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Astellas Pharma Supervisor, QC Microbiology in South San Francisco, California

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: www.astellasgenetherapies.com

About Astellas

Astellas Pharma Inc. is a pharmaceutical company conducting business in more than 70 countries around the world. We are promoting the Focus Area Approach that is designed to identify opportunities for the continuous creation of new drugs to address diseases with high unmet medical needs by focusing on Biology and Modality. Furthermore, we are also looking beyond our foundational Rx focus to create Rx+® healthcare solutions that combine our expertise and knowledge with cutting-edge technology in different fields of external partners. Through these efforts, Astellas stands on the forefront of healthcare change to turn innovative science into value for patients. For more information, please visit our website at https://www.astellas.com/en.

Our Values:

  • Be BOLD (Find a Way)

  • Care Deeply -- for our patients, each other and our work

  • #GSD (Get Stuff Done)

What is the catalyst for you in your professional career? Are you ready to be a part of a bold, innovative company, to make a change and to make a difference? Listed below is a current opening for a smart, driven, experienced, and just plain nice individual who wants to join us and be a part of our journey.

The Role

Astellas Gene Therapies is seeking an experienced Supervisor, QC to join the Quality Control Microbiology group. The QC Micro Supervisor will be responsible for supervising analysts and maintaining lab operations in support of clinical and commercial viral vector products in compliance with GMP requirements. This position will also support environmental monitoring of the viral vector product manufacturing and plasmid manufacturing plants, testing of stability samples, and equipment validation. This role will be located in our South San Francisco Quality laboratories.

Primary Responsibilities

  • Supervise analysts in a microbiology lab for testing of in-process/Drug Product samples and Environmental Monitoring

  • Maintain GMP audit ready operations

  • Coordinate with Manufacturing and Process Development and schedule assignments accordingly

  • Review and approve data worksheets

  • Manage environmental monitoring activities conducted by in-house staff and third-party contract testing laboratory

  • Perform microbiological testing and environmental monitoring activities, as required. Record, analyze, and interpret raw data

  • Trend environmental monitoring data and generate EM reports

  • Perform environmental and lab investigations as needed. Implement corrective actions, as applicable

  • Author, review and execute SOPs relating to equipment maintenance and test methods

  • Train and provide technical assistance and guidance to QC Micro staff

  • Perform other related duties and responsibilities as assigned

  • Perform all job function in accordance with cGMPs

About you

Must Have/Required

  • B.S. degree in microbiology, biological sciences, or related field with 5+ years of relevant experience and at least 2 years of experience mentoring and training personnel

  • Strong knowledge of GMP, SOPs and quality control processes

  • Working knowledge of quality systems and regulatory requirements

  • Strong data integrity knowledge and practices

  • Experience in coaching, mentoring, and training QC Analysts in quality principles, procedures and analytical methods Hands-on experience with microbiological testing and in environmental control and monitoring of clean rooms and utilities

  • Sets clear expectations with individuals and as a team for achieving results, and his/her team consistently achieves results that are in line with expected job standards

  • Fosters an empowering environment where team members develop innovative solutions that improve performance, gains team support for change

  • Establishes expectations for collaboration within the team and models effective collaboration; supports collaborative efforts with other teams and departments and builds strong partnerships that lead to improved results

  • Creates opportunities for direct reports to improve their knowledge and skills needed in the current job; shows courage in delivering tough feedback; feedback improves direct reports' performance; works with direct reports to identify and facilitate career growth opportunities

  • Demonstrated experience in analyzing and interpreting data and information, drawing conclusions and making recommendations and decisions

  • Good to excellent technical writing skills and verbal communication skills

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

  • Strong interpersonal skills, highly collaborative within a multi-discipline team and contributes to a supportive and positive work environment

  • Highly self-motivated and goal oriented

  • Models our Core Values: Be Bold, Care Deeply, #GetStuffDone -- is experienced as someone who exemplifies the culture we want to create; operates with transparency; is trusted

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

  • Referral bonus program

Category Quality Control

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

EOE including Disability/Protected Veterans

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