Director, Quality Control
Company: Emergent BioSolutions
Posted on: January 16, 2020
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
The QC Director provides strong leadership, strategic planning, and
laboratory system oversight for Quality Control unit at Emergent
BioSolutions Operations in Lansing, Michigan. The QC Director is
responsible for the testing of raw materials, in-process samples,
final products, and stability. The QC Director has oversight for
the QC Value stream, QC Improver, Environmental Monitoring,
Forensic Laboratory, QC Support, Laboratory Management and Lab
Resources groups. The incumbent is also responsible for method
improvement projects, transfer and validation of methods to be used
for release of licensed products.
* 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
* 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, 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.
Education, Experience & Skills
Educational Requirement: BS in, Biochemistry, Microbiology,
Chemical Engineering or other closely related scientific field. PhD
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
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
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
Type/keyboard, visual acuity, good eye/hand coordination, stand,
walk, sit, twist/turn, reach outward, reach above shoulder, hand
dexterity, bend, squat/keel, sense of feel, sense of hearing, sense
of smell, lift carry 10lbs, push/pull 10lb. Use phone, fax, copier,
and computer. Organize/coordinate, analyze/interpret, problem
solve, make decisions, supervise, plan, communicate, prepare
written communications, and prepare transaction documents. Work
around noise above conversation level, multiple locations,
restricted access laboratory, and contact with select agents.
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.
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
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
Keywords: Emergent BioSolutions, Lansing , Director, Quality Control, Executive , Lansing, Michigan
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