Thermo Fisher Scientific Senior Manager of Process Engineering in St. Louis, Missouri
The Process Engineering (PE) Sr. Manager's role is to oversee the Technology Transfer and Manufacturing Technical Support organizations under the direction of the Director/ Manufacturing Sciences & Technology (MS&T).
The PE Sr. Manager is part of the MS&T organization. The PE Sr. Manager is responsible for overseeing the technological quality and progress of the implementation and execution of the customer and technology projects within the Operations department, the PE Manager works in close collaboration with supervisors, other Engineers, line management and (senior) scientists from PD and QA (compliance) managers. All activities are executed in projects (technology (Operational Excellence), Customer projects).
The PE Manager is responsible for overseeing the transfer of client programs from the development into manufacturing:
Generating the process flow diagrams (PDF) for all programs. Working with process development to define common methodologies for conducting unit operations at the manufacturing scale, and documenting those procedures via template (non-process specific) PFD, SOPs and job aids. Generate good faith estimates and bill of materials (BOMs) for all client programs. Complete or delegate the supplier material qualification (SMQ) paperwork in accordance with current SOPs for all programs. Draft or oversee the drafting of manufacturing batch records. Review and comment on GMP documentation as appropriate SOP, TTP, MBRs, PFDs, etc.
Provide the highest example of safety and quality mindedness in all job functions and instill this mindset in the teams you lead.
Provide an atmosphere which fosters a questioning attitude, empowerment (appropriate to job level), and an error prevention/ continuous improvement mindset in all personnel.
Oversee a team which will provide the framework to manufacturing for the optimal methodology to conduct standard unit operations for processes.
Oversee the building of an effective system to determine Raw Material Requirements for manufacturing processes.
Oversee the ontime completion of documentation package (drafted, reviewed and fully approved documents by ThermoFisher Scientific and Client) for production scale processes, including
Manufacturing Batch Records (MBR)
PFDs including all disposable line builds for each program
Technology Transfer and Campaign Summary reports
Inform process development decisions with respect to facility fit and the manufacturability of development programs. Thereby, providing PD with the information required to develop fit for Suite/Site processes (i.e. raw material preferences, standard procedures, preferred operating methodologies)
Oversee a team of highly trained biotechnology engineering experts to support the ongoing execution of manufacturing operations of clinical and commercialized processes.
Oversee the generation and continued implementation of a site RACI chart, mapping out (in substantial detail) the roles and responsibilities of each group on site as it pertains to the completion of a client’s technology transfer program.
Identify good candidate actions to modify or improve procedures so as to stream line the activities of this position and maintain an optimal level of operational efficiency. Provide performance management and career coaching for direct and indirect reports.
Oversee a team Equipment Requirements including identifying required equipment upgrades and new equipment requirements. These tasks will be conducted in close collaboration with the engineering group.
Will have both direct (Managers/ Supervisors) and indirect reports.
Education & Experience:
Bachelor’s or Master’s in a scientific field, preferably chemical engineering, with ≥ 12 (BS), 10 (MS) or 8 (PhD) years of experience in a highly relevant field.
Minimum of a total of fours years of direct experience in technology transfer and manufacturing technical support (i.e., process engineering) roles to/ at the manufacturing scale in the biotech industry. A minimum of two of those years will be in technology transfer.
Minimum of two years as a manager of staff. Experience indirectly managing staff to accomplish directives is a plus.
Extensive experience within the Biotech industry including an understanding of the regulatory requirements is required.
Detailed knowledge of GMP and other biopharmaceutical regulations from FDA, EU, and ICH guidelines.
Demonstrated success in running multiple projects of high complexity. Expert knowledge of process development, process scale-up and cGMP manufacturing.
Knowledge or the regulatory requirements. Proven success in conducting engineering tasks of high complexity. Proven success in interacting with customer preferred.
Proven ability to form teams and produced desired results through direct and indirect. reporting.
Position requires ordinary ambulatory skills and physical coordination sufficient to move about office locations; ability to stand, walk, stoop, kneel, crouch periodically for prolonged periods of time; manipulation (lift, carry, move) of light to medium weights of 10-35 pound pounds; visual acuity to use a keyboard, computer monitor, operate equipment, and read materials for prolonged periods of time; ability to sit, reach with hands and arms, talk, and hear for prolonged periods of time.
If you are an individual with a disability who requires reasonable accommodation to complete any part of our application process, click here at https://jobs.thermofisher.com/page/show/eeo-affirmative-action-statement#accessibility for further assistance.
Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.