Northway Biotech · 4 hours ago
USP Scientist (CDMO Biotechnologist)
Waltham, MA
Full-time
Onsite
Mid, Senior Level
$70K/yr - $90K/yr
4+ years expNorthway Biotech is a company focused on biotechnological advancements, and they are seeking a USP Scientist to develop scalable upstream processes. The role involves hands-on execution of cell culture, supporting process development, and ensuring compliance with GMP standards.
BiopharmaBiotechnologyManufacturing
Hiring Manager
Ieva Pranckeviciute
Responsibilities
Perform hands-on execution of all aspects of cell culture and primary recovery activities to develop scalable and robust upstream processes
Prepare reagents, components, media, buffers and other solutions. Maintain equipment and raw materials/consumables inventory to ensure smooth operation
Perform analytical methods to monitor cell growth and metabolites, and analyze productivity of cultures
Support upstream process development activities including clone selection, technology development, media development, and process optimization studies
Coordinate with cross-functional departments on various projects
Interpret data and contribute to technical reports
Identify technical issues and implement solutions
Ensure high-quality, timely documentation in laboratory notebooks and technical reports
Execute upstream unit operations within GMP manufacturing suites, including seed train expansion, bioreactor operations, and harvest activities according to established batch records and SOPs
Perform GMP-compliant cleaning, equipment preparation, line clearance, and area readiness activities to support manufacturing operations
Adhere to cGMP requirements, including gowning procedures, environmental monitoring practices, and controlled-area behavior expectations
Support manufacturing investigations, deviation documentation, and implementation of corrective/preventive actions (CAPAs) related to upstream operations
Assist in tech transfer of upstream processes into the GMP environment, ensuring alignment between development and manufacturing requirements
Collaborate with Quality Assurance and Manufacturing teams during production runs to ensure compliance, timely execution, and operational efficiency
Qualification
Required
BS/MS in Chemical/Biochemical Engineering, Biotechnology, or a related discipline required
4–6 years of upstream process development and/or GMP upstream manufacturing experience, depending on education and background
Demonstrated hands-on experience in aseptic technique and execution of cell culture operations in shake flasks and/or bioreactors, including routine culture monitoring (e.g., cell counts, metabolites, productivity)
Working knowledge of upstream process steps such as cell banking, thaw, expansion, production, and harvest, as well as scale‑up and bioprocess engineering principles
Experience performing upstream unit operations in GMP manufacturing suites, including seed train expansion, bioreactor preparation and operation, and primary recovery activities following batch records and SOPs
Familiarity with GMP-compliant cleaning, equipment preparation, line clearance, and readiness activities in controlled manufacturing environments
Understanding of cGMP expectations, including gowning requirements, environmental monitoring practices, controlled‑area behavior, and deviation/CAPA processes
Strong collaboration, communication, and documentation skills, with the ability to work effectively in cross-functional teams (Manufacturing, QA, QC, Process Development)
Independently motivated, detail-oriented, and capable of identifying and resolving technical issues in both development and GMP environments
Ability and desire to work in a fast-paced, dynamic environment, managing multiple priorities while maintaining compliance and high-quality execution
Preferred
Experience supporting tech transfer activities from development to GMP operations is desirable
Familiarity with high-throughput cell culture systems and/or automation tools is highly desirable
Experience with DOE methodologies for process development and optimization is a plus
Company
Northway Biotech
Northway Biotech is a contract development and manufacturing organization.
51-200 employees
H1B Sponsorship
Northway Biotech has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2024 (3)
2023 (2)
2021 (2)
Funding
Current Stage
Growth StageTotal Funding
$0.69M2015-07-01Grant· $0.34M
2015-04-01Grant· $0.34M
Recent News
DelveInsight Business Research LLP
2025-07-15
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