Step into a hands-on role guiding bioanalytical assays-from qPCR to cell potency-through validation, method transfers, and global regulatory approval. You'll be the technical backbone ensuring critical biopharmaceuticals transition seamlessly from late-stage development to market.
location: Norwood, Massachusetts
job type: Contract
salary: $65 - 90 per hour
work hours: 9 to 5
education: Bachelors
responsibilities:
- Lead method lifecycle activities, including implementation, validation, transfer, optimization, remediation, and complex technical investigations.
- Develop scientifically justified validation and transfer strategies compliant with global regulatory requirements.
- Author method validation/transfer protocols, SOPs, technical reports, and Module 3 regulatory submission documents/RTQs.
- Partner with QC, Analytical Development, contract testing labs, and global sites to transition methods and support health authority inspections.
- Ensure compliance with cGMP, Data Integrity, and Quality Systems while mentoring junior laboratory personnel.
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 related scientific discipline.
- Bioanalytical experience with biopharmaceuticals, vaccines, or nucleic acid therapeutics in a cGMP environment.
- Expertise in cell-based potency assays, ELISA, PCR, qPCR, digital PCR, and Sanger sequencing.
- Hands-on experience authoring validation/transfer protocols, regulatory documents (Module 3, RTQ responses), and managing changes via eQMS.
- Solid understanding of ICH Q2(R2) and USP guidelines, laboratory automation, and cross-functional project management.
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 HRsupport@randstadusa.com.
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.
