Senior Scientist External Manufacturing API and Drug Product Support

About the role

We are seeking an exceptional individual for a technical position within the Analytical Sciences – Science and Technology organization. The successful candidate will join a group of innovative scientists with broad deliverables spanning activities across Active Pharmaceutical Ingredient (API) and Drug Product (DP) to drive efficiency gains in support of global supply operations. The incumbent will interact closely with external Contract Manufacturing Organization sites across the manufacturing network to identify, develop, implement, and troubleshoot laboratory test methods, technologies, and workflows, as well as materials to ensure compliant, robust, and responsive supply.

The individual will understand the technical, regulatory, and business needs for API and DP development and commercial supply, providing essential analytical support to ensure success. A strong technical background, superior problem-solving skills, exceptional leadership abilities, and strong knowledge of Current Good Manufacturing Practices (cGMP) and Data Integrity are essential.

Responsibilities

• Author analytical procedures, methods development and validation protocols and reports, technical reports, experimental designs, and regulatory submission documents.
• Perform investigations with strong technical troubleshooting skills and assist in developing/implementing Corrective Action and Preventative Actions (CAPA).
• Provide documentation and technical input during inspections and audits (Regulatory and Internal) and maintain a working knowledge of data integrity and recent industry trends.
• Conduct technical training of staff on analytical techniques and problem-solving, as needed.
• Stay updated with regulation changes to support plans for implementing new strategies.

Requirements

• BS or MS degree with at least 5 years of experience, or a PhD degree with at least 1 year of experience.
• Hands-on analytical chemistry lab experience.
• Practical knowledge in developing and applying analytical techniques such as liquid and gas chromatography, and various spectroscopic methods to support drug substance and product development, registration, and unknown peak identification investigations.
• Experience collaborating with external service providers, proficiency in regulatory filing requirements, and ability to work effectively within cross-functional and interdisciplinary teams.
• Excellent interpersonal skills, adaptability, and cultural sensitivity; ability to tailor communication, coaching, and collaboration to colleagues with diverse experience and expertise.
• Self-motivated with the ability to take ownership and accountability of issues and drive them to completion.
• Ability to speak up, raise issues, identify and communicate risks, and help drive resolution.
• Ability to quickly adapt to changes and develop appropriate plans for managing risks.
• Knowledge of drug product and/or API development and commercialization, and understanding of needs related to commercial quality control testing.

Preferred Skills

• Experience with LCMS, GCMS, NMR.
• Use of statistical software for data analysis (e.g., Excel, Minitab).
• Basic proficiency with internal approved AI tools.

About Us

Organon delivers ingenious health solutions that enable people to live their best lives. We are a $6.5 billion global healthcare company focused on making a world of difference for women, their families, and the communities they care for. Our portfolio addresses unmet needs in Women’s Health, biosimilars, and a diverse range of trusted health solutions. Our vision is clear: A better and healthier every day for every woman.

Pay

Annualized salary range for this position in the U.S. is $103,100.00 - $175,300.00.

Benefits

• Retirement savings plan.
• Paid vacation and holiday time.
• Paid caregiver/parental and medical leave.
• Health benefits including medical, prescription drug, dental, and vision coverage, in accordance with the terms and conditions of the applicable plans.

Schedule

• Employee Status: Regular.
• Relocation: Not offered for this position.
• VISA Sponsorship: Not provided.
• Travel Requirements: Employees must be able to satisfy all applicable travel and credentialing requirements, including associated vaccination prerequisites.
• Shift: Flexible work arrangements.
• Valid Driving License: Required.