Advance your biopharmaceutical career with a top-tier global pharma leader! We are seeking a Contract Scientist to provide dedicated technical and operational support across mid-stage and late-stage parenteral drug product development programs. Based on-site in a modern laboratory environment, you will drive hands-on in-use compatibility studies, support drug product manufacturing oversight, and manage critical technical documentation to advance clinical deliverables.
location: Lexington, Massachusetts
job type: Contract
salary: $70 - 81 per hour
work hours: 9 to 5
education: Bachelors
responsibilities:
- Design and execute in-use studies for parenteral products, including dose preparation, dilution, compatibility, hold-time, and simulated clinical administration.
- Perform physicochemical and analytical characterization (MFI subvisible particles, SEC, pH, osmolality, and protein concentration) to trend stability data.
- Author technical protocols, plans, and reports to support clinical administration instructions and regulatory filings.
- Oversee sample management, testing logistics, and stability pull schedules with analytical and quality laboratories.
- Maintain inspection-ready electronic document management systems (EDMS) adhering strictly to GMP, GDP, and data integrity standards.
qualifications:
- B.S. with 6+ years, M.S. with 4+ years, or Ph.D. with 0-2 years of biotech experience in Pharmaceutical Sciences, Chemistry, Biochemistry, or related fields.
- Proven background in parenteral/sterile drug product formulation, development, or manufacturing support.
- Hands-on experience with in-use, compatibility, and stability studies for injectable/infusion products.
- Solid laboratory expertise in analytical characterization (SEC, MFI, pH, osmolality, appearance).
- Demonstrated experience authoring technical reports and navigating EDMS tools (e.g., Veeva, Documentum).
- Practical understanding of GMP, GDP, and regulatory expectations.
skills: Chromatography, Good Manufacturing Practices (GMP), Good Documentation Practices (GDP), International Council for Harmonization (ICH), Chemistry Manufacturing and Controls (CMC)
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.
