QC Scientist I Raw Materials

Astellas; Westborough (MA); On-site; USD 95,000 - 135,000; Full time

Benefits offered by this job

On-site role

Competitive benefits

401(k) match

Job summary

Astellas is seeking a QC Scientist I Raw Materials in Westborough, MA to execute and troubleshoot laboratory test methods, support method transfers and ensure data quality in a cGMP environment.

In this on-site role, you will mentor junior analysts, develop SOPs, and collaborate across network sites to share best practices while maintaining strict compliance with USP, ICH, and FDA guidelines.

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.
• Hands-on experience with techniques such as FTIR, Raman, Near-IR, HPLC and other compendial assays.
• Knowledge of 21CFR, ICH, USP, Ph.Eur. and FDA guidance documents and cGxP in clinical and commercial manufacturing.

Responsibilities

• Develop, author, revise technical reports and SOPs.
• Execute and troubleshoot raw material testing in support of production.
• Perform routine release sampling and testing of raw materials per USP, Ph.Eur., JP and general chapters.

Skills

GMP knowledge

Data integrity

Laboratory skills

Excellent communication

Education

B.S./M.S. in chemistry or related field

Tools

LIMS

HPLC

FTIR

Raman

Job description

Westborough, Massachusetts, United States

Job Description

QC Scientist I Raw Materials

Astellas is a global life sciences company committed to turning innovative science into VALUE for patients. We provide transformative therapies in disease areas that include oncology, ophthalmology, urology, immunology and women's health. Through our research and development programs, we are pioneering new healthcare solutions for diseases with high unmet medical need. Learn more at Astellas.com.

Are you driven to make a real difference in the lives of patients?

We're seeking passionate individuals who thrive in dynamic environments, embrace new ideas, and aren't afraid to take intelligent risks. People who act with unwavering integrity and are deeply committed to making a tangible impact.

Purpose & 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.

Location(s)

Westborough , Massachusetts , United States

Requirements

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.

What awaits you at Astellas?

• Global collaboration: Become part of a connected global business of like-minded life science leaders, all dedicated to improving patients' lives worldwide.
• Real-world patient impact: Contribute to transformative therapies that reach patients around the world, knowing your work makes a difference every day.
• Relentless Innovation: Join a company at the forefront of scientific breakthroughs, where you'll have the opportunity to shape the future of healthcare.
• A Culture of Growth: Chart your own course within a supportive environment that values your contributions, champions your development, and empowers you to pursue your passions.

Our Organizational Values and Behaviors

Values: Innovation, Integrity and Impact sit at the heart of what we do.

Behaviors: We come together as ‘One Astellas’, working with courage and a sense of urgency. We are outcome focused and consistently take accountability for our personal contribution.

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.)

• 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
• Annual Corporate Bonus and Quarterly Sales Incentive for eligible positions
• Long Term Incentive Plan for eligible positions
• Company fleet vehicle for eligible positions

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Our organization is committed to diversity, equal opportunity, and affirmative action. We are an equal opportunity employer. All applicants will be considered without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity, or any other protected characteristic.

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