Manufacturing Sciences and Technologies (MSAT) Engineer II

The main responsibility of the MSAT Engineer II is to support the manufacturing team, fellow MSAT Scientists, and Process Engineers as a technical advisor and through the development, implementation and continual improvement of technical transfers of processes to manufacturing scale. The MSAT Engineer II will have a thorough understanding of adaptation of mammalian upstream and downstream processes demonstrated at the R&D/Lab scale to the suitable manufacturing scale, authoring bill of materials, process flow diagrams, risk assessments, facility fit assessments of equipment capabilities, validation protocols (as needed for manufacturing execution) and investigations, and reviewing process descriptions or other internal or external process documents. Collaborates with Facilities and Engineering to determine equipment requirements and to support equipment troubleshooting.

Responsibilities

·         Follow established policies, procedures, and strategies that are consistent with cGMP regulations for early and late-phase programs.

·         Adhere to Quality standards and regulatory requirements.

·         Possess proficiency in understanding the concepts and scale-up requirements for mammalian cell culture and downstream purification, including TFF, chromatography and viral clearance.

·         Advise internal and external development groups on manufacturing scale feasibility throughout process lifetime.

·         Assist in the generation of process and facility fit assessments by providing technical expertise on equipment capabilities

·         Author and review Bill of Materials for internal or external processes and assist in material readiness for manufacturing activities.

·         Author, review, and approve documents for technology transfer 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 documents for Failure Mode and Effects Analysis (FMEA) for processes as needed.

·         Provide support to manufacturing or MSAT personnel during active manufacturing campaigns by performing and analyzing data trending and troubleshooting issues with the ability to interpret process trends and data.

·         Collaborate with the Quality Assurance department as needed to provide input 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.

·         Other duties as assigned.

Knowledge / Skills / Experience Requirements

·         PhD or MS in engineering or a relevant life-science field with a minimum of 3 years industry experience in GMP production.

·         BS in engineering or relevant life-science related field with a minimum of 5 years industry experience in GMP Production.

·         Experience in technical transfer and scale-up of biologics drug substance required; experience with single-use technologies preferred.

·         Knowledge of FDA, ICH, EMA, JP, and other regulatory guidance on CGMP manufacturing.

·         Strong written, oral, and presentation skills.

·         Strong attention to detail with a focus on product quality requirements.

·         Proven track record of complex problem solving with use of 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.