The Scientist/Engineer is responsible for assisting in the development and implementation of manufacturing processes used to manufacture client cell and gene therapy products at the Center for Breakthrough Medicines. This individual will work with internal and external organizations to plan, execute, and document studies/assessments to support GMP operations stand-up and maintenance, yield process improvements, reduce errors, and support investigations.The Scientist/Engineer will provide ownership and management for process and characterization knowledge related to the GMP production of advanced therapy products.
Additionally, this individual will be responsible for supporting the collection and interpretation of continued process verification data and collaboration with other departments on manufacturing related issues to drive resolution and process improvements.This position will involve hands-on troubleshooting of the manufacturing processes and writing of technical reports.
Other responsibilities include providing assistance in manufacturing led investigations through partnerships with Quality and other business units at the site.Work to determine root cause, implement a solution and a verification check to ensure the fix was effective.
The Scientist/Engineer will be responsible for owning a portion of the process, planning ahead to avoid delays, good documentation practices, and participating in continuous improvement and operational excellence projects to help drive efficiency, while error proofing the process.
- Serving as a scientific and technical representative for process-related issues at the facility.
- Partnering with Process Development and Operations to meet the production schedule, ensure product supply and uphold quality standards.
- Performing trending and monitoring of critical quality attributes/critical process parameters to maintain product quality and to control process drift.
- Implementing potential process improvements in conjunction with operations.
- Participating in start-up efforts of new equipment, software or processes in manufacturing.
- Assisting in documenting changes/updates to manufacturing processes and working with manufacturing, engineering and validation to implement those changes
- Providing technical/scientific support on project deliverables, i.e. remediation initiatives, plan reports, etc.
- Utilizing small-scale production processes and using scaled-down lab processes to enable process troubleshooting
- Support tech transfer of new products and processes to ensure smooth transition from process development into GMP manufacturing
- Assist in implementing opportunities for operational excellence and continuous improvement
- Partner with Quality to ensure a quality and compliant manufacturing environment
- Assist the technical operations team to resolve any issues related to production
- Minimum B.S. degree in biochemistry, chemical engineering, bioengineering, or related technical field
- Excellent oral and written communication skills.
- 2 – 5 years of experience in biopharmaceutical based GMP manufacturing operations including direct experience in cell culture, recovery, purification, and/or aseptic fill/finish
- Familiar with global regulations on cGMP manufacturing of drug substance, drug products devices, validation/qualification requirements
- Strong technical writing ability
- Proven ability to effectively lead and participate on teams
- Entrepreneurial experience dealing with customers in product development
- Working knowledge of cGMPs related to the production of microbial therapeutics
- Extremely high levels of flexibility, initiative, solution-orientation, and tenacity.