Primary Duties : The Sr. Engineer reports to Principal Engineer and is an integral part of mRNA Drug Substance Process Development team. This position offers opportunities to focus on mRNA drug substance process development, manufacturing, regulatory and analytical support, validation, and data review for drug substances and drug products. The Engineer is responsible for leading and assisting the development and execution of scalable and robust processes for drug substance. This position will act as a Subject Matter Expert (SME) for process knowledge transfer for drug substance to support current Good Manufacturing Practices (cGMP) manufacturing.
Responsibilities include but are not limited to:
40%
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- Provide technical support for scale-up and manufacturing issues, and develop solutions to improve process efficiency and product quality
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- Scale-up:
- Lead/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
- Scale-up:
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- Lead and assist implementation of Digital Tools
- Lead implementation of digital tools for process data acquisition (Electronic lab notebooks and Electronic Batch Records.)
- Lead and assist implementation of Digital Tools
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- Lead project activities for the design of mRNA manufacturing processes by contributing and reviewing of Batch Records/Master Production Records (MBR) and Standard Operating Procedures (SOPs).
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- Document Generation
- Author and review MBRs
- Author and review SOPs
- Effectively communicate with cross functional teams like Manufacturing Analytical
- Document Generation
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- Development, R&D, Process Development, Quality Assuance (QA), Project Management, Regulatory Affairs and Legal teams.
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- Work with internal and external manufacturing on harmonization of electronic batch records.
- Work with Digital team withing PD and CMC on the implementation of eBRs and data capture strategy.
- 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.
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- Assist in the preparation of technical reports and presentations that support scale-up activities and process improvements
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- Technical reports (2.5%)
- Generate/review Technical reports such as batch summaries, process descriptions, Tech transfer, etc.
- Technical reports (2.5%)
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- Presentations (2.5%)
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- Present on batch performance, technical issues, etc.
Education and Experience Requirements:
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- 6+ (Masters) or 8+ (Bachelors) years of relevant experience is required.
- A Bachelor’s degree and/or Master’s degree in Chemical engineering, Biomedical engineering or related field.
Key Skills, Abilities, and Competencies:
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- Demonstrated experience in process development, tech transfer, and/or scale-up to support the manufacturing of biopharmaceuticals is required.
- Experience in biopharmaceutical manufacturing, MSAT, and/or Process Development (PD) is required (4+ years).
- Experience with mRNA Drug Substance is strongly preferred.
- Experience implementing and maintaining electronic batch records (eBRs) is required (1+ years). Experience using Tempo Apprentice strongly preferred.
Estimated Min Rate: $33.60
Estimated Max Rate: $48.00
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.
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