DSP GMP Manufacturing Scientist (Biologics)

Position Summary

Northway Biotech is seeking a motivated and detail-oriented DSP GMP Manufacturing Scientist to join our biologics manufacturing team at our Waltham, MA facility.

This is a hands-on position responsible for executing downstream purification and filtration operations, operating manufacturing equipment, and maintaining accurate GMP documentation. The ideal candidate has practical experience in biologics manufacturing, preferably within a small to mid-sized CDMO, and can thrive in a fast-paced, collaborative environment.

Position responsibilities:

• Perform hands-on downstream GMP manufacturing operations for biologics, including purification, filtration, and bulk drug substance handling.

• Execute downstream unit operations, including column chromatography, viral inactivation (VI), viral filtration (VF), depth filtration, and ultrafiltration/diafiltration (UF/DF), according to approved batch records and SOPs.

• Prepare buffers, solutions, equipment, and materials required for GMP manufacturing activities.

• Perform equipment setup, assembly, cleaning, sanitization, and line clearance activities within GMP manufacturing suites.

• Accurately complete batch manufacturing records, equipment logbooks, and other GMP documentation in accordance with Good Documentation Practices (GDP).

• Monitor manufacturing processes, perform in-process sampling, and promptly report equipment issues, deviations, or process abnormalities.

• Support manufacturing readiness, equipment troubleshooting, and continuous improvement activities.

• Collaborate with Manufacturing, Quality Assurance, Quality Control, and Process Development teams to ensure successful manufacturing operations.

Position requirements:

· Associate's or Bachelor's degree in Biology, Biochemistry, Biotechnology, Chemical Engineering, or a related discipline, or equivalent relevant experience.

· Minimum 3 years of relevant hands-on experience in biologics manufacturing or bioprocessing, including experience in a GMP manufacturing environment.

· Prior experience in a small to mid-sized Contract Development and Manufacturing Organization (CDMO) is strongly preferred.

· Practical experience with downstream operations, including chromatography, filtration, UF/DF, or TFF.

· Familiarity with GMP documentation practices, including batch records, logbooks, and equipment cleaning records.

· Strong understanding of cGMP requirements, gowning procedures, cleanroom behavior, and controlled manufacturing environments.

· Experience operating, assembling, and troubleshooting bioprocess equipment and single-use systems.

· Ability to adapt to changing manufacturing priorities, support multiple client projects, and perform a variety of hands-on activities within a small team.

· Strong attention to detail, communication, teamwork, and problem-solving skills.

· Flexibility to work extended hours or weekends as required by manufacturing schedules.