Lead Analytical Scientist, Method Validation & Transfers
Randstad USA
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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
Education
Tools
Job description
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.
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