ProClinical is currently seeking a Cell Therapy Manufacturing Supervisor for a leading global pharmaceutical, biopharmaceutical, and medical device open-access capability and technology platform with global operations. The Manufacturing Supervisor provides on-the-floor production leadership to ensure that manufacturing processes are optimized and managed efficiently. This is a permanent position based in Philadelphia, PA.
- Schedule and coordinate day-to-day manufacturing operations. Ensure conformance to the daily production schedule.
- Provide clear objectives for daily manufacturing operations to meet customer and cGMP requirements.
- Train, develop and supervise personnel in assigned activities
- Work closely with all operations support functions (Quality Assurance, Quality Control, Facilities, Engineering, Validation, Project Management and Materials Management groups) to ensure that Company objectives are met on schedule. Interact with material/equipment vendors and commercial partners, as required.
- Ensure full compliance with CGMPs and applicable health and safety regulations (OSHA) is achieved and maintained
- Author and revise SOPs and batch records
- Ensure cGMP compliance, confirming that all production equipment is properly working and production processes meet quality standards.
- Perform review of batch documentation and logbooks for completeness and accuracy.
- Establish objectives and conduct performance reviews, monitoring progress toward objectives and provide timely and professional feedback to Manufacturing Management
- Timely status communication of operations, safety and maintenance problems to Area Management.
- Participate in internal meetings, client and regulatory audits, and conference calls as appropriate.
- Demonstrates strong supervisory skills and contributes to the achievement of company and departmental goals and objectives.
- Has a strong working knowledge of the regulatory compliance requirements for the commercial production of biologics.
- Remains current regarding current Good Manufacturing Practices (cGMP) guidelines and develops and/or modifies production batch records and SOPs to fully address compliance issues.
- Demonstrates innovative technical knowledge and significantly contributes to the overall manufacturing operations.
- Demonstrates strong oral and written communication skills and actively contributes to training, report generation and documentation.
- Participates in manufacturing operations in assigned area.
- Analyses scientific data with accuracy and precision, critical at time of processing.
Skills and Requirements:
- High School diploma and at least 6 years in cell production/biologics facility or Bachelor's degree with major in Biology, Chemistry or related Science major and 4 - 6 years of experience in cell production/biologics facility or equivalent.
- Meets physical requirements of the job, as follows: must have the ability to lift a minimum of 50 pounds, stand for long periods, bend, reach, stretch, climb ladders and work in tight spaces in order to complete job tasks.
- Significant experience in aseptic processing techniques and a thorough understanding of regulatory requirements for a cGMP manufacturing facility is required.
- Ability to work under limited supervision and to handle problems of a more difficult nature.
Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.
In case you have difficulty in applying or if you have any questions, please call Hannah Cihlar on +1 267 983 0133 or upload your resume on our website - www.proclinical.com.
A full job description is available on request.
ProClinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.