The Senior Director will be responsible for leading the Quality Control Laboratory and oversight of Contract Testing QC labs in support of clinical manufacturing, establishment of internal QC processes, and maintenance of the control strategy for investigational products and moving towards licensure. 

Key Responsibilities 

• Plan and able to perform multiple bioanalytical assays  

• Manage QC quality records including, but not limited to, Out-of-Specification Investigations, Deviations, CAPAs, and Change Controls, and ensure all related activities are completed in a timely manner 

• Establish routine operations to govern QC activities, including scheduling sample testing, performing documentation reviews, ordering supplies, and oversight of QC equipment maintenance and calibration 

• Serve as the QC Subject Matter Expert (SME) 

• Author, review, and approve QC-related documentation (CoA, Methods, SOPs, reports, etc.) and provide documentation support to QA, as needed 

• Collaborate with the Research and Product Development team in the transfer of analytical assays to QC 

• Coordinate with Manufacturing for in-process and product release test sample submission and testing 

• Direct testing for and support the product stability program 

• Attend functional and cross-functional meetings to discuss ongoing work and align priorities 

• Lead the efforts for the Quality Control Laboratory to obtain an FDA Establishment Identifier number  

• Manage, coach, and develop a growing team of QC Scientists 

Qualifications 

• BS or MS degree in Biology, Biochemistry, Chemistry, or a relevant scientific discipline is required, at a minimum
• 8-10+ years of relevant biotech/pharma industry experience, including Quality Control experience supporting cGMP areas 

• 3+ years’ experience supervising/managing direct reports 

• Experience in western blot, flow cytometry, cell-based assays, particle size analysis, Karl Fischer assay, compendial assays 

• Demonstrated industry knowledge of cGMP 

• Experience leading people and/or projects with history of achieving results and outstanding outcomes 

• Strong communications skills: a team player who can lead, mentor, and inspire others 

• Experience participating and/or supporting regulatory inspections preferred 

• Gene or cell therapy product experience preferred 

Additional Information 

• Schedule: Monday – Friday  

• Work Location: Rochester, MN 

• Relocation Assistance: Yes 

• Job Type: Full-time, Salaried 

Position Overview 

Perform analytical testing designed to characterize cell-based therapeutic products at various stages during the manufacturing process, up to and including release of the product for administration to patients.

Responsabilities

• Perform analytical testing (e.g. residual moisture, viscosity, pH, content uniformity, particle analysis) of GMP and non-GMP samples, and maintain required documentation according to departmental policy to support product release and process development, respectively.
• Monitor and trend GMP Quality Control testing data to assure validity of test system results. Troubleshoot and remedy suboptimal performance of test systems.
• Maintain instrumentation. Monitor instrument performance to assure optimal operation.
• Coordinate equipment maintenance and repairs with the manufacturers. Develop and maintain a schedule for planned maintenance activities across the QC laboratory.
• Assist in the development of laboratory procedures.
• Procure laboratory supplies and consumables.
• Organize the laboratory and maintain inventory of laboratory consumables.

Qualifications

• A bachelor’s degree in biology, chemistry, or a related field is required. The ideal candidate has worked at least one year in a GMP laboratory for the Associate role and three years for the Sr. Associate role, but less experience will be considered provided the individual can demonstrate robust laboratory skills in testing execution and documentation. Eagerness to learn new skills and techniques is required.