Quality Control Analytical Operations Scientist
Do you want to be part of an inclusive team that works to develop innovative therapies for patients? Every day, we are driven to develop and deliver innovative and effective new medicines to patients and physicians. If you want to be part of this exciting work, you belong at Astellas!
Astellas Pharma Inc. is a pharmaceutical company conducting business in more than 70 countries around the world. We are committed to turning innovative science into medical solutions that bring value and hope to patients and their families. Keeping our focus on addressing unmet medical needs and conducting our business with ethics and integrity enables us to improve the health of people throughout the world. For more information on Astellas, please visit our website at www.astellas.com .
Astellas Institute for Regenerative Medicine (AIRM) is a wholly-owned subsidiary of Astellas Pharma Inc and focused on the development and commercialization of stem cell and regenerative medicine therapies. Astellas is an R&D-driven global pharmaceutical company whose philosophy is to contribute to the improvement of people's heath around the world through the provision of innovative and reliable pharmaceutical products.
AIRM has a world-class R&D team, and is pursuing a diverse range of disease indications, ranging from macular degeneration (currently in clinical trials) and other ocular indications to vascular and autoimmune disease. AIRM's intellectual property portfolio includes pluripotent stem cell platforms -- both embryonic and induced pluripotent stem cells as well as other cell-based therapy research programs. AIRM is headquartered in Massachusetts.
Astellas is announcing a Quality Control Analytical Operations Scientist opportunity at their Astellas Institute for Regenerative Medicine (AIRM) site in Westborough, MA.
Purpose:
AIRM is seeking a highly motivated individual with strong organizational skills to join us as a Quality Analytical Operations Control Scientist. This position supports Quality Control Operations. The Scientist provides testing support for AIRM cell therapy products, including qualification, validation, troubleshooting and testing related investigations. 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.
Maintain, calibrate and operate equipment and instruments supporting Microscopy, Flow Cytometry, and molecular biology assays (DDPCR/QPCR) including URS, reports and quality system investigations.
Oversee and execute analytical method testing, qualifications, validations and transfers including drafting technical protocols, reports and assay troubleshooting.
Track and test products according to stability protocols.
Work with internal and external resources to maintain lab in a audit ready GMP compliant state
Monitor and trend QC data.
Complete routine record review of test data and related documents for in-process testing, drug substance and drug product release and stablity.
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.
Quantitative Dimensions:
This position interacts with QC, AD, DPD, Mfg, MST and QA management. Will contribute to the development of QC departmental processes and strategies.
Organizational Context:
Reporting to QC Analytical Operations Associate Director.
Qualifications:
Required:
Bachelors 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, molecular biology (QPCR/DDPCR), and cell bioassays and other applicable methods to the testing of biopharmaceuticals.
Working knowledge of quality systems and regulatory requirements (21 CFR Part 11/210/211).
Experience in the biotech and/or pharmaceutical industry.
While most of the schedule will be during a standard work-week, there will be occasional weekend work required.
Preferred:
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
Benefits:
Medical, Dental and Vision Insurance
Generous Paid Time Off options, including Vacation, Sick time, plus national holidays including 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
#LI-LK
Category Massachusetts TC
Astellas is committed to equality of opportunity in all aspects of employment.
EOE including Disability/Protected Veterans