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.