QC Systems Support Senior Scientist

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 QC Systems Support Senior Scientist to join the Quality Control Systems group. Reporting to the Manager, Quality Control Systems Support, the Senior Scientist, QC Systems Support will be responsible for providing support for the Quality Control labs for processes and systems including sample and data management (including stability study management and contract lab coordination), as well as processing QC requests/actions for investigations, change controls and document revisions. This role will also assist with the coordination of the departmental training program. This role will work closely with the multiple QC groups including Enterprise QC, Quality Assurance and Manufacturing. This role is based in Sanford, NC at our new, state of the art manufacturing and laboratory facility.

Primary Responsibilities

• Support/oversee quality control laboratories processes and systems including sample and data management, stability study management and contract lab shipment/testing coordination.

• Ensure samples are packaged and shipped to contract testing laboratories, including completion of required paperwork. Also, includes receipt of summary reports/results.

• Manage external sample turnaround times, receipt of data and creation of data packets

• Responsible for significantly contributing to and/or leading laboratory investigations for events and OOS results. Evaluates and approves the best CAPA for root cause to eliminate repeat events.

• Oversee/process QC change controls and document revisions

• Proactively identifies, takes remedial action, and/or seeks advice when a project, team, department, or network goal/deliverable is off schedule

• Assist with coordination of the QC departmental training program.

• Collaborate with multiple QC groups to continuously improve programs (e.g., transition from paper-based systems to electronic systems).

• Ensure lab compliance with applicable cGMP regulations and SOPs, and support both internal and external

• Assists in the preparation and review of CMC regulatory submissions.

• Collect and report, track and maintain metrics for QC systems/equipment and QC users.

• Provide guidance and training to junior colleagues and oversee training activities for groups.

• Ensures that the integrity and accuracy of all laboratory documents/processes are maintained; must assess overall document/process compliance with protocols, SOPs, company policies, and applicable regulations.

About you

Must Have/Required

• B.S. degree in biological sciences, cell biology, chemistry, or related field with 5+ years or M.S. degree with 3+ years of relevant experience in working with laboratory/quality systems

• Prior hands-on experience with a variety of laboratory/quality systems/processes such as sample management, data management, stability management, investigations, change controls, document control and/or training.

• Experience with electronic systems such as Master Control or other EDMS (Electronic Data Management System), Veeva and/or TrackWise.

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

• Strong knowledge of GMP, SOPs and quality control processes

• Strong knowledge of quality systems and regulatory requirements

• excellent technical writing skills and verbal communication skills

• Excels in a fast-paced team environment, handles multiple tasks concurrently, and in a timely fashion with a focus on quality and attention to details

• Displays strong investigative skills and makes significant independent contributions to the development/improvement/trouble shooting of methodology including new technologies

• Highly self-motivated and goal oriented

• 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 and knowledge with utilization of LIMS

• Experience managing a business system (e.g., stability or CAPA system) from the QC perspective

• Experience serving as a change agent and driving continuous improvement and automation across QC

• Expertise with the investigations quality system and able to independently handle complex investigations and determine associated CAPA with no guidance

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