Principal Analyst QC Analytical

Profile

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.astellasgenetherpaies.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 Quality Control professional with scientific technical expertise in molecular biology and cell-based assays to join the team. The Principal Analyst, QC will be a subject matter expert (SME) for all cell-based assays and be responsible for implementing and executing analytical testing in support of clinical and commercial viral vector products in compliance with GMP requirements. The individual will also support stability studies, method transfer and validation studies. This role will be reporting to the Associate Director, Analytical QC and will be located in our South San Francisco Quality laboratories.

Primary Responsibilities

Serves as a Subject Matter Expert (SME) for Quality Control cell-based assays

Perform analytical testing for drug product, in-process, and other samples as necessary, using methods including but not limited to PCR, ELISA, and gel electrophoresis

Review test results, support/address investigations regarding out of specifications (OOS) results, invalid or atypical test results following Quality procedures

Manage critical materials qualification

Review, analysis and trending of data

Author, revise, and review SOPs, qualification/validation protocols and reports, stability protocols and reports

Support and/or lead assay optimization, transfer and validation

Ensure that lab safety standards are maintained

Ensure lab compliance with applicable cGMP regulations and SOPs

Requirements

About you

Must Have/Required

B.S. degree in biological sciences, cell biology, chemistry or related field with 8 years of relevant QC Analytical GMP experience

Hands-on experience and strong expertise with mammalian cell culture and cell-based assays

Prior laboratory hands-on experience with a variety of analytical techniques, including UV spectroscopy, protein concentration determination, osmolality, physicochemical tests, ddPCR, ELISA, electrophoresis techniques (agarose and polyacrylamide)

Exercises judgment within broadly defined practices and policies using SOPs/best practices in selecting methods, techniques and evaluation criteria for obtaining results

Drives QC activities to accomplish company goals

Able to identify and implement solutions for complex problems

Strong knowledge of GMP, SOPs and quality control processes

Ability to perform work independently and prioritize tasks to meet deadlines

Working knowledge of quality systems and regulatory requirements

Strong data integrity knowledge and practices

Advanced technical writing skills and verbal communication skills

Excels in a fast-paced team environment, handles multiple tasks concurrently, and in a timely fashion

Leads collaborations within a multi-discipline team and contributes to a supportive and positive work environment

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

Familiarity with HPLC, and other protein chemistry methods

Understanding of phase appropriate GMP

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

Equal Opportunity Employer Minorities/Women/Protected Veterans/Disabled

Type

Full-time

Location

CA, South San Francisco

Category

Quality Control

Company info

Astellas Us, LLC
Website : https://www.astellas.com/us/