Scientist II, Analytical Development (Mass Spec Expert)

Audentes Therapeutics • South San Francisco, CA

217d • $114,800 - $153,000

About The Position

The Scientist II will take a lead in developing, qualifying and transferring assays for the GMP release of drug substances and drug products as well as in-depth product characterization activities. In addition, the Scientist II will be a point person for supporting early stage development and understanding of product behavior throughout the manufacturing process. This will involve collaboration with colleagues across different departments of AGT. This role will be at our South San Francisco R D facility.

Requirements

• PhD with 3+ years, or MS with 8+ years, in Biochemistry with technical expertise in small molecule and/or protein chemistry of industry experience in biopharma development with a primary focus on the characterization of proteins, viruses or other macro-biologics using standard methods.
• Proven expertise with a range of physicochemical methodologies consistent with ICH guidelines for quantifying purity/quality of small molecules, proteins, and viruses.
• Extensive experience in separation technologies including multiple modes for HPLC and Mass Spectrometry.
• Success designing experiments, analyzing data and making decisions based on results from biophysical characterization techniques, such as CE, DLS, BCA, CD, intrinsic fluorescence, SEC, SEC-MALS et al, and AUC as applied to protein and/or viral vectors is required.
• Prior history in compiling and analyzing data and generating reports which is routinely presented to project teams to enable decision making and writing for regulatory filings.
• Success in development and transfer of qualified or validated methodologies to manufacturing consistent with project timelines and regulatory expectations.
• Excellent communication and interpersonal skills.
• A clear and organized thought process, with attention to detail and a high quality work ethic are essential.
• Strong work ethic with transparency, teamwork and a passion for working in a fast-paced, dynamic and diverse work environment.
• Ability to exercise sound judgment, tact, diplomacy, integrity and professionalism in all interactions.
• Ability to keep current with regulation guideline, compendia requirement, scientific publications, and innovative technologies.
• Proven track record of excellent judgment, problem resolution, decision-making skills, and the ability to work under pressure required.
• Proficient in MS Office Suite and work-related software.

Nice To Haves

• Prior AAV or protein drug characterization and release method development experience.
• Protein engineering and modification.

Responsibilities

• Develop and transfer assays for the GMP release of gene therapy products.
• Lead in-depth product characterization activities for gene therapy products.
• Troubleshoot problems that occur during release testing, process development, scale-up or in manufacturing.
• Evaluate product testing results and support product formulation and processes.
• Report project status (development plans, timelines) to supervisor and technical teams.
• Write tech development and transfer reports and SOPs.
• Keep current with all regulatory guidelines, compendia requirements, work related publications and technical innovations.
• Attend training sessions and conferences in order to maintain and increase skills and knowledge of cGMP's, safety awareness and scientific knowledge.
• Follow relevant Operating Procedures.

Benefits

• Medical, Dental and Vision Insurance
• Generous Paid Time Off options, including Vacation, Sick time, plus national holidays including Heritage Days, and Summer and Winter Breaks
• 401(k) match and annual company contribution
• Company paid life insurance
• Annual Corporate Bonus and Quarterly Sales Incentive for eligible positions
• Long Term Incentive Plan for eligible positions
• Referral bonus program

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Industry: Chemical Manufacturing
• Education Level: Ph.D. or professional degree