Sr. Director, Biologic Services

Waltham, Massachusetts; Research Triangle Park, North Carolina; King of Prussia, Pennsylvania; Collegeville, Pennsylvania
February 22 2021
Other, Other
Organization Type
The Senior Director, Biologics Operations will build, lead, and manage team of scientists/engineers responsible for the development and commercialization of biologics drug substance using an external network of providers. This position is integral to the advancement of GSK's growing portfolio of biopharmaceutical drug candidates and technology programs and will provide technical oversight and strategic guidance for the development of all externalized biologics drug substance related activities. The scope of the role encompasses the full breadth of biologics lifecycle, ranging from discovery, early stage development, late stage development, process validation, preparation of CMC content for regulatory (e.g., BLA/MAA) submissions, regulatory approval, product life cycle management and supporting GSK's pharma supply chain infrastructure for ongoing commercial manufacturing. The role will work seamlessly with GSK's extensive internal knowledge and capabilities to ensure optimized development, reduced risk profiles and ultimately accelerate the development cycle of assets.

The incumbent will play a leading role within GSK's Strategic External Development Enterprise, that is focused on further expanding and defining an external network of partners, collaborators and preferred suppliers with whom the end to end development of biologics will be leveraged. This individual will be a key stake holder in GSK's externalization strategy for biologics, diligence and relationship management activities with potential network providers and will oversee the planning and execution of outsourced biologics drug substance development and manufacturing. S/he will work proactively with service providers to define project scope and ensure successful delivery with regard to technical quality, timelines and budget. S/he will be responsible for building/maintaining strong working relationships with their respective technical staff and management.

The Senior Director, Biologics Operations will work within a cross-functional team environment, supporting GSK's senior leadership team in defining and executing against short-, intermediate- and long-term strategic goals for all biologics programs. Specifically, the incumbent will be responsible for shaping and defining CMC strategies for the development, GMP manufacturing, and life cycle management of drug substance, including evaluation of available development options/pathways and assessment of attendant benefits and risks . S/he will be expected to represent GSK at scientific and regulatory meetings and participate in due diligence activities associated with potential in-licensing of new biologics assets.

The successful candidate will report directly to the Vice President, Head of Strategic External Development

Job Responsibilities:
  • Provide technical leadership and oversight for:
  • End-to-end global externalization strategies for the development and commercialization of biologics drug substance.
  • Assist the GSK organization define short and long-term supply strategy for biologics assets.
    • Technical partnership and relationship management with a network of external providers with whom GSK's pipeline of biologic molecules will be developed and commercialized.
    • Oversee the development and scale up of robust cell lines and cell culture processes that meet productivity and quality requirements based upon quality by design (QBD) concepts that address critical quality attributes and process parameters. Processes must ensure protein quality, afford satisfactory yields and provide for transferability to commercial manufacturing operations.
    • Oversee the development and scale up of robust protein isolation and purification processes based upon quality by design (QBD) concepts that address critical quality attributes and process parameters. Processes must ensure protein purity, afford satisfactory yields, and provide for transferability to commercial manufacturing operat ions .
  • Manufacture of biologics drug substance to support all stages of preclinical and clinical lifecycle
  • Preparation of CMC documentation for regulatory approval and/or patent filings.
  • Establish and maintain an understanding of current trends, emerging upstream and downstream process technologies and ensure full awareness of current and emerging global capabilities for biologics production.
  • Apply innovative technical ability and knowledge to critically analyze experimental data and results.
  • Set clearly defined goals/objectives to ensure delivery of high-quality res ults.
  • Provide clear communication to core teams and functional line management regarding progress against technical objectives/milestones.
  • Ensure well-organized, clear and complete records of all activities across areas of responsibility.
  • Develop and maintain SOPs, policies and guidance documents relevant to areas of responsibility.
  • Manage and execute personnel qualification/training program.

Basic Qualifications:

  • Ph.D. in bio/chemical engineering, chemistry, biochemistry (or other relevant physical or life sciences discipline) with 15+ years of experience in biologics drug development in biotech or pharma industry, with significant experience in the areas of protein expression, isolation, purification, process characterization, process validation and product life cycle management or BS/MS with equivalent education or experience is required.

  • Ability to travel, extent of travel is variable but typically will not exceed 10-20% (domestic and international)
  • Knowledge of and experience with GMP manufacturing of recombinant proteins using mammalian cell lines.
  • Knowledge of biologics drug substance life cycle management.
  • Knowledge of biologics analytical method development, transfer, qualification and validation.
  • Hands-on working experience of CMC regulatory submissions from IND/IMPD filing to BLA/MAA submission and approval.

Preferred Qualifications:
  • Demonstrated ability to work outside of the box and influence novel CMC and regulatory pathways to accelerate development.
  • Demonstrated track record of CDMO management in supporting manufacturing process development, optimization, characterization, and GMP manufacturing. Excellent written and oral communication skills, including the maintenance of technical data and reports; proactive collaboration a multi-disciplinary business and science team environment is essential.
  • Personal att ributes : self-starter; attentive to details; results oriented; accountable; committed while maintaining balance and perspective. Others will describe you as honest, trustworthy, and respectful of others; a person of high integrity, a good listener, a straightforward communicator, and a team builder.
  • Expert knowledge of protein manufacturing process and process technologies and experience in advancing biologics processes through clinical development to successful regulatory approval/ licensing .
  • Demonstrated history working in a virtual CMC development/commercialization environment with a minimum of 5+ yrs experience leading and managing CMC partnerships with global providers.
  • Ability to work in a fast-paced and dynamic corporate environment with changing priorities, and flexibility to support multiple programs simultaneously.
  • Ability to attract, develop and retain talent is an essential component of this position.
  • Ability to work under pressure, meeting time sensitive deadlines, while maintaining a high level of confidentiality.
  • Ability to problem solve using innovative thinking and good decision making.
  • Ability to lead innovation, change and drive for results.
  • Experience in building technical teams, managing and developing senior technical personnel and building/maintaining business relationships with CDMO's and strategic partners.
  • Strong collaboration and communication skills; ability to build and maintain good working relationships with internal and external stakeholders.

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