Tech Transfer Person in Plant
- Research Triangle Park, NC
Site Name: RTP, USA - Maryland - Rockville
Posted Date: Jul 28 2020
This role will provide you the opportunity to lead and support key activities to progress your career, including some of the following responsibilities:
- Provide technical support for transfer and manufacture of critical specialty products representing GSK at Contract Manufacturing Organizations (CMOs)
- Provide Pharma Supply Chain Technical input into developing product control strategy, author relevant sections of NDA/MAA, conduct OpTRA with contract manufacturers and ensure implementation of product control strategy on to shop floor/manufacturing operations.
- Agree and enforce all Technical standards related to the manufacture and supply of GSK products by Contract Manufacturers, including new product introduction and validation of facilities, equipment and processes.
- Ensure that any issues related to product or process technology are identified, a root cause analysis conducted, and corrective actions implemented to ensure resolution
- Maintain product robustness through continued process verification plan and periodic product reviews. Support ongoing product supply by ensuring robust and capable processes are in place and monitored.
- Impact assessment and support of changes (GSK or CMO driven) including change control and risk assessment
- Support execution of validation activities to current standards (e.g. Product Lifecycle Management) in line with GSK QMS
- Support technical risk assessment of new and existing products and facilities and identify/drive mitigation plans
- Apply OE tools and principals in the implementation of technical projects and improvement initiatives
- Work with multi-functional teams of Procurement, Quality, Technical, Supply, Project management, Strategy, Regulatory, Finance and Business Development professionals across the Global network.
- Support key improvement initiatives with GSK's partner organizations on delivery of objectives
- Support the implement standards of quality by design into robust manufacturing operations
- Support mid-late phase portfolio projects and provide Pharma Supply Chain Technical input into design selection and manufacture considerations.
- Support due diligence activities by providing technical assessment of potential new products/CMOs
We are looking for professionals with these required skills to achieve our goals:
- BS in Chemical/Biochemical Engineering, Biochemistry, Chemistry or equivalent
- 5+ years experience in technical support of pharmaceutical manufacturing and/or process development
- Excellent verbal and written communication skills
- Ability to influence, lead and drive change
- Demonstrated record of achievement, including ability to work effectively in cross-functional teams
- Broad and integrated knowledge and experience that can impact project and team direction
- Working knowledge of regulatory requirements in the industry and drug development
Preferred Qualifications: If you have the following characteristics, it would be a plus:
- MS or PhD Chemical/Biochemical Engineering, Biochemistry, Chemistry or equivalent
- Experience in technical support of commercial products, program management, technology transfer to commercial manufacturing sites (internal and to external CMO)
- Experience in process validation, regulatory file preparation, PAI support
- Technical support of product lifecycle activities (i.e. CPV, PPR, Change and Deviation Management)
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 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 trust and collaboration, maintaining strong 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 Employer and, in the US, we adhere to Affirmative Action principles. This ensures that 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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