The Associate Director, Quality Control will be responsible for leadership of a functional team as well as individual contributions to establish quality control operations for ProKidney located in Winston Salem NC. This role will manage and execute GMP quality control activities directly related to batch release for clinical trial material supply. The leader in this role must assure that quality controls for investigational new drugs (investigational medicinal products) meet all quality requirements, regulatory standards, and meet continuous clinical supply and delivery expectations.

Primary Responsibilities and Job Functions:

• Developing/qualifying/validating analytical methods based on experience, first principles, sound theory, etc.
• Manage/coordinate/drive efforts of staff in conjunction with approved plant scheduling; ensure adherence to agreed-upon deadlines; timely completion of work.
• Assure compliant, staffed analytical laboratory support.
• Recommend/justify new/additional equipment, upstaffing or organizational positions, promotions.
• Develop/maintain/improve Analytical Procedures/SOPs/systems/procedures/similar.
• Ensure training, development, and mentoring of laboratory colleagues.
• Represent GMP Analytical in production meetings, customer discussions, etc.
• Design, develop, conduct and/or review experiments including method qualification/validation, method transfer, and unknown identification utilizing typical instrumentation including but not limited to LC, MS, GC, etc.
• Use/facility in various instrumental methods (IR, NMR, XRPD, TGA, KF, etc.) as well as non-instrumental methods (wet chemical methods)
• Write reports documenting outcomes of experiments/exercises.
• Organize workflow and tasks to maximize laboratory efficiency (e.g., prioritize sample analysis, manage/assign tasks, preventative maintenance)
• Act as scientific, regulatory, technical or quality expert/liaison in team meetings and other settings by providing timely input to project activities/support to customers, responding to targeted questions, etc.
• Participate in the laboratory quality system activities such as internal audits, writing standard operating procedures, and documentation review.
• Prepare samples for analysis and record data from analyses or experiments in a computer, logbook, or laboratory notebook.
• Perform data audits in order to ensure accuracy of data and analytical processes.
• Provide leadership including cross-training and technical development to other laboratory colleagues as needed.
• Maintain laboratory equipment and instrumentation (e.g., troubleshooting, conducting preventative maintenance, calibrating and repairing);
• Ensure compliance with company policies and SOPs as well as FDA and other applicable guidelines.
• Demonstrate insight in design of experiments and gathering/interpreting data in order to deduce and/or test mechanistic or systematic hypotheses.

Education level and/or relevant experience required:

• Bachelor’s degree in a scientific or allied health field (or equivalent degree) and 10+ years of demonstrated success in leading teams and managing projects along with 7+ years relevant analytical experience in a cGMP-compliant pharmaceutical laboratory environment. Any ASQ or other certifications is a plus.

Knowledge and skills (general and technical) preferred:

• Broad background, strong comprehension, and demonstrated skills in analytical methods development/validation/transfer/similar, reference standards characterization/structural elucidation, and unknown identification.

Preferred Experience and Skills:

• Experience in stability study performance/evaluation and/or knowledge/familiarity with USP/compendial testing is helpful.
• Excellent verbal and written communication/interpersonal skills, problem-solving skills, organizational skills, and the ability to work in a diverse team environment are essential.
• Proficiency with Microsoft software (Word / EXCEL / PowerPoint) is expected.

Qualified, interested candidates should send resume to: careers5@prokidney.com