Principal Scientist, TSMS Contamination Control Strategy - ADN RAMP Team

Role Summary

Principal Scientist, TSMS Contamination Control Strategy - ADN RAMP Team. Lead development and implementation of the Contamination Control Strategy for new site facilities, coordinate cross-functional startup activities, and mentor local CCS teams to enable rapid site readiness and startup.

Responsibilities

• Develop, implement, and monitor the Contamination Control Strategy (CCS) for new site facilities.
• Collaborate with New Site CCS team to design and validate environmental monitoring programs and, where needed, clean utilities microbiological monitoring programs.
• Support aseptic qualification and requalification programs.
• Coordinate with engineering on facility design requirements to support CCS (pressurization cascades, area classification, material, personnel and equipment flows).
• Provide microbiological control strategy support for Raw Materials and resin management programs; participate in vendor management and GMP service provider assessments.
• Coordinate with cleaning validation, commissioning and qualification activities (autoclaves, parts washers, SIP systems) and support PSQ studies (media challenges, hold time studies, resin lifetime studies).
• Ensure microbiological requirements are integrated into the product control strategy and advise on non-conforming results; perform trend analysis and metrics reporting.
• Act as a deviation response team member for management of suspect microbiological contamination events; update procedures and batch records as required.
• Stay current with ISO/GMP guidelines and coach site CCS teams on CCS program implementation and maintenance.

Qualifications

• Required: BSc in Microbiology, Biochemistry or related science with 8‚Äì10 years in pharmaceutical manufacturing.
• Required: MSc in Microbiology, Biochemistry or related field with a minimum of 5 years industry experience.

Skills

• Deep technical understanding of Contamination Control Strategy.
• Excellent verbal and written communication; strong analytical and problem-solving abilities.
• Collaborative skills with operations, process engineering, QCL, and other process teams.
• Technical knowledge of microbial and viral product control; ability to coach others and influence without authority.
• Ability to clarify and simplify complex issues; strong trust-building with peers and leaders.
• Willingness to work off-shift hours to support milestones and training.

Education

• BSc Microbiology, Biochemistry or related science field (8‚Äì10 years experience) or MSc Microbiology, Biochemistry or related field (minimum 5 years experience).

Additional Requirements

• Ability to travel significantly to startup sites; willingness to undertake short-term assignments across the network (including international relocations).