Senior Manager, Process Development, Reagents
Pacific Biosciences is looking for a highly motivated, technical Senior Manager to lead the commercialization and development of molecular biology reagent products for the SMRT™ Sequencing system. In this Manufacturing NPI leadership position, this lead scientist will guide the team to launch new molecular biology products through the stable transfer of kit design from RD into Manufacturing. The candidate must exhibit a strong interest in working/leading in a fast-paced environment with varied responsibilities and have a proven track record of product launches in the reagent life sciences field.
- Provide technical direction and leadership to a process development/NPI team in order to commercialize new molecular biology reagent kits.
- Deliver well characterized, robust, and reliable manufacturing processes to allow sustainable production of high quality kits spanning from Sample Preparation to Sequencing.
- Develop and characterize analytical methods and other QC test for release of quality product.
- Structure manufacturing processes and documentation (Bills of Materials, Batch Records, Materials Receiving documentation, Work Instructions, etc).
- Establish specifications for new manufactured parts.
- Establish relationship between product performance, physical specifications, and manufacturing capabilities.
- Complete vendor selection, vendor qualification, and lead technical discussions to establish vendor requirements.
- Coordinate first prototype builds and pilot production builds with Reagent Operations.
- Ensure smooth transition of new products into Reagent Manufacturing through a defined operator training program.
- Maintain a stability program.
- Optimize manufacturing processes to increase efficiency and reduce cost.
- Support technical troubleshooting and failure analysis during production nonconformances.
- Project core team representative for Reagent Manufacturing NPI.
- Ph.D. in Molecular Biology, Biochemistry, or related scientific discipline.
- A minimum of 3 years leading and providing technical guidance to a Process Development team or NPI team in a relevant industry of Life Sciences, Medical Devices, or Diagnostics.
- Strong technical skills and broad knowledge in molecular biology and biochemistry (in particular, nucleic acids, DNA modifying enzymes, fluorophores, and formulation design/optimization). Knowledge of sequencing technologies and sequencing data analysis is a plus.
- Broad knowledge of analytical tools and assay development for molecular biology reagents.
- Broad knowledge of manufacturing systems (e.g. PLM system such as Agile, ERP system such as SAP) and reagent manufacturing operations.
- Well versed in statistical analysis tools to ensure the delivery of robust, reliable, and accurate processes to routine manufacturing.
- Prior experience in goal setting and managing projects through project management tools to meet aggressive product launch timelines.
- Proven track record of commercializing molecular biology reagents and completing projects on schedule.
- Detailed oriented manager who excels at data driven decision making, effective experimental designs, and ability to identify problems with concurrent development of corrective solutions.
- Effective verbal and written communication skills in the form of presentations, reports, and formal manufacturing documentation.
- Ability to interface and drive change from team members of various disciplines: RD, Marketing, Planning, Purchasing, Regulatory, Quality Assurance, and Logistics.
- Ability to lead and take independent initiative in an environment of fast pace innovation.
- A driven, flexible, goal-oriented leader and collaborative team member.
- Knowledge of ISO9001 and ISO13485 a plus
All qualified applicants will receive consideration for employment without regard to race, sex, color, religion, national origin, protected veteran status, or on the basis of disability, gender identity, and sexual orientation.