Job: Sr. Manager, MS&T (Tech Services), Seqirus, Holly Springs, NC
The incumbent is accountable for supporting the Bulk and Fill-Finish operational business units in Holly Springs, NC and external manufacturing facilities. This includes accountability for technical support of daily operations, inclusive of the relationship between the process, equipment and automation in the facility as well as process/product ownership for drug substance and drug product. This individual will provide strategic technical direction and support for the manufacturing organizations to achieve supply targets and maximize capacity. The Sr. Manager of MS&T Technical Services will direct a team of 10+ MS&T Engineers and contractors, as necessary, including suite team leads, shift engineers, and members of expansion project teams. Direct functional responsibility includes commercial operations (Drug Substance and Drug Product), Small Scale Filling Facility, third party commercial manufacturing as necessary, Pilot Plant(s), as well as ongoing and future facility expansions. Seqirus operates in a global network. The holder of the position will interact closely with the MS&T organisations at the other Seqirus production sites to established and maintain a common shared vision, scientific direction, workflows and work practices. An important aspect of the job is to ensure that knowledge and learnings are shared across Sites.
Responsible for managing a team of process experts, providing guidance to the team, colleagues and/or customers. Develops and Drives team performance, objectives, direction & priorities.
Ensure that equipment works to its specification and capacity. Troubleshoots and investigates equipment problems in the facility, coordinating with appropriate teams to resolve issues and prevent reoccurrence.
Responsible for leading, coordinating, and aligning the DS and DP suite teams to ensure swift resolution of manufacturing issues, accurate root cause diagnosis for investigations, alignment and prioritization of projects, real-time trending and analysis of KPIs, and appropriate escalation and dissemination of information.
Owns all documentation associated with the manufacturing process including SOPs, batch records, training materials, etc.
Support or lead initiatives related to process issues, liaising with Manufacturing, QA, C&Q, Engineering and line management by supporting the manufacturing suite team leads. Provides shift support to manufacturing for troubleshooting of equipment/process/automation issues, maintenance of the finite manufacturing schedule, and proper escalation and decision making based on technical expertise.
Intermittent responsibilities: partners with MS&T Tech Transfer team during tech transfers into and out of the Seqirus Holly Springs site. Provides technical support and ownership for aspects of expansion projects in both DS and DP. Provides key input and ownership of after action reviews and resulting projects in order to align the manufacturing suites with site goals and objectives for current and future commercial seasons.
Responsible for supporting and/or leading critical deviation investigations, robust CAPA and relevant follow-up, lead product process-related investigations including complex customer complaints, OOT, OOS, etc. Investigate and resolve recurring process capability deviations and issues that emerge from data trending and annual batch monitoring. Ensures that investigations outcomes are shared across the global Seqirus network.
Responsible for supporting the global MS&T team to implement the suite team model. Supports the global network via collaboration with the other manufacturing sites in order to effectively transfer technical information and solve problems.
Partner with Manufacturing to ensure the execution of the production processes is in conformity with up-to-date, registered, filed manufacturing process, approved instructions, cGMP and Health Authority regulations.
Provide technical information and support to define the technical standards of training for process-related matters within production to maximize process understanding and to enhance knowledge-based decision making in order to maximize quality, yields and efficiency. Ensures that learnings and knowledge is shared across the global Seqirus network.
Subject matter experts for internal and external inspections and audits. Responsible for authoring and approving regulatory submission sections.
Collects and analyses data (e.g. KPI, process performance indicators) that drive continuous improvement initiatives. Leverages process and compliance expertise to facilitate cross functional and cross Site decision making and strategy alignment.
Develop creative solutions to technical and organizational problems in order to keep projects on schedule.
Maintains a depth of knowledge on the relationship between the process, the equipment, and the automation in the facility.
And other job duties that may be assigned from time to time.
Bachelor’s degree in chemical/mechanical/systems engineering, chemistry, microbiology or cell engineering or equivalent is required. Master’s degree or PhD preferred.
Minimum 10+ years’ related industry experience required, or 8 years with an advanced degree.
At least 7 years of production management experience preferred
Demonstrated knowledge of GMPs and FDA requirements
Strong demonstrated team leadership skills
Strong project management skills preferred