Senior Manager, Upstream Process Development (Biologics)
GSK is seeking to hire a Senior Manager, Upstream Process Development (Biologics) to manage the collaboration with CDMOs with a focus on the upstream 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 incumbent will oversee the planning and execution of outsourced CMC activities and work proactively with service providers to define project scope and ensure successful delivery with regard to technical quality, timelines and budget. She/he will contribute to the identification and selection of CROs and CDMOs and building/maintaining strong working relationships with their respective technical staff and management. The Senior Manager, Upstream Process Development (Biologics) will work within a cross-functional team environment, supporting GSK's biologics 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).
This role will provide YOU the opportunity to lead key activities to progress YOUR career, these responsibilities include some of the following:
- 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 CMC 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.
Why you? Basic Qualifications:
We are looking for professionals with these required skills to achieve our goals:
- Ph.D. in (bio)chemical engineering, biochemistry or closely related field with 3+ years or MS with 6+ years relevant experience.
- Experience in upstream process development from early phase cell culture process development to late stage cell culture process characterization study.
- Experience managing projects and working with cross-functional teams comprised of internal and/or external contacts.
- Experience building relationships and working with CDMOs.
- Familiar with cGMP regulations.
- Experience in preparing CMC documentation for regulatory submissions.
If you have the following characteristics, it would be a plus:
- 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.
- Experience in managing technical teams and external partners
- 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 expectationsare 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.
- Managing individual and team performance.
- Committed to delivering high quality results, overcoming challenges, focusing on what matters, execution.
- Implementing change initiatives and leading change.
- Sustaining energy and well-being, building resilience in teams.
- Continuously looking for opportunities to learn, build skills and share learning both internally and externally.
- Developing people and building a talent pipeline.
- Translating strategy into action - a compelling narrative, motivating others, setting objectives and delegation.
- Building strong relationships and collaboration, managing trusted stakeholder relationships internally and externally.
- Budgeting and forecasting, commercial and financial acumen.
If you require an accommodation or other assistance to apply for a job at GSK, please contact the GSK Service Centre at 1-877-694-7547 (US Toll Free) or +1 801 567 5155 (outside US).
GSK is an Equal Opportunity/Affirmative Action Employer. All qualified applicants will receive equal consideration for employment without regard to race, color, national origin, religion, sex, pregnancy, marital status, sexual orientation, gender identity/expression, age, disability, genetic information, military service, covered/protected veteran status or any other federal, state or local protected class.
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