Analyst II, Quality Control Biochemical

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 Analyst II, QC will be responsible for implementing and executing analytical testing in support of clinical and commercial viral vector products in compliance with GMP requirements. Will also support testing for stability studies, methods validation studies and equipment validation. This position typically reports to the Manager, QC Biochemical Ops.

Responsibilities:

• Author/revise technical reports and laboratory procedures (SOPs and methods).

• Perform release, stability, and in-process testing in supporting production activities.

• Perform analytical testing in supporting method transfer/validations.

• Participate in equipment qualification/validation studies.

• Participate in deviation and OOS investigations.

• Troubleshoot methods, as needed.

• Perform QC lab support activities including but not limited to sample management, reagent preparation, instrumentation maintenance, and instrument calibration.

• Other duties as required.

Quantitative Dimensions:

The Analyst II, QC will be responsible for implementing and executing analytical testing in support of clinical and commercial viral vector products in compliance with GMP requirements.

Organizational Context:

The Analyst II, QC Biomedical Operations will typically report to the Manager QC Biomedical Operations. This role is expected to Model our Core Values and to demonstrate work performance as someone who exemplifies the culture we want to create; operates with transparency; is trusted; and supports the overall mission and vision of Astellas Gene Therapies and the Astellas organization.

Required Qualifications:

• B.S. degree in Biological Sciences with 2-5+ years of relevant industry experience or M.S. degree in Biological Sciences with 0-3+ years of relevant industry experience in a quality control role.

• Experience in molecular/cell biology required (minimum 1 year) preferred.

• Prior laboratory hands-on experience with a variety of analytical techniques including, but not limited to ddPCR, nucleic acid purification/detection, protein quantification, ELISA, and gel electrophoresis.

• Proven experience analyzing experimental data and excellent technical writing skills.

• Must be capable of observing and adhering to lab safety standards and procedures and will be required to successfully perform routine work independently with minimal instructions.

• Excels in a fast-paced team environment, handles multiple tasks concurrently, and in a timely fashion.

• Strong interpersonal skills, highly collaborative within a multi-disciplinary team and contributes to a supportive and positive work environment and is highly self-motivated and goal-oriented.

• This role is scheduled to work during normal business hours, typically starting at 8:00 AM, Monday - Friday, along with flexibility to cover off-shift work may be required.

• Will support and demonstrate quality standards to ensure data of highest quality and will work closely with team and other functional key stakeholders on the Astellas AGT Technical Operations team to execute work and will be expected to perform other duties and/or special projects as assigned.

Preferred Qualifications:

• Prior experience in GMP QC environment (minimum 1 year)

• Knowledge of cGMPs and regulatory requirements pertaining to biotechnology and pharmaceutical industries is strongly desired

• Background in biochemistry or virology

• Experience with mammalian cell culture and cell-based assays

Working Conditions:

• This role frequently requires long periods of sitting, standing and use of hands and regular motion to include bending, stooping, and lifting up to 20lbs.

• This is an on-site role working in a cGMP regulated manufacturing facility.

• On occasion, this role may travel to other Astellas Gene Therapies manufacturing facilities (0-5%).

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.

Category Sanford TC

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

EOE including Disability/Protected Veterans