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Astellas Pharma Analyst II, Quality Control Analytical 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 molecular biology and protein chemistry to join the team. The QC Analytical Analyst II 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 role will be reporting to the Manager, Analytical QC and will be located in our Sanford NC Quality laboratories.

Primary Responsibilities

  • Perform release, stability, and in-process testing in support of production activities

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

  • Perform analytical testing in supporting technology transfers

  • Review data and performs analysis and interpretation of test results

  • Participate in method transfer and qualification/validation studies

  • 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, and instrumentation maintenance and 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

  • 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

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

  • Prior laboratory hands-on experience with a variety of analytical techniques including, but not limited to, HPLC, UV spectroscopy, wet chemistry assays, TOC, and Dynamic Light Scattering (DLS)

  • Experience analyzing experimental data

  • Must be capable of observing and adhering to lab safety standards and protocols

  • Successfully performs routine work independently with minimal instructions

  • Strong technical writing skills and verbal communication skills

  • Excels in a dynamic 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

  • This role is scheduled to work during normal business hours, Monday -- Friday

  • Flexibility to cover off-shift work may be required

May Have/Preferred

  • Experience in a small company and high growth, fast-paced environment

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

  • Experience with HPLC techniques (Waters HPLC with Empower preferred)

  • Utilization of a Laboratory Information Management System (LIMS) such as Labware LIMS

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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