Senior Chemical R&D Scientist - API Process Innovation

Sterling Pharma Solutions Limited; Town of Germantown (WI); On-site; USD 130,000 - 180,000; Full time

Job summary

Sterling Pharma Solutions Limited in Germantown, Wisconsin, seeks a Senior/Principal Chemical R&D Scientist to drive development and optimization of scalable synthetic processes for small molecule APIs, from early development to manufacturing transfer.

The role requires leading technical transfer, documenting complex data for clients and regulatory filings, and mentoring junior scientists in a fast-paced CDMO environment.

Qualifications

• 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.

Responsibilities

• As 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.

Skills

Synthetic route development

Scale-up from lab to manufacturing

Design of Experiments (DOE)

Regulatory documentation

Education

Bachelor’s degree in Chemistry or related field

Master’s degree in Chemistry or related field

PhD in Organic Chemistry or related field

Job description

Sterling Pharma Solutions Limited in Germantown, Wisconsin, seeks a Senior/Principal Chemical R&D Scientist to drive development and optimization of scalable synthetic processes for small molecule APIs, from early development to manufacturing transfer.

The role requires leading technical transfer, documenting complex data for clients and regulatory filings, and mentoring junior scientists in a fast-paced CDMO environment.