Specialist Manufacturing

100% onsite
Monday-Friday, regular business hours.
May require occasional non-standard hours (early, late, or weekend) depending on implementation needs.
Onsite presence is expected, though there is some flexibility for remote work to handle administrative tasks.
The ideal candidate for the Manufacturing Specialist role will have at least 1 year of relevant experience in a biotech or pharmaceutical manufacturing environment, with a strong preference for those with upstream operations experience. This position supports manufacturing from a process owner's perspective, so candidates should be comfortable working onsite Monday through Friday, with occasional flexibility for non-standard hours (including weekends) based on implementation needs. While some remote administrative work (e.g., SOP revisions, tracker updates) may be allowed, onsite support is expected. Candidates should demonstrate a go-getter attitude, strong adaptability to changing priorities, and a willingness to ask questions and escalate when unsure. Familiarity with project management, as well as tools like Smartsheet and Excel, is highly desirable but not required.

Responsibilities
include:
Support manufacturing by providing subject-matter expertise for Drug Substance Upstream and Downstream processes as Process Owner (PPO).
Lead cross-function and complex projects using project management skills.
Resolve quick issues and lead troubleshooting, including execution of function tests to troubleshoot and optimize process.
Write protocols and reports in support of validation, function testing, equipment commissioning and qualification, and change management.
Own Quality Records, such as CCMS, CAPA, and CAPA-EV.
Apply technical process, scientific, operational, and compliance knowledge with analytical troubleshooting skills to support the implementation of new technologies into the plant.
Demonstrate strategic problem-solving skills and champion continual improvement.
Available to work various shifts (day, swing, graves, weekends, holidays, 5x8hrs, 4x10hrs) as instructed by the production schedule to execute function-testing and project tasks with minimal disruption to operations.
Must be able to work in a clean room environment wearing steel toe shoes, full clean room gowning, hairnet and gloves when performing all work while following GMP documents (SOPs) with strict adherence to safety and compliance.
Ability to be on-site (flexible worker)
As Process owner:
Support operational readiness of new technologies, equipment, or processes by applying technical process, scientific, operational, and compliance knowledge with project management skills
Develop/own drug substance manufacturing processes and procedures. Draft and revise GMP manufacturing documents (SOPs, Forms).
Draft and develop user requirements for new technologies.
Preferred Qualifications
Degree in Engineering or Life Sciences
3 years or more experience in Drug substance GMP technical support roles, GMP manufacturing, Engineering, Process Development, or equivalent.
Technical knowledge of drug substance processing and broad understanding of related disciplinary areas
Ability to successfully communicate complex technical information with internal and external colleagues of varying organizational levels in both presentation and technical writing forms
Ability to navigate through ambiguity and identify and deliver on key milestones.
Ability to advise and influence using experience and data.
Ability to successfully communicate complex technical information with internal and external colleagues of varying organizational levels in both presentation and technical writing forms
Ability to coach and/or cross train colleagues within core technical area.
Team player - Ability to support process owner team by reprioritizing or readjusting projects, tasks, or responsibilities.
Ability to drive results through leadership of cross-functional teams
Experience leading and managing projects
Understanding of single-use technologies
Data analysis and/or data visualization skills
Excellent writing skills. Presentation experience - presentation to leadership or auditors.
Proficiency in Smartsheet and excel, Trackwise, visio, pi, SAP, spotfire