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Astellas Pharma Analyst II, Quality Control Microbiology in Sanford, North Carolina

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

  • #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 experienced Quality Control professionals with scientific technical expertise in Microbiology, or a related field, to join the team. The Analyst II, Quality Control Microbiology will be responsible for implementing and executing microbiological testing in support of clinical and commercial products in compliance with GMP requirements. This role will also support testing for stability studies, method validation studies and equipment validation. This position will be based in our Sanford, NC facility.

Primary Responsibilities

  • Perform release, stability, and in-process testing supporting production activities. Testing includes, but is not limited to, bioburden, endotoxin, pH/conductivity

  • Perform growth promotion/media qualification

  • Perform plate reading, generate microbial isolates, and Gram stain

  • Author/revise technical reports and laboratory procedures

  • Perform testing in support of method transfer/validations

  • Assist in data trending and summarization

  • Participate in equipment qualification/validation studies

  • Participate in deviation and OOS investigations

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

  • Receive, unpack and organize supplies for QC areas

  • Perform routine cleaning, schedule equipment preventative maintenance, and organization of laboratory areas in accordance with cGMP

  • Other duties as required

About you

Must Have/Required

  • Analyst II: B.S. Degree in Microbiology, or other science-related degree, with 2-5+ years' relevant industry experience in a quality control role, or M.S. degree in Microbiology, or other science-related degree, with 0-3+ years of relevant industry experience in a quality control role

  • Demonstrated experience of aseptic technique and common microbiological testing

  • Knowledge of relevant compliance and guidance documents

  • Must be able to gown into cleanrooms in support of testing and manufacturing activities

  • Good documentation and data organization

  • Detail oriented and willingness to learn

  • Strong interpersonal skills which contribute to a supportive and positive work environment

  • Proven history of working in a fast-paced team environment, time management, and meeting deadlines.

  • Highly collaborative team player with the ability and willingness to support other colleagues in the Quality Control department. This support may include future cross training with analytical assays as needed

  • Flexibility to cover off-shift work (e.g., weekends) may be required

  • 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 small company and high growth, fast-paced environment

Physical and Work Environment

Must be proficient in use of computer, particularly Microsoft Word and Excel programs, and be able to sit/stand and be gowned inside the cleanroom for extended periods of time. Some lifting required (not more than 50 lbs.). Use of a respirator may be required. Exposure to biohazards and viruses.

This position description intends to describe the general nature and level of work being performed by people assigned to this job. It is not intended to include all duties and responsibilities. Other responsibilities and task may be assigned.

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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