GMP Product Development Manager - Exploratory

$120,000 - $150,000/Yr

Revvity - San Diego, CA

Part-time - Mid Level

San Diego, CA

Professional, Scientific, and Technical Services

About the position

The GMP Product Development Manager - Exploratory at Revvity is responsible for leading a team of Scientists and Research Associates in the development and launch of ancillary reagents for Gene & Cell Therapy product manufacturing. This role emphasizes team management, training, and performance communication, while also fostering continuous improvement and collaboration with various departments to ensure high-quality product delivery and customer support.

Responsibilities

• Lead and manage the Exploratory PD group for developing new products under ISO9001:2008/ISO13485:2016.
• Manage and support the optimization and troubleshooting for existing processes and products.
• Maintain scientific and technical knowledge, and critically evaluate scientific literature and industry trends to contribute to new product development.
• Effectively communicate project progress, experimental results, and strategies in presentations and written reports.
• Create SOPs, WIs, and Forms that efficiently control processes and meet ISO and regulatory requirements, ensuring personnel are trained and compliant.
• Maintain and monitor group operational documentation and laboratory equipment.
• Create and enact plans and projects that support group performance goals, budgets, and business strategy.
• Ensure adherence to policies, procedures, and regulations governing processes, products, and employee safety.
• Provide ongoing leadership, support, and mentorship to direct reports and team members.
• Manage other projects or responsibilities as required.

Requirements

• PhD in Immunology, Cell Biology, Biochemistry, or related scientific field.
• 3+ years of progressive leadership experience.
• 8+ years of hands-on experience with in-depth knowledge of technology, procedures, assays, and equipment used in cell analysis, primary cell isolation, and cultures.

Nice-to-haves

• 5+ years of progressive leadership experience.
• Strong leadership skills including people management, time management, and project management.
• Effective verbal and written communication skills in English.
• Understanding and working knowledge of cGMP and ISO13485 guidelines as well as quality management systems.
• Experience in Gene & Cell Therapy ancillary reagent industry.
• Proven history of effective People and Project Management.

Benefits

• Medical, Dental, and Vision Insurance Options
• Life and Disability Insurance
• Paid Time-Off
• Parental Benefits
• 401k with Company Match
• Employee Stock Purchase Plan