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Astellas Pharma QC Raw Materials and Control, Analyst II in South San Francisco, California

Are you ready to use your experience and expertise to make an impact on patients' lives? Astellas Gene Therapies is a biotechnology company developing new genetic medicines for rare, life-threatening diseases. We are working urgently to progress our medicines and need additional team members to help us do so. Because our mission is so important, our values are to: Be BOLD: Find a Way, Care Deeply, and Get Stuff Done. If you'd like to be a part of this important mission, please apply to join our team.

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

  • #GSDR (Get Stuff Done Right)

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

Reporting to the Senior Manager, QC, the Quality Control Analyst II or Senior Analyst, QC Raw Materials and Control, will be responsible for all raw materials inspection, sampling and testing in support of clinical and commercial viral vectors products in compliance with GMP requirements. This role also will support QC sample management for GMP raw materials and QC samples (In-process, DS, and DP). This position will be located in South San Francisco, CA.

Primary Responsibilities

  • Perform routine release sampling and managing testing of raw materials, such as compendial analysis per USP, Ph.Eur., and JP monographs and general chapters, based on cGMP and internal procedures

  • Performs wet chemistry, use of FTIR, Raman, Near-IR analysis and other compendial assays.

  • Ensures inspection, testing and release timelines are met.

  • Ensures that the integrity and accuracy of all laboratory documents are maintained; adheres to all SOP (Standard Operating Procedure), GLP (Good Laboratory Practice) and cGMP (current Good Manufacturing Practice) and regulatory requirements.

  • Supports raw material qualification program by ensuring proper documentation of raw material qualification testing status

  • Develops and reviews non-compendial method qualification protocols and reports

  • Creates and/or revises SOPs and RM specifications

  • Prepares sample reconciliation reports and other reports as needed

  • Cross functional communication and routine interaction with stakeholders or various departments for oversight of in-coming QC raw materials

  • Coordinate with all contract testing laboratories (CTLs) for QC RM testing activities including but not limited to obtaining quotes and POs, scheduling testing and shipments to meet timelines

  • Manages data packages from CTLs for meeting timeline: tracking sample shipments, monitoring test process, creating data packages and ensuring data review accuracy

  • Implements and manages appropriate QC systems for data compliance and data management

  • Takes ownership of initiated Change Control Records, Non-Conformance Investigation and CAPA records

  • Participates in deviation investigations related to QC RM and CTL data results

About you

Must Have/Required

  • BS or BA degree in Biological Science or other relevant degree, with 2+ years (Analyst II) or 4+ years (Sr. Analyst) related experience in raw material and bio-pharma

  • Technical knowledge and experience in relevant areas of 21CFR, ICH, USP, Ph. Eur. and FDA guidance documents as well as cGXPs in support of clinical and commercial manufacturing

  • Proven knowledge in cGMP raw material program (RM sampling plans and testing requirements)

  • Excellent project management and organizational skills, with attention to detail

  • Excellent oral and written communication skills. Ability to communicate professionally with vendors, internal customers and sales professionals regarding quality issues

  • Demonstrated proficiency in Microsoft Office suite

  • Proven ability to handle multiple tasks concurrently, and in a timely fashion

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

  • Dedicated and self-motivated and engaged to learn new methodologies or provide recommendations for optimization

  • Models our Core Values: Be Bold: Find a Way, Care Deeply, Get Stuff Done -- is experienced as someone who exemplifies the culture we want to create; operates with transparency; is trusted

Preferred Qualifications

  • Experience in a start-up environment and commercial GMP Manufacturing

  • Technical knowledge with a variety of analytical techniques

  • Experience working in a GMP Raw Material Control group desired

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 CMC Operation

Astellas is committed to equality of opportunity in all aspects of employment. EOE including Disability/Protected Veterans

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