Principal Scientist, Cleaning Verification Center of Excellence Strategy Lead, Pharmaceutical Analysis and Digital Technologies

The Strategy Lead will drive the development, validation, and lifecycle management of cleaning verification methods and practices, ensuring cGMP compliance, operational excellence, and a sustained state of inspection readiness. The Principal Scientist should be engaged with regulatory and industry trends, including health-based exposure limits (HBELs), and have thorough working knowledge of cGMPs, ICH, and relevant FDA and global health authority expectations for cleaning verification and validation.

In addition, the Strategy Lead will partner with Analytical leadership, extended leadership teams, and cross-functional stakeholders in Process Engineering, Clinical Manufacturing, and Quality to identify and advance key departmental strategic and cultural initiatives. As the recognized subject matter expert, the Principal Scientist will mentor scientists and build cleaning verification capability across the organization through training, knowledge sharing, and coaching. The role will also be responsible for proactive resource planning, risk assessment strategies, and continuous improvement of CoE processes, standards, and tools.

Primary Responsibilities

• Technical expertise in analytical methodologies applied to cleaning verification for both small and large molecules, such as liquid chromatography, total organic carbon (TOC), spectroscopy, and conductivity, including swab/rinse sampling and recovery studies.
• Define and execute the Cleaning Verification CoE strategy and roadmap, including harmonized standards, best practices, and governance across programs and sites.
• Lead the development, validation, and transfer of cleaning verification methods to enable on-time, right first-time equipment release for clinical manufacture of drug substance and drug product.
• Partner with Process Engineering, Clinical Manufacturing, and Quality to establish science- and risk-based cleaning acceptance limits across small and large molecule modalities (e.g., HBEL-based carryover calculations).
• Provide technical and compliance oversight on cleaning-related lab investigations and deviations including root cause analysis and identification of robust corrective and preventative actions.
• Review and approval of cleaning verification data, protocols, technical reports, and SOPs.
• Serve as the cleaning verification subject matter expert during internal and external compliance audits and regulatory inspections.
• Drive operational excellence, innovation, and process improvements, including evaluation and implementation of new analytical technologies and digital tools.
• Technical mentorship and development of scientists, building cleaning verification capability across the organization.
• Cross-functional leadership and influence, including working with senior management to drive departmental strategic and cultural initiatives.

Education Minimum Requirements

• PhD Degree in Analytical Chemistry, Biochemistry, Pharmaceutical Sciences or related fields with at least 7 years of pharmaceutical industry experience.
• Master's Degree in Analytical Chemistry, Biochemistry, Pharmaceutical Sciences or related fields with at least 10 years of pharmaceutical industry experience.
• Bachelor's Degree in Analytical Chemistry, Biochemistry, Pharmaceutical Sciences or related fields with at least 12 years of pharmaceutical industry experience.

Required Experience and Skills

• Proven technical leadership in analytical cleaning verification and/or validation, ideally in a GMP setting; experience with both small and large molecules preferred.
• Track record of shaping and delivering strategy and influencing without direct authority in a matrixed organization.
• In-depth knowledge of cGMP, ICH, FDA, and global health authority expectations for cleaning verification and validation.
• Excellent scientific communication skills and a creative, collaborative approach.
• Strong coaching and interpersonal skills, with the ability to work effectively in cross-functional teams.