This position is responsible for some oversight of the Process Research and 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 and early phase CTM services to the biopharmaceutical industry
The position will be responsible for co-managing PR&D and related activities for all the above phases of development. The candidate will work with a team of PR&D scientists in conjunction with the Analytical Chemistry Department and assist in developing, safe, efficient and easily scalable processes for producing starting materials, intermediates and active pharmaceutical ingredients (API’s). In addition, the candidate will work with Quality Assurance to ensure that high quality standards are maintained and appropriate documentation such as process development and scale-up reports 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 PR&D work, the ability to manage activities and solve challenges, experience reviewing and organizing PR&D data, experience leading PR&D scientists and be the go to person for technical consultations.
• Manages and directs PR&D projects to ensure that client timelines and expectations are delivered.
• co-Manages a team to develop easily scalable chemical processes for the production of starting materials, intermediates and API.
• Guides/mentors bench chemists to ensure that research and development projects are on track.
• Responsible for the coordination and completion of specific project tasks with other departments.
• Ensures that scientists are evaluating chemical reactivity hazards using techniques such as reaction calorimetry, online analytics, and batch process modeling tools.
• Contributes to the approval, execution, and documentation of cGMP and “GLP-like” laboratory work which supports regulatory submissions and patent prosecutions.
• Works with a team which researches and develops novel and cost effective processes using innovative approaches.
• Collaborates with other functional groups and accepts other duties and responsibilities as needed.
• Authors/reviews SOP’s, technical reports and sections for regulatory filings.
• Actively communicates, consults and collaborates with colleagues and clients to ensure optimal execution and record of PR&D activities.
The position requires a strong background in drug substance PR&D, as well as thorough knowledge of relevant equipment and cGMPs ICH and relevant FDA guidelines. CMO/CRO experience is beneficial.
• Significant experience in pharmaceutical process R&D work.
• Experience in supporting all phases of API development, ideally spanning early development to registration.
• Demonstrated in-depth 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.
• Possess strong project management skills while maintaining high quality and efficiency standards.
• Provide technical and trouble-shooting support for all Process R&D activities.
• Supervise, mentor, and inspire direct reports (PR&D scientists) to enable them to be productive contributors and facilitate their scientific and career growth.
• Is seen as a technical leader and go to person.
• Provide regular updates, documentation and communication of PR&D results to development team/clients.
• Communicates directly with clients as required.
• Collate and present results in various forms, such as weekly/monthly reports, technical reports, and oral presentations for internal review and to clients.
Customary Education and Experience:
• PhD in synthetic organic chemistry or related field with 10+ years of relevant experience, or equivalent combination of education (MS, BS) and industry experience.