Aseptic Manufacturing Supervisor

Proclinical is seeking an Aseptic Manufacturing Supervisor with a leading biopharmaceutical company. This is a permanent role located in Philadelphia, PA.

In this role, you 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.

Must be eligible to work in the US.

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.

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 3+ 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 the teams within the manufacturing environment.
• 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.

If you are having difficulty in applying or if you have any questions, please contact Taylor Smith at (+1) 570-277-7056 or t.smith@proclinical.com.

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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