B.S. or M.S. in Bioprocess/Biochemical Engineering or related Biological Sciences with >5 yrs of industrial experience. Candidate must have hands on experience in the development and transfer of mammalian cell culture processes for the manufacture of protein theraputics.
Candidate must have good understanding of chemically defined cell culture media/feeds impact on recombinant protein productivity. A thorough knowledge of small scale bioreactors and previous hands-on experience with process characterization/process scale-up, transfer and authoring of related reports supporting regulatory submissions is required.
The candidate must be a highly motivated self-starter, with excellent verbal and written communication skills, and the ability to work effectively in team and matrix environments. The candidate should have demonstrated record of scientific achievement and a broad and integrated knowledge of the cell culture process optimization. Basic knowledge of statistical science/analysis and project management is highly desired. Previous experience with process scale-up/transfer and authoring of CMC sections for regulatory filings is preferred. The candidate will be responsible for writing and reviewing technical documents, technology transfer documents and will participate in authoring of CMC sections for regulatory filings.
The candidate will be responsible for the characterization, and transfer of animal component free cell culture processes into cGMP facilities for early phase projects. The candidate will also evaluate and/or optimize processes for improved facility fit. The candidate will be interfacing with scientists in the maintenance, operation, and harvesting of bioreactors in a small scale development facility. The candidate will interact with scientists/engineers involved in the process scale-up and technology transfer of manufacturing processes for the production of early and late stage clinical supplies. The candidate will represent the department on project teams. In addition, the candidate will be responsible for authoring technical reports, protocols, technology transfer documents, and CMC sections for regulatory filings. The candidate will be expected to interact on a routine basis with colleagues in downstream process development, analytical methods development, clinical manufacturing groups. The candidate will be responsible for evaluating and implementing new technologies in the cell culture area.
The candidate must be highly motivated, have excellent organization and communication skills. The candidate must demonstrate evidence of leadership and teamwork skills. The candidate will also be expected to work independently and in a matrix team environment.
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.