The individual will be expected to monitor and provide support for upstream manufacturing operations.  Responsibilities will include design, implementation and daily review of production operations and data trends, process event response and troubleshooting, deviation/investigation support, ownership of quality system deliverables and manufacturing personnel training.  This role also includes providing technical leadership and ownership of key deliverables for early to late stage clinical Tech Transfer projects. The individual will also be responsible for sampling and/or testing protocol authoring and execution, as well as SOP and batch record review.   Leadership and guidance of junior staff members in certain situations will also be expected.

Responsibilities
40% Operations Support:

Support ongoing operations on the manufacturing floor.Respond and troubleshoot process issues; evaluate process data including bioreactor and recovery performance.Conduct batch review.Provide training to manufacturing personnel.Identify and advance continuous improvement initiatives.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.

   
20% Process Quality Systems:

Support deviation initiation and containment, conduct operator interview, and provide detailed event description.Own action items, CAPA effectiveness checks

     
10% Documentation:

Author testing/sampling protocol.Review SOP and batch record as needed.Education and Experience Requirements:BS in Chemical/Biochemical Engineering or Bio/Chemistry with 5 to 7 years or MS with 3 to 5 years of process development / manufacturing experience for mammalian cell culture of recombinant proteins.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:

Candidate must have cell culturing manufacturing or process development experience, preferably with recombinant proteins.Candidate must have working knowledge of cGMPs and statistical analysis methods. A familiarity with software based statistical analysis programs as well as training in quality improvement techniques, operational excellence tools and project management is a plus.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:

Develop solutions to a variety of complex problems.May refer to established precedents and policies.Work on problems of diverse scope where analysis of data requires evaluation of identifiable factors. Demonstrate good judgment in selecting methods and techniques for obtaining solutions. Network with senior internal and external personnel in own area of expertise.Have complete understanding and application of principles, concepts, practices, and standards.Full knowledge of industry practices..Interacts with senior internal and external personnel on significant matters often requiring coordination between organizations.Internal and External Contacts:Incumbent will work closely with Manufacturing, Quality, Engineering, Validation, Process Development, Facility and vendors.