4 days left
- Salary Type
Celularity is seeking a dynamic, technical leader that will oversee the company's cGMP microbiology function. This role will work cross-functionally with Manufacturing, Quality Assurance, Analytical QC and Process Development to support the manufacture and release of multiple cell therapy and human tissue products. Responsibilities include, but not limited to, the direct oversight of a dynamic Microbiology team, cleanroom qualifications and daily cleanroom release, personnel monitoring, gowning qualifications and compendial testing. All responsibilities are in support of continually ensuring a compliant, robust, and reproducible facility wide contamination control and microbiological program.
- Directly oversee, establish, implement, and maintain microbiological methods and systems in support of the company's clinical and commercial stage products. Routinely ensure that existing and future microbiological/compendial methods and systems meet all required quality and regulatory standards.
- Ensure the Microbiology function operates with efficiency and technical and quality excellence. This includes resource planning, material forecasting, departmental budgeting and establishing innovative and industry-leading methods and practices.
- Assess and implement microbiological platforms and systems to increase operational strength, product offerings and departmental efficiencies. As needed, develop, qualify, and implement microbiology test methods in support of functional needs. Routinely collaborate with other functional heads/teams to improve operational efficiency and flexibility across clinical and commercial programs.
- Direct guidance, oversight, and implementation of compendial methods to support method validations, sterility methods and platforms, microbial analysis of excipients, APIs and finished products. Media preparation and testing, growth promotion, gram staining and routine isolation and identification of microbes is required.
- Oversee the direct training and continued performance of a team of laboratory operators and scientists to complete all operations/testing associated with the Microbiological function. This includes support of routine manufacturing, products and facility wide environmental monitoring. Provide regular guidance and mentorship to team, with accountability for the quality of their work.
- Maintain and oversee environmental monitoring and contamination control programs for multiple manufacturing suites, fill suites, media prep laboratories and other related facility spaces. Track, trend, and review collected data and routinely report to functional leadership. Serve as microbiological SME for internal/external audit and support excursion, OOS investigations with focus on determining root cause and maintaining continued control.
- Assure laboratory operation in compliance with Celularity Quality systems and Federal and State Regulations.
- In collaboration with Analytical QC, participate in stability and visual inspection programs as required. Provide support and guidance.
- Ensure the review and completion of all related Microbiological records and all routine sampling/tests both paper-based and electronic. Assure timelines are met and potential impacts minimized. Confirm team members comply with environmental health and safety policies and procedures (e.g. OSHA).
- BS. degree in Microbiology
- 15+ years' of demonstrated ability and experience overseeing Microbiological function and teams.
- Understanding of human cell and tissue-based therapies.
- Detailed experience working in cGMP environments and facilities.
- Strong understanding of federal regulations for Quality Systems (21CFR820)
- Strong understanding of both federal regulations for cGMP manufacturing (21CFR 210,211) and HCT/P (21CFR1271) regulations
- Understanding and experience with gowning for classified clean room environments.
- Strong organizational and time management skills
- Ability to work well in a team environment and motivate said team.
- Excellent verbal and written communication skills as well as strong focus and attention to detail.
- Flexible scheduling required.
- Advanced degree in Microbiology or related scientific discipline
- Experience with implementing automated microbiological platforms, software, etc.
- Experience in a fast-paced, scientific, start-up environment
- Dynamic individual with the ability to communicate and engage others.
- Independent and self-starting.
- Eager and adaptable.
- Position primarily supports classified laboratory environments. Routine gowning and operations in classified clean room environments is required.
- Open office environment outside of laboratory zones
- Fast paced, start-up environment which may periodically require work beyond standard business hours.
- Must be able to lift and transport at least 50 pounds.
- Handling of potentially biohazardous material (human cells, tissues, etc.)