• Broad knowledge of CGT or biological manufacturing. Qualified to at least graduate level in Biochemistry, Biotechnology and/or (Bio)Chemical Engineering with a minimum of 5 years experience in a CMC development and/or manufacturing environment, or qualified to Bachelors level with 10+ years experience a CMC development and/or manufacturing environment.
• Strong interpersonal and leadership skills. Solid team player able to function within a matrix team environment. Capable of working independently with minimal direct supervision.
• Excellent troubleshooting/problem analysis skills. Familiarity with Lean Sigma and Root Cause Analysis methodologies highly desirable.
• Effective time and energy management with an ability to clearly identify priorities and manage multiple tasks while working in a matrix team environment.
• Ability to manage a dynamic project workload and evolving CMC priorities suitably balancing demands of individual assets vs. the needs of the overall CGT portfolio.
• Influences organizational thinking and/or research and development activities by leveraging their scientific or technological expertise.
• Has direct experience managing activities and/or services provided by external suppliers/contractors and has experience supporting negotiation of timelines, costs, and deliverables for such work packages.
• Has experience in "identifying outsourcing opportunities and presenting business cases to key internal partners"
• May be required to provide direct oversight of development/ cGMP activities and may support due diligence activities with some travel required.
• Maintains awareness of scientific literature and new technologies in their technical discipline which have relevance for CGT.
• Knowledge of external supplier capabilities/organizations (philosophy, culture, business goals) and how they relate to GSK.
• Experience developing innovative, simple and cost effective alternatives for delivering CMC activities of suitable/ phase appropriate quality.
Key responsibilities include, but are not limited to the following:
• Capably leads joint teams with external parties tasked with manufacture and testing/release of CGT products or critical inputs (e.g. plasmids, cell banks, viral vector).
• Effectively communicates across extended matrix teams comprising CGT, QA, Program/ Project Teams/ GSK Procurement organizations, and external supplier organizations.
• Proactively defines and implements CGT CMC and sourcing plans, critically evaluating these against business requirements to ensure project objectives are met. Develops contingency plans and proposes alternative strategies as appropriate.
• Initiates and implements continuous improvements in ways of working.
• Develops relationships with internal partners and external suppliers whilst maintaining the highest level of professional and ethical conduct.
• Actively involved in on-boarding and on-going management of external parties. Effectively integrates external partners into the project structure and educates suppliers on the mechanics of doing business with GSK.
• Significant external influencing required ensuring alignment of GSK business requirements with supplier's expectations. Ensures protection of GSK IP in all Supplier interactions.
• Manages and delivers against all project objectives as per agreed Scope of Work (scope, time, budget, resources and quality).
• Participates in performance reviews of preferred suppliers. Coordinates, manages & reports Key Performance Indicators (Performance measures) on a regular basis.
• Must have experience ensuring adherence to regulatory guidelines and corporate policies as they relate to outsourcing of development and manufacturing activities for CGT or biopharms.
• Responsible for monitoring the integrity and quality of partner derived data ensuring it is suitable to support robust manufacturing/ testing and associated GSK regulatory filings.
• Contributes to global outsourcing policies and third party oversight for CGT / R&D.
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.