Senior Scientist Plasmid
About Audentes Therapeutics
Audentes Therapeutics (NASDAQ: BOLD) is a biotechnology company committed to the development and commercialization of innovative gene therapy products for patients living with serious, life-threatening rare diseases. We believe gene therapy technology has tremendous potential as a treatment approach for many genetic diseases. We are currently conducting Phase 1/2 clinical studies of our lead product candidates, AT132 for the treatment of X-linked Myotubular Myopathy (XLMTM), and AT342 for the treatment of Crigler-Najjar syndrome. We have two additional product candidates in development, including AT845 for the treatment of Pompe disease, and AT307 for the treatment of the CASQ2 subtype of catecholaminergic polymorphic ventricular tachycardia (CASQ2-CPVT). We are a focused, experienced and passionate team driven by the goal of improving the lives of patients.
Audentes takes pride in strong, global relationships with the patient, research and medical communities, and we take equal pride in carefully selecting our colleagues. If you believe you match what we're looking for, we'd love to hear from you. Our compensation philosophy embodies what you'd expect from an innovative life sciences employer competing for the best talent available.
Listed below is a current opening for which we are seeking smart, driven, experienced, and just plain nice people to join us in realizing Audentes' mission.
Reporting to the Senior Director of Plasmid Operations, the Senior Scientist, will contribute to development of process design and manufacturing of plasmids for use in our expanding pipeline of Adeno-Associated Virus (AAV) vectors for human gene therapy. This is a hands-on laboratory based leadership position located in South San Francisco.
Specific Job duties include:
- Leading a development team in experiments to develop and optimize a plasmid production process platform
- Initial responsibility for a team of one to two Development/Manufacturing Associates with an opportunity to lead and mentor a larger team as the program continues to grow
- Collaborating with consultants
- Conducting fermentation experiments to develop an upstream plasmid production process
- Maintaining cell banks
- Conducting purification experiments to develop a downstream process to achieve plasmid quality targets
- Determining in-process testing requirements
- Documenting: preparation and maintenance for process development and research grade plasmid production operations, including SOPs, batch records, reports, and supporting regulatory filings
- Maintaining digital records of all research production activities using in-house systems and shared digital document repositories
- Facilitating process transfer to other groups within the company, as well as outside vendors or collaborators
- Providing guidance to junior lab members
- Ensuring safe and compliant laboratory operations
Required Education, Skills and Experience
- PhD with 5+ years' experience as a scientist developing process operations in a biopharmaceutical company, biotechnology or within an integrated and productive academic/industry collaborative setting
- Demonstrated experience developing fermentation and purification methods for recombinant proteins, plasmids and/or biologics
- Success independently designing and executing experiments to answer scientific questions
- History of managing multiple projects simultaneously while meeting project deadlines in fast moving start-up environment
- Prior history drafting detailed protocols, SOPs, technology transfer documents and sections of regulatory filings
- Positive, professional self-starter with a passion for science
- Outstanding collaboration, problem solving team player with excellent communication and organizational skills
Preferred Skills and Experience
- Experience developing plasmid production processes
- Statistical design of experiments and use of JMP or equivalent statistical software package to analyze results