Lead Biopharmaceutical Manufacturing Associate
Where
- Rockville, MD
What you'll be doing
- The lead biopharmaceutical manufacturing associate is responsible to operate bioprocess equipment under the company policies and regulations, or others as required. Complete daily manufacturing tasks per standard operating procedures and batch document instructions. The candidate will monitor critical process parameters, draft and revise sops and batch records as necessary. Document all manufacturing activities clearly and accurately. S/he will train new and less experienced team members. Conduct relevant process, cGMP and safety training. Effectively troubleshoot equipment and processing problems. Actively participate in the creation and revision of batch records, standard operating procedures and other GMP documents. Maintain a high level of mechanical and technical aptitude and training. During technical transfer and the start up activities, provide input on design and operation of equipment. Ensure that all production activities are completed in a safe and compliant manor. Provide information to the supervisor on performance of the team. Coach, facilitate, solve work problems, and participate in the work of the team. Communicate assignments, milestones, and deadlines to the team and individuals based on supervisor instructions. Observe training needs and relay training needs and requests to supervisor. Relay request for resources and supplies. Lead the production team as required in the absence of supervisor, resolution of technical and process problems, and initiate change control for equipment/process modifications. Lead closure of process deviations, investigations and corrective actions, new production projects, develop commissioning plans and author commissioning documents. Perform other duties as assigned.
What your background should be
- The candidate must have 5+ years of directly related experience. S/he should have 5+ years of manufacturing experience with the demonstration of a high level of performance. The applicant should have the understanding of basic FDA, cGMP regulations. Small scale upstream experience with knowledge on the following: bioreactors (25l-2k), disk stack centrifugation, aseptic hood operations, cell culture analytics (VICELL, CEDEX, BGA). Understanding of darts data review. Strong team player with strong verbal and written communication skills, demonstrated ability to work effectively in a team, lead teams, and implements project plans on time and on budget is preferred. Must be able to follow detailed processing instructions, as well as accurately documenting all necessary documentation. Other physical movements is preferred.
Required Schooling / Training
- BS/BA or associate degree
Who is the client company
- The company provides pharmaceutical, biologics, vaccines and consumer healthcare service.
- If you are interested in this position, send your resume to apply@kochdavis.com
