Senior Engineer, mRNA Process Development & Digital Data

Sr. Engineer - Process Development
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%

• • Provide technical support for scale-up and manufacturing issues, and develop solutions to improve process efficiency and product quality

• • 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

• • Lead and assist implementation of Digital Tools
    • Lead implementation of digital tools for process data acquisition (Electronic lab notebooks and Electronic Batch Records.)

• • Lead project activities for the design of mRNA manufacturing processes by contributing and reviewing of Batch Records/Master Production Records (M ) and Standard Operating Procedures (SOPs).

• • Document Generation
    • Author and review MBRs
    • Author and review SOPs
    • Effectively communicate with cross functional teams like Manufacturing Analytical

• • Development, R&D, Process Development, Quality Assuance (QA), Project Management, Regulatory Affairs and Legal teams.

• • 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.

• • Assist in the preparation of technical reports and presentations that support scale-up activities and process improvements

• • Technical reports (2.5%)
    • Generate/review Technical reports such as batch summaries, process descriptions, Tech transfer, etc.

• • Presentations (2.5%)

• • Present on batch performance, technical issues, etc.

• • 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.

• • 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.

• Medical, Prescription, Dental & Vision Benefits (for employees working 20+ hours per week)
• Heal…