Research and Development Process and Product Expert

Job description

Details:
We are currently seeking a Process and Product Expert to join our R&D department. If interested, please read further.

GMP Manufacturing and Clinical Supply (GMP Mfg.) is critical to robust product and process development and launch of novel vaccines. The Process and Product Validation function is instrumental in supporting this work from Development into TRD and from TRD out to GIO for commercial scale manufacturing. These individual will serve at the GMP experts, 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 TDL project plans; and for being the GMF Mfg. point of contact for the whole organization.

Key Responsibilities:

• 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 GMP's across all phases of manufacturing (I-III), keeping future commercial production in mind.
• Function as the link between GMP Mfg. the TDL/core team; participate in appropriate core meetings across all stages to assure the appropriateness of the manufacturing process and to adapt, as needed, to meet GMP expectations and remain efficient and flexible.
• Drives execution, coordinates and tracks 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, BOMs, and 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.

Job-Related Experience:

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.

Other Job-Related Skills/Background:

• Certified Project Manager credentials are desirable (or extensive project management experience).

Our Offer:

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.

The Department:

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.

Our Company:

GSK is a science-led global healthcare company with a mission to help people do more, feel better, live longer. At GSK, we research, manufacture and make available a broad range of medicines, vaccines and consumer healthcare products.

GSK Vaccines is a world's leading company, involved in vaccine research, development and production. We have 16 candidate vaccines in development and our broad portfolio of around 40 vaccines prevent illnesses such as hepatitis A, hepatitis B, diphtheria, tetanus, whooping cough, measles, mumps, rubella, polio, typhoid, influenza and bacterial meningitis. Globally, we have more than 16.000 people working to deliver vaccines safely, every day, to people in 90% of the world's countries. In 2014 we distributed around 800 million doses of vaccine, 80% of them to least developed, low and middle income countries.
For further information, please visit www.gsk.com.

*LI-GSK

Contact information:
You may apply for this position online by selecting the Apply now button.

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Desired profile

Basic qualifications:
University degree in Biology, Biochemistry, Chemical Engineering, Bioengineering, Pharmacy, or other relevant discipline.
Biological product manufacturing, Quality/ GMP, Project Management (pharmaceutical experience), Business/Finance.
English & French a must.

Preferred qualifications:
See Basic Qualifications