Senior Process Development Engineer - Scale-Up & Tech Transfer Job Waltham area,Massachusetts USA,Quality Assurance

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 majorpharmaceutical company, and requires aBachelors and/or Masters of Science and 1-2+ years of relevant experience. Schedule isfull-time M-F (7am-8am start time, 8 hour shift)and may require flexibility to work some evenings and overtime due to projects.

Key Responsibilities:

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.

Qualifications:

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

What’s In It for You?
We welcome you to be a part of the largest and legendary global staffing companies to meet your career aspirations. Yoh’s network of client companies has been employing professionals like you for over 65 years in the U.S., UK and Canada. Join Yoh’s extensive talent community that will provide you with access to Yoh’s vast network of opportunities and gain access to this exclusive opportunity available to you.

Benefit eligibility is in accordance with applicable laws and client requirements. 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 &…