Manager/Senior Manager, Process Engineering

Employment Type

: Full-Time

Industry

: Miscellaneous



Title: Manager/Senior Manager, Process Engineering Reports To: Senior Director, Manufacturing Operations Location: Redwood City, California Classification: Exempt Overview: The Manager/Senior Manager, Process Engineering will be responsible for process transfer, troubleshooting manufacturing issues, scaling up biopharmaceutical manufacturing processes, process characterization and process & equipment validation activities. The Manager/Senior Manager will also support routine drug substance manufacturing at Contract Manufacturing Organizations through batch data analysis, change control assessments, and deviation/investigation resolution. Principle Responsibilities and Duties: * Provide technical oversight of routine drug substance manufacturing including, but not limited to, batch data analysis, change control assessment, and deviation resolution. * Assist in the development of manufacturing documentation such as process descriptions, batch records and SOPs. * Support feasibility assessments of additional manufacturing projects and partners for capabilities such as automation, equipment, GMP facility, process enhancement, and general requirements for scale-up and manufacturing * Work in collaboration with manufacturing partners to define process requirements to meet production needs * Use design of experiments techniques and basic statistical methods to analyze data and communicate results, conclusions, and recommendations. * Monitor and communicate task status for project/program success. * Participate in product and process FMEAs and related risk management processes. * Potential travel to manufacturing sites (ex-US) Experience, Education, Training, Traits: * BS degree in Chemical / Manufacturing Engineering or equivalent experience. * Minimum 5+ years of experience in biotech/pharmaceutical industry required. * Experience working with Contract Manufacturing Organizations (CMOs) * Experience in process development and scale up through process validation and technology transfer including CMC preparation for regulatory filings * Experience in support of routine drug substance manufacturing * Detailed knowledge of cGMP requirements and application * Proven ability to work collaboratively with all levels to meet project deliverables * Must operate with a high degree of autonomy and professionalism * Must be innovative, technical, resourceful and well organized * Must communicate in a timely and accurate manner to ensure project participants are fully informed of project status, action items and deliverables * Demonstrated ability to be flexible and maintain a professional attitude when priorities change * Demonstrated ability to work in a fast paced, start-up environment * Ability to travel up to 25%. * Excellent interpersonal and communication skills. * Strong computer skills, including all MS Office applications and MS Project Beginning July 19, 2021, Coherus BioSciences requires all new hires to be fully vaccinated against COVID-19 as of their start date. This requirement is a condition of employment at Coherus BioSciences, and it applies regardless of whether the position is located at a Coherus BioSciences facility or is fully remote. If you are unable to receive the vaccine due to a disability or serious medical condition, or because it is prohibited as a result of your sincerely held religious beliefs, you will have an opportunity to request a reasonable accommodation.

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