3 Key Consulting, Inc.

Engineer, Biologics Purification, Upstream/Downstream/Tech Transfer - Remote (JP15407)

3 Key Consulting, Inc.  •  $34 - $37/hr  •  Cambridge, MA (Remote)  •  6 days ago
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Job Description

Job Title: Engineer, Biologics Purification, Upstream/Downstream/Tech Transfer - Remote (JP15407)
Location: Cambridge MA, Remote
Employment Type: Contract
Business Unit: Drug Substance Technology Engineering Group
Duration: 1+ years with possible extensions and/or conversion to permanent
Posting Date: 5/21/2026
Pay Rate: $34 - $37/hour W2
Notes: Remote (Any TZ - Local to Cambridge, MA is highly preferred.

 

3 Key Consulting is hiring an  Engineer for a consulting engagement with our direct client, a leading global biopharmaceutical company.



Seeking a Process Development Engineer to join the Drug Substance Technology Engineering team at our client Cambridge site. Providing strong process engineering/ technology transfer support of human therapeutic drug substance products in clinical development through commercial production. Our mission is to translate developmental processes to commercial reality for patients through scientific expertise and engineering innovation. Knowledge of processes/equipment; scale-up factors, process deviations, quality attributes. GMP experience is a plus.

The Engineer will apply upstream and downstream process engineering knowledge in support of technology transfer and clinical/commercial drug substance manufacturing in both stainless and single-use formats. Will partner with manufacturing, quality, analytical, and bench scientists to support a highly dynamic technology transfer.


JOB RESPONSIBILITIES:

Under guidance of senior staff, the Engineer will perform the following:
  • Transfer processes for drug substance manufacturing and translate process improvements from the laboratory into manufacturing facilities
  • Provide technical support for successful scale-up, transfer of process technology, and for clinical and/or commercial manufacturing operation. Experience is technical report writing an expectation.
  • Assist in troubleshooting clinical and commercial runs
  • Execute data trending and statistical process analysis
  • Support technical direction for process-related deviations, CAPAs, and change controls
  • Identify and support process-related operational excellence opportunities
  • Represent process development and collaborates with other functions such as Manufacturing, Quality, and Regulatory.
  • Experience related to Process characterization for manufacturing of biologics highly preferred. This includes technical support for authoring and review of process characterization reports.

Why is the Position Open?

Supplement additional workload on team.


BASIC QUALIFICATIONS:

Master’s degree and 2 years of Engineering or Operations experience

Bachelor’s degree and 4 years of Engineering or Operations experience

Associate’s degree and 7 years of Engineering or Operations experience

High school diploma / GED and 8 years of Engineering or Operations experience

PREFERRED QUALIFICATIONS:
  • Master’s Degree in Chemical or Biochemical Engineering
  • 2+ years of Process Engineering experience preferably related to downstream/ purification of commercial cGMP manufacturing facilities
  • Background in biologics technology transfer into commercial facilities, new product introductions (NPIs)
  • Biologics purification process knowledge: Knowledge of upstream ( cell culture/bioreactor operations) or purification processes (chromatography, viral filtration/inactivation, ultrafiltration/diafiltration, and final fill. )/ equipment; scale-up factors, process deviations, quality attributes
  • Strong analytical capability, troubleshooting, and problem solving
  • Independently motivated with ability to multi-task and work in teams, especially if remote or hybrid.
  • Excellent written and verbal communication skills with technical writing and presentation experience. Experience in PC documentation, report reviews and technical writing preferred.
Top Must Have Skills:
  • Cell culture experience, Purification /downstream experience, process characterization experience
  • Nice to have:

    Monoclonal antibodies or mAbs 

    manufacturing or on floor support 


Day to Day Responsibilities:

Assist senior staff in technical writing, process tech transfer, data monitoring


Red Flags:
No experience, not enough experience in biopharma or biotech, no experience in cell culture/upstream, purification/downstream or technical report writing

Interview process:

Teams interview. Screening 30 minute Microsoft team's interview with me. Second round- Team's interview 30 minute each approximately with 3 other team members.


We invite qualified candidates to send your resume to  resumes@3keyconsulting.com  If you decide that you’re not interested in pursuing this particular position, please feel free to take a look at the other positions on our website www.3keyconsulting.com/careers. You are also welcome to share this opportunity with anyone you think might be interested in applying for this role.
3 Key Consulting, Inc.

About 3 Key Consulting, Inc.

3Key Consulting specializes in the rapid recruitment and placement of business and IT professional within the life sciences and healthcare industries. With 12 years of experience, 3Key has established a vast network of industry professionals and forged strong partnerships/alliances with key academic institutions across the country to continually develop our business professional and niche skill pipeline.

3KC offers a full suite of staffing solutions including PEO and compliance services. 3KC has several technology and industry domain practices including competencies in business intelligence, healthcare and life sciences.

People, process, and technology are 3 key areas of focus that we carefully examine individually and jointly, in order to deliver on our client's 3 key areas of focus - better, faster and cost effective BI and staffing solutions.

MISSION:

To create a better work experience for our customers, partners and employees through exceptional dedication and performance.

• We make hiring easier

• We build strong teams

• We bring about positive outcomes

VISION:

3 Key Consulting’s responsibility is to continually improve the manner and efficiency in which human resources and businesses are brought together to create value. Our vision is to put programs into action that improve market efficiencies while helping businesses and people be more productive.

Industry
Unknown
Company Size
1-10 employees
Headquarters
Simi Valley, CA
Year Founded
2009
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