Scientist III

Are you ready to take your scientific expertise to the next level at one of the most advanced biotech hubs in Massachusetts? Nestled in Framingham, this state-of-the-art biomanufacturing site is a cornerstone of innovation, driving next-generation drug development in a collaborative, hands-on environment. This opportunity places you at the forefront of commercial manufacturing support and downstream process development, where you'll be directly involved in scaling life-saving therapies from lab bench to large-scale production. You'll work alongside a global team of experts using cutting-edge technologies to enhance efficiency, solve complex challenges, and push the boundaries of what's possible in protein purification.

This role is ideal for a scientist with a strong background in GMP manufacturing, tech transfer, and lifecycle management who thrives in dynamic, high-impact environments. With a rich portfolio spanning 17 commercial products and ambitious plans to launch 20 more in the next five years, your work here will help transform experimental treatments into market-ready solutions. If you're passionate about working with novel modalities like bispecific antibodies, antibody-drug conjugates, and nanobodies-and making a real-world impact-this is your chance to be part of a mission-driven team shaping the future of biologics.

location: Framingham, Massachusetts
job type: Contract
salary: $85.00 - 88.77 per hour
work hours: 9 to 5
education: Masters

responsibilities:

• Develop robust and scalable downstream purification processes for biologics, including monoclonal antibodies, bispecific antibodies, fusion proteins, and enzymes.
• Support commercial manufacturing by troubleshooting and optimizing existing purification processes in a GMP environment.
• Participate in and lead MSAT development and pilot-scale projects, ensuring alignment with commercial manufacturing needs.
• Design and execute experiments to support process characterization, including DOE studies to establish proven acceptable ranges (PAR).
• Perform data analysis, technical report writing, and contribute to regulatory filings (e.g., dossier sections, PAI preparation).
• Implement and evaluate new technologies and innovations in downstream process sciences for lifecycle management and efficiency gains.
• Manage or support technology transfer activities for internal and external manufacturing partners.
• Conduct and support virus clearance studies and other validation efforts critical to product safety and quality.
• Operate and troubleshoot process equipment, including automated chromatography platforms (e.g., GE Healthcare AKTA) and TFF systems.
• Ensure compliance with GMP standards, contributing to deviations, CAPA investigations, and ongoing manufacturing improvements.

qualifications:
Required Skills and Qualifications:

• Must be authorized to work in the United States without the need for current or future sponsorship. This role is not eligible for employment-based visas, including STEM OPT, OPT, or H-1B.
• Bachelor's (B.S./B.A.) degree in Biotechnology or related scientific field with a minimum of 5+ years of relevant experience, or Master's (M.S./M.A.) degree with at least 3+ years of relevant experience.
• Proven experience in commercial-scale manufacturing support and development, including cGMP operations.
• Hands-on experience with deviation investigations, CAPA processes, and implementing improvements in ongoing commercial manufacturing.
• Background in reviewing and updating product manufacturing processes for greater efficiency and new technology integration.
• Experience supporting late-stage or commercial manufacturing (not early-phase/clinical trial or Phase I/II development).
• Strong technical writing skills for protocols, reports, and regulatory documents.
• Ability to work onsite full-time and collaborate in cross-functional teams.

Preferred Skills and Experience:

• Experience with downstream biologics manufacturing processes, including chromatography, TFF (ultrafiltration/diafiltration), micro- and nanofiltration.
• Familiarity with operating and troubleshooting automated purification systems (e.g., GE Healthcare AKTA).
• Prior involvement in process scaling, tech transfer, and lifecycle management (LCM) activities.
• Experience in executing virus clearance studies and related validation work.
• Exposure to next-generation manufacturing concepts such as continuous processing, digital labs, or advanced analytics.
• Demonstrated ability to implement innovative solutions in a fast-paced, matrixed global environment.

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skills: Quality control, Quality Assurance, CAPA, Chromatography, GMP (Good Manufacturing Practice), Manufacturing Operations

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 ....

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.