This position reports to the Chemical Research & Development Department at STA Pharmaceutical US LLC. STA Pharmaceutical US LLC, a WuXi AppTec Company, is a contract development and manufacturing organization focused on providing high quality process development, R&D, GLP Tox lots and up to P1/P2 GMP small molecule manufacturing services to the biopharmaceutical industry. The candidate will work within a team of process R&D scientist’s in conjunction with the Analytical Development Department and be co-responsible for developing, safe, efficient and easily scalable processes for producing starting materials, intermediates and active pharmaceutical ingredients (API’s). In addition, the candidate will assist in tech transferring projects to kilo lab, pilot plant, and plant scales and contribute to the safe and cGMP compliant execution of API manufacturing processes. The candidate will work with Quality Assurance to ensurethat high quality standards are maintained and appropriate documentation such as process development and scale-up documentation including batch production records (BPR’s) are completed in a timely manner and that standard operating procedures (SOP’s) are written and followed. The ideal candidate will have shown proficiency in hands-on synthetic organic chemistry and the ability to solve process and scale-up problems through laboratory-scale investigations of organic synthesis reactions, separations, and milling processes. The position requires a strong background in process chemistry, as well as thorough knowledge of analytical techniques and understanding of cGMPs ICH and relevant FDA guidelines. CMO/CRO experience is beneficial.
Evaluate chemical reactivity hazards using techniques such as reaction calorimetry, online analytics, and batch process modeling tools. Plan, execute, and document cGMP and “GLP-like” laboratory work supporting regulatory submissions and patent prosecutions.
Research and develop novel and cost effective processes using innovative approaches such as chemoenzymatic synthesis, biocatalysis, and green chemistry principles.
Collaborate with other functional groups and accept other duties and responsibilities as needed.
The position requires a strong background in process chemistry, as well as thorough knowledge of analytical techniques and understanding of cGMPs ICH and relevant FDA guidelines. CMO/CRO experience is beneficial.
Technical Skills / Knowledge:
Significant experience in process development for small molecules.
Experience in supporting all phases of API development, ideally spanning early development to registration.
Demonstrated understanding of cGMP manufacturing for biopharmaceutical products.
Demonstrated success working effectively outside defined scope of responsibility, when required.
Have a bias for action and display a sense of urgency.
Provide technical and trouble-shooting support for process scale-up runs.
Establish a good working relationship with peers to support and enable the delivery of intermediates/API in a timely fashion.
Collate and present results in various forms, such as weekly/monthly reports, technical reports, and oral presentations for internal review and to management.
Customary Education and Experience:
PhD in synthetic organic chemistry or related field with 3+ years of relevant experience, or equivalent combination of education (MS, BS) and industry experience.