Manufacturing Manager - Biopharmaceutical
Rockville , Maryland
November 22, 2017
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

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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