Scientist II - CMC Analytical Development

Scientist II - CMC Analytical Development

Astellas is a global life sciences company committed to turning innovative science into VALUE for patients. We provide transformative therapies in disease areas that include oncology, ophthalmology, urology, immunology and women's health. Through our research and development programs, we are pioneering new healthcare solutions for diseases with high unmet medical need. Learn more at Astellas.com.

Are you driven to make a real difference in the lives of patients?

We're seeking passionate individuals who thrive in dynamic environments, embrace new ideas, and aren't afraid to take intelligent risks. People who act with unwavering integrity and are deeply committed to making a tangible impact.

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.

Essential Job 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.

Qualifications Required:

• 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.

Preferred:

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

Location and Working Environment

This position is based onsite in South San Francisco, CA R&D facility.

At Astellas we recognize the importance of work/life balance, and we are proud to offer a hybrid working solution allowing time to connect with colleagues at the office with the flexibility to also work from home. We believe this will optimize the most productive work environment for all employees to succeed and deliver. Hybrid work from certain locations may be permitted in accordance with Astellas’ Responsible Flexibility Guidelines.

What awaits you at Astellas?

• Global collaboration: Become part of a connected global business of like-minded life science leaders, all dedicated to improving patients' lives worldwide. Real-world patient impact: Contribute to transformative therapies that reach patients around the world, knowing your work makes a difference every day.
• Relentless Innovation: Join a company at the forefront of scientific breakthroughs, where you'll have the opportunity to shape the future of healthcare.
• A Culture of Growth: Chart your own course within a supportive environment that values your contributions, champions your development, and empowers you to pursue your passions.

Our Organizational Values and Behaviors

Values: Innovation, Integrity and Impact sit at the heart of what we do.

Behaviors: We come together as ‘One Astellas’, working with courage and a sense of urgency.  We are outcome focused and consistently take accountability for our personal contribution.

Salary Range: $105,280 - 150,400 (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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