Biopharmaceutical Platform Leader, Downstream Processing
Site Name: USA - Maryland - Rockville, USA - Massachusetts - Waltham, USA - Pennsylvania - King of Prussia
Posted Date: Jan 2 2020
The successful candidate will join a team of scientists and engineers supporting GSK's portfolio of commercial and late stage biopharmaceutical and steriles assets (internal and/or external). As an SME in drug substance manufacturing, the candidate will possess in depth knowledge of downstream processing manufacturing requirements and expertise in the associated unit operations.
The role will include working across the supply chain network to drive progression of platforms, standards, and new technology industrialization. By identifying and focusing on the highest priority areas to drive business value and patient impact, this role will flex across the portfolio to deliver proactive and reactive solutions to complex problems. To ensure alignment across the business, shared learnings, and technical capability build, the candidate will also lead effective communities of practice, as appropriate. Engagement with suppliers and external CMOs will be required.
In partnership with R&D and Pharma Supply Chain (PSC), the person in role will work to implement standards of quality by design (QbD) into robust manufacturing operations, maintaining knowledge of latest industry trends and becoming an advocate in the external community. The position requires the ability to manage across multiple projects simultaneously, lead matrix teams, and mentor site based technical staff members. Requires excellent oral and written communication skills.
Why you? Basic Qualifications:
We are looking for professionals with these required skills to achieve our goals:
- BS/MS/PhD in Chemical/Biochemical Engineering, Biochemistry, Chemistry, or equivalent industrial experience and knowledge.
- Minimum of 10 years pharmaceutical industry experience in technical support of commercial manufacturing and/or process development.
- Demonstrated record of achievement and broad integrated knowledge of all aspects of biopharmaceutical production processes, and ability to work effectively in cross-functional teams to deliver results to agreed timelines.
- Broad and integrated knowledge and experience that can impact project and workgroup direction.
- Working knowledge of regulatory requirements in the industry and drug development.
- Must have excellent verbal and written communication skills, and ability to influence, lead and drive change.
If you have the following characteristics, it would be a plus:
- Experience in technical support of commercial products, program management, technology transfer to commercial manufacturing sites (internal and to external CMO), validation (including engineering project progression through IQ/OQ/PQ), regulatory submissions, PAI support for biopharmaceuticals, technical support of product lifecycle activities (i.e. CPV, PPR, Change and Deviation Management), and knowledge management.
- Knowledge of relevant regulatory requirements, including principles of quality by design. Ability to support due diligence activities.
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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