Sr Manager, Upstream Process Development
- Waltham, MA
Site Name: USA - Massachusetts - Waltham
Posted Date: Apr 22 2020
Senior Manager, Upstream Process Development
GSK is seeking to hire a Senior Manager, Upstream Process Development in Strategic External Development (SED) group to manage the collaboration with CDMOs with a focus on the upstream cell line development, process development and manufacture of biologics drug substance. 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 input for upstream biologics drug substance development and manufacturing activities. The scope of the role spans from early phase cell culture process development to late stage cell culture process characterization study. It extends further to the preparation of CMC content for regulatory submissions, technology transfer and manufacturing support.
The Senior Manager, Upstream Process Development will work within a cross-functional team environment, supporting GSK's SED leadership team in defining and executing against short-, intermediate- and long-term strategic goals for all biologics programs. Specifically, under minimal guidance, the incumbent will be responsible for developing and executing CMC goals for upstream process development for multiple biologics programs. She/he will be expected to represent GSK at scientific and regulatory meetings as needed.
The successful candidate will report directly to the Director, Upstream Process Development (Biologics).
DUTIES & RESPONSIBILITIES:
- Provide technical leadership, management and oversight for:
- Development of stable mammalian cell lines and establishment of cell banks for GMP manufacturing.
- Development, optimization and characterization of robust upstream manufacturing processes based upon quality by design (QbD) principles.
- Tech transfer, scale-up and manufacture of biologics drug substance to support nonclinical studies and clinical evaluation.
- Prepare CMC documentation for regulatory and/or patent filings.
- Establish and maintain an understanding of current trends and emerging cell line and upstream process development technologies
- Set clearly defined goals/objectives to ensure delivery of high-quality results.
- Provide clear communication to cross-functional teams and functional line management regarding progress against technical objectives/milestones.
- Ensure well-organized, clear and complete documentations of all activities across areas of responsibility.
- Ph.D. in (bio)chemical engineering, molecular biology, biochemistry or closely related field with 3+ years or MS with 6+ years relevant experience.
- Hands on working experience in stable cell line development
- In-depth understanding and demonstrated experience in modifying - vectors, sub-cloning of cDNAs into vectors, and associated molecular biology techniques
- Proven ability to manage projects and work with cross-functional teams comprised of internal and/or external contacts.
- Experience building relationships and working with CDMOs is a plus.
- Familiar with cGMP regulations.
- Experience in preparing CMC documentation for regulatory submissions.
- Excellent written and oral communication skills, including the maintenance of technical data and reports; proactive collaboration in a multi-disciplinary business and science team environment is essential.
- Personal attributes: self-starter; attentive to details; 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.
- Ability to work in a fast-paced and dynamic corporate environment with changing priorities, and flexibility to support multiple development programs simultaneously.
- Ability to solve the problems using innovative thinking and good decision making.
- Ability to lead innovation, change and drive for results.
- Strong collaboration and communication skills; ability to build and maintain strong ties with internal and external stakeholders.
- Ability to travel, not to exceed 20% (domestic and international).
Our values and expectations are at the heart of everything we do and form an important part of our culture. These include Patient focus, Transparency, Respect, Integrity along with Courage, Accountability, Development, and Teamwork. As GSK focuses on our values and expectations and a culture of innovation, performance, and trust, the successful candidate will demonstrate the following capabilities:
- Agile and distributed decision-making - using evidence and applying judgement to balance pace, rigour and risk, governance and control, managing ambiguity and paradox.
- Managing individual performance.
- Creating a performance culture and driving results, prioritisation, execution, delivering performance.
- Setting strategic direction and leading on-going organisational transformation.
- Building a resilient organisation. Building strong relationships and collaboration in service of common goals, engaging the organisation and building trusted external networks for mutual benefit.
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