3 Key Consulting, Inc.

Engineer, Upstream/Downstream Drug Substance Process Development & Tech Transfer – REMOTE (JP15076)

3 Key Consulting, Inc.  •  $36 - $41/hr  •  Thousand Oaks, CA (Remote)  •  3 months ago
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Job Description

Job Title:   Engineer, Upstream/Downstream Drug Substance Process Development & Tech Transfer – REMOTE (JP15076)
Location: Thousand Oaks, CA. 91320 (100% Remote)
Employment Type: Contract
Business Unit: Drug Substance Technology Engineering
Duration: 1+ year (with likely extensions and/or conversion to permanent)
Posting Date: 03/5/26
Pay Rate: $36 - $41/hour W2
Notes: Only qualified candidates need apply.  Remote - EST preferred - Open to all US remote candidates

3 Key Consulting is hiring an Engineer, Upstream/Downstream Drug Substance Process Development for a consulting engagement with our direct client, a leading global biopharmaceutical company.


Our ideal candidate will have 3+ years of experience in tech transfer of Biologics Drug Substance upstream and/or downstream required (Cell Culture, Harvest, Chromatography, filtration, UFDF unit ops), Knowledge of upstream and downstream processes/equipment; scale-up factors, process deviations, quality attributes. GMP or lab experience is a nice to have. Strong problem solving and troubleshooting experience would be a plus.

Seeking a Process Development Engineer to join the Drug Substance Technology Engineering team at our client’s Cambridge, MA. site. Providing strong process engineering/ technology transfer support of human therapeutic 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.

The Engineer will apply process engineering knowledge in support of upstream and/or downstream 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.

Why is the Position Open?
Supplement to the teams ongoing needs.

Top Must Have Skills:
  • At least 2 years of Biologics / Drug Substance tech transfer experience required (Cell culture/ harvest/ Chromatography/ filtration/ UFDF unit ops).
  • At least 2 years of experience in the lab scale development work or in the manufacturing environment (pilot plant or GMP)
  • Strong analytical capability, troubleshooting, and problem solving skills


Day to Day 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
  • 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


Basic Qualifications:
Master’s degree
OR
Bachelor’s degree and 2 years of Engineering or Operations experience
Associate’s degree and 7 years of Engineering or Operations experience
OR
High school diploma / GED and 8 years of Engineering or Operations experience

Preferred Qualifications:
  • Master’s Degree in Chemical or Biochemical Engineering
  • 1+ years of Process Engineering experience preferably related to upstream and/or downstream purification of commercial cGMP manufacturing facilities
  • Background in biologics technology transfer into commercial facilities, new product introductions (NPIs)
  • Biologics process knowledge: Knowledge of processes (cell culture, harvest, chromatography, viral filtration/inactivation, ultrafiltration/diafiltration, and final fill) and 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


Red Flags:
  • Too much experience (15+ years)
  • Many job changes within a year or less


Interview process:

1. Teams screening first

2. Panel interviews second

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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