial manufacturing. Experience in supporting commercial registration of one or more biological products is required.
Demonstrated leadership in driving and implementing technical innovation.
In depth knowledge of CMC, quality and compliance, as well as regulatory aspects of biopharmaceutical development and life-cycle management.
Extensive experience in authoring and reviewing global regulatory submissions and response to questions for clinical development (IND/IMPDs) and commercial registration (BLA/MAA/JNDA). Experience interacting with regulators and global health authorities.
Experience working with CMOs and managing external development projects.
Strong business acumen: must be able to prioritize and manage resources, timelines, and scope of work to meet program goals and milestones.
Working knowledge of data governance, knowledge management, digitalization, automation, and AI approaches.
Demonstrated enterprise leadership skills.
Executive presence: ability to work effectively under pressure, communicate clearly and efficiently, lead with confidence and poise.
Proven ability to build high performing teams, setting clear and measurable goals, driving accountability, ensuring cross-functional engagement and a fierce commitment to delivery of objectives.
Demonstrated success in mentoring people, developing talent, and supporting the professional development of employees.
Strong interpersonal skills and demonstrated ability to effectively work with peers and senior leaders across a large organization.
Desirable Skills:
Experience with new biopharmaceutical modalities such as antibody-drug conjugates, viral products, nucleic acids and/or cell therapies.
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The position resides within the Cell Culture and Fermentation Sciences (CCFS) department in Biopharmaceutical Development (BPD) within AZ’s R&D organization. This is a highly visible and influential role in the organization. The incumbent will work collaboratively with other CCFS groups and BPD functions, MS&T, Global Technical Operations, clinical and commercial Manufacturing, external CMOs, regulatory affairs, and QA to ensure development of robust and capable manufacturing processes as well as appropriate scale up and transfer of clinical/commercial processes to manufacturing facilities.
Responsibilities:
Provides leadership and strategic guidance to a large group of engineers and scientists responsible for upstream process development activities to support early to late stage clinical and commercial manufacturing. Products include mAbs, ADCs, bi- and tri-specific antibodies, fusion proteins, vaccines, and other new biologic modalities.
Process development responsibilities include development, optimization and characterization of robust cell culture processes used in fed-batch and continuous manufacturing operations to produce clinical and commercial biological products.
Provides technical and strategic guidance and drives alignment of short-term deliverables and long-term plans for upstream development activities for portfolio projects in line with BPD’s/AZs priorities, goals, and timelines.
Responsible for developing and implementing the next generation of upstream manufacturing processes to improve productivity, increase robustness and throughput, and lower costs of manufacturing.
Leads strategy and implementation of new technologies, digitalization, and automation of upstream processes for traditional and emerging biologics modalities.
Drives development and implementation of agile and risk-based approaches to define CMC strategies for process development and characterization to support efficient and accelerated project delivery.
Senior member of the CCFS governance team that is responsible for providing leadership and decisions for the upstream process development and commercialization strategies for pipeline projects and technical development initiatives.
Supports regulatory filings by authoring, reviewing, and approving technical reports, CMC sections of clinical and registration submissions (INDs/BLAs), and responses to questions. Also supports interactions with Health Authorities and product-related inspections.
Builds strong relationships and partners with other leaders across Biopharmaceutical Development, AZ Bio-Operations, Quality, Regulatory, and external CMOs to ensure that AZ Biologics Portfolio is progressed with a sense of urgency.
As a member of the CCFS leadership team, works collaboratively with his/her peers to establish and drive strategic goals and ensures that department objectives are in alignment to overall BPD and R&D goals.
Participates and drives BPD-wide initiatives and represents CCFS in cross-functional BPD and AZ teams.
Builds and develops high performance teams. Hires, mentors, and develops team members within the organization.
Builds and sustains a culture that embraces AZ’s values and behaviors, promotes inclusion and diversity, and is committed to making CCFS and BPD a great place to work.
Required Skills:
Demonstrated experience leading cell culture process development of biologics from pre-clinical to commercial launch/post-launch and life-cycle management, including phase-appropriate approaches for process development, process characterization , and process validation. Must have experience with multiple product modalities such as mAbs, bi/tri-specifics, fusion proteins, etc.
Advanced education (Ph.D or equivalent) in biology, chemical engineering, biochemical engineering or related scientific discipline is required.
Candidate must have 15+ years of industrial experience in cell culture development and commercialization of biologics with people leadership accountabilities.
Extensive experience leading technical line functions and working with cross-functional matrix teams in the biotech and/or pharma industry.
Proven track record of success in developing, optimizing, and transferring cell culture processes to clinical and commercial manufacturing. Experience in supporting commercial registration of one or more biological products is required.
Demonstrated leadership in driving and implementing technical innovation.
In depth knowledge of CMC, quality and compliance, as well as regulatory aspects of biopharmaceutical development and life-cycle management.
Extensive experience in authoring and reviewing global regulatory submissions and response to questions for clinical development (IND/IMPDs) and commercial registration (BLA/MAA/JNDA). Experience interacting with regulators and global health authorities.
Experience working with CMOs and managing external development projects.
Strong business acumen: must be able to prioritize and manage resources, timelines, and scope of work to meet program goals and milestones.
Working knowledge of data governance, knowledge management, digitalization, automation, and AI approaches.
Demonstrated enterprise leadership skills.
Executive presence: ability to work effectively under pressure, communicate clearly and efficiently, lead with confidence and poise.
Proven ability to build high performing teams, setting clear and measurable goals, driving accountability, ensuring cross-functional engagement and a fierce commitment to delivery of objectives.
Demonstrated success in mentoring people, developing talent, and supporting the professional development of employees.
Strong interpersonal skills and demonstrated ability to effectively work with peers and senior leaders across a large organization.
Desirable Skills:
Experience with new biopharmaceutical modalities such as antibody-drug conjugates, viral products, nucleic acids and/or cell therapies.
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