Downstream Manufacturing Associate III (1st shift)Apply Now
Location: Milford, Massachusetts 01757
Employment Type: Contract
Job Description
Title: Downstream Manufacturing Associate III – Overnight Shift
Location: Milford, MA
Work Arrangement: 100% Onsite
Employment Type: Contract
Schedule: Overnight 4/3 schedule, 6:00 PM–6:30 AM, Wednesday–Saturday, working every other Wednesday
About the Role
We are seeking an experienced Downstream Manufacturing Associate III to support biologics manufacturing and purification operations within a cGMP environment.
This is a senior-level, hands-on manufacturing role focused on downstream processing, including TFF, chromatography, monoclonal antibody purification, buffer preparation, and disposable manufacturing systems. The successful candidate will also troubleshoot equipment and processes, support investigations, train operators, and provide leadership when needed.
Key Responsibilities
Key Skills
Downstream Manufacturing | TFF | Chromatography | Monoclonal Antibody Purification | ÄKTA Ready | ÄKTA Process | cGMP | Biologics Manufacturing | Buffer Preparation | Single-Use Systems | Deviations | Investigations | Batch Records | Process Troubleshooting
Compensation
In accordance with applicable pay transparency requirements, the anticipated hourly rate for this role is $34.00–$40.00/hr, based on experience and qualifications, plus an applicable overnight shift differential.
Location: Milford, MA
Work Arrangement: 100% Onsite
Employment Type: Contract
Schedule: Overnight 4/3 schedule, 6:00 PM–6:30 AM, Wednesday–Saturday, working every other Wednesday
About the Role
We are seeking an experienced Downstream Manufacturing Associate III to support biologics manufacturing and purification operations within a cGMP environment.
This is a senior-level, hands-on manufacturing role focused on downstream processing, including TFF, chromatography, monoclonal antibody purification, buffer preparation, and disposable manufacturing systems. The successful candidate will also troubleshoot equipment and processes, support investigations, train operators, and provide leadership when needed.
Key Responsibilities
- Perform downstream biologics manufacturing and purification activities in accordance with cGMP requirements
- Operate chromatography and purification equipment including ÄKTA Ready, ÄKTA Process, XDUO buffer systems, and disposable technologies
- Execute TFF, chromatography, buffer preparation, and other downstream processing activities
- Monitor and document batch parameters, production data, and manufacturing records in accordance with GDP/GMP requirements
- Troubleshoot process and equipment issues, respond to alarms, and support root-cause investigations
- Support deviations, investigations, batch record revisions, and other manufacturing documentation
- Train and mentor newer operators and provide subject matter expertise on production equipment and processes
- Lead or support continuous improvement activities including 5S, Gemba, and related initiatives
- Coordinate with cross-functional teams and provide manufacturing support during audits and other operational activities
- Strong hands-on experience in GMP downstream biologics manufacturing
- Experience with TFF, chromatography systems, and monoclonal antibody purification
- Experience troubleshooting downstream manufacturing equipment and processes
- Strong knowledge of cGMP manufacturing practices and pharmaceutical production equipment
- Ability to complete accurate batch records, technical documentation, and production calculations
- Experience supporting deviations, investigations, or other manufacturing events
- Ability to train other operators and provide technical leadership
- Strong communication, teamwork, and problem-solving skills
- Ability to work the required overnight schedule in Milford, MA
- High school diploma with 6+ years of related experience, or
- Associate degree in Life Sciences, Engineering, or a related field with relevant experience, or
- Bachelor's degree with 4+ years of related experience
- Biotechnology certificate is preferred
- Experience with ÄKTA Ready or ÄKTA Process systems
- Experience with XDUO buffer systems and single-use/disposable technologies
- Experience authoring or revising manufacturing procedures and batch records
- Familiarity with root cause analysis and structured troubleshooting methods
- Experience leading continuous improvement initiatives
- Prior experience supporting clinical or commercial biologics manufacturing
Key Skills
Downstream Manufacturing | TFF | Chromatography | Monoclonal Antibody Purification | ÄKTA Ready | ÄKTA Process | cGMP | Biologics Manufacturing | Buffer Preparation | Single-Use Systems | Deviations | Investigations | Batch Records | Process Troubleshooting
Compensation
In accordance with applicable pay transparency requirements, the anticipated hourly rate for this role is $34.00–$40.00/hr, based on experience and qualifications, plus an applicable overnight shift differential.
Contact
Thomas "TJ" Medlin
Principal Recruiter
Back to Jobs Email to a Friend Apply Now