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Research Associate Downstream Process Development Jobs in Massachusetts

Amgen

Process Development Associate

Cambridge, MA · On-site

... we research, manufacture, and deliver innovative medicines to help people live longer, fuller ... and downstream manufacturing processes supporting Ph II/III clinical trials to marketing ...

Amgen

Process Development Associate

Cambridge, MA · On-site

... we research, manufacture, and deliver innovative medicines to help people live longer, fuller ... and downstream manufacturing processes supporting Ph II/III clinical trials to marketing ...

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Research Associate Downstream Process Development information

What is a research associate downstream process development?

A Research Associate in Downstream Process Development works within biotechnology or pharmaceutical companies to optimize and scale up the purification and recovery of biological products, such as proteins or antibodies, after initial production. They focus on processes like filtration, chromatography, and centrifugation to ensure product quality and yield. These professionals design experiments, analyze data, and support the transfer of processes from laboratory scale to manufacturing. Their work is crucial for developing efficient, reproducible, and regulatory-compliant methods for producing biopharmaceuticals.

What are the key skills and qualifications needed to thrive as a research associate in downstream process development?

To thrive as a Research Associate in Downstream Process Development, you need a solid background in biochemistry, molecular biology, or chemical engineering, often demonstrated by a bachelor's or master's degree in a related field. Familiarity with chromatography systems (such as AKTA), filtration technologies, and Good Manufacturing Practice (GMP) standards, along with data analysis software, is typically required. Strong problem-solving skills, attention to detail, and effective teamwork and communication abilities help individuals excel in this role. These competencies are crucial for ensuring efficient, scalable purification processes and maintaining product quality in biopharmaceutical development.

What are the typical challenges faced by a research associate in downstream process development, and how can they be addressed?

A Research Associate in Downstream Process Development often encounters challenges such as optimizing purification processes for new biologics, troubleshooting equipment issues, and ensuring scalability from laboratory to production scale. Effective communication with cross-functional teams, such as upstream scientists and analytical specialists, is essential to resolve issues quickly. Staying current with new purification technologies and maintaining meticulous documentation can also help address these challenges and support successful process development.

What is the difference between Research Associate Downstream Process Development vs Research Associate Upstream Process Development?

AspectResearch Associate Downstream Process DevelopmentResearch Associate Upstream Process Development
Primary FocusPurification, filtration, chromatography of bioproductsCell culture, media optimization, bioreactor operation
Skills & CertificationsProtein purification, chromatography techniques, GMP complianceCell culture, aseptic techniques, bioreactor handling
Work EnvironmentLaboratory, manufacturing, quality controlLaboratory, bioprocessing facilities
Industry UsageBiopharmaceutical manufacturing, biotech researchBiopharmaceutical development, biotech research

While both roles support bioprocess development, Research Associate Downstream Process Development focuses on purification and filtration of bioproducts, whereas Research Associate Upstream Process Development emphasizes cell culture and bioreactor processes. Understanding these differences helps candidates align their skills with the appropriate role in biopharmaceutical production.

What cities in Massachusetts are hiring for Research Associate Downstream Process Development jobs?

Cities in Massachusetts with the most Research Associate Downstream Process Development job openings:

Research Associate Downstream Process Development jobs near you
Infographic showing various Research Associate Downstream Process Development job openings in Massachusetts as of September 2026, with employment types broken down into 1% Internship, 1% As Needed, 79% Full Time, 17% Part Time, and 2% Contract. Highlights an 86% Physical, 3% Hybrid, and 11% Remote job distribution.

Director, Process Development

Lexington, MA • On-site, Remote

Keros Therapeutics
Biotechnology Research and Development • 1 - 10 employees
Learn more about Keros Therapeuticsexternal

$200K - $230K/yr

Full-time

Re-posted 19 days ago

Job description

At Keros, our mission is to deliver significant clinical benefit to a wide range of patients with disorders that are linked to dysfunctional signaling of the transforming growth factor-beta (TGF-ß) family of proteins. With a focus on developing differentiated product candidates that are designed to alter TGF-β signaling, we aim to target the pathways critical for the growth, repair and maintenance of blood cells and a number of tissues, including bone, skeletal muscle, adipose and heart tissue. We believe our product candidates have the potential to unlock the full therapeutic benefits of modulating the TGF-β superfamily and provide disease-modifying benefit to patients.
Job Summary
This role is responsible for providing overall management of the Process Development group with a focus on biologics. The position will lead a group of Process Scientists and Engineers in the development and tech transfer of processes for different stages of multiple biologics programs. The candidate will also coordinate with multiple internal teams to support successful, early program transition from Research to Development, internal process development studies, and production of material for toxicology studies.
Primary Responsibilities
  • Serves as Process Development department head overseeing planning, execution, and project delivery in a fast-paced environment
  • Manage, mentor and facilitate the development of the staff in Upstream and Downstream Process Development
  • Strong working knowledge of upstream and downstream process technologies
  • Provide hands-on expertise and strategic guidance for bench-scale to pilot-scale bioreactor operations, ensuring scalable and robust processes
  • Design and execute studies to evaluate critical culture conditions (e.g., pH, DO, feeding profiles, shear stress) to optimize growth, viability, and product quality
  • Drive innovation and development of process technologies that can result in significant increases in efficiency and purity
  • Partner closely with downstream teams to ensure seamless interface between cell culture harvest and purification steps
  • Operate within a cross-functional project team environment and coordinate efforts with all relevant internal functional areas including Quality, Manufacturing, Analytical Development, Program Management, Formulation Development, Research, non-Clinical (Tox)
  • Lead group in successful operations for supply of material for use by other groups (Bioanalytical, Tox, etc) and process development studies
  • Have direct experience with establishing production processes for biologics in cGMP manufacturing settings
  • Determine areas for gaining efficiency, coordinates with individual groups and ensure harmonized implementation of best practices
  • Support the development and maintenance of budgets, manpower and capital requirements for process development group
  • Actively provides career path and development for team members
  • Execution of process development studies, review of the data, and documentation of all activities according to the appropriate laboratory procedure
  • Experience throughout the biopharmaceutical product life-cycle including process characterization studies, in-process control strategy and process validation is preferred but not required

Preferred Skills
  • Management experience must include managing a team of at least 5
  • Experience reviewing and/or authoring CMC sections for regulatory submissions
  • Demonstrated ability to work cross functionally to achieve goals
  • Knowledge of upstream and downstream process development for biologics
  • Proven track record of running, programming, and scaling bench-to-pilot scale bioreactor systems
  • Ability to multi-task and handle successful execution of multiple parallel programs
  • Knowledge of cGMP and manufacturing operations
  • Knowledge of tech transfer
  • Knowledge of good lab practices including hands-on implementation
  • Knowledge of regulatory guidelines, particularly those for IND filing

Education Requirements
  • Minimum requirement is a Bachelor of Science degree in a scientific discipline with a minimum of 10 years of technical management experience; a Master's degree with 8 years or a Doctorate degree in a scientific or biochemical engineering area (or equivalent. Additionally, at least 5 years' experience serving in a relevant managerial capacity required

This pay range represents the base hourly rate or base annual full-time salary for all positions in the job grade within which this position falls. The actual base salary offer will depend on a variety of factors including experience, education, and other relevant factors.
Potential base pay range
$200,000-$230,000 USD
Our Diversity, Equity & Inclusion Mission Statement:Keros is an inclusive company. We believe that diversity drives innovation. We continue to build an inclusive culture that encourages, supports, and celebrates the diverse voices of our employees. As such, Keros takes a holistic approach in mentoring, coaching, and developing all of our Keros team members.
Keros Therapeutics is an Equal Opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex including sexual orientation and gender identity, national origin, disability, protected veteran status, or any other characteristic protected by applicable federal, state, or local law.
Recruitment & Staffing Agencies:Keros Therapeutics does not accept unsolicited resumes from any source other than the candidate directly. Any unsolicited submission by an agency to Keros is prohibited. Any resume submitted by an agency without a signed contract or expressed consent by a member of the Keros Therapeutics Human Resources Department, will be considered property of Keros Therapeutics, and no fee shall be owed with respect thereto.

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