Manufacturing Operations Manager

R&D Partners is seeking to hire a Manufacturing Operations Manager in Philadelphia, PA.

Your main responsibilities as a Manufacturing Operations Manager:

Oversees the Manufacturing Operations team to support startup and clinical production, as well as initial plan for commercial material in support of strategic objectives.

Develop schedules for manufacturing that meet monthly and quarterly targets. Ensure resources are adequate to complete operations and fully optimized from an operational excellence perspective.

Lead critical level investigations as related to the manufacturing and initial validation steps. Approve deviations, non-conformances, and CAPAs as required. Partner with Quality to address these issues effectively and compliantly.

Identify, lead, and implement continuous improvement opportunities for process and production related items. Expert level in visual management, KPIs, huddle boards etc. Continuously seek and support new approaches, practices, and processes to improve the efficiency and effectivity of the operation.

Ensure batch-related documentation (batch records and SOPs) is closed in a timely manner to support batch release. Since it is a just-in-time manufacturing process, careful coordination and communication will be required between Operations, Quality Release and Supply Chain team.

What we are looking for in a QC Analyst I, Micro:

As this person will be the responsible for oversight of the autologous cell therapy manufacturing program, a background in cell culture, aseptic gowning and qualification, and ISO class 5 cleanroom operations is required. Cell/gene therapy experience.

Minimum of 5-10 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.

Quality mindset, familiar with 21 CFR Part 11 and standard GxP best practices and FDA regulations.

Why Choose R&D Partners?

As an employee, you have access to a comprehensive benefits package including:

• Medical insurance PPO, HMO & HSA
• Dental & Vision insurance
• 401k plan
• Employee Assistance Program
• Long-term disability
• Weekly payroll
• Expense reimbursement
• Online timecard approval

Pay Scale:

$125,000 $130,000 (Dependent on Experience)

R&D Partners is a global functional service provider and strategic staffing resource specializing in scientific, clinical research & engineering. We provide job opportunities within major pharmaceutical, biopharmaceutical, biotechnology, and medical device companies.

R&D Partners is an equal-opportunity employer.