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The Senior Manager, Downstream Process Development (Biologics) will work within a cross-functional team environment, supporting SED's (Strategic External Development) biologics leadership team in defining and executing against short, intermediate and long-term strategic goals for all biologic's programs. Specifically, under minimal guidance, the incumbent will be responsible for developing and executing CMC goals for downstream process development for multiple biologics programs. She/he will be expected to represent GSK at scientific and regulatory meetings as needed.
Senior Manager, Downstream Process Development will manage the collaboration with CDMOs with a focus on the downstream process development and manufacture of biologics drug substance. This position is integral to the advancement of SED's growing portfolio of biopharmaceutical drug candidates and technology programs and will provide technical oversight and strategic input for downstream biologics drug substance development and manufacturing activities. The scope of the role spans from early stage process definition to late stage process characterization study. It extends further to the preparation of CMC content for regulatory submissions, technology transfer and manufacturing support.
In accordance with SED's virtual (100% outsourcing) model for drug development, 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 regarding 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.
o Provide technical leadership, management and oversight for:
o Development of robust purification processes utilizing multiple chromatography modes, filtration (normal and tangential flow) and clarification technologies.
o Optimization and characterization of downstream manufacturing processes based upon quality by design (QbD) principles including linkage and worst-case studies.
o Tech transfer, scale-up and manufacture of biologics drug substance to support nonclinical studies and clinical evaluation.
o Interface with upstream, analytical, formulation, Regulatory, QA/QC groups to ensure alignment with overall program objectives.
o Process Validation activities of biologics drug substance to support product commercialization.
o Oversee phase appropriate viral clearance studies to enable regulatory submissions.
o Prepare CMC documentation for regulatory and/or patent filings and prepare/reconcile responses for responsible topics.
o Establish and maintain an understanding of current trends in purification technologies
o Set clearly defined goals/objectives to ensure delivery of high-quality results.
o Provide clear communication to CMC teams and functional line management regarding progress against technical objectives/milestones.
o Ensure well-organized, clear and complete documentations of all activities across areas of responsibility.
Ph.D. in (bio)chemical engineering, biochemistry or related field with 5+ years or MS with 7+ years relevant experience.
Experience in downstream process development from early process definition to late stage process characterization study.
Proven ability to manage projects and work with cross-functional teams comprised of internal and/or external contacts.
Experience working with CDMOs.
Experience with cGMP regulations.
We are looking for professionals with these required skills to achieve our goals:
If you have the following characteristics, it would be a plus:
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.
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 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
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.
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