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Astellas Pharma Principal Analyst, QC Raw Materials and Control 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.audentestx.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

Reporting to the Senior Manager, QC, the Principal Analyst, QC Raw Materials and Control, will be a subject matter expert (SME) for all raw materials inspection and testing methods in support of clinical and commercial viral vectors products in compliance with GMP requirements. The individual will also be responsible for development and qualification of analytical methods for use in raw material testing, conducting raw material sampling, inspection and analytical testing per approved SOPs, analyzing and reporting data, data review and maintaining lab equipment, for raw material samples. Incumbent exercises judgment within well-defined and established procedures and practices to determine appropriate action -- identifies problems and generates alternatives and recommendations to resolve problems within defined guidelines. This position will be located in South San Francisco, CA.

Primary Responsibilities

  • Serves as a Subject Matter Expert (SME) for all raw materials inspection and testing methods

  • Assist in training new QC Analysts on routine procedures and practices

  • Lead analytical method optimization, transfer and validation

  • Performs sampling, inspection and testing of raw materials, conducts lab investigations, problem solving and reports aberrant results to management

  • Author, revise, and review SOPs, qualification/validation protocols and reports

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

  • Lead in working and monitoring of testing activity with various Approved Contract Testing Laboratories

  • Ensures sampling, inspection, testing and release timelines are met. Follows well-defined and established procedures and best practices

  • Reviews QC test results and Certificate of Analysis

  • Generates, reviews, and/or maintains records or documents in a detailed and consistent manner

  • Prepares sample reconciliation reports and other reports as needed

  • QCs data management, including report writing and data review

About you

Must Have/Required

  • Bachelor's degree in Chemistry or equivalent, with 8-+ years related experience in pharmaceutical raw material inspection, sampling and testing or Master's degree in Chemistry or equivalent, with 6+ years related experience in pharmaceutical raw material sampling and testing

  • Demonstrated background in raw material testing

  • Strong laboratory experience with a variety of analytical techniques including use of FTIR, Raman, Near-IR analysis but not limited to, USP and Ph. Eur. compendial general methods

  • Knowledge of cGMPs and regulatory requirements pertaining to biotechnology and pharmaceutical industries.

  • Enjoys a teamwork environment with good oral and written communication skills

  • Strong attention to detail and working on multiples projects with tight deadlines

  • Strong experience collaborating with Regulatory Affairs as an SME regarding quality systems and regulatory requirements

  • 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

May Have/Preferred

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

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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