QC Scientist I Raw MaterialsPurpose & Scope The QC Scientist I Raw Materials will be responsible for executing and troubleshooting a variety of laboratory test methods, defining the requirements for implementation of procedures, processes and assays within QC, and identifying and implementing continuous improvement initiatives related to overall laboratory functionality. This role will work closely with the assay transfer technical lead. This role will mentor junior analysts and develop and facilitate training initiatives within the labs.
Role and 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
Quantitative Dimensions:The QC Scientist I Raw Materials will be accountable for executing and troubleshooting a variety of laboratory test methods, defining the requirements for implementation of procedures, processes and assays within QC, and identifying and implementing continuous improvement initiatives related to overall laboratory functionality.
Organizational Context:The QC Scientist I Raw Materials will typically report to the Senior Manager, Quality Control Raw Materials. This role is expected to Model our Core Values and to demonstrate work performance as someone who exemplifies the culture we want to create; operates with transparency; is trusted; and supports the overall mission and vision of Astellas Gene Therapies and the Astellas organization.
Required Qualifications - 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 Qualifications - 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
Location and Working Environment- This role frequently requires long periods of sitting, standing and use of hands and regular motion to include bending, stooping, and lifting up to 20lbs.
- This is an on-site role working in a cGMP regulated manufacturing facility.
Salary Range$94,570-$135,100(Final compensation will be determined based on a variety of factors, including but not limited to skills, experience and organizational equity considerations.)
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
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