Principal Scientist, TSMS Contamination Control Strategy - ADN RAMP Team

Role Summary

Principal Scientist, TSMS Contamination Control Strategy - ADN RAMP Team. Responsible for developing, implementing and monitoring the Contamination Control Strategy for new site facilities, coordinating with cross-functional teams to support site startups, and coaching local CCS teams to readiness for full operation.

Responsibilities

• Develop, implement and establish ongoing monitoring of the Contamination Control Strategy (CCS) for new site facilities.
• Design, implement, validate and maintain environmental monitoring programs (routine and batch-specific).
• Design and validate clean utilities microbiological monitoring programs and support aseptic qualification/requalification.
• Collaborate with engineering on New Facility design requirements to support CCS, including area classification, flows, and pressurization.
• Provide microbiological control strategy support for Raw Materials and Resin Management programs; liaise with QA on vendor management and GMP service provider approvals.
• Coordinate with cleaning validation and provide microbiological support for commissioning/qualification of autoclaves, parts washers, SIP systems, and related processes.
• Support process qualification studies (e.g., media challenges, hold times, resin lifetime) and advise on filtration requirements for CCS.
• Ensure microbiological requirements are integrated into the product control strategy and manage non-conforming results; perform trend analysis and metrics reporting.
• Serve on deviation response teams for microbiological contamination events and update procedures/batch records as required.
• Remain current with industry guidelines (ISO, GMP) and coach site CCS teams on CCS implementation and maintenance.

Qualifications

• Required: BSc in Microbiology, Biochemistry or related science field with 8–10 years of pharmaceutical manufacturing experience.
• Required: MSc in Microbiology, Biochemistry or science-related field with a minimum of 5 years of industry experience.
• Preferred: Deep technical interest in Contamination Control Strategy; strong analytical and problem-solving skills; excellent verbal and written communication; ability to coach others and influence without authority.

Skills

• Microbial and viral product control knowledge.
• Cross-functional collaboration with operations, process engineering, QA/QC, and other teams.
• Ability to coach and mentor teams; strong documentation and reporting skills.
• Willingness to work off-shift hours to meet milestones and training needs.

Education

• BSc Microbiology, Biochemistry or related science field
• MSc Microbiology, Biochemistry or science-related field

Additional Requirements

• Travel: The role will support multiple new API/Dry Product sites in the US and abroad; significant travel to startup sites and potential short-term assignments across the network (including international relocations) may be required.