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QC-Biochemistry and Bioassay Manager

52501
QC-Biochemistry and Bioassay Manager
Branchburg Park
New Jersey
United States
North America
Local
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As a QC Biochemistry/Bioassay Manager you will direct the group activities of up to 15 analytical QC staff, which may include supervisory levels. You will plan work for the group to respond to changing priorities and maintain a safe, orderly and compliant work area according to company safety standards and cGMP regulations. Additionally, you will assist with workload, as needed and effectively represent the company with FDA and other Regulatory Agency officials related to QC expertise.
  • Take full responsibility for deliverables of the QC Bioassay team, which includes routine testing to support product release, stability, and process validations.
  • Coordinate routine and non-routine analyses of test articles by methods such as residual impurity by ELISA and qPCR, potency determination by ELISA and cell-based methods. Manage the critical reagent, reference standard, and product control qualifications.
  • Serve as a technical expert on the bioassay related methods performed in the group and the results obtained. Strong knowledge of analytical trending programs to evaluate and investigate data to detect product or method-related trends.
  • Monitor workload distribution, prioritize as needed and ensure completion of all tasks.
  • Identify analytical projects required to achieve group and corporate objectives. Plan and coordinate implementation of desired outcome(s).
  • Work independently but ensure communication of critical information upward with agreement from senior management for key decision-making.
  • Evaluate, coach and manage personnel performance. Set team group objectives, monitor progress, and be accountable to commitments.
  • Take part in the budget process. Monitor group spending to remain on track with budget.
  • Take initiative to make things better for the company, be ambitious with your work and assertive in your interactions, lead by example and foster collaborative relationships.
  • Build a strong, responsive team that is reliable, agile and flexible to shifting demands
  • Use technical knowledge, understanding of policies, remain current on regulatory and industry trends to make sound decisions that serve and move forward the business.
  • Use scientific expertise to provide assistance to team with troubleshooting, laboratory investigations, problem solving and implementation of process improvements.
  • Assure adherence of acceptable cGMP practices by staff during execution of all work tasks.
  • Review test results for conformance with specifications and effective documents.
52501BR
  • Combination of education, training and previous technical experience in a biopharmaceutical or similarly regulated GMP laboratory that provides the knowledge, skills, and abilities to perform the job:
    • Bachelors degree requires 6+ years experience
    • Masters degree requires 4+ years experience
    • PhD requires 2+ years experience
  • 3+ year(s) of leadership responsibility.
  • Cell based bioassay laboratory experience is strongly preferred.
  • Cell-culture, ELISA, flow cytometry/ FACS and/or automated instrumentation experience preferred.
  • Advanced Degree Preferred
  • Demonstrated competence in area to manage with at least 10 years of technical experience in protein product. Experience in monoclonal antibody is not required but a definite asset.
  • Critical thinking capabilities to advocate and move the business forward. High level of ownership/accountability.
  • Excellent working knowledge of cGMP regulations for QC laboratory applications is required
  • Excellent teamwork and communication skills. Attentive to detail. Good computer skills
  • Ability to take initiative, to be assertive, to lead by example and to build relationships.
  • Strategic thinking capabilities to advocate and move the business forward. High level of ownership/accountability.
Lilly is an EEO/Affirmative Action Employer and does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status.