Manager of Process Development
Natick, MA /
The Manager of Process Development will build and supervise a process development team responsible for the rapid and successful technology transfer from R&D to manufacturing. The process development team will develop optimized manufacturing processes, storage containers and conditions, as well as measures of raw material, process, and product performance to allow process monitoring and robust manufacture at the appropriate scale. The Manager of Process Development will interface closely with R&D, Quality Control, Manufacturing, and Program Management.
Duties and Responsibilities:
- Build out and direct the activities of a new Process Development organization
- Coordinate with R&D, Quality Control, Manufacturing, and Program Management to collect process requirements
- Formulate development and testing strategy to address major risks related to process and materials
- Optimize manufacturing steps for robustness and to meet performance and scale requirements
- Working closely with Manufacturing, generate required work instructions, test methods, protocols, batch records, and report templates to support product manufacture
- Contributes to evaluate, hire, and train personnel where applicable
- MS degree with 1-2 years of industry experience preferably in cGMP and ISO9001 environments OR BS degree with 5-7 years of experience in biology, molecular biology, biochemistry or a related field and/or equivalent combination of education and experience
- Experience with nucleic acid diagnostics, especially PCR or Next Generation Sequencing considered an asset
- Proficient with design of experiment (DOE) methodology and application of statistical methods to process and test data to set control limits and understand the expected type and frequency of errors and deviations
- 5+ years of laboratory experience, 3+ years in an industry setting, 1+ years as a manager working in cGMP and ISO13485 environments
- Direct process development experience in transferring, improving, and scaling diagnostic reagent or biologics manufacturing processes
- Must have demonstrated expertise in authoring SOPs or similar process directed documentation
Knowledge, Skills, and Abilities:
- Effective supervisor with strong organizational and multi-tasking skills to work in a dynamic environment with evolving priorities
- Excellent analytical, organizational, communication, and documentation skills. A strong, collaborative team player
- Deep understanding of design of experiments (DOE), descriptive and inferential statistics, and tools for process trending and control
Pillar Biosciences' mission is to create technologies that make precision medicine accessible. We are a growing company with a plan to disrupt the clinical testing market.
Our focus is on building NGS diagnostic and software solutions from the ground up, leveraging experiences in genomics, data analytics, clinical testing and patient focus to quickly innovate and penetrate the market. If you thrive in a brilliant, fast-paced, and mission-driven environment, Pillar Biosciences is the place for you!
Pillar Biosciences is an Equal Opportunity and Affirmative Action employer committed to a culturally diverse workforce. All qualified applicants will receive consideration for employment without regard to race; religion; age; nationality; marital status; sexual orientation; disability or any other characteristic protected by law.