Engineer

Cambridge, MA 02138

Posted: 09/20/2024 Job Number: 39736

Job Description


Engineer


Top 3 Must Have Skill Sets:
  1. Purification/"downstream" laboratory (PD) or MFG experience with monoclonal antibodies, HR/EWC can look for keywords such as chromatography, filtration, UFDF, UF/DF, final fill, viral filtration, viral inactivation.
  2. Technology Transfer/NPI experience is a plus.
  3. PPQ experience is a plus

Red Flags:
  • Short job durations (less than 6 months).
  • Not looking for a recent graduate - the team is looking for a candidate who can join the team and make a

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 cell culture and purification 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:    

Under guidance of senior staff, the Engineer performs the following:
  • 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 collaborates with other functions such as Manufacturing, Quality, and Regulatory

Basic Qualifications:
  • Master degree

OR
  • Bachelor degree and 2 years of experience

OR
  • Associate degree and 6 years of experience

OR
  • High school diploma / GED and 8 years of experience

 

Pay range is $31 - $36 per hour with full benefits available, including paid time off, medical/dental/vision/life insurance, 401K, parental leave, and more. Our compensation reflects the cost of labor across several US geographic markets. Pay is based on several factors including market location and may vary depending on job-related knowledge, skills, and experience.

THE PROMISES WE MAKE:

At Crystal Equation, we empower people and advance technology initiatives by building trust.  Your recruiter will prep you for the interview, obtain feedback, guide you through any necessary paperwork and provide everything you need for a successful start.  We will serve to empower you along the way and provide the path for your professional journey.

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