We are seeking a MCS Manufacturing Sr. Associate to support drug substance upstream and downstream manufacturing operations. This role involves providing technical expertise, leading process improvements, and ensuring operational readiness for new technologies. The ideal candidate will have strong project management skills, hands-on experience in troubleshooting and process optimization, and the ability to collaborate across teams in a GMP-regulated environment.
Responsibilities:
- Serve as Process Owner (PPO) or Single-Use SME to support drug substance manufacturing operations.
- Lead complex projects and quality improvement initiatives to optimize production processes.
- Troubleshoot issues, execute function tests, and implement solutions to enhance process efficiency.
- Develop and own manufacturing processes, including drafting and revising SOPs, forms, and user requirements for new technologies.
- Write protocols and reports for validation, function testing, equipment commissioning, qualification, and change management.
- Own and manage quality records (CCMS, CAPA, CAPA-EV) and ensure compliance with GMP regulations.
- Support new technology implementation by applying scientific, operational, and compliance knowledge.
- Work in a cleanroom environment, following strict GMP, safety, and compliance guidelines (full gowning, gloves, steel-toe shoes, hairnet required).
- Ability to work flexible shifts (day, swing, graveyard, weekends, and holidays) based on operational needs.
- High School Diploma/GED and 4 years of relevant experience, OR
- Associate’s Degree and 2 years of relevant experience, OR
- Bachelor’s Degree and 6 months of relevant experience, OR
- Master’s Degree
- Strong technical communication skills for internal and external collaboration.
- Experience in leading/managing projects and owning quality records.
- Proficiency in Smartsheets, CDOCS, Trackwise, Spotfire, and other quality management systems.
- Ability to work in a fast-paced, team-oriented environment with strong problem-solving skills.
