Scientist II - CMC Development

Astellas Pharma•Burlingame, CA

8d•Onsite

About The Position

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 www.astellas.com [http://www.astellas.com]. Purpose: The Scientist will take a lead in developing and transferring assays for the GMP release of drug substances and drug products as well as product characterization activities. The Scientist will work closely with research group to develop first-in-class drugs and will be a representative of AD in supporting product development, understanding of product behaviour throughout the manufacturing process, project timeline and requirement for product release. The Scientist will work collaboratively with colleagues across different departments of AGT, and will be responsible for drafting JOS, CQA-RA and protocols and reports for comparability study. This role will be at our South San Francisco R&D facility.

Requirements

PhD with 3+ years, or MS with 8+ years, in Biology with industry experience in biotech/biopharma companies with technical expertise on viruses, proteins, DNA and other macro-biologics using standard methods.
Proven expertise with drug development in CMC group.
Extensive experience in viral, cell and molecular biological technologies including but not limited to cell-based assay, DNA cloning, PCR, ELISA, Western etc. Expertise with range of biological methodologies consistent with ICH guidelines for quantifying purity/quality of viruses, proteins or DNA.
Success designing experiments, analyzing data and making decisions based on results applied to viral vectors, protein and DNA is required.
Success in development and transfer of qualified or validated methodologies to QC and manufacturing consistent with project timelines and regulatory expectations.
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.
Experience in writing comparability protocol, setting spec for product release and identification of critical quality attributes.
Experience in technical leading and supervising research associates to perform experiments.
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 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, teamwork, some budgeting and/or excel skills, decision-making skills, and the ability to work under pressure required.
Proficient in MS Office Suite and work-related software.

Nice To Haves

AAV experience
Familiar with viral vector design
Cable of statistical analysis using JMP or other tools

Responsibilities

Develop and transfer assays for the GMP release of gene therapy products, write assay development report and SOP.
Work collaboratively cross teams and author protocol and report for comparability study, report of justification of spec (JOS) setting and report of critical quality attributes risk assessment (CQA-RA).
Collaborate with research group to develop first-in-class drugs.
Lead product characterization activities for gene therapy products.
Troubleshoot problems that occur during product development, 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.
Keep current with all regulatory guidelines, compendia requirements, scientific publications, and technical innovations.
Attend training sessions and conferences in order to maintain and increase skills and knowledge of GXP’s, safety awareness and scientific knowledge.
Follow relevant Operating Procedures.

Benefits

Medical, Dental and Vision Insurance
Generous Paid Time Off options, including Vacation and Sick time, plus national holidays including year-end shut down
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
Company-paid fleet vehicle for eligible positions
Referral bonus program

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