Manufacturing Sciences and Technologies (MSAT) Engineer II

Wheeler Bio • Oklahoma City, OK

6d

About The Position

The MSAT Engineer II supports manufacturing teams, fellow MSAT Scientists, and Process Engineers as a technical advisor. The role develops, implements, and continually improves technical transfers of processes to manufacturing scale. It requires a thorough understanding of adapting mammalian upstream and downstream processes demonstrated at R&D or laboratory scale to an appropriate manufacturing scale. The engineer authors bills of materials, process flow diagrams, risk assessments, facility fit assessments of equipment capabilities, validation protocols as needed for manufacturing execution, and investigations, and reviews process descriptions and other internal or external process documents. The role also collaborates with Facilities and Engineering to determine equipment requirements and support equipment troubleshooting.

The position applies established policies, procedures, and strategies consistent with cGMP regulations for early- and late-phase programs, while adhering to quality standards and regulatory requirements. The MSAT Engineer II provides technical expertise throughout process development and manufacturing, supports technology transfer and active manufacturing campaigns, and works cross-functionally to maintain process timelines and improve operations.

Requirements

• PhD or MS in engineering or a relevant life-science field and at least 3 years of industry experience in GMP production; alternatively, a BS in engineering or a relevant life-science-related field and at least 5 years of industry experience in GMP production.
• Experience in technical transfer and scale-up of biologics drug substance.
• Knowledge of FDA, ICH, EMA, JP, and other regulatory guidance on cGMP manufacturing.
• Strong written, oral, and presentation skills.
• Strong attention to detail and focus on product quality requirements.
• Proven track record of complex problem solving using ingenuity and creativity.
• Strong interpersonal, collaboration, and leadership skills.
• Ability to work flexible hours and inconsistent schedules as necessary to meet production demands and timelines.

Nice To Haves

• Experience with single-use technologies.

Responsibilities

• Follow established policies, procedures, and strategies consistent with cGMP regulations for early- and late-phase programs.
• Adhere to quality standards and regulatory requirements.
• Advise internal and external development groups on manufacturing-scale feasibility throughout a process's lifetime.
• Assist in generating process and facility fit assessments by providing technical expertise on equipment capabilities.
• Author and review Bills of Materials for internal or external processes and assist with material readiness for manufacturing activities.
• Author, review, and approve technology-transfer documents as needed, including batch records, protocols, and Summary/Engineering run reports.
• Provide technical expertise for equipment readiness and operations for internally or externally developed processes.
• Participate in, and author, review, or approve, Failure Mode and Effects Analyses (FMEAs) for processes as needed.
• Support manufacturing or MSAT personnel during active manufacturing campaigns by performing and analyzing data trending, troubleshooting issues, and interpreting process trends and data.
• Collaborate with Quality Assurance as needed on materials, deviations, impact assessments, risk assessments, change control, CAPAs, and process validation, if applicable.
• Coordinate with other departments to maintain process timelines.
• Lead and participate in troubleshooting to improve operations.
• Perform other duties as assigned.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level