Director of Testing Operations (US-PA-Philadelphia)
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.
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.
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.