Senior/Principal Chemical R&D Scientist
About the Role
The Senior/Principal Chemical R&D Scientist drives the development and optimization of robust, scalable synthetic processes for small molecule APIs from early development to technology transfer into manufacturing in a fast-paced CDMO environment. This role involves writing and reviewing technical documents such as SOPs, training modules, technical transfer documents, specifications, and development reports for clients or regulatory filings. The position ensures complex technical information is well understood by team associates, management, and clients, while demonstrating leadership aligned with Sterling’s core competencies.
Responsibilities
- Design, plan, and execute process development and optimization for small molecule APIs, owning synthetic strategy through to scalable processes with minimal supervision.
- Perform process characterization using techniques such as Design of Experiments (DOE) and impurity fate/purge studies to control critical process parameters.
- Oversee and support lab-to-plant scale-up activities, including on-site troubleshooting and collaboration with analytical, quality, EHS, and manufacturing teams.
- Execute synthesis activities from gram to multi-kilogram scale (up to 20 L), including equipment maintenance and troubleshooting.
- Isolate and purify products/intermediates using standard laboratory techniques; design multi-step synthetic processes from commercially available starting materials.
- Perform routine analytical procedures (e.g., TLC, GC, NMR, HPLC, LC-MS, KF) to monitor reaction progress and interpret/communicate data effectively.
- Prepare high-complexity project documentation, including development reports, material specifications, and technology transfers with minimal supervision.
- Serve as the chemistry technical lead and client point of contact during project meetings, technical reviews, and site visits.
- Coordinate activities at contract chemical and analytical laboratories as required.
- Ensure compliance with cGMP, safety, and company training requirements.
- Mentor, train, and coach junior scientists.
Requirements
- Proficiency in synthetic route development, reaction optimization, and scale-up for small molecule APIs.
- Hands-on experience with analytical techniques (HPLC, GC, NMR, etc.).
- Ability to apply scientific principles to research problems and develop compliant solutions under SOPs and regulatory guidelines.
- Strong data analysis skills to interpret experimental outcomes and propose follow-up actions with minimal supervision.
- Competency in writing reports, business correspondence, and procedure manuals; ability to present technical information to diverse audiences.
- Strong working knowledge of GMP principles and regulatory requirements for API development.
- Proficiency in IT systems and Microsoft Office (Outlook, PowerPoint, Word, Excel).
Qualifications
- Required:
- Bachelor’s degree in Chemistry or related field with 15+ years of experience, or
- Master’s degree in Chemistry or related field with 9+ years of experience, or
- PhD in Organic Chemistry or related field with 5+ years of experience.
- Preferred:
- Experience in a CDMO or fast-paced development environment.
- Track record of mentoring or managing junior scientists.
Travel
Up to 5% travel may be required.
Physical Demands and Work Environment
- Regularly stand, bend, sit, walk, crawl, and stoop; frequent use of hands to handle tools/objects.
- Must be able to talk, hear, and lift up to 25 pounds unassisted (over 50 pounds with mechanical aid).
- Requires close vision, distance vision, depth perception, and ability to adjust focus and observe color changes.
- Moderate to noisy work environment; occasional exposure to airborne particles, fumes, chemicals, moving mechanical parts, electrical shock, burn hazards, and microbial contamination.
- Must wear appropriate personal protective equipment (PPE), including safety eyewear, respirators, lab coats, gloves, etc.
About the Company
Sterling Pharma Solutions is a global CDMO with over 50 years of experience in developing and manufacturing Active Pharmaceutical Ingredients (APIs) and providing Antibody Drug Conjugate (ADC) research and bioconjugation services. With facilities in the UK, Europe, and the US, Sterling employs over 1,300 people dedicated to delivering first-class science and service. The company fosters a supportive, team-oriented culture focused on exceptional customer and employee experiences.