Aseptic Manufacturing Supervisor

Proclinical is currently recruiting for an Aseptic Manufacturing Supervisor with a pharmaceutical company located in Philadelphia, PA. This role will provide guidance and oversite to the process and production as well as timely document review, ensuring material is made in a safe and compliant manner and meeting company targets. The Aseptic Manufacturing Supervisor will also be responsible for the development of staff, ensuring a highly effective "First time right" program, to accommodate our needs as a growing organization. This role will provide support to the on- boarding program and support the management of any deviations and CAPAs for the training and learning team. The supervisor should demonstrate innovative technical knowledge and will significantly contribute to the overall manufacturing operation. As this role is part of the leadership team for autologous cell therapy manufacturing operations, a background in cell culture and manufacturing in ISO class 5 cleanrooms is required

Job Responsibilities:

• Supervision and Development of direct reports (operators), mentoring/coaching to motivate and mentor peers/ staff, to foster a culture of continuous improvement and operational excellence.
• Schedule and coordinate day-to-day activities, ensuring conformance to the daily schedule
• Develop a comprehensive understanding of current production process, as this role is viewed as a subject matter expert within specific area. Significant experience in aseptic processing techniques and a thorough understanding of regulatory requirements for a cGMP manufacturing facility is required.
• Perform review of batch documentation and logbooks for completeness and accuracy.
• Ability to work under limited supervision and to handle problems of a more difficult nature.
• Continuously seek and support new approaches, practices and processes to improve the efficiency and efficacy of the operation.
• Establish objectives and conduct performance reviews, monitoring progress toward objectives and provide timely feedback to Management.
• Author and revise documentation, including drafting and approval of SOPs, Batch Records, Deviations, CAPAs, etc.
• Ensure the department understands and complies with quality standards and requirements as documented.
• Ensure efficient operations, and compliance with cGMPs and safety regulations. Education and Qualifications

Skills and Requirements:

• Minimum B.S. degree in biology, biochemistry, bioengineering, or related technical field, or equivalent industry and technical experience.
• Minimum of 5 years of experience in biopharmaceutical based GMP manufacturing operations, including experience in cell culture and associated downstream processing. Minimum of 2 years in a Lead/Leadership/Supervisory Role is desired.
• Demonstrated technical knowledge of aseptic processing in cleanroom environments a must.
• Strong knowledge and experience of the end-to-end learning process, i.e., learning needs assessment, program design and delivery, and learning evaluation and training effectiveness assessment.
• Demonstrates strong oral and written communication skills and actively contributes to training, report generation and documentation (batch records, deviations, etc.). Strong technical writing ability required.
• Experience leading "development" initiatives, i.e., training, coaching, learning initiatives.
• Ability to mentor and provide best practices to other members of the team.
• Ability to build relationships quickly and credibly. Provide consistent, excellent support to entire staff, with the ability to manage and influence large teams within the manufacturing environment (potentially 50+ employees) representing a variety of personalities and experience levels.
• Proactive, results oriented, self-starter with demonstrated strong leadership skills and experience in a complex manufacturing environment.
• Ability to deal with ambiguity - ready to change gears and plans quickly, with the need to manage constant change.
• Ability to work successfully in a fast-paced team-oriented environment.
• Quality mindset, familiar with 21 CFR Part 11 and standard GxP best practices and FDA regulations.
• Remains current regarding current Good Manufacturing Practices (cGMP) guidelines and develops and/or modifies production methods to fully address compliance issues.
• This position is for regular work week hours (M-F); however, due to the nature of cell therapy manufacturing schedules, must be willing to work weekends, evenings, and holidays, as needed. It is also expected that regular work weeks may change once commercial manufacturing commences and may involve shift changes (i.e. Tuesday to Saturday).
• May require up to 10% travel based on business need.

If you are having difficulty in applying or if you have any questions, please contact Mike Raletz at 267-428-7770.

ProClinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.

Proclinical Staffing is an equal opportunity employer.

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