Senior​/Principal Process Development Scientist - HPAPIs - at Sterling Pharma

Senior/Principal Process Development Scientist - HPAPIs

The Senior/Principal Process Development Scientist - HPAPIs is accountable for driving the development and optimization of robust, scalable synthetic processes for small molecule APIs - with a focus on highly potent active pharmaceutical ingredients (HPAPIs), payloads, linkers, payload-linker intermediates - 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. The role requires expertise in the development of synthetic routes and scalable manufacturing processes for highly potent compounds, including antibody-drug conjugate (ADC) payloads, linker technologies, payload-linker intermediates, and related HPAPI molecules, with a strong focus on safety, containment, and successful transfer into cGMP manufacturing environments.

Essential Functions

• As a part of a cross-functional development team, designs, plans, and executes process development and optimization for HPAPIs, payloads, linkers, payload-linker intermediates, and 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, including those relevant to highly potent compounds and payload-linker syntheses.
• 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 while meeting containment and safe handling requirements for highly potent compounds.
• Executes synthesis activities from gram to multi-kilogram scale at up to 20 L scale, including routine maintenance and troubleshooting of laboratory equipment, containment systems, and engineering controls utilized for handling HPAPIs and payload-linker intermediates.
• Isolates and purifies products and intermediates by using standard laboratory techniques, including automated preparative chromatography systems.
• Designs multi-step synthetic processes from commercially available starting materials to target compounds, including ADC payloads, linker molecules, payload-linker intermediates, highly potent cytotoxic agents, and related pharmaceutical compounds.
• Performs routine analytical procedures to monitor reaction progress (i.e. TLC, GC, NMR, HPLC, LC-MS, KF), and interprets and communicates data effectively, including assessment of impurity profiles and product quality attributes.
• Prepares project documentation such as development reports, material specifications, containment assessments, 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.
• Provides technical leadership in the safe handling, process development, scale-up, and manufacture of HPAPIs, payloads, and linker technologies, while mentoring, training, and coaching junior scientists.
• Contributes to the evaluation, implementation, and continuous improvement of containment strategies, risk assessments, and operational practices associated with highly potent compounds.
• 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, HPAPIs, ADC payloads, linker molecules, payload-linker intermediates, and related organic molecules.
• Proficiency in hands-on execution of analytical techniques such as HPLC, GC, NMR etc.
• 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…