Scientist II, Analytical Development

Scientist II, Analytical Development

Do you want to be part of an inclusive team that works to develop innovative therapies for patients? Every day, we are driven to develop and deliver innovative and effective new medicines to patients and physicians. If you want to be part of this exciting work, you belong at Astellas!

Astellas Pharma Inc. is a pharmaceutical company conducting business in more than 70 countries around the world. We are committed to turning innovative science into medical solutions that bring value and hope to patients and their families. Keeping our focus on addressing unmet medical needs and conducting our business with ethics and integrity enables us to improve the health of people throughout the world. For more information on Astellas, please visit our website at ~~~ .

About Astellas Gene Therapies

Astellas Gene Therapies is an Astellas Center of Excellence developing genetic medicines for patients with rare, life-threatening diseases. Based on our innovative approach to developing genetic medicines, as well as our industry-leading internal manufacturing capability and expertise, we have become the Astellas Center of Excellence for their newly-created Genetic Regulation Focus Area. We are currently exploring three gene therapy modalities: gene replacement, exon skipping gene therapy, and vectorized RNA knockdown, with plans to expand our focus and geographic reach under Astellas. We are based in San Francisco, with manufacturing and laboratory facilities in South San Francisco and Sanford, North Carolina. For more information, please visit our website: ~~~.

The Role:

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.

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.

Organizational Context:

• This position reports to the Lead, Analytical Development.

• This position is an individual contributor role.

• This position requires onsite work.

Required Qualifications:

• PhD with 3+ years, or MS with 10+ 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.

Preferred Qualifications:

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

• Protein engineering and modification.

Working Conditions:

• This position is a hands-on laboratory-based position that requires onsite work.

Salary Range: $114,800 - $153,000 (NOTE: Final salary could be more or less, based on experience)

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

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.

#LI-TD

Category GT - Technical Development

Astellas is committed to equality of opportunity in all aspects of employment.

EOE including Disability/Protected Veterans