Metagenomi is seeking a Manager/Senior Manager of Manufacturing operations at its pilot plant facility. This position has the opportunity to build the pilot plant manufuacturing operations, procedures, tools and team from the ground up. The person will work alongside Process Engineering, QA, QC, facilities and logistics teams within the technical operations department and help establish robust manufacturing operations with adherence to safety and quality. The person should be a problem solver, experienced with GMP operations and be proactive about learning new bioprocessing technologies for upstream and downstream operations.
The exact level of this position will be based on experience and qualifications, and as such, we encourage all interested candidates to apply. If you have relevant experience or knowledge that is not reflected on your resume, we welcome you to include a comment explaining any additional details you would like us to consider when reviewing your application.
About the Role
- Manage the GxP pilot plant operations for upstream (fermentation), downstream and filling of recombinant proteins with participation of the daily operation as needed.
- Develop a procedural and operational plan to utilize the GxP Pilot Plant facility for multiple modes of production i.e recombinant protein and mRNA.
- Plan, organize and execute upstream and downstream production targets within the cGMP pilot plant setting for internal and external clients.
- Generate metrics related to production to be used for communication with management, cross-functionally and to partners.
- Monitor inventory management and equipment in coordination with supply chain, logistics and facilities.
- Support OpEx budgeting activities and identify COGs reduction where possible.
- Lead vendor selection for any supportive activities related to the upkeep of the facility.
- Author and review technical documentation pertaining to Pilot Plant operations, e.g. batch records, SOPs, deviations, CAPA’s and risk assessments
- Lead operational readiness activities in preparation for the start-up of a GMP manufacturing facility
- Initiate investigations for operational and process failures with the appropriate corrective actions implemented
- Ensure all records and logs used for cGMP manufacturing are in compliance with regulatory and GMP standards.
- Ensure the required quality and safety standards are met with cGMP operating procedures
- Drive Continuous Process Improvements (CPI) in collaboration with the Process Engineering team.
- Support the qualification and validation of new equipment.
- Recruit and lead a multidisciplinary team accountable for all activities in the muti-modal GxP Pilot Plant facility.
- Create team performance goals and lead team and every individual towards achieving those goals
- Support career development plans and perform full performance evaluations for all direct reports
- Provide mentorship and coaching to individuals within the team
- Additional responsibilities may be assigned as needed
- Bachelor’s degree with 6+ years or Masters degree with 4+ years in Biology, Molecular Biology, Biochemistry, Biotechnology or related field with relevant experience in manufacturing or research laboratory. Equivalent industrial and academic experience will be considered in a manufacturing and/or operations setting.
- 2+ years of proven track record in managing, supervising and developing staff.
- Technical proficiency required for GMP production of biological products as well as technical problem solving.
- Experience in fermentation and chromatography operations is highly preferred.
- Experience in technology transfer and support of production processes for generation of clinical trial materials.
- Goal-oriented approach and demonstrated ability to effectively prioritize and focus on time-sensitive objectives.
- Ability to troubleshoot issues, identify root causes and implement effective solutions.
- Team oriented with experience working in a matrix team environment.
- Should be able to work in a dynamic start-up environment.
Why work at Metagenomi?
- We are passionate about developing technologies derived from microbial-rich ecosystems that have the power to enable therapeutic development and the potential to cure devastating disease.
- We have cultivated an amazing culture that values teamwork, curiosity, scientific rigor, and fun.
- Metagenomi offers competitive salary, annual target bonus, equity in an early-stage startup, and a comprehensive benefits plan, including 401(k) matching, a retirement safe harbor plan, and other perks.
At Metagenomi, we know that our people drive our success. Metagenomi provides an open, collegial, and friendly work environment where we empower people and provide them with opportunities to develop their long-term career. We are an equal opportunity employer and believe in and value diversity and inclusion. All employment is decided on the basis of qualifications, merit, and business need.
If you need assistance or accommodation due to a disability, you may contact us at email@example.com and we would be happy to help.