Sr. Director, Viral Vector Cell Line Development

Found in: Jooble US O C2 - 2 weeks ago

Boston MA, United States AstraZeneca GmbH Full time

Position Summary

The Senior Director of Cell Line Development (CLD) will lead and direct the production of novel viral vector plasmids and high-producing, high quality packaging and/or producer cell lines for AAV. They will also be responsible for new technology evaluations, due diligence activities, and cell line strategy across the entire product lifecycle. They will be responsible for all aspects cell line generation, including raw materials, adventitious agents, and project planning. Accountable for authoring technical reports and cell line sections of Regulatory sections for world-wide regulatory submissions through successful licensure. They will work closely with key stakeholders in Research, Development, Quality, and Global Regulatory Affairs on cell line development strategy and phase-appropriate product details. The incumbent will be a key member of the Viral Vector Drug Substance team, providing input on the team strategy, including budgeting and internal resources. They will devote significant time and effort in developing colleagues and the requisite bench strength to deliver on Alexion’s growing viral gene therapy pipeline.

Responsibilities

  • The Senior Director, Cell Line Development will be part of the Viral Vector Drug Substance (VVDS) Leadership team. They will support the Head of VVDS in budget and internal resources strategy
  • The incumbent is accountable for all cell line development activities, including externalization and in-licensing, across the entire product life-cycle, from pre-clinical to commercialization.
  • They lead and develop an innovative team of molecular and cell biology scientists.
  • Leading projects and/or providing leadership to junior Project Leaders for multiple programs from early discovery into development
  • Direct the development and characterization of the plasmid vectors and high-productivity cell lines. Will collaborate closely with research and Drug Substance process development teams to establish systems with appropriate quality and expression levels.
  • Providing early development leadership and strategy on project teams and collaborating across all areas of pharmacology, CMC, and clinical development functions
  • Establishing positive relationships within the AstraZeneca discovery team to share innovative technologies
  • Identifying, negotiating, and delivering partnerships with academic institutions or industry to evaluate, development and implement new technologies and improved workflows.
  • Provide subject matter expertise for regulatory interactions including inspections, audits and is accountable for the technical content of cell line development sections of regulatory submissions.
  • Collaborate with appropriate stakeholders to identify and deliver on life-cycle management opportunities for commercial products with respect to next generation processes.
  • Actively seek and achieve alignment on CLD strategies within the VVDS and PDCS teams with key stakeholders in Research, Global Operations, Global Regulatory Affairs, Quality, and Commercial organizations.
  • Devote significant time and effort in developing colleagues and the requisite bench strength to deliver on Alexion’s growing R&D pipeline.

Qualifications

  • The successful candidate will have 10+ years of cell line development experience with direct experience in AAV and late-stage molecular biologics development, including participation in projects involving cross-functional teams
  • At least 8+ years of experience in managing a cell line development group with direct deep expertise in developing cell lines from pre-clinical through licensure of viral vectors, gene therapies, and/or molecular biologics
  • Must be proficient in cell line development analytical tools and state-of-the art technologies to establish viral vector plasmid systems and cell lines in compliance with global regulatory standards and guidance.
  • Knowledge of current regulatory guidelines and cGMP requirements is essential. Knowledge of preclinical and clinical drug development is a prerequisite
  • Direct experience in preparing and supporting regulatory submissions including INDs/CTAs, BLA/MAAs and engaging with regulatory agencies is required. Be a key subject matter expert in for CLD activities when working with CMOs, Quality, Commercial, and other key stakeholders, both internal and external.
  • The candidate will have people-leadership, management, and development expertise, with a proven track record of leading, prioritizing, and managing multiple successful projects and support strategy thinking and actions.
  • Well-developed leadership, communication, team building and influencing skills; unquestioned integrity; and the experience to help establish a global function that is critical to our organization’s success

Education

  • Must have a BS/MS/PhD or equivalent in Pharmaceutical Sciences, Bio/Chemical Engineering, Biochemistry, Molecular Biology, or related discipline.

Competencies

  • Leadership
  • Accountability
  • Collaboration
  • Decision making
  • Change management
  • Perseverance
  • Problem Solving
  • Results oriented
  • Developing Direct Reports and Others
  • Hiring and Staffing
  • Managing Performance
  • Motivating Others

AstraZeneca requires all US employees to be fully vaccinated for COVID-19 but will consider requests for reasonable accommodations as required by applicable law.

AstraZeneca embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills. We believe that the more inclusive we are, the better our work will be. We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics. We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorization and employment eligibility verification requirements.

#J-18808-Ljbffr

  • Senior Scientist

    Found in: Jooble US O C2 - 2 weeks ago

    Boston, MA, United States Asimov Full time

    Our mission at Asimov is to advance humanity's ability to design living systems, enabling biotechnologies with outsized benefit to society. We're developing a mammalian synthetic biology platform––from cells to software––to enable the design and manufacture of next-generation therapeutics. We are seeking aSenior Scientist, Biologics Cell...

  • Senior Downstream Production Engineer, AAV Bioprocessing and Development

    Found in: Jooble US O C2 - 2 weeks ago

    Boston, MA, United States Ginkgo Bioworks Full time

    Senior Downstream Production Engineer, AAV Bioprocessing and Development (DSP) Ginkgo is looking for a highly motivated Senior Downstream Production Engineer, Cell and Gene Therapy to join the Foundry’s expanding High-throughput Screening (HTS) team. In this role, you will play a critical role to help establish, plan, develop and execute bioprocessing of...

  • Sr. Research Associate

    Found in: Jooble US O C2 - 1 week ago

    Cambridge, MA, United States Joulé Full time

    Title: Sr. Research Associate - Analytical Testing Location: Cambridge, MA. area Start Date: ASAP! Duration: Minimum 12 month contract (possible contract-to-hire) Hours: Mon-Fri; 8am-4pm (could be flexible to 7am-3pm or 9am-5pm) Degree/Experience/"Must Haves": BS in biology, chemistry or relevant field2+ years industry experience; 1+ years industry exp....

  • Senior Production Engineer I

    Found in: Jooble US O C2 - 2 weeks ago

    Boston, MA, United States Ginkgo Bioworks Full time

    Senior Downstream Production Engineer, AAV Bioprocessing and Development (DSP) Ginkgo is looking for a highly motivated Senior Downstream Production Engineer, Cell and Gene Therapy to join the Foundry’s expanding High-throughput Screening (HTS) team. In this role, you will play a critical role to help establish, plan, develop and execute bioprocessing of...

  • Scientist (Biologics Cell Line Development)

    Found in: beBee S US - 1 week ago

    Boston, United States Asimov Full time

    Our mission at Asimov is to advance humanity's ability to design living systems, enabling biotechnologies with outsized benefit to society. We're developing a mammalian synthetic biology platform––from cells to software––to enable the design and manufacture of next-generation therapeutics. Asimov, Inc. seeks a full time Scientist at our...

  • Scientist (Biologics Cell Line Development)

    Found in: beBee jobs US - 1 week ago

    Boston, Massachusetts, United States Asimov Full time

    Our mission at Asimov is to advance humanity's ability to design living systems, enabling biotechnologies with outsized benefit to society. We're developing a mammalian synthetic biology platform––from cells to software––to enable the design and manufacture of next-generation therapeutics.Asimov, Inc. seeks a full time Scientist at our offices...

  • Research Fellow

    Found in: Jooble US O C2 - 1 week ago

    Cambridge, MA, United States Joulé Full time

    Title:  Sr. Research Associate - Analytical Testing Location: Cambridge, MA. area Start Date: ASAP! Duration: Minimum 12 month contract (possible contract-to-hire) Hours: Mon-Fri; 8am-4pm (could be flexible to 7am-3pm or 9am-5pm) Degree/Experience/"Must Haves": - BS in biology, chemistry or relevant field - 2+ years...

  • Sr. Scientist, Upstream Process Development

    23 hours ago

    Boston, United States EPM Scientific Full time

    Job DescriptionJob DescriptionSUMMARYThis clinical-stage biopharmaceutical company is looking for an innovative scientist with a strong background in Upstream Process Development to oversee the development of all upstream technical activities for their lead vaccine program. They will also be expected to oversee CRO/CDMOs to make sure all areas of the drug...

  • Principal Associate Scientist, Cell Therapy Discovery, B Cell Therapeutics

    Found in: Jooble US O C2 - 2 weeks ago

    Waltham, MA, United States ElevateBio Full time

    Home / About / Careers / Principal Associate Scientist, Cell Therapy Discovery, B Cell Therapeutics Principal Associate Scientist, Cell Therapy Discovery, B Cell Therapeutics ElevateBio is a technology-driven cell and gene therapy company, accelerating access to the cutting-edge technologies and expertise to change the future of medicine. Our integrated...

  • Senior Director, Manufacturing

    Found in: Jooble US O C2 - 2 weeks ago

    Waltham, MA, United States ElevateBio Full time

    ElevateBio is a technology-driven cell and gene therapy company, accelerating access to the cutting-edge technologies and expertise to change the future of medicine. Our integrated technologies model offers turnkey scale and biotechnological capabilities to power genetic medicines processes, programs, and companies to their full potential. The Role: ...

  • Research Associate II Process Development

    Found in: Resume Library US A2 - 1 week ago

    Boston, Massachusetts, United States Vertex Pharmaceuticals Full time

    Job Description: Research Associate II, Process Development Engineering    Position Summary:  Vertex Cell and Genetic Therapies (VCGT) is seeking a Research Associate II to join our Process Dev Engineering Team in Boston, MA. Cell and genetic therapies represent two rapidly emerging therapeutic modalities with the potential to treat—and even...

  • Director Scientific Research, Cancer Center

    Found in: Jooble US O C2 - 7 days ago

    Boston, MA, United States Massachusetts General Physicians’ Organization Full time

    Job Description - Director Scientific Research, Cancer Center (3285679) Director Scientific Research, Cancer Center - ( 3285679 ) The Cellular Immunotherapy Program at Massachusetts General Hospital is seeking a Director of Scientific Research to work in the Maus Lab. The Director of Scientific Research plays a key role in the day-to-day administration of...

  • Principal Scientist

    Found in: Appcast US C2 - 1 week ago

    Boston, United States Scienta Full time

    Company – A leading Biotechnology Cell Therapy company Location – Boston, on site About the company This company focuses on developing cell therapies to treat cancer.They are seeking Scientists on all levels from Associate Researcher to Senior Scientists to join the cell Biology and Immunology Research and Development department. Duties Plan and design...

  • Principal Scientist

    Found in: Appcast Linkedin GBL C2 - 2 weeks ago

    Boston, United States Scienta Full time

    Company – A leading Biotechnology Cell Therapy company Location – Boston, on site About the company This company focuses on developing cell therapies to treat cancer.They are seeking Scientists on all levels from Associate Researcher to Senior Scientists to join the cell Biology and Immunology Research and Development department. Duties Plan and design...

  • Director/Sr. Director

    Found in: Jooble US O C2 - 2 weeks ago

    Boston, MA, United States Jnana Therapeutics Full time

    Director/Sr. Director, Medicinal Chemistry About Us Jnana Therapeutics is a clinical-stage biotechnology company leveraging its next-generation RAPID chemoproteomics platform to discover medicines for highly validated, challenging-to-drug targets to treat diseases with high unmet needs. Jnana is focused on developing first- and best-in-class therapies to...

  • Research Associate/Senior Research Associate, Synthetic Biology

    Found in: beBee S US - 2 weeks ago

    Boston, United States Asimov Full time

    Our mission at Asimov is to advance humanity's ability to design living systems, enabling biotechnologies with outsized benefit to society. We're developing a mammalian synthetic biology platform––from cells to software––to enable the design and manufacture of next-generation therapeutics. As a Research Associate or Senior Research...

  • Research Associate/Senior Research Associate, Synthetic Biology

    Found in: beBee jobs US - 1 week ago

    Boston, Massachusetts, United States Asimov Full time

    Our mission at Asimov is to advance humanity's ability to design living systems, enabling biotechnologies with outsized benefit to society. We're developing a mammalian synthetic biology platform––from cells to software––to enable the design and manufacture of next-generation therapeutics.As a Research Associate or Senior Research Associate,...

  • Director of Nursing

    Found in: Jooble US O C2 - 2 weeks ago

    Boston, MA, United States Children's Hospital Boston Full time

    74446BRJob Posting Title:Director of Nursing & Patient Services, Stem Cell Transplant UnitDepartment:Patient Services-NursingAutoReqId:74446BRStatus:Full-TimeStandard Hours per Week:40 Job Posting Category:NursingJob Posting Description:The Nursing Director for Inpatient Stem Cell Transplant will be responsible to: + Provide 24-hour supervision of daily...

  • Research Technician

    Found in: Resume Library US A2 - 1 week ago

    Boston, Massachusetts, United States Tufts University Full time

    Overview: The faculty in Molecular Biology and Microbiology (MBM) are united by a common interest in the biology of microbes (bacteria, fungi, viruses, and parasites) and the effects of microbes on human and animal hosts. The microbial pathogens program studies microorganisms that cause infectious diseases, with emphasis on rigorous analysis of these...

  • Director/Sr. Director, Clinical Science

    Found in: Jooble US O C2 - 2 weeks ago

    Boston, MA, United States Atlas Venture Full time

    Director/Sr. Director, Clinical Science (Early Oncology Development) Company Address: 1 Winthrop Square, Suite 400, Boston, MA, 02110 About Scorpion Therapeutics Scorpion Therapeutics was founded to expand the reach of precision medicine to more people with cancer. The company is integrating cutting-edge technologies across target discovery, medicinal...