Senior​/Principal Chemical R&D Scientist

Senior/Principal Chemical R&D Scientist

The Senior/Principal Chemical R&D Scientist is accountable for driving 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. The incumbent will write and review technical documents including SOPs, training modules, technical transfer documents, specifications, and development reports to be sent to clients or used in regulatory filings and is responsible for ensuring complex technical information is well understood by team associates, management and clients.

The position requires superior leadership behaviors of the Sterling core competencies and non-negotiables, as well as expertise in functional competencies included in this position profile.

Essential Functions

• As a part of a cross-functional development team, designs, plans, and executes process development and optimization for small molecule APIs, with ownership of synthetic strategy through to robust, scalable processes with minimal supervision.
• Performs process characterization through techniques such as Design of Experiments (DOE), and impurity fate/purge studies to understand and control critical process parameters.
• Oversees and supports lab to plant scale-up activities providing on site support as needed for critical operations and troubleshooting, including collaboration with analytical, quality, EHS, and manufacturing colleagues to ensure programs are delivered right first time.
• Executes synthesis activities from gram to multi-kilogram scale at up to 20 L scale, including routine maintenance and troubleshooting of laboratory equipment.
• Isolates and purifies products and intermediates by using standard laboratory techniques.
• Designs multi-step synthetic process from commercially available starting materials to target compounds.
• Performs routine analytical procedures to monitor reaction progress (i.e. TLC, GC, NMR, HPLC, LC-MS, KF), and interprets and communicates data effectively.
• Prepares project documentation such as development reports, material specifications, and technology transfers of high technical complexity with minimal supervision.
• Serves as a chemistry technical lead and point of contact for client technical representatives during project meetings, technical reviews and site visits.
• Establishes and coordinates activities at contract chemical and analytical laboratories, as required.
• Ensures timely completion and compliance with cGMP, Safety, and all other relevant company training requirements.
• Mentoring, training, and coaching junior scientists.
• An individual in this position must be able to successfully perform the essential duties and responsibilities listed above. Reasonable accommodation may be made to enable individuals with disabilities to perform the essential functions of this position.

Key Competencies

• Understands reaction mechanisms and can apply them to practical execution of given synthesis.
• Knowledge in handling, analyzing and characterizing chemicals, pharmaceuticals and related organic molecules.
• Proficiency in hands-on execution of analytical techniques such as HPLC, GC, NMR etc.
• Ability to apply scientific principles, theories and concepts to research problems and develop solutions for challenges related to APIs in compliance with appropriate Standard Operating Procedures (SOPs) and regulatory guidelines.
• Demonstrates technical ability to independently design and execute non-routine experiments.
• Demonstrates ability to correctly analyze data/results and interpret outcome of experiments and to propose appropriate follow-up with minimal supervision.
• Ability to read, analyze and interpret general business periodicals, professional journals technical procedures and governmental regulations and write reports, business correspondence and procedure manuals.
• Ability to effectively present information and respond to questions from groups of managers, clients, customers and the general public.
• Ability to perform complex math functions, compute ratios, rates and percentages while drawing and interpreting graphs and charts.
• Demonstrates a strong working knowledge of GMP principles and expectations for API development, as well as relevant regulatory requirements.
• Candidates need to be competent with IT systems, and Microsoft Office including Outlook, PowerPoint, Word and Excel.
• Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job.
• Duties, responsibilities and activities may change at any time with or without notice.

Education and Experience

• Demonstrated experience in synthetic route development, reaction optimization, and scale-up for small molecule APIs.
• Bachelor's degree in Chemistry or related field required with minimum of 15+ years' experience
• OR
• Master's degree in Chemistry or related field with minimum of 9+ years' experience, OR
• PhD in Organic…