Scientist I - Analytical Development

Scientist I, 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 www.astellas.com.

The Role

The Scientist will take the lead in independently planning, executing, 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 Analytical, CMC and Research teams to develop first-in-class Gene Therapy products. Through this understanding of product characteristics and the manufacturing process, the Scientist will establish Target Analytical Profiles and develop analytical methods that appropriately evaluate the quality of both drug substances and drug products. The Scientist will also work collaboratively with colleagues across many functions in Astellas.

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 according to Target Analytical Profiles, with a deep understanding of our products. Write assay development report and standard operation procedures (SOPs).
• 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.

• Lead or support product characterization activities for our products
• Report project status (development plans, timelines) to supervisor and technical teams.
• Work collaboratively cross teams and support or author protocol and report for comparability study, report of critical quality attributes risk assessment (CQA-RA).
• Collaborate with CMC and research teams to develop first-in-class drugs.
• 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.

Required Qualifications:

• PhD with 1 years, or MS with 5 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.
• 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.
• 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 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.

Preferred Qualifications:

• Experience in writing comparability protocol, setting spec for product release and identification of critical quality attributes
• Success in development and transfer of qualified or validated methodologies to QC and manufacturing consistent with project timelines and regulatory expectations.
• AAV experience
• Familiar with viral vector
Cable of statistical analysis using JMP or other tools

Working Environment:

Salary Range: $91,000 - $143,000 (Final compensation will be determined based on a variety of factors, including but not limited to skills, experience and organizational equity considerations)

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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