Lead Biopharmaceutical Manufacturing Associate, P03
GSK is hiring Lead Biopharmaceutical Manufacturing Associate, P03.
- BS/BA or Associates Degree with 5+ years of directly related experience. Degree in other discipline (or lack of degree) may be considered if sufficient technical depth has been achieved from professional experience.
- 5+ years prior manufacturing experience in the pharmaceutical or biotechnology industry, with the demonstration of a high level of performance
- Understanding of the basic FDA cGMP regulations
- Demonstrated ability to work effectively in a team, lead teams and implement project plans on time and on budget.
- Must be able to follow detailed processing instructions as well as accurately documenting all necessary documentation.
- Ability to work a shift that covers a 24/7 operation
- Ability to lift and carry materials weighing as much as 40lbs.
Performs and leads all production operations in the area of assignment within the Rockville Manufacturing facilities. Support Start-up/changeovers/tech transfer activities and perform production operations in areas assigned. Duties include: preparation of buffers and medias and other solutions, following written procedures and batch records. Operate process equipment such as tanks, CIP/SIP skids, agitators, filtration devices autoclaves, glass washers, integrity testing and other small equipment following a high standard of GMP compliance and SOP and BRs as written, as well as supporting more complex, strategic projects.
- Must demonstrate GSK values and behaviors at all times.
- Operation of Bioprocess Equipment under strict adherence to and enforce cGMP, local EH&S, OSHA and polices and regulations, or others as required.
- Completes daily manufacturing tasks with strict adherence and compliance to Batch Records, SOPs and good GMP practices and procedures.
- Monitors critical process parameters; Ensures any changes noticed in process parameters are communicated to the next level of supervision.
- Documents/Communicates all manufacturing activities clearly and accurately.
- Qualified and authorized to train on most/all processes within department; Conduct relevant process, cGMP and safety training
- Actively participates in the creation and revision of Batch Records, Standard Operating Procedures and other GMP documents.
- Maintains 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.
- 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’s instructions.
- Actively leads continuous improvement processes and/or represents department cross-functionally.
- Leads the production team as required in the absence of supervisor. Ability to adapt to shifting priorities and schedule changes based on minimal supervisor instruction
- Lead troubleshooting/resolution of technical and process problems, initiate change control for equipment/process modifications
- Identify, develop and implement process improvements, equipment improvements/upgrades
- Ability to process maintenance, calibration, and equipment repair work orders and informs supervisor in timely manner.
- Assists specialist/management in investigations for departmental deviations; Lead closure of process deviations, investigations and corrective actions as needed
- Ability to represent department as a Subject Matter Expert (SME) during internal/external audits; Present the manufacturing areas in a state of audit readiness.• Develops effective working relationships with team members and across functions.
- Lead new production projects, develop commissioning plans and author commissioning documents
- Actively represents and/or lead in cross-functional team activities such as BDS, Changeover, Process/Cleaning Validation, Technical Transfers, New Product introduction (NPI), etc.
You may apply for this position online by selecting the Apply now button.
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