Analyst I QC Raw Materials and Control

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.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

#GSDR

(Get Stuff Done Right)

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

Reporting to the Senior Manager, the Analyst I, QC Raw Materials and Control, will be

responsible for conducting raw material sampling and analytical testing per approved SOPs, analyzing and reporting data, data review and maintaining lab equipment, for raw material samples. Incumbent exercises judgment within well-defined and established procedures and practices to determine appropriate action -- identifies problems and generates alternatives and recommendations to resolve problems within defined guidelines. This position will be located in South San Francisco, CA.

Primary Responsibilities

Under supervision, performs sampling and testing of raw materials, conducts lab investigations, problem solving and reports aberrant results to management

Performs wet chemistry, use of FTIR, Raman, Near-IR analysis and other compendial assays.

Ensures inspection, testing and release timelines are met. Follows well-defined and established procedures and best practices

Reviews QC test results

Generates, reviews, and/or maintains records or documents in a detailed and consistent manner

Prepares sample reconciliation reports and other reports as needed

Assists with QC's data management, including report writing and data review

Requirements

About you

Must Have/Required

Bachelor's degree in Chemistry or equivalent, with 1 years related experience in pharmaceutical raw material sampling and testing.

Demonstrated background in raw material testing.

Strong laboratory experience with a variety of analytical techniques including use of FTIR, Raman, Near-IR analysis but not limited to, USP and Ph. Eur. compendial general methods

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

Enjoys a teamwork environment with good oral and written communication skills

Strong attention to detail and working on multiples projects with tight deadlines

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 in a start-up environment

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

CMC Operation

Company info

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