Senior Process Development Engineer, CMO Tech Transfer

Redwood City, CA 94063

Posted: 04/07/2020 Employment Type: Direct Hire Industry: Clinical & Scientific Job Number: 17367

Job Description


 

Senior Process Development Engineer, CMO Tech Transfer
Redwood City, CA


JOB DESCRIPTION


Our Process Science team is looking to bring onboard a Senior Process Engineer. The position is responsible for planning and executing process transfers to CMOs, including providing scientific and technological input as SME on-site. Responsibilities also include providing support for internal tech transfer of processes from the Process Science group into Manufacturing. As a Process SME, the individual will be responsible for working with cross-functional teams to lead process related investigations.

Key Accountabilities/Core Job Responsibilities:


• Serve as the Process Subject Matter Expert (SME) representing Process Science group when working with external CMOs for transfer of new processes and/or troubleshooting processrelated events
• Provide onsite support at CMO during tech transfer, including hands-on training of new processes and process oversight during manufacturing runs
• Lead the facility fit evaluation for process transfers to the GMP-manufacturing facility,
• Manage, author, and review technical documentation including draft and executed batch records, tech transfer protocols, campaign summaries, and risk assessments,
• Create, standardize, and refine tech transfer workflows including templates and data
presentations for new and current processes
• Monitor and analyze process trends and present data obtained from manufacturing campaigns, including metrics on the success of a process transfer
• Interface with other members of the CMC organization to track activities against project timelines and production forecasts
• As a Process SME, lead process related investigations, including designing investigational smallscale studies
• Provide support to adjacent functions including Quality Assurance, Quality Control, and Regulatory to document product related tech transfer and GMP manufacturing activities, including supporting regulatory filing documents
• Closely collaborate with Process Science on internal process improvement projects,

Position Requirements and Experience:


• MS with 5+ years of experience or BS with 8+ years of experience in Chemical Engineering, Biochemistry, Cell & Molecular Biology or related life science engineering fields,
• Experience in cGMP biologics manufacturing and documentation is required,
• Must have a deep knowledge of engineering principles applicable to cell culture and purification process, including operational understanding of equipment such as bioreactors and chromatography skids,
• Must have excellent time management skills and the ability to multitask/prioritize work in order to support organizational needs, meet deadlines and timeframes,
• Previous experience interfacing with CMOs and third-party vendors is desired,
• Some travel is required to oversee critical activities at CMOs,

WORKING CONDITIONS:


• PHYSICAL DEMANDS: While performing the duties of this job, the employee is required to stand, walk; sit; talk and hear. Specific vision abilities required by this job include close vision, distance vision, peripheral vision, depth perception and the ability to adjust focus. Walk and lift up to 10 pounds.

WORK ENVIRONMENT: The noise level in the work environment is usually moderate.
Position Type/Expected Hours of Work: This is a salaried regular full-time position. General work schedule Monday through Friday, 8: 30 a.m. to 5 p.m. As an exempt employee you may be required to work additional hours as necessary.
 

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Jesse Ashworth

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