Senior Engineer - Lexington , MA 2421 (Onsite)

The individual will collaborate with key subject matter experts (SMEs) from the Manufacturing Sciences team as well as cross functional groups such as Automation Engineering, Process Development and Manufacturing to assist with the further development of this real time process monitoring system. As a key member of Manufacturing Sciences team, this individual will be responsible for providing technical and scientific leadership to support the cell culture processes of commercial manufacturing operations.

Title: Senior Engineer
Location:  Lexington , MA 2421 (Onsite)
Duration: 6+ Months (Possible extension)
 

As a key member of Manufacturing Sciences team, this individual will be responsible for providing technical and scientific leadership to support the cell culture processes of commercial manufacturing operations. Responsibilities will include monitoring of the process, containment of process failures and deviations that occur during cell culture processes, and coordination and implementation of associated corrective and preventative actions. The individual will also participate and function as the Manufacturing Sciences lead on technology transfer and process improvement teams. This individual will also provide expertise and leadership in tech transfer to the upstream Manufacturing Sciences group.

Responsibilities: Job Function and Description

Floor Support – Support ongoing operations on the manufacturing floor. Attend Manufacturing morning meetings. Respond and troubleshoot process issues; evaluate process data including bioreactor performance. Provide training to manufacturing personnel. Provide inspection support as needed. Provide weekend call-in coverage as needed. Continuous Improvement – Identify and advance continuous improvement initiatives. Process Monitoring – A key part of this role will be assisting with continued development of the process monitoring capabilities for manufacturing cell culture operations. This will include support of a real time multivariate process monitoring system for bioreactor operations. The individual will collaborate with key subject matter experts (SMEs) from the Manufacturing Sciences team as well as cross functional groups such as Automation Engineering, Process Development and Manufacturing to assist with the further development of this real time process monitoring system. Tech Transfer – Support the transfer of phase I, II/III clinical processes into the existing GMP manufacturing facilities as defined by Tech Transfer group Quality System Support – Lead consistent and well documented response to process operations events to support investigations, deviation closure as well assistance to change control/CAPA as appropriate.

Education and Experience Requirements: BS in Chemical/Biochemical Engineering or Chemistry with 5 to 8 years, MS with 5 to 8 years, or Ph.D. with a minimum of 2 years of process development / manufacturing experience with mammalian cell culture of recombinant proteins. proteins Hands-on experience with large-scale cell culture/purification manufacturing 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 mammalian cell culture, bioreactors. Demonstrated experience making science based and/or data-driven recommendations for manufacturing operations. Experience with process / technology transfers.

Candidate must have excellent knowledge and experience with cell culture manufacturing or process development experience, including protein capture and recovery preferably with recombinant proteins. Candidate must have working knowledge of cGMPs and statistical analysis methods. A familiarity with software based statistical analysis programs. 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 demonstrate teamwork and collaboration skills. The candidate must also possess the ability to communicate appropriately and effectively both in verbal and written communications. This person will have been involved in cell culture process development or manufacturing support, and have technical leadership including the ability to influence, motivate, and drive technical rigor.

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: Lead cell culture process improvement, trouble-shooting and tech transfer supports. Identify and analyze complex technical problems and then find and implement solutions. Develop solutions to complex problems which require the regular use of ingenuity and innovation. Ensure solutions are consistent with organization objectives. Works on complex issues where analysis of situations or data requires an in-depth evaluation of variable factors. Exercises judgment in selecting methods, techniques and evaluation criteria for obtaining results. Networks with key contacts outside own area of expertise. Contributes to the development of new concepts, techniques, and standards. Considered expert in field within the organization. Work is performed without appreciable direction. Exercises considerable latitude in determining objectives and approaches to assignment. Effects of decisions are long-lasting and heavily influence the future course of the organization. Errors in judgment or failure to achieve results would result in the expenditure of large amounts of company resources.