(2nd shift) M-F 3pm to 11:30pm
12% shift premium
Overview
In this position, one provides 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. This individual is directly responsible for the teams whose goals are to produce products on the manufacturing floor. The Manufacturing Manager is also responsible for the development of staff, to accommodate needs as a growing organization.
Essential Functions and Responsibilities
• 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.
• Maintain robust training program to ensure timely, efficient, and effective training of individuals. A highly effective "First time right" program is required for autologous cell therapy.
• Participate in tours or information requests for all agency and internal audits of the manufacturing facilities/processes and respond to any observations received per procedure.
• Develop and provide monthly manufacturing metrics and "Health of the Operations"
• Lead personnel actions to include recruiting, onboarding, performance management, training, promotions, transfers, etc.
• Supervision and development of direct reports, mentoring/coaching to motivate and mentor peers/ staff, to foster a culture of continuous improvement and operational excellence.
• 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.
• Comply with Safety SOPs, SDS sheets, and laboratory procedures per company policy and OSHA regulations.
• Perform miscellaneous duties as assigned.
Travel
• May require travel based on business needs
Required Education, Skills, and Knowledge
• Minimum B.S. degree in biology, biochemistry, bioengineering, or related technical field, or equivalent industry experience.
• Minimum 3+ years of experience in biopharmaceutical-based GMP and management experience manufacturing operations, including experience in cell culture and associated downstream processing.
• Demonstrated technical knowledge of aseptic processing in cleanroom environments a must.
• Solid knowledge of FDA regulations and GMP systems.
• Solid knowledge of human error reduction strategies, right-first time execution, and just culture.
• Demonstrated project management skills. Excellent oral and written communication skills. Strong technical writing ability.
• Experience leading "development" initiatives, i.e., training, coaching, learning initiatives.
• Ability to motivate and mentor peers and staff as well as foster a culture of continuous improvement and operational excellence.
• Proactive, results oriented, self-starter with demonstrated strong leadership skills and experience in a complex manufacturing environment. Self-motivated and willing to accept temporary responsibilities outside of initial job description.
• Must be comfortable in a fast-paced small company environment with minimal direction and able to adjust workload based upon changing priorities.
• Ability to deal with ambiguity - ready to change gears and plans quickly, with the need to manage constant change.
• 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.
Preferred Education, Skills, and Knowledge
• 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.
• Proactive, results oriented, self-starter with experience in a complex manufacturing environment.
The physical demands described here represent those that an employee must meet to perform the essential functions of this job successfully. Reasonable accommodations may be made upon request to enable individuals to perform essential functions. Please contact Human Resources to request an accommodation.
For the Visual Inspection Program, the technician must be able to pass a Vision Exam that includes the following:
• Must not be color blind
• Must have 20/20 near vision in both eyes (can be corrected)
Physical Demands and Activities Required:
• Must be able to wear appropriate clean room attire and all Personal Protective Equipment (PPE), i.e. scrubs, gowning coverall, masks, gloves, etc.
• Must meet requirements for and be able to wear a half-face respirator.
• Able to stand and/or walk 90% (and sit 10%) within your scheduled workday, which may include climbing ladders or steps.
• Able to crouch, bend, twist, reach, and perform activities with repetitive motions.
• Must be able to lift and carry objects weighing 45 pounds.
Mental:
• Clear and conceptual thinking ability; excellent judgment, troubleshooting, problem-solving, analysis, and discretion; ability to handle work-related stress; ability to handle multiple priorities simultaneously; and ability to meet deadline.
Work Environment:
• This position will work in both an office and a manufacturing lab setting.
• When in the lab, must be able to work in Lab setting with various chemical/biochemical exposures, including latex and bleach.
• Able to work in cleanroom with biohazards, human blood components, and chemicals.
• Potential exposure to noise and equipment hazards and strong odors.