Supervisor, Quality Control, Analytics

Supervisor, Quality Control, Analytical

About Audentes Therapeutics

Audentes Therapeutics is a leading AAV-based genetic medicines company focused on developing and commercializing innovative products for serious rare neuromuscular diseases. We are leveraging our AAV gene therapy technology platform and proprietary manufacturing expertise to develop programs across three modalities: gene replacement, vectorized exon skipping, and vectorized RNA knockdown. Our product candidates are showing promising therapeutic profiles in clinical and preclinical studies across a range of neuromuscular diseases. Audentes is a focused, experienced and passionate team driven to improve the lives of patients.

Audentes leverages strong, global relationships with the patient, research, and medical communities, and we take pride in carefully selecting our colleagues. Listed below is a current opening for a smart, driven, experienced, and just plain nice individual who wants to join us on our journey.

The Role

Audentes Therapeutics is seeking an experienced Supervisor, QC to join the Quality Control group. The Supervisor, QC will be responsible for implementing and executing analytical testing in support of clinical and commercial viral vector products in compliance with GMP requirements. Will also support stability studies, method transfer and validation studies and equipment validation. This role will be reporting to the Senior Manager, QC and will be located in our South San Francisco Quality laboratories.

Responsibilities

• Supervise analysts in an analytics lab for testing of in-process and drug product samples using methods, including PCR, ELISA, HPLC
• Conduct work assignments, monitor progress, and lead problem solving
• Perform analytical testing as necessary
• Review test results, support/address investigations regarding out of specifications (OOS) results, invalid or atypical test results following Quality procedures
• Develop, revise, and review SOPs, qualification/validation protocols and reports, stability protocols and reports as assigned by management
• Support assay optimization, transfer and validation
• Author method transfer and validation protocols and reports
• Coordinate with Manufacturing and Process Development to maintain lab priorities and scheduling assignments as well as provide analytical information and expertise
• Ensure lab personnel receive proper and prompt training
• Ensure that lab safety standards are maintained
• Ensure lab compliance with applicable cGMP regulations and SOPs, and support regulatory audits

Required Qualifications

• B.S. degree in biological sciences, cell biology, chemistry or related field with 5+ years of relevant experience at least 1 year of management experience
• Coach, mentors  and trains QC Analysts in quality principles, procedures and analytical methods
• Sets clear expectations with individuals and as a team for achieving results, and his/her team consistently achieves results that are in line with expected job standards
• Fosters an empowering environment where team members develop innovative solutions that improve performance; gains team support for change
• Establishes expectations for collaboration within the team and models effective collaboration; supports collaborative efforts with other teams and departments and builds strong partnerships that lead to improved results
• Creates opportunities for direct reports to improve their knowledge and skills needed in the current job; shows courage in delivering tough feedback; feedback improves direct reports' performance; works with direct reports to identify and facilitate career growth opportunities
• Hands on experience and strong expertise with chromatography and HPLC  techniques or with  molecular biology techniques
• Prior laboratory hands-on experience with a variety of analytical techniques, including UV spectroscopy, protein concentration determination, osmolality, physicochemical tests
• Familiarity with ddPCR, qPCR, DNA/RNA purification/detection, ELISA assays
• Demonstrated experience in analyzing and interpreting data and information, drawing conclusions and making recommendations and decisions
• Strong knowledge of GMP, SOPs and quality control processes
• Working knowledge of quality systems and regulatory requirements
• Strong data integrity knowledge and practices
• Good to excellent technical writing skills and verbal communication skills
• Excels in a fast-paced team environment, handles multiple tasks concurrently, and in a timely fashion
• Strong interpersonal skills, highly collaborative within a multi-discipline team and contributes to a supportive and positive work environment
• Highly self-motivated and goal oriented
• Sets clear expectations with individuals and as a team for achieving results
• Models our Core Values: Be Bold, Care Deeply, #GetStuffDone – is experienced as someone who exemplifies the culture we want to create; operates with transparency; is trusted.

Preferred Qualifications

• Prior supervisor experience and demonstrated leadership capabilities
• Hands-on experience with mammalian cell culture and bioassays

All qualified applicants will receive consideration for employment without regard to race, sex, color, religion, sexual orientation, gender identity, national origin, protected veteran status, or on the basis of disability.