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Director, QC - Rockville, United States - Emergent BioSolutions
Description
We go where others won't, taking on some of the biggest public health challenges to protect and enhance millions of lives, and create a better, more secure world. Here, you will join passionate professionals who advance their scientific, technical and professional skills to develop products designed-to protect and enhance life.
I. JOB SUMMARY
The QC Director provides strong leadership, strategic planning, and laboratory system oversight for Quality Control unit at Emergent BioSolutions Operations in Rockville, MD. The QC Director leads the group responsible for the testing of raw materials, in-process samples, final products, and stability. The QC Director has oversight for the QC Operations, QC Improver, Forensic Laboratory, QC Support, Laboratory Management and Lab Resources groups.
II. ESSENTIAL FUNCTIONS
• Provide strong leadership for a cGMP Quality Control testing laboratory within a commercial vaccine manufacturer. The Quality Control organization responsibilities include bioanalytical, chemical, microbiological, and in vivo testing of raw materials, in-process materials and finished products. Method validations and transfers, laboratory animal facility management, laboratory data management and stability programs are also managed by the Quality Control Organization.
• Provide strategic planning to the QC department in terms of multi-year plan for method and equipment replacement including consideration of capital and validation needs.
• Ensure cGMP compliance in the testing of products including vaccines, raw materials, in-process materials and other product. In addition, responsible for leadership in contact with regulatory agencies and customers.
• Provide strong technical leadership assuring QC laboratory compliance standards for the division as well as oversight of the development of methods, method transfer protocols, technology transfer to and from the QC division, and management of contract services.
• Provide leadership and guidance to ensure operational execution of batch release activities, assay transfer validation, stability programs, cultural deliverables and all employee-related deliverables (reviews, merit, etc.).
• Participate in interdepartmental/site leadership and operational excellence initiatives. Interact with other functional areas to define and execute project requirements and objectives and maintain compliance across the site.
• Manage and mentor QC management staff to emphasize positional responsibility, personnel development and succession planning throughout the unit.
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. MINIMUM EDUCATION, EXPERIENCE, SKILLS
Educational Requirement: BS in, Chemistry, Biochemistry, Microbiology, Chemical Engineering or other closely related scientific field. MS preferred.
At least 10 years' experience in Management in Vaccine, Biologics or Pharmaceutical testing facility.
Knowledgeable of FDA/ICH/EU regulations and guidance's and USP and other Pharmacopeia standards of testing.
Experience in FDA, HC, EMA, corporate and third-party audits.
Strong management skills coupled with relationship management is essential.
Strong technical knowledge in Chemical, Biochemical, and Microbiological theory and methods such as HPLC, GC, SDS-PAGE, Protein Analysis, AAA, Animal-Based and Cell-Based Bioassays, and Sterility testing.
Track record of working effectively in teams to resolve issues and elevate as appropriate.
Ability to teach intent and common industry implementation of the Quality Control Systems is essential. Ability to prioritize and multitask necessary.
Per CDC guidelines, Emergent strongly recommends that all employees working on site are vaccinated to help ensure their safety, as well as the safety of fellow employees. This includes the use of good judgment when determining when the CDC guidelines advise that you stay home when ill.
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. Emergent BioSolutions is an Equal Opportunity/Affirmative Action Employer and values the diversity of our workforce. Emergent does not discriminate on the basis of race, color, creed, religion, sex or gender (including pregnancy, childbirth, and related medical conditions), gender identity or gender expression (including transgender status), sexual orientation, age, national origin, ancestry, citizenship status, marital status, physical or mental disability, military service or veteran status, genetic information or any other characteristics protected by applicable federal, state or local law. Information submitted will be used by Emergent BioSolutions for activities related to your prospective employment. Emergent BioSolutions respects your privacy and any use of the information submitted will be subject to the terms of our Privacy Policy . 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.
