Astellas Pharma · 13 hours ago
QC Scientist I Raw Materials
Westborough, MA
Full-time
Onsite
Mid, Senior Level
$91K/yr - $143K/yr
4+ years expAstellas Pharma is a global pharmaceutical company focused on developing innovative therapies. The QC Scientist I Raw Materials will execute and troubleshoot laboratory test methods, mentor junior analysts, and ensure compliance with quality control processes.
BiotechnologyHealth CareMedical
Responsibilities
Develop/author/revise technical reports and laboratory procedures (SOPs, methods)
Execute and troubleshoot raw material testing in support of production activities
Perform routine release sampling and managing testing of raw materials, such as compendial analysis per USP, Ph.Eur., and JP monographs and general chapters, based on cGMP and internal procedures
Design and perform testing in support of method transfer/validation/qualification/verification
Review/authorize data and perform analysis and interpretation of test results and trends
Design and/or participate in method development; equipment qualification/validation studies; deviation and OOS investigations
Perform QC lab support activities including but not limited to sample management, reagent preparation, instrumentation maintenance, and instrument calibration
Support and mentor junior team members
Collaborate with other network sites to share best practices
Other duties as required
Qualification
Required
B.S. degree in chemistry, biological sciences or related field with 6+ years or M.S. degree with 4+ years of relevant experience in a GMP Quality Control role
Prior laboratory hands-on experience with a variety of techniques such as FTIR, Raman, Near-IR, HPLC analysis and other compendial assays
Technical knowledge and experience in relevant areas of 21CFR, ICH, USP, Ph. Eur. and FDA guidance documents as well as cGXPs in support of clinical and commercial manufacturing
Proven knowledge in cGMP raw material program (RM sampling plans and testing requirements)
Ensures inspection, testing and release timelines are met
Strong understanding of data integrity requirements and regulatory requirements pertaining to biotechnology and pharmaceutical industries and proven experience analyzing experimental data
Experience using LIMS as an end user; Excellent technical writing and verbal communication skills
Must be capable of observing and adhering to lab safety standards and procedures
Successfully performs work independently with minimal instructions
Strong interpersonal skills, highly collaborative within a multi-discipline team and contributes to a supportive and positive work environment, strong knowledge of GMP, SOPs and quality control processes, and strong knowledge of quality systems and regulatory requirements
Excels in a fast-paced team environment, handles multiple tasks concurrently, and in a timely fashion
Highly self-motivated and goal oriented
Will support and demonstrate quality standards to ensure data of highest quality and works closely with team and other functional key stakeholders on the Astellas Operations team to execute work and will be expected to perform other duties and/or special projects as assigned
Preferred
Experience in a Biotech/Pharmaceutical company with a high growth, fast-paced environment
Experience in qualification of analytical equipment, including those with computerized systems
Experience in method validation/qualification/verification/transfer
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
Company fleet vehicle for eligible positions
Referral bonus program
Company
Astellas Pharma
Astellas Pharma is a global pharmaceutical research & development company.
10001+ employees
H1B Sponsorship
Astellas Pharma has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (7)
2024 (4)
2023 (4)
2022 (2)
2021 (3)
2020 (5)
Funding
Current Stage
Public CompanyTotal Funding
unknownKey Investors
National Institute on Drug Abuse (NIDA)
2020-07-22Grant
2008-10-13IPO
Leadership Team
Amanda Hart
Head, Global Commercial Analytics and Reporting
Recent News
2026-01-07
Company data provided by crunchbase