Astellas Pharma Scientist I, Analytical in Westborough, Massachusetts
AIRM is seeking a highly motivated individual with strong organizational skills to join us as a Quality Control Scientist . This position provides Quality Control qualification, validation, testing support for AIRM cell therapy products. Looking for strong GMP and cell culture background with method validation and quality control testing experience.
Essential Job Responsibilities:
Perform routine in-process and release QC testing of AIRM cell products.
Oversee and execute analytical method qualifications, validations and transfers including drafting technical protocols, reports and assay troubleshooting.
Maintain, calibrate and operate equipment and instruments supporting Immunofluorescence, Flow Cytometry, and PCR assays.
Track and test products according to stability protocols.
Work with internal and external resources to maintain lab in a audit ready GMP state
Monitor and trend QC data.
Support validation and testing of cell bank programs.
Complete routine record review of test data and related documents for in-process testing, drug substance and drug product release and stability.
Perform shipment of materials for QC testing to contract labs and perform data review.
Author, revise and review SOPs, qualification/validation protocols and reports.
Conduct investigations regarding out of specifications (OOS) results. Address and manage deviations, Change Requests and CAPAs related to analytical procedures.
Monitor the GMP systems currently in place to ensure compliance with documented policies.
Assist in the preparation of reports and data packages for interactions between AIRM and Regulatory agencies. Interact with agents from Regulatory agencies and participate in Pre-Approval Inspections.
Perform QC lab duties and technical projects as required.
Bachelor’s Degree in biotechnology or related field with 8+ years of Quality Control experience, a master’s degree in biotechnology or related field with 6+ years of Quality Control experience or PhD molecular biologist or biochemist preferred with 0-3 years of Quality Control experience
Strong knowledge of GMP, SOP’s and quality control process
Identifying, writing, evaluating and closing laboratory (OOS) investigations.
Proficient in MS Word, Excel, Power Point and other applications.
Strong written and verbal communication skills.
Ability to communicate and work independently with scientific/technical personnel.
The ideal candidate is well versed in various analytical techniques such as Flow Cytometry, ELISAs, PCR, and cell bioassays and other applicable methods to the testing of biopharmaceuticals.
Working knowledge of quality systems and regulatory requirements (21 CRF Part 11/210/211).
Experience in the biotech and/or pharmaceutical industry.
While most of the schedule will be during a standard workweek, there will be occasional weekend work required.
Experience with ICH guidelines and parenteral test methods
Experience with 21CFR Part 11 Compliance
Experience with Validation of Analytical Test Methods
GMP Cell Culture experience and Environmental Monitoring
Experience with JMP software and data tracking/trending analysis
Medical, Dental and Vision Insurance
Generous Paid Time Off options, including Vacation, Sick time, national holidays, two Heritage Days, and Summer and Winter Breaks
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 GMP Technical Operations
Astellas is committed to equality of opportunity in all aspects of employment.
EOE including Disability/Protected Veterans