Manager-Senior Manager, QC Operations

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 a highly motivated and experienced Manager/Senior Manager to join the Quality Control group. The candidate will be responsible for leading and managing the QC Operations group. This role will report to the Associate Director, Quality Control and will be located in our South San Francisco Quality laboratories.

Primary Responsibilities

• The Manager/Senior Manager is responsible for QC operations with strong analytical testing background, strong knowledge in cell-based assays including ddPCR, ELISA assays and physicochemical methods in support of nonclinical, clinical, and commercial viral vector products in compliance with GxP requirements.

• Develops, optimizes, modifies, and follows standard operating procedures (SOPs).

• Prepares and reviews of relevant documentation such as Certificates of Analysis (COAs), specifications, methods, protocols and, reports

• Directs QC Operations staff and daily operations to include:

• Sample management oversight

• QC inspections and audits

• QC documentation and reporting

• Equipment maintenance and calibration

• QC lab design and maintenance

• Review documents related to IP, DS/DP and stability testing

• Performs analysis and interpretation of test results, 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.

• Assists in managing analytical activities at contract manufacturing organizations and contract testing laboratories (CMOs and CTOs), including assay validation, assay transfer, sample testing, and data review.

• Responsible for technical writing of investigations, audit responses, compliance observations, and CMC regulatory submissions

• Drive continuous improvement to increase efficiency and productivity.

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

• Provides guidance to junior staff and applies technical knowledge daily.

• Ensures QC staff training compliance.

• Familiar with LIMS system

• Develops departmental budget for analytical operations.

• Coordinates interdepartmental activities and engagement

• Additional responsibilities as requested to support the business needs for Quality Control.

About you

Must Have/Required

• Manager , BS degree in Chemistry, Biological Sciences or equivalent with 8+ years or MS 6+ years related experience in biopharma and 2+ years of management experience

• Sr Manager, BS degree in Chemistry, Biological Sciences or equivalent with 10+ years or MS with 8+ years related experience in bio-pharma industry, and 4+ years of managerial experience in a cGMP compliance environment.

• Demonstrated track record of leadership and management of analytical personnel.

• A strong background in cell-based assays, ddPCR and ELISA, HPLC, separation science and physicochemical analysis of proteins and nucleic acids is required. Must have laboratory experience with a variety of analytical techniques including, but not limited to, cell-based assays, HPLC, dynamic light scattering (DLS), sub-visible particulate analysis, pH, osmolality and other chromatographic and physicochemical techniques.

• Proven experience in assay development, qualification, and validation.

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

• Demonstrated experience with problem solving and the ability to make sound decisions regarding team activities and scheduling, allocation of resources, and priorities.

• A demonstrated manager and mentor that enjoys and fosters a positive team environment

• Strong written and technical writing skills with demonstrated experience supporting documentation for audit responses, CMC regulatory submissions, and compliance observations or other technical writing experience.

• 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.

• 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

• Advanced degree in Chemistry or Biological Sciences is desirable

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