Sr Manager, QC Biochemistry 6/5/2020
JOB DESCRIPTIONAPPLY Those who join Emergent BioSolutions feel a sense of ownership about their future. You will excel in an environment characterized by respect, innovation and growth opportunities. Here, you will join passionate professionals who advance their scientific, technical and professional skills to develop products designed-to protect life.
I: 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 complaint manner.
II: 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 specialists / supervisors 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, product specification management, routine data and investigation review.
* Provide strategic planning and execution to support Quality Control and site vision. Contribute to the business development process providing estimates for proposed CMO work.
* 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 scheduled test period.
The above statements are intended to describe the general nature of work performed by those in this job. It is not an exhaustive list of all duties, and other duties may be assigned.
III: Education, Experience & Skills
* BS in, Biochemistry, Microbiology, Chemical Engineering or other closely related scientific field.
* At least 10 years experience in Management in Vaccine, Biologics or Pharmaceutical testing facility.
* Must possess skills and knowledge of general bioanalytical and chemical test methods such as IEF, SDS-PAGE, Western Blot, GC, UV, sub-visible particle analysis, HPLC with multiple modes of detection, CE, and UV and IR spectroscopy.
* 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.
* Ability to influence
IV. PHYSICAL/MENTAL DEMANDS AND WORK ENVIRONMENT CHARACTERISTICS
The physical/mental demands are representative of those that must be met by an individual to successfully perform the essential functions of the job.
The work environment characteristics described here are representative of those an individual would encounter while performing the essential functions of the job.
Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
Emergent BioSolutions is an Equal Opportunity/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, gender, age, national origin, disability, Protected Veteran status, sexual orientation, or any other characteristic protected by federal, state or local law.
Emergent BioSolutions does not accept non-solicited resumes or candidate submittals from search/recruiting agencies not already on Emergent BioSolutions approved agency list. Unsolicited resumes or candidate information submitted to Emergent BioSolutions by search/recruiting agencies not already on Emergent BioSolutions approved agency list shall become the property of Emergent BioSolutions and if the candidate is subsequently hired by Emergent BioSolutions, Emergent BioSolutions shall not owe any fee to the submitting agency.