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.

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 (MBR) 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 & Disability Insurance (for employees working 20+ hours per week)
• MetLife 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 https://www.yoh.com/applicants-with-disabilities to contact us if you are an individual with a disability and require accommodation in the application process.

For California applicants, qualified applicants with arrest or conviction records will be considered for employment in accordance with the Los Angeles County Fair Chance Ordinance for Employers and the California Fair Chance Act. All of the material job duties described in this posting are job duties for which a criminal history may have a direct, adverse, and negative relationship potentially resulting in the withdrawal of a conditional offer of employment.

It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.

By applying and submitting your resume, you authorize Yoh to review and reformat your resume to meet Yoh’s hiring clients’ preferences. To learn more about Yoh’s privacy practices, please see our Candidate Privacy Notice: https://www.yoh.com/privacy-notice
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