Technical Lead, PIP
- Qinnan, China
Site Name: China - Jiangsu - Wuxi
Posted Date: Dec 1 2020
Are you seeking an opportunity to leverage your scientific and leadership expertise to optimize the technical performance of GSK products in the supply chain?If so, this role could be a fit for you.
As Technical Manager (Product Leader/Owner) you will provide project technical leadership and oversight for New Product Introduction and ongoing manufacturing to ensure process robustness and successful commercial supply.
This role will provide you the opportunity to lead key activities to progress your career, including some of the following responsibilities:
- Serve as GSK Technical Lead on manufacture of critical specialty products, including serving as technical lead / Person-In-Plant representing GSK at Contract Manufacturing Organizations (CMOs)
- 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.
- Support of product transfers from GSK sites to a CMO, between CMOs or from CMOs to GSK sites
- Impact assessment and support of changes (GSK or CMO driven) including change control and risk assessment
- Ensure with Quality Assurance that necessary validation activities have been planned and executed to current standards (e.g. Product Lifecycle Management) in line with GSK QMS
- Lead 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
- Support due diligence activities by providing technical assessment of potential new products/CMOs
- Work with multi-functional teams of Procurement, Quality, Technical, Supply, Project management, Strategy, Regulatory, Finance and Business Development professionals across the Global network.
- Provide leadership of key improvement initiatives with GSK's partner organizations on delivery of objectives
- Work to implement standards of quality by design into robust manufacturing operations
- Represent Technical at CMC Steering Team and New Product Supply Board as required
- Support mid-late phase portfolio projects and provide Pharma Supply Chain Technical input into design selection and manufacture considerations.
- 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.
We are looking for professionals with these required skills to achieve our goals:
- BS in Chemical/Biochemical Engineering, Biochemistry, Chemistry or equivalent
- 10+ 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
- Ability to manage across multiple projects simultaneously, lead matrix teams, and mentor site based technical staff members
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.
Our goal is to be one of the world's most innovative, best performing and trusted healthcare companies. We believe that we all bring something unique to GSK and when we combine our knowledge, experiences and styles together, the impact is incredible. Come join our adventure at GSK where you will be inspired to do your best work for our patients and consumers. A place where you can be you, feel good and keep growing.
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