Analytical Lab Manager
Primary responsibilities for role:
- Manages a team of Associates performing laboratory-based studies in either Fermentation (microbial and mammalian fermentation, scale up, fed batch, culture analysis), Purification (recombinant protein purification, IEC, GFC, RP-HPLC, HIC and other process improvements) or Analytical Methods (HPLC, SEC, DLS, Mass Spectroscopy, SDS PAGE, Silver Stain, Western Blot, ELISA, for in-process and release testing) to support process characterization, process improvement or investigations into process-related deviations.
- Provides leadership, motivation and career development of laboratory staff
- Acts as the key point of contact for study owners for related studies and be the group representative in team meetings
- Manages the laboratory budget and preparing the annual budget forecast and capital equipment requests
- Prepares CARs and all other required forms for laboratory equipment purchases and facilities modifications/improvements
- Identifies staff that perform each study according to required number of fermentations, purifications or analytical tests and complexity of the study
- Maintains a monthly experimental schedule for the Laboratory running whenever possible at a capacity of >80%
- Review and approves Technical Protocols, Method development and Qualification reports
- Ensures timely review of all data supporting technical studies.
- Ensures laboratory equipment and instrumentation upkeep which include troubleshooting, PM/calibration/qualification as needed
- Ensures staff are on-boarded and compliant with required trainings
- Communicates frequently with senior colleagues on project timing, progress and issues promptly.
- Provides weekly and monthly progress reports to Director of TD.
- Communicates with personnel from other Departments such as Facilities, Engineering Metrology/Calibration, Supply Chain Management, and Technical Services, to ensure laboratories are operational at least 48 weeks per year
- All equipment and the facility is maintained in a usable state at least 48 weeks per year
- All Associates have appropriate career development plans and are actively pursuing the agreed activities
- Hiring appropriately qualified personnel to fulfill teams functions and responsibilities
- Studies are completed on agreed time lines.
- Laboratory operates at a capacity of >80% whenever possible
- Functional group operates within expected budget target amount
Knowledge, Skills, and Abilities:
- Capable of effective use of Microsoft Word, Excel and Powerpoint
- Strong working knowledge of DOE approaches for experimental design
- Extensive working knowledge developing and qualifying analytical assays
- Very strong ability to plan and coordinate complex studies involving multiple departments
- Excellent written and verbal communication skills
Ph.D. in Protein Biochemistry, Molecular Biology, or a related life sciences discipline.
- 10+ years of experience with a Ph.D. in Analytical Development, Process Development environment in the biotechnology or diagnostics industry
- Strong understanding of microbial and Mammalian derived recombinant protein processes and Analytical characterization of recombinant proteins and monoclonal antibodies is highly desirable.
- At least 5 years previous experience managing a team of Associate Scientists
- Previous experience developing budget forecasts would be advantageous
- Experience working with design of experiments approaches and Process Analytical tools.