Position: Senior Manager, Process Engineer Reports to: Director of Engineering Position Summary The Senior Manager of Process Engineering is responsible for continuously improving the manufacturing equipment and processes, new product introductions, new equipment specification, in partnership with Operations and the Manufacturing, Science and Technology (MSAT) group. This individual will be required to develop an in-depth understanding of all current and future processes and translate these into the facility and equipment requirements for successful production at the Libertyville manufacturing site. This individual shall have a strong understanding of GMP’s and experience providing engineering support in a highly regulated or pharmaceutical / biotech facility. Significant experience in the development, automation, and manufacture of gene therapy products, medical devices, instruments, or biotechnology. A strong track record working closely with process development scientists to establish efficient clinical and commercial manufacturing processes. Experience with virus manufacturing or cell processing would be an advantage. Excellent communication and project management skills to facilitate interactions with internal groups and with external collaborators and partners. Primary responsibilities include ensuring the equipment and processes runs in a compliant manner and any equipment/process/product deviations are fully investigated with a corrective action implemented to prevent reoccurrences from happening. Work collaboratively with scientific leads, process/analytical development scientists, QC, and Operations, for the development of user requirement specifications.. Responsible for either leading or being a key team member on multiple capital related projects annually to improve yield, lower costs and increase overall efficiency. The Senior Manager of Process Engineering will review and monitor the equipment and process performance for consistency, abnormalities and possible future improvements. Ensure all processes, procedures, etc. related to operations are in full accordance with good manufacturing practices, code of federal regulations, site quality systems and company policies. Drive investigations through partnerships with Quality and other business units at the site to determine root cause, implement a solution and follow up with a verification check to ensure the fix was effective. Participate in the interpretation of data and collaboration with other departments on all manufacturing related issues to drive resolution. Partner with Operations and MST on all process development activities and production of drug products for clinical trial studies.
2275 Half Day Road, Suite 160, Bannockburn, Illinois 60015 Office: (847) 572-8280 Toll Free: (844) 4-AVEXIS avexisbio.com
Initiate continuous improvement and operational excellence projects to help drive efficiency, while error proofing the process. Responsibilities Develops project objectives working with user requirement and business plans Determines project specifications and most cost effective technology to be implemented Participate in discussions with internal business partners on priorities, timelines and transparent sharing of information Establish equipment specifications in standard documentation – User Requirements (URS), Functional Specification (FS) and Detail Design Specifications (DDS) Review and approve critical documentation such as batch records, SOP’s and URS’s Support the product requirements to ensure that all products are produced according to plan and do not go into backorder Take programs from concept thru execution while managing all stages in the process utilizing a strong set of project management tools Participate in all FDA and internal audits of the manufacturing facilities and processes and respond to any observations received Responsible for maintaining quality standards to meet GMP requirements, CFR’s and internal company policies Participate and/or lead new product implementation product transition processes to ensure smooth transition from process development into GMP manufacturing Provide direct technical and managerial leadership to the operations group Drive operational excellence and continuous improvement Partner with Quality to ensure a quality and compliant manufacturing environment Problem solve any technically related issues impacting production Required Education and Experience Minimum B.S. degree in biochemistry, bioengineering, or related technical field A minimum of 5-7 years of experience in biopharmaceutical based GMP manufacturing operations including direct experience in cell culture, recovery, purification, aseptic fill/finish Demonstrated ability to tech transfer new processes In-depth knowledge of FDA regulations and GMP systems Applied knowledge of Quality by Design, six sigma, and operational excellence tools in creating efficient and high quality processes and end products Excellent oral and written communication skills. Strong technical writing ability required Understanding of new manufacturing technologies including single use disposable
2275 Half Day Road, Suite 160, Bannockburn, Illinois 60015 Office: (847) 572-8280 Toll Free: (844) 4-AVEXIS avexisbio.com
manufacturing within modular facilities Experience with 3rd parties (both in-sourcing and outsourcing) Strong project management skill set with extensive experience in strategic / tactical planning, demonstrated ability to perform long-term project planning Ability to prepare contingency plans and logically work through complex issues in a pressure filled atmosphere Provide technical support on all manufacturing issues when driving towards issue resolution
Approximately 10% travel required Other Duties Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities and activities may change at any time with or without notice. This position will be located out of our Libertyville IL office. To apply for this position, please submit a resume.
2275 Half Day Road, Suite 160, Bannockburn, Illinois 60015 Office: (847) 572-8280 Toll Free: (844) 4-AVEXIS avexisbio.com
