US-MA, Principal Purification Engineer, Technical Services - Manufacturing Sciences SR0034833-MZ
The individual will be expected to monitor and provide support for manufacturing cell culture, recovery and Purification operations. Responsibilities will include providing technical leadership of investigations into process failures and deviations that occur during cell culture and recovery processes. The individual will also participate and function as TS lead on technology transfer teams. The individual will be responsible for oversight, coaching and mentorship of direct reports.
30% Operations Support Support ongoing operations on the manufacturing floor. Respond and troubleshoot process issues; evaluate process data including bioreactor, recovery and purification performance. Provide training to manufacturing personnel. Provide inspection support as needed.
30% Tech Transfer- Provide technical leadership and ownership of key project deliverables for early to late stage clinical Tech Transfer projects.
30% Continuous Improvement - Identify, design and drive continuous improvement projects of significant impact and complexity. Provide technical oversight and leadership to junior team members; drive science based and compliant solutions.
10% Documentation Author testing/sampling protocol. Review SOP and batch record as needed.
Education and Experience Requirements
MS or PhD in Chemical/Biochemical Engineering or Bio/Chemistry with 12 + years of process development I manufacturing experience in cell culture, fermentation, recovery, separation and purification operations associated with clinical commercial biopharmaceutical GMP manufacturing.
Hands-on experience with large-scale cell culture processes, preferably with commercial or licensed products. A working familiarity with single use process systems, automation (local and distributed control systems), and sterile/aseptic processing in a cGMP environment. A detailed knowledge of the science and technology for the major unit operations associated with manufacturing operations to include cell culture, recovery, fluid transfer, filtration, chromatography, CIP/SIP, and UF/DF processes. Experience with troubleshooting / problem solving and risk assessment / mitigation. Demonstrated experience making science based and/or data-driven recommendations for manufacturing operations. Experience with process historian/data collection systems and data analysis/reporting applications such as PI Historian, MVDA (e.g. SIMCA), PI Process Book, Excel, JMP and Statistica (e.g.) is a plus.
Key Skills, Abilities, and Competencies
Hands-on experience with large-scale cell culture, recovery manufacturing and purification processes, preferably with clinical and commercial products. A working familiarity with single use process systems, bioprocess probe and sensor technology, automation (local and distributed control systems), and sterile/aseptic processing in a cGMP environment. A detailed knowledge of the science and technology for the major unit operations associated with manufacturing operations to include cell culture, filtration, CIP/SIP, UF/DF, Chromatography, Column packing and VRF processes. Experience with troubleshooting, problem solving and risk assessment I mitigation. Demonstrated experience making science based data-driven recommendations for manufacturing operations. Experience with process technology transfers. As an active participant on multiple cross-functional teams, the candidate must also demonstrate excellent written and verbal communication skills.
Complexity and Problem Solving
Candidate will make complex decisions regarding product impact on a regular basis. Candidate will also be required to assess the requirements of processes against the capabilities of existing equipment/facilities interacting with cross-functional team members for review and resolution. Candidate must be able to work in a dynamic environment, be able to set and balance priorities, and serve as a change agent.
The candidate will:
Internal and External Contacts
Incumbent will work closely with Manufacturing, Quality, Engineering, Validation, Process Development, Facility and vendors.
Other Job Requirements
Limited travel may be required.
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