Manufacturing Manager - Biopharmaceutical
Location:
Rockville , Maryland
Posted:
November 22, 2017
Reference:
WD145667
Basic qualifications:
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.

Preferred qualifications:
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

Details:
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.

Contact information:

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