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Director of Testing Operations (US-PA-Philadelphia)

Overview:

  • The Director, Quality Control oversees the Functional Laboratory groups within Philadelphia Testing Operations, including Virology Operations, Molecular Biology, Viral Clearance, Quality Control & Analytical.  Works closely with the groups’ Associate Directors and Manager’s as well as other departmental leaders in the organization to ensure day-to-day testing operations are performed timely, efficiently, and accurately.
  • Key Accountibilities:

  • Operational Leader with focus on driving operational and technical efficiencies across the testing groups as well as compliance. 
  • Demonstrates leadership and support of company goals and objectives
  • Responsible for the direction of the Testing Operational Groups in Philadelphia
  • Develops revenue and budget projections, staffing plan and capacity management for Testing Operations
  • Drives continuous improvement and operational efficiencies to improve client satisfaction, testing efficiencies and company profit
  • Challenges and improves the technical capabilities in testing groups
  • Execution and operational metric improvement within Testing Operations
  • Manages and develops Staff. 
  • Supervises, plans and reviews operations for assigned staff, including responsibility for training, managing and evaluating as well as coordinating, scheduling and assigning work and maintaining standards.
  • Recommends hire / transfer / promotion / discharge and salary changes and acts on employee problems.
  • Conducts employee performance appraisals in a timely and objective manner.
  • Provides li in-house guidance on science and technology.
  • Interacts with internal staff to identify assays requiring further improvement or development and directs the team that oversees improvement of these assays.
  • Responsible for labs that appropriately conduct assays in accordance with GLPs or cGMPs. 
  • Assures that laboratory personnel are following all company SOPs and safety rules. 
  • Assures that batch records and other paperwork are completed according to GLPs / cGMPs and company SOPs. 
  • Responsible for strategic planning and process improvements within Testing Operations.
  • Continually demonstrate scientific skills in biologics and a li working knowledge of the Good Laboratory Practice (GLP) / current Good Manufacturing Practice (cGMP) compliance requirements for biosafety testing Interacts with Clients, Regulatory Authorities on technical and business development matters. 
  • Demonstrates a clear understanding of the business and efficiently manages testing operations to address overall scientific and business needs in a timely manner. 
  • Assures accountability to performance and operational metrics and continuous improvement. 
  • Other duties as assigned.
  • Requirements:

  • 10+ Years experience
  • Bachelor’s degree with major in Biological Sciences or science related major or equivalent training and/or experience.
  • Demonstrated Leadership Skills
  • Possesses rigorous managerial skills
  • Operational management experience to drive improvements and deliver to lead times while maintaining rigorous compliance practices and technical understanding
  • Knowledge of GLP and cGMP guidelines is desirable.
  • Ability to make decisions based on a wide knowledge of factors where application of advanced or technical concepts is predominantly required.
  • Ability to evaluate technical data and write technical documents.
  • Ability to use judgment as dictated by complexity of situation.
  • Ability to work under limited supervision and to handle problems of a difficult nature.
  • Ability to accomplish the described duties through the use of appropriate laboratory equipment (i.e. biohazard hood, centrifuge, incubator, and autoclave) and computer equipment and software. (i.e. Microsoft Word, Outlook).
  • Ability to accurately and reproducibly perform arithmetic calculations including fractions, decimals and percentages and basic algebraic and geometric calculations.
  • Ability to record data accurately and legibly.
  • Ability to understand and follow verbal or demonstrated instructions.
  • Ability to express or exchange ideas by means of the spoken word.
  • Ability to work effectively as part of a team and to exhibit effective interpersonal skills.
  • Ability to receive and comprehend and to effectively communicate detailed information through verbal and written communication.