Manufacturing Technical Support Specialist/ Deviations Specialist

Position: Manufacturing Technical Support Specialist/ Deviations Specialist

Location: Madison, WI (100% onsite)

Duration: 2+ year contract

Hours per week: 40+ (occasional OT)

Job Description:

Our client is looking to build out a team that is responsible for the execution of clinical and commercial manufacturing in accordance with regulatory, site, and client requirements. Manufacturing cGMP production activities include solution preparation, master/working cell bank production, upstream cell culture, downstream protein purification, mRNA and molecular therapeutics production, and small-scale fill/finish. Further, Manufacturing Operations is tasked to utilize continuous improvement methodologies to realize process optimization, efficiency gains, and waste reduction to maximize capacity outputs.

The Manufacturing organization operates through two integrated functional groups: Manufacturing Process Execution and Manufacturing Process Compliance, which collectively ensure safe, compliant, and efficient batch production in a cGMP environment.

* Manufacturing Process Execution is responsible for the accurate execution of batch production records and adherence to Standard Operating Procedures (SOPs). The team focuses on delivering “right -firsttime” performance, maintaining regulatory compliance, and ensuring on-time completion of manufacturing activities.

* Manufacturing Process Compliance provides oversight and operational support to ensure adherence to cGMP requirements, internal procedures, and client/regulatory expectations. This includes ownership of training compliance, deviation management, and execution of corrective and preventive actions (CAPA). The team also delivers real-time, on-the-floor technical support, enabling prompt issue resolution, sustained manufacturing performance, and daily client notifications for ongoing batch production.

1. Act as the incident commander in the Rapid Response process providing real time advanced troubleshooting and technical support for manufacturing processes .

2. Client interactions/project leadership: participate in client meetings offering technical support.

3. Work cross functionally with Process Development, Manufacturing, Quality Assurance, Quality Control, Supply Chain, Project Management, Facilities, and other departments to effectively transfer and maintain processes in the facility.

4. Work closely with Manufacturing to author appropriate batch documentation and provide technical and strategic oversight associated with GMP manufacturing.

5. Lead and/or support the compilation of process data, including communicating project status, trend identification, and delivering internal or client presentations.

6. Evaluate existing processes and identify process or equipment improvements to advance efficiency, consistency, and competitiveness within the market.

7. Support the building of business case(s) for process improvement projects.

8. Support technical deviations, change controls, and CAPAs including determination of product or process impact, root-cause analysis, and corrective action identification.

9. Responsible for motivating, coaching, and developing coworkers as a subject matter expert.

10. Perform responsibilities associated with the evaluation, alignment, and recommendation of equipment and process improvements.

11. Work alongside a group of engineers, scientists, and other colleagues to drive the facility fit and technical transfer of biologic processes.

12. Perform other responsibilities to support group, site, and network-based initiatives, as required.

Education:

* Associate's degree in a STEM discipline and 6 -8 years of related experience, OR

* Bachelor's degree in a STEM discipline with 3 -4 years of related experience, OR

* Master’s degree in a STEM discipline with 1-2 years of related experience

Experience:

* Experience in reporting and documentation skills.

* Understanding statistical techniques for data analysis and reporting.

* Experience drafting and revising standard operating procedures, batch production records, and reports.

* Experience with operating and troubleshooting process equipment, including single -use systems and consumables.

* Experience working on late phase, process performance qualification and commercial programs is a plus.

* Understanding of or/experience in facility fit, process scaling and technology transfer.

* Experience with Upstream (mammalian cell culture), Downstream (chromatography, tangential flow filtration, etc.) and/or molecular therapeutics (mRNA or new modality) processes across cGMP production scales.

Technical Requirements:

* Maintain high quality technical documentation in accordance with applicable regulatory guidance and site SOPs.

* Ability to learn and retain technical information.

* Proactively address work issues at both an individual level and a team level.

* Ability to follow and interpret a variety of instructions furnished in written, oral, diagram, or schedule form.

* Proactively seek information to fill gaps in knowledge base.

* Mathematical and scientific reasoning ability.

* Advanced in core techniques. Advanced understanding of instrument operations and troubleshooting skills in multiple techniques.

* Ability to identify aberrant/out of spec data and interpretation of data expected.

* Well organized with ability to handle and direct multiple activities simultaneously.

* Ability to use Microsoft Office®️ (e.g., Excel, Word, Project, Visio) programs, as well as software associated with various manufacturing systems.

* Ability to independently interpret data, analyze trends, and provide insight into potential issues and subsequent solutions.

* Ability to problem solve to initiate, execute, and monitor corrective action.

* Ability to write SOPs, batch production records, and other required documents independently.

* Ability to work with and support other groups to develop, qualify and transfer methods, and drive complete investigation, deviation, and change control practices.

* Strong technical knowledge and hands-on experience with biological manufacturing and validation concepts and procedures in a GMP environment.

* Ability to provide ideas, introduce new technology, and drive process improvements.

* Work with other groups to develop, qualify and transfer methods accordingly.

* Strong interpersonal and presentation skills to discuss technical concepts internally and with clients.

* Ability to learn and use software packages (e.g., TrackWise®️, ComplianceWire®️, Unicorn®️).

* Demonstrated working knowledge of Tech Transfer between Development and Manufacturing, including the ability to operate within a clean room environment.

* Demonstrated understanding of multiple applicable techniques, including purification, buffer preparation, operation and troubleshooting of stirred vessel bioreactors, incubators, chromatography columns and processing, and filtration apparatuses.

* Understanding and application of quality risk management and associated tools (Hazard Analysis, FMEA, etc.).

* Ability to formulate complex and comprehensive materials such as authoritative reports to create or deliver presentations based on customer requirements.