Sr. Associate Engineer - Process Development

Yoh presents an excellent long-term Sr. Associate Engineer – Process Development opportunity with a trusted, long-term client located in Waltham, MA
.

This position is part of a major pharmaceutical company
, and requires a Bachelors and/or Masters of Science and 1-2+ years of relevant experience
. Schedule is full-time M-F (7am-8am start time, 8 hour shift) and may require flexibility to work some evenings and overtime due to projects.

• Provide technical support for scale-up and manufacturing issues and develop solutions to improve process efficiency and product quality.
  • Scale-up
    • Perform process scale-up and Pilot batches
    • Generate and execute scale down models for GMP manufacturing
    • Generate scale-down models to assist with process scale-up
  • Solution Development
    • Generate process changes to address process issues
  • Lead and assist implementation of Digital Tools
    • Assist with the implementation and use of digital tools for inventory management, genealogy, and sample submission
    • Assist with the implementation and use of digital tools for process data acquisition (Electronic lab notebooks and Electronic Batch Records.)
  • Assist with project activities for the design and technology transfer of mRNA manufacturing processes by contributing and reviewing of Batch Records/Master Production Records (M ) and Standard Operating Procedures (SOPs).
    • Tech Transfer
      • Assist with Tech Transfer batches
      • Support knowledge packages for Tech Transfer
    • Document Generation
      • Assist with the review MBRs
      • Assist with the review SOPs
  • Troubleshoot process/analytical issues that occur during scale-ups and/or in production of drug substance and drug product.
    • Contact vendors for equipment support
    • Conduct investigations using techniques such as 5 why’s, Fishbone diagrams, etc.
    • Determine the root cause of process/analytical issues
    • Develop solutions to process/analytical issues
  • Effectively communicate with cross functional teams like Analytical Development, R&D, Process Development, Quality Assurance (QA), Project Management, Regulatory Affairs and Legal teams.
    • Provide Samples to AD
    • Obtain data from AD and compile into reports
    • Obtain processes from R&D and PD and implement at-scale
    • Generate procedures (SOPs, MBRs, Protocols) and work with QA on review and approval
    • Review and follow QA procedures
  • Assist in the preparation of technical reports and presentations that support scale-up activities and process improvements.
    • Technical reports
      • Generate/review Technical reports such as batch summaries, process descriptions, Tech transfer, etc.
    • Presentations
      • Present on batch performance, technical issues, etc.

• 1+ (Masters) or 2+ (Bachelors) years of relevant experience is required
• A Bachelor’s degree and/or Master’s degree in Chemical engineering, Biomedical engineering or related field.
• Demonstrated experience in process development, manufacturing, tech transfer, and/or scale-up to support the manufacturing of biopharmaceuticals (1+ year) is required
• Experience with mRNA Drug Substance is strongly preferred

Estimated Min Rate: $35.00

Estimated Max Rate: $42.00

Benefits include:

• Medical, Prescription, Dental & Vision Benefits (for employees working 20+ hours per week)
• Health Savings Account (HSA) (for employees working 20+ hours per week)
• Life & Disability Insurance (for employees working 20+ hours per week)
• Met Life Voluntary Benefits
• Employee Assistance Program (EAP)
• 401K Retirement Savings Plan
• Direct Deposit & weekly epayroll
• Referral Bonus Programs
• Certification and training opportunities

Note:

Any pay ranges displayed are estimations. Actual pay is determined by an applicant's experience, technical expertise, and other qualifications as listed in the job description. All qualified applicants are welcome to apply.

Yoh, a Day & Zimmermann company, is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.

Visit to contact us if you are an individual with a disability and require accommodation in the application process.

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