Engineer

Overview

On Site
Hybrid
$30 - $36 hr
Contract - Independent
Contract - W2
Contract - 12+ mo(s)

Skills

BIOLOGICS
DRUG SUBSTANCE
PURIFICATION
CHROMATOGRAPHY
FILTRATION
UFDF
UF/DF
EQUIPMENT
DEVIATIONS
TECH TRANSFER
TECHNOLOGY TRANSFER
SCALE

Job Details

Payrate: $30.00 - $36.00/hr.

Summary:
Seeking a Process Development Engineer to join the Drug Substance Technology Engineering team at our Cambridge 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 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.

Responsibilities:
  • Transfer purification 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 collaborate with other functions such as Manufacturing, Quality, and Regulatory

Top 3 Must Have Skill:
  • Downstream Process
  • Tech Transfer
  • Scale-up

Pay Transparency: The typical base pay for this role across the U.S. is: $30.00 - $36.00/hr. Final offer amounts, within the base pay set forth above, are determined by factors including your relevant skills, education and experience and the benefits package you select. Full-time employees are eligible to select from different benefits packages. Packages may include medical, dental, and vision benefits, 10 paid days off, 401(k) plan participation, commuter benefits and life and disability insurance.

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