Team Member, Drug Product, Global External Development & Supply
Location:
Pennsylvania
Posted:
September 10, 2016
Position Type:
Full Time
Reference:
WD83589
Basic qualifications:
The incumbent will have a Bachelor's degree or equivalent in an appropriate scientific discipline plus experience in authoring of regulatory documentation, product development-commercial manufacturing interface and expertise in continuous improvement and change management.

Preferred qualifications:
Having a Masters or equivalent in an appropriate scientific discipline with significant drug product formulation experience would be an added benefit.

Details:
In this role you will provide overall leadership for and direction of formulation science carried out externally at CRO/CMO's. In scope your work will include developability, formulation development, and clinical trial supply manufacture across all phases of clinical development. You will provide technical expertise and CRO/CMO oversight at all stages of product development. You will ensure CRO/CMO's develop phase appropriate, robust formulations suitable for clinical evaluation. As the incumbent you will manage the development and supply elements associated with external CRO/CMO activities. You will also progress externally manufactured Drug Product through the internal GSK receipt and release process.

KEY RESPONSIBILITIES:
• Ensure that Drug Product is formulated and supplied to meet the agreed needs of the Project Team.
• Engage with GSK project teams to identify and understand project requirements and timeframes.
• Provide the GEDS interface with the wider Project Team.
• Coordinate the activities of the external team and raise issues as necessary with project teams
• Engage and assess supplier proposals against project requirements and make sourcing recommendations with Procurement/NCGOM
• Ensure safety, quality and ethical standards are appropriately maintained in CRO/CMO operations.
• Ensure generation and storage of appropriate documentation (including contribute to regulatory submissions in support of clinical studies where required).
• Have a project plan and an assessment of risks that are reviewed and endorsed by the relevant lines.
• Make appropriate and accurate budget provision to deliver the agreed project plan.
• Use current R&D project governance processes for communication and review of project progress and issues.
• Be responsible for contributions from own line to regulatory submissions and ensure coordination with the contributions from other GEDS/PDS lines.
• Comply with applicable quality and regulatory requirements in all aspects of work.

Contact information:

You may apply for this position online by selecting the Apply now button.
If you require an accommodation or other assistance to apply for a job at GSK, please contact the GSK HR 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.

Important notice to Employment businesses/ Agencies

GSK does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. All employment businesses/agencies are required to contact GSK's commercial and general procurement/human resources department to obtain prior written authorization before referring any candidates to GSK. The obtaining of prior written authorization is a condition precedent to any agreement (verbal or written) between the employment business/ agency and GSK. In the absence of such written authorization being obtained any actions undertaken by the employment business/agency shall be deemed to have been performed without the consent or contractual agreement of GSK. GSK shall therefore not be liable for any fees arising from such actions or any fees arising from any referrals by employment businesses/agencies in respect of the vacancies posted on this site.

Please note that if you are a US Licensed Healthcare Professional or Healthcare Professional as defined by the laws of the state issuing your license, GSK may be required to capture and report expenses GSK incurs, on your behalf, in the event you are afforded an interview for employment. This capture of applicable transfers of value is necessary to ensure GSK's compliance to all federal and state US Transparency requirements. For more information, please visit GSK's Transparency Reporting For the Record site.
A little about us:
We are a science-led global healthcare company on a mission to help people to do more, feel better and live longer.

Know someone who would be interested in this job? Share it with your network.