Scientist, AS&T

Randstad USA; Norwood (MA); On-site; USD 90,000 - 124,000; Full time

Job summary

Randstad Life Sciences in Norwood, MA is seeking a Scientist, AS&T for a 6-month extendable contract. You will oversee analytical method lifecycle management, validation, transfers, regulatory submissions, and investigations for late-stage and commercial biopharmaceuticals.

Location: Norwood, Massachusetts. Salary: $65 - 90 per hour. Education: Bachelors. 9 to 5 work hours. This role offers a dynamic, global exposure and cGMP environment experience.

Qualifications

• PhD/MS/BSc with relevant experience in chemistry/biochemistry/molecular biology.
• Experience supporting bioanalytical methods in a cGMP environment.
• Experience authoring validation/transfer protocols and regulatory submissions.
• Strong knowledge of ICH Q2(R2) and eQMS.
• Experience with laboratory automation systems.

Responsibilities

• Lead analytical method lifecycle activities including validation, transfer, optimization and continued verification in a cGMP environment.
• Author and own validation/transfer protocols, SOPs and technical reports per ICH Q2(R2) and regulatory standards.
• Provide technical leadership for complex analytical investigations and root cause analyses.
• Author and review regulatory submission documents (Module 3) and respond to RTQs.
• Collaborate with Analytical Development, Quality Control and global testing labs.

Skills

SOP Development

GMP

QC

ICH

QMS

Education

PhD in Chemistry/Biochemistry/Molecular Biology

Master's in related field

Bachelor's in related field

Tools

Laboratory automation systems

Job description

Job Summary

Advance your career in the premier biotech hub of Norwood, MA! Randstad Life Sciences is seeking a Scientist, AS&T for a 6-month extendable contract position with a top-tier global biopharmaceutical leader. In this technical leadership role, you will oversee analytical method lifecycle management, method validation, transfers, regulatory submissions, and complex technical investigations for late-stage and commercial biopharmaceutical products.

Location: Norwood, Massachusetts

Job type: Contract

Salary: $65 - 90 per hour

Work hours: 9 to 5

Education: Bachelors

Responsibilities

• Lead analytical method lifecycle activities including validation, transfer, optimization, remediation, and continued verification within a cGMP environment.
• Author and own validation protocols, transfer protocols, SOPs, and technical reports adhering to ICH Q2(R2) and global regulatory standards.
• Provide technical leadership for complex analytical investigations, root cause analyses, and method troubleshooting.
• Author and review regulatory submission documents (Module 3) and draft responses to Regulatory Authority Questions (RTQs).
• Partner cross-functionally with Analytical Development, Quality Control, and global contract testing laboratories.

Qualifications

Required:

• Ph.D. with 0-3 years, Master's with 5+ years, or Bachelor's with 7+ years of experience in Chemistry, Biochemistry, Molecular Biology, or a related scientific discipline.
• Experience supporting bioanalytical methods (cell-based potency assays, ELISA, PCR/qPCR/dPCR, Sanger sequencing) within a cGMP environment.
• Demonstrated experience authoring analytical method validation/transfer protocols and regulatory submission documents.
• Strong knowledge of ICH Q2(R2) guidelines and electronic Quality Management Systems (eQMS).
• Experience with laboratory automation systems.

Skills

• SOP Development
• Good Manufacturing Practices (GMP)
• Quality Control (QC)
• International Council for Harmonization (ICH)
• Quality Management Systems (QMS)

Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.

At Randstad, we welcome people of all abilities and want to ensure that our hiring and interview process meets the needs of all applicants. If you require a reasonable accommodation to make your application or interview experience a great one, please contact [e-mail].

Pay offered to a successful candidate will be based on several factors including the candidate's education, work experience, work location, specific job duties, certifications, etc. In addition, Randstad offers a comprehensive benefits package, including: medical, prescription, dental, vision, AD&D, and life insurance offerings, short-term disability, and a 401K plan (all benefits are based on eligibility).

This posting is open for thirty (30) days.

It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.