Contract Senior Process Development Engineer

Job Summary:

We are seeking a Contract Senior Process Development Engineer to join our team. The ideal candidate will have a deep understanding of biologics drug substance production (upstream and downstream), process development, process optimization, scale up, tech transfer, and regulatory submission support. The candidate will work in the Process Development team to transfer processes internally within different types of bioreactors (ie Eppendorf, Sartorius, Applikon) and at different scales (2L up to 200L). The candidate will also engage and work with external partners (CDMOs) to ensure successful process transfer to cGMP manufacturing campaigns and provide technical leadership of deviations, investigations, and change controls. The individual will also serve as a key process owner by evaluating process performance to drive continuous improvements. The individual should also be flexible to provide support for weekend activities for cell culture operations.

Primary Responsibilities:

• Collaborate cross-functionally with process development to deliver manufacturing processes that meet the speed, yield, and product quality requirements of the development programs
• Provide key technical upstream and downstream leadership for development programs including technology transfer, scale up, process design, manufacturing support, and person-in-plant
• Support Process Development team by performing USP or DSP experiments as necessary, with a focus on process scalability across different control strategies
• Perform, develop and optimize robust, efficient, scalable strategies for improving process performance
• Activities will include small-scale studies and pilot scale expression studies
• Analyze complex datasets involving cell growth kinetics, viability, metabolic profiles, and product titers. Identify root causes of process deviations and implement corrective actions.
• Develop scalable upstream processes, establish reliable scale-down models, and author technical transfer documentation to transition protocols seamlessly to pilot and cGMP manufacturing facilities.
• Lead technology transfer activities, including process fit and facility design at external CDMO, ensuring gap analyses and risks assessments are performed technical mitigations are in place for early stage MFG (Phase 1 and Phase 2)
• Author, review and approve technical documentation including protocols, master batch records, and reports related to engineering and GMP runs
• Support continuous process improvement and scale up activities using data analysis for larger scale production while maintaining quality attributes for manufacturing process lifecycle management
• Partner closely with Downstream Process Development, Analytical Development, and Quality Control teams to ensure seamless workflow integration.
• Collaborate cross-functionally to support clinical drug substance manufacturing processes, tech transfer, supply chain, quality compliance, change management and product life cycle management
• Partner with product development, manufacturing, quality and regulatory, lead quality investigations and data analysis as SME to address OOS, OOT, complex deviations/non-conformances and implement change controls to ensure timely/prompt release of batches to meet regional demand forecast and ensure CAPAs are in place
• Cultivate excellent working relationship with CMC stakeholders to deliver successful manufacturing campaigns

Qualifications:

• BS with 10+ years or MS with 8+ years or PhD with 5+ years of experience in biologics process development (upstream and/or downstream); process scale-up; technology transfer; cGMP manufacturing support; and regulatory submissions for protein therapeutics
• Experience working in process development labs required
• Hands-on experience with aseptic technique, mammalian cell culture maintenance, scale-up principles, and bench-scale bioreactor operations is required.
• Experience working with CDMOs for facility fit and tech transfer preferred but not required
• Experience with cell culture and/or purification and scale-up
• Experience with different types of bioreactors and control systems
• Experience with process data analysis and trending and statistical analysis preferred
• Experience with technical support of commercial products in external cGMP manufacturing including investigations and change management
• Understanding of regulatory requirements and experience with authoring and reviewing CMC documents for multiple regulatory submissions
• Excellent collaboration skills and ability to work cross functionally to achieve objectives
• Strong work ethic, motivation, and scientific curiosity