Manager, QC Immunology

Location
Baltimore (Bayview), MD, US
Posted
Sep 25, 2020
Ref
656560600
Hotbed
BioCapital
Required Education
Bachelors Degree
Position Type
Full time
JOB SUMMARY

Responsible for managing the QC Biochemistry group, production, stability, and method transfer activities, to ensure the testing and documentation are accomplished efficiently and in compliance with cGMP rules and regulation. The manager will provide support in transferring new projects into the Bayview site and maintain routine analysis and release of product. The manager will serve in supporting other Emergent sites as needed and support documentation required to conduct laboratory and data services in a compliant manner.

ESSENTIAL FUNCTIONS
  • Manage the Biochemistry Group operations in support of production by ensuring the timely execution of QC testing.
  • This position is also responsible for the day-to-day coordination and execution of in-process, release and stability testing at the Bayview site (EMOB).
  • Manage the analysts / specialists who perform the activities related to biochemistry testing, method transfers and support execution of transfer protocols and reports.
  • Review current laboratory practice to identify alternative strategies or cost saving measures for laboratory improvement.
  • Responsible for generating management review metrics and KPIs.
  • Provides scientific review and approval of protocols, reports, study design and standard operating procedures.
  • Provides mentoring and Conducts Performance Management of direct reports.
  • Works with the QC Sr. Manager and QC Director to ensure that QC operations are appropriately staffed, training is complete, and the operation meets both internal and external compliance (GMP) requirements.
  • Performs managerial duties, as assigned, in support of QC operations such as resource management, and routine data and investigation review.
  • Demonstrated strong organizational and technical writing skills.
  • Assists in creating and maintaining the unit budget.
  • Monitor laboratory equipment and coordinate with other groups to ensure all equipment is maintained in a calibrated and qualified state.
  • Regularly monitor QC reagent sample inventory.
  • Accurately track and maintain outstanding QC data throughout the testing lifecycle and ensure that scheduled testing is initiated within the defined test period.

The above statements are intended to describe the nature of work performed by those in this job and are not an exhaustive list of all duties. Nothing in this job description restricts managements right to assign or reassign duties and responsibilities to this job at any time which reflects management's assignment of essential functions.

MINIMUM EDUCATION, EXPERIENCE, SKILLS
  • B.S. degree in microbiology, Biochemistry, or closely related scientific discipline with at least 10 years of relevant experience or M.S. degree with a minimum of 5-8 years of relevant experience.
  • At least 3 years prior supervisory experience in a GMP laboratory required.
  • Must possess skills and knowledge of general immunological, bioanalytical and chemical test methods such as ELISA, qPCR, Viral and Cell-based assays, SDS-PAGE, Western Blot, UV, sub-visible particle analysis, Bioassay.
  • Ideal candidate will have laboratory skills that include compendial testing such as appearance and fill volume, container closure integrity testing, and simple analytical instrumentation.
  • Ability to apply statistical analysis to QC monitoring and trending.
  • Previous LIMS experience is required, and LIMS administrator experience is highly desired.
  • Experience in assay method transfer, product release, and raw material testing and release.
  • Previous experience with vaccines and cell bank stability is preferred.
  • Must possess skills and knowledge of implementing and managing a compliant stability program.
  • Advanced knowledge of cGMPs, safety and data integrity.
  • Experience in laboratory control including sample accessioning and product testing.
  • Experience in oversight of QC laboratory investigations including root cause analysis, OOS, and invalid assay investigation.
  • Knowledge of Good Manufacturing Practices and Good Laboratory Practices.
  • Must be highly organized, detail oriented and able to manage multiple projects.
  • Solid communication and presentation skills required.


PHYSICAL/MENTAL DEMANDS AND WORK ENVIRONMENT CHARACTERISTICS
  • There are physical/mental demands and work environment characteristics that must be met by an individual to successfully perform the essential functions of the job.
  • This information is available upon request from the candidate.
  • Reasonable accommodations may be made to enable individuals with disabilities to perform all essential functions.