Laboratory Manager (Analytical Development) - Emeryville, CA | Biospace
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Laboratory Manager (Analytical Development)

Apex Life Sciences

Emeryville, CA
Posted Date:
Position Type:
Job Code:
Required Education:
Areas of Expertise Desired:
Analytical Chemistry, Biology, Chemistry, Drug Discovery, Fermentation, HPLC, Immunology, Manager, Microbiology, Molecular Biology, PhD, Protein Purification,

Job Description

We are looking for an Analytical Lab Manager for a large Biotech company in the East Bay Area!


This key role in provides scientific leadership and laboratory support for all analytical testing to support Fermentation and Purification studies, QC, Manufacturing deviation investigations, and Process Characterization studies.
This position drives experimental design for laboratory-based testing to either develop new methods/processes or to improve existing methods/processes.
Works closely and interacts with internal and external customers to provide the appropriate level of support.
A key focus for the bio-analytical lab manger is identifying and implementing process analytical tools and technologies to improve process understandings and drives innovation, efficiency and productivity in the lab.
Manages the laboratory budget and prepares the annual budget forecast and capital equipment requests.
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.
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.



Capable of effective use of Microsoft Word, Excel and PowerPoint
Strong working knowledge of DOE approaches for experimental design
Extensive working knowledge of cGMP environments
Very strong ability to plan and coordinate complex studies involving multiple departments
Excellent written and verbal communication skills
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 Testing 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.
Education: Ph.D. in Microbiology/Biochemical Engineering or related discipline