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Astellas Pharma Manager, Quality Control Systems Support 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 an experienced Manager to join the Quality Control team during a five-day work week (M-F). Flexibility to cover off-shift work as needed may be required. Reporting to the Associate Director of QC, the Manager, Quality Control (QC) System Support will lead the QC sample management, stability study management and contract lab management functions in the QC department with respect to regulatory and quality requirements for the Company's development and production of the Company's pre-clinical, clinical, and commercial therapeutic. This role will also oversee processing of QC requests for systems including change control, document management, and investigations, as well as coordination of the departmental training program. This is a hands-on role that will involve close collaboration with and active support of the Quality Assurance, Manufacturing, Regulatory, and CMC/Process Development groups.

Primary Responsibilities

  • Manage QC personnel in the QC Systems Support group. Sets clear expectations with direct reports and as a team for achieving results, and ensuring the team consistently meets timelines. Excels in a fast-paced environment that handles multiple tasks concurrently, and in a timely fashion.

  • Design, implementation and oversight of QC Sample Management and Test Record Management programs, which includes the sample receiving and tracking process, data sheet implementation for test records, and organization of QC documents

  • Implement and manage appropriate QC systems (both paper-based and electronic) for sample tracking, data compliance, and data management

  • Ensure all procedures are performed in compliance with applicable regulatory requirements in a timely fashion

  • Coordinate QC sampling and testing activities with manufacturing and development groups

  • Management of stability program, studies, samples, protocols and reports, including establishment and maintenance of stability policies and procedures

  • Direction and oversight of outsourced QC activities including quality agreements, scope of work, budgeting, auditing and the review/generation of data and certificates of analysis

  • Management of QC Sample Management staff and daily operations to include:

  • Ensure samples are packaged and shipped to contract testing laboratories, including completion of required paperwork

  • Manage sample turn-around times, receipt and review of data, creation of data packets

  • Manage sample storage freezer and refrigerator maintenance, inventory, cleaning

  • Preparation for QC audits and inspections

  • Performs analysis and interpretation of test results from out-sourced testing, identifies deviations, and makes appropriate recommendations.

  • Oversees laboratory investigations/out of specification (OOS) results, impact assessments, root cause analysis and corrective actions in collaboration with QA and other departments

  • Oversees processing of QC requests for systems including change control, document management, and investigations.

  • Coordinates the departmental training program for QC

  • Partners with the LIMS support function to be the business process owner for sample management and related workflows (e.g. chain of custody, inventory management, investigation management, etc.)

  • Assist in the preparation and review of CMC regulatory submissions

  • Ensure continuous lab compliance with applicable cGMP regulations and SOPs, and support regulatory audits

About you

Required Qualifications

  • BS degree in Microbiology, Biological Sciences, or related field with 8+ years or MS 6+ years related experience in Biopharma and 3+ years of management experience

  • Strong people management skills with proven ability and enthusiasm to lead, motivate, inspire, develop, and encourage staff

  • Demonstrated track record of leadership with strong facilitation, collaboration, and teamwork skills

  • A strong background of the theory and practice of analytical/biochemical/microbiological techniques relevant to the release and stability testing of gene therapy drug substances and drug products

  • Knowledge of cGMPs and regulatory requirements pertaining to biotechnology and pharmaceutical industries required. Ability in problem solving and to make sound decisions about team activity scheduling, allocation of resources, and priorities.

  • Enjoy teamwork environment with good oral and written communication skills.

  • Knowledge and understanding of regulatory requirements for Stability testing

  • Knowledge of, and experience with LIMS, Empower and EDMS systems is desired

  • Strong attention to detail, excellent organizational skills and history of success leading and working on multiples projects with tight deadlines

  • History of success operating in a fast-paced, multi-disciplinary biotechnology industrial environment

  • This role is scheduled to work Monday -- Friday, the successful candidate must be willing to work second shift, rotating shifts, overtime, weekends, and holidays, as required.

  • 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

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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