Principal ScientistSenior Principal Scientist, Process Chemistry

Role Description

Position Summary:

The Principal Scientist / Senior Principal Scientist is an experienced scientific leader within process chemistry leveraging advanced knowledge across multiple disciplines to innovate troubleshoot and optimize complex chemical syntheses and scale-up processes. This role requires a highly motivated and independent leader with a proven track record in pharmaceutical or veterinary medicine research and development capable of driving projects from lead candidate identification through commercial process technical transfer. The successful candidate will lead multi-disciplinary teams applying deep technical and functional expertise to independently design and execute complex experiments and projects often in ambiguous situations with significant uncertainty. As a key scientific resource incumbent influences strategic direction drives novel experimental approaches across multiple projects and ensures alignment of work with departmental and organizational goals. The role demands strong people management skills including mentoring coaching and career development of colleagues while championing productivity improvements and fostering collaboration across functions. Additionally the candidate may serve as a project leader for various corporate initiatives providing strategic direction and driving alignment with broader organizational objectives in a global setting.

Essential Duties and Responsibilities:

• Lead process chemistry efforts including design development and scale-up of chemical syntheses for novel veterinary therapeutics.
• Independently design scale-up and optimize synthetic processes from mg to multi-kilogram scale.
• Apply the principles of green chemistry in API process design to select safer solvents and reagents minimize waste reduce environmental impact and improve overall efficiency.
• Develop and execute impurity control strategies to ensure product quality safety and regulatory compliance
• Provide strategic direction and support across multiple projects simultaneously acting as a scientific resource and technical leader within the group.
• Lead technology transfer activities to commercial manufacturing facilities ensuring processes are safe robust economical and environmentally responsible.
• Collaborate effectively with cross-functional teams understanding the significance and impact of decisions on project progression. Make recommendations to management regarding key sensitive and high impact decisions; involves stakeholders in important decisions affecting them.
• Prepare and review technical and regulatory documentation including CMC dossiers and development reports.
• Develop and implement innovative strategies tools and technologies for continuous process improvement.
• Collaborate with cross-functional teams to drive digital transformation initiatives in Process Chemistry.
• Champion novel experimental approaches and business management tools to enhance productivity and impact.
• Mentor and supervise colleagues providing guidance coaching and career development support.
• Represent the chemistry function on global research project teams and develop constructive relationships with internal and external partners.
• Contribute to intellectual property strategy including the protection and filing of small molecule IP.

Requirements:

• Ph.D. in Synthetic Organic Chemistry with minimum of 8 years of industry experience in pharmaceutical or veterinary medicine process chemistry research and development and at least 2 years of leadership experience managing teams or projects.
• Broad expertise in modern synthetic organic chemistry with a track record of strategic and innovative solutions to synthetic problems. Proficiency in chemical literature searching (SciFinder Reaxys etc.) and in compound characterization and spectral analysis (HPLC GC NMR UV LC-MS).
• Extensive hands-on experience in process chemistry scale-up including multi-kilogram scale API manufacturing and technology transfer.
• Experience with technical and operational risk assessments (e.g. process robustness/FMEA mutagenic impurities nitrosamines PFAS E&L etc.).
• Excellent written and verbal communication skills with the ability to effectively influence project teams external partners and management.
• Working knowledge of ICH guidelines and cGMP requirements.
• Knowledge of process safety requirements and regulations (such as OSHA REACH and other relevant standards) applicable to chemical manufacturing and API processes.
• Experience with automated laboratory reactors and data-rich experimentation Design of Experiments (DOE) Quality by Design (QbD) concepts
• Experience working in dynamic global environments and collaborating with contract organizations (CROs/CMOs/CDMOs).
• Knowledge of small molecule intellectual property strategies and filings.

Preferred/Plus Qualifications

• Post-doctoral experience.
• Experience with animal health Industry and veterinary medicine drug development.
• Experience with the development and implementation of continuous flow manufacturing processes.
• Experience with data analytics digital transformation and use of AI/ML in Process Chemistry.

Full time

Regular

Colleague

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Required Experience:

Staff IC