Sr. Specialist - Product & Process Expert
* Requisition ID: WD158674
* Position: Full-Time Regular
* Open date: Mar 10, 2018 10:01 AM
* Functional area: Manufacturing
* Required degrees: Not Indicated
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GMP Manufacturing and Clinical Supply (GMP Mfg.) is critical to robust product and process development and launch of novel vaccines. The Product and Process function is instrumental in supporting this work from Development into Technical R&D (TRD) and from TRD out to Global Industrial Operations/ Manufacturing (GIO) for commercial scale manufacturing. The Product & Process Expert will serve as the GMP expert, following the products and processes through the development manufacturing lifecycle, ensuring quality of product and process and, ultimately, reproducibility, scalability and manufacturability. Each of these individuals is accountable for an efficient, timely and cost effective transfer (into and out of TRD), in alignment with the Technical Development Lead (TDL) project plans; and for being the GMP Manufacturing point of contact for the whole organization.
* Lead the transfer of new vaccine products into the GMP Manufacturing and Clinical Supply (GMP Mfg.) from Development and out to GIO from the GMP perspective.
* Ensure product activities are planned in a timely efficient manner within the manufacturing space, in accordance with TDL plans, communicate and remediate risks to plans in a clear and timely fashion.
* Ensure processes are planned and executed in accordance with Phase Appropriate GMPs across all phases of manufacturing (I-III), keeping future commercial production in mind.
* Function as the link between GMP Mfg. the TDL/ core team and participate in appropriate core meetings.
* Drive execution, coordinate and track progression or GMP Mfg plans against agreed milestones in
collaboration with the TDL.
* Support the TDL at governance meetings to ensure readiness and appropriateness of stage gate evidence in the Process Development Value Stream (PDVS) concept.
* Establish the list of equipment and raw materials needed for production and lead procurement/ onboarding activities from the GMP Mfg. perspective.
* Lead/support the writing of GMP documentation as required, including but not limited to, SOP's, Work Instructions, filing documents (CMC), protocols and reports, specification, batch records, ...
* GMP expertise requires working within the GSK manufacturing network and as the manufacturing SME at CMO's, as required; the global nature of the role may require minimal travel.
Why You?Basic qualifications:
- University degree in Biology, Biochemistry, Chemical Engineering, Bioengineering, Pharmacy, or other relevant discipline. Area of specialization: Biological product manufacturing, Quality/ GMP, Project Management (pharmaceutical experience), Business/Finance.
- Project Management experience within the pharmaceutical industry.
- GMP manufacturing knowledge across all development stages (Phase I - III). Communication across all organizational levels is required.
- Ability to communicate issues, risks, data, and make decisions.
- Equally important is the ability to lead within a large matrix international organization, build successful collaborations within and outside GMP Mfg.
- Certified Project Manager credentials are desirable (or extensive project management experience).
At GSK we provide a supportive working environment, and a range of development challenges and opportunities. We also offer competitive benefits and compensation packages designed to attract and to retain the very best. GSK is proud to promote an open culture, encouraging people to be themselves and giving their ideas a chance to flourish. GSK is an equal opportunity employer.
Patient-focused Research and Development (R&D) is the heart of our business. Our R&D department seeks to discover and develop new vaccines, to protect against diseases where vaccines are not yet available and to improve on those vaccines that already exist. Part of our R&D programme targets diseases particularly prevalent in the developing world, including the World Health Organisation's three priority diseases - HIV/AIDS, tuberculosis and malaria. Research into candidate vaccines for other diseases of the developing world, such as dengue are at an earlier stage of development.
When it comes to developing the vaccines of the future, we're looking for real experts in their respective fields who are interested in working in the stimulating environment of an international healthcare company.
We emphasise the value of teamwork and we look for people ready to share our values of transparency, respect, integrity and patient focus.
GSK is one of the world's leading research-based pharmaceutical and healthcare companies - is committed to improving the quality of human life by enabling people to do more, feel better and live longer.
GSK Vaccines is one of the world's leading vaccine companies, with a comprehensive portfolio of 39 vaccines for infants, adolescents and adults and 15 more in development. We have more than 16,000 people working worldwide to deliver nearly 2 (1.9) million vaccines every day to people in around 90% (172) of the world's countries.
For further information, please visit www.gsk.com.