Summary of Role
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 requireme
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
Required:
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
Master’s degree in Chemistry or related field with minimum of 9+ years’ experience, OR
PhD in Organic Chemistry or related field with a 5+ years of previous experience.
The level of this position – Senior or Principal Scientist - will be determined based on the experience of the candidate.
Preferred:
Experience working within a CDMO or other fast paced development environment.
Track record of mentoring or managing junior scientists in a laboratory environment.
Travel Requirement
Up to 5%
Physical Demands and Work Environment
The physical demands and work environment described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. While performing the duties of this position, the employee must regularly stand and bend, and is frequently required to sit and walk, crawl, stoop. Employee must frequently use hands to finger, handle or feel objects, tools or controls. Must be able to talk and hear. Employee must frequently lift up to 25 pounds without assistance and move over 50 pounds with mechanical aid. Specific vision ability required by this job includes close vision, distance vision, depth perception; the ability to adjust focus, and observe color changes. The noise level is moderate to noisy. Occasionally, employee is exposed to airborne particles and fumes. Employee is exposed to various chemicals. While performing the duties of this job, the employee is frequently exposed to moving mechanical parts and risk of electrical shock, burn hazards and microbial contamination. The employee is occasionally exposed to fumes or airborne particles, toxic or caustic chemicals and vibration. The noise level in the work environment is usually moderate. The employee will be required to wear the appropriate personal protective equipment for specific job duties to be performed. Such personal protective equipment may include, but not limited to: safety eyewear, various types of respirators/breathing apparatus, lab coats, full protective body coverings, various types of gloves, etc.
Diversity and Inclusion:
Sterling values diversity and we are committed to creating an inclusive environment for all employees. All employment decisions are based on business needs, job requirements and individual qualifications, without regard to race, color, religion, sex, pregnancy, age, national origin, physical or mental disability, past or present military service, marital status, gender identification or expression, medical condition (including genetic characteristics) or any other protected characteristic as established by law.
Why Consider Sterling?
Sterling Pharma Solutions is a global contract development and manufacturing organisation (CDMO) with more than 50 years’ experience in developing and manufacturing Active Pharmaceutical Ingredients (APIs). This is complimented by Antibody Drug Conjugate (ADC) research and development bioconjugation services. We are a fast growing, dynamic business with facilities in the UK, Europe and the US, where we employ more than 1300 talented and passionate people who support our customers in bringing new medicines to market, improving and saving the lives of patients. Our culture and our way of working is what really sets us apart as a business; we aim to deliver an exceptional experience to our customers and our employees. You can expect to be part of a supportive team, all working towards a shared goal: to deliver first-class science and service to our customers every day.
