Production Support Chemist

About the Role

The Production Support Chemist is accountable for driving results in a fast-paced environment by executing chemical reactions for programs in the commercial portfolio on a gram to multi-kilogram scale and performing routine analytical procedures to monitor reaction progress. This role requires efficiently organizing work, properly evaluating and communicating generated data, and exercising judgment to determine appropriate action. The key function of the role is to troubleshoot, identify root causes, and provide solutions for issues occurring at plant scale during manufacturing. Additionally, the successful candidate will identify areas of improvement, conduct lab-scale experiments, write reports, and provide recommendations for plant-scale implementation. This support chemist will act as the Subject Matter Expert (SME) for chemical syntheses for all programs under the commercial portfolio.

Responsibilities

• Executes synthesis activities from gram to multi-kilogram scale under supervision.
• Performs routine analytical procedures (e.g., KF, NMR, HPLC, XRPD) necessary for support of development activities.
• Writes project documentation, including notebook entries, protocols, and reports.
• Serves as a technical contact for projects transferring internally to production groups (e.g., research kilo laboratory to GMP kilo laboratory, or kilo laboratory to plant).
• Conducts manufacturing investigations associated with commercial products and writes investigation reports.
• Performs routine maintenance and troubleshooting of laboratory equipment.
• Ensures timely completion of CGMP and other required training and compliance with CGMP.
• Works closely with project team engineers and analytical scientists to manage the lifecycle of commercial programs.

Key Competencies

• Ability to perform chemical reactions at laboratory scale, isolate and purify reaction products, and analyze reaction mixtures and products using techniques such as LC, NMR, infrared spectroscopy, and Karl Fischer titration.
• Ability to analyze results and propose appropriate follow-up actions.
• Ability to read, analyze, interpret, review, and improve company documents, professional journals, and governmental regulations, and to write, review, and improve reports, business correspondence, and procedures.
• Ability to effectively present information verbally, respond to questions from colleagues and customers, and train other employees.
• Ability to perform complex math functions and create and interpret graphs and charts.
• Working knowledge of Microsoft Office software.
• Performs routine work without instruction; receives general instructions on new projects or assignments.

Qualifications

• Bachelor's degree in Chemistry or related field required; minimum 1-2 years of relevant experience.
• GMP experience preferred.
• Hands-on experience in analytical techniques such as HPLC and GC is required.
• The level of the role (e.g., I vs. II) will align with the candidate's experience level.

Travel

Up to 5% travel required.

Physical Demands and Work Environment

• Regularly required to use hands to finger, handle, or feel; reach with hands and arms; talk or hear; and smell.
• Frequently required to sit.
• Occasionally required to stand, walk, stoop, kneel, crouch, or crawl.
• Must regularly lift and/or move up to 10 pounds, frequently lift and/or move up to 25 pounds, and occasionally lift and/or move up to 50 pounds.
• Specific vision abilities required include close vision, distance vision, color vision, peripheral vision, depth perception, and ability to adjust focus.
• Noise level is moderate to noisy.
• Occasional exposure to airborne particles, fumes, chemicals, moving mechanical parts, and vibration.
• Must have the ability to wear PPE as required.

Schedule

This position is eligible for a flexible schedule.

Work Location

This position is not eligible for remote/hybrid work; on-site presence is required.

About the Company

Sterling Pharma Solutions is a global contract development and manufacturing organization (CDMO) with over 50 years of experience in developing and manufacturing Active Pharmaceutical Ingredients (APIs). This is complemented by Antibody Drug Conjugate (ADC) research and development bioconjugation services. We are a fast-growing, dynamic business with facilities in the UK and the US, employing more than 800 talented and passionate people who support our customers in bringing new medicines to market, improving and saving the lives of patients. Our culture prioritizes delivering an exceptional experience to both our customers and employees.