Bachelor's degree in biological, chemical science, engineering or equivalent technical discipline
7 years of production in biopharm/biotech or similar technology-based industry with at least 3 years production management.
5 years of large scale cell culture / fermentation or purification based processing preferred as well.
Strong quality/compliance orientation and track record. Excellent interpersonal and leadership skills. Strong influence and relationship building skills with an emphasis on teamwork
To manage production operations in the Biopharmaceutical Manufacturing Facility at the Rockville site
• The Manager of Biopharmaceutical Production is responsible for the production biotechnology platforms operating on a 24hour/7day basis. The job duties require a high level of technical knowledge combined with a sense of urgency and responsibility to meet delivery schedules.
• Responsible for the preparation of bulk biopharmaceutical drug substance to meet all quality standards for GSK, FDA and any other regulatory agency which applies.
• Responsible for assuring full compliance against all appropriate manufacturing regulations such as local policy and procedures, GSK QMS and CFR/cGMP.
• Responsible for all operations, to ensure personnel, product and equipment safety. Maintain compliant operations against all required GSK EHS/OSHA standards and all applicable environmental regulations (local, state, and federal).
• Partner with the NPI lead for successful implementation of new products and processes into the facility production equipment and schedules.
• Accountable for the accurate preparation and execution of manufacturing procedures and batch records.
• Establish production standards and manpower requirements to meet delivery schedules.
• Direct the evaluation and implementation of Continuous Improvement and OE methods and tools to improve the overall efficiencies of production operations and reduce costs.
• Accountable for the personnel development and performance management planning for all direct and indirect reports.
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.