Principal Scientist, Process Safety

Duties & Responsibilities

• Independently develops and executes plans to complete assigned project within timeline
• Manages all aspects of laboratory and scale up operations including recruiting, coaching, mentoring, training, supervising and developing junior scientific staff and ensuring that entire staff is trained and working in conformance with cGMP requirements, BIPI policies, SOPs and safety regulations
• Directs a team of multiple disciplinary personnel to perform experiments to define process parameters intended for manufacturing API for later stage clinical trials and even for commercialization; Must apply organic chemistry, chemical engineering, safety and green chemistry principles to design experiments, optimize reactions, streamline workup procedures, and reduce cycle times
• Defines milestones of a project and coordinate the execution of tasks within defined time frames in order to meet a pre-set project timeline
• Clearly communicates and presents project progress in verbal and in written forms to the various disciplines; Interfaces with functional groups primarily within Chemical Development and manages resources to facilitate project development process
• Writes operating procedures, protocols and batch records for scale up and production
• Identifies and introduces new process technologies, new techniques/equipment and modifies equipment to improve efficiency and productivity
• Mentors process chemists on process development issues including process safety, scale up, equipment and operational issues
• Represents in departmental project team and assumes specific responsibility for departmental operation commensurate with technical ability and experience
• Keeps abreast of relevant literature and research

Requirements

• Ph.D. Degree in organic chemistry or chemical engineering with 5+ years relevant experience or equivalent preferably in pilot plant and scale up environment producing API under cGMP
• Demonstrated broad knowledge of process optimization, process and operation safety associate with scale up and manufacturing in addition to demonstrating excellent data processing / evaluation skill using different software packages and simulation techniques to interpret the data and their impact on process scale-up
• Independently apply innovative and customized research techniques and methods to design experiments and utilize the instruments in generating necessary and relevant process safety information
• Perform/supervise work in a safe manner in conformance with all applicable BIPI policies, SOPs, and governmental regulations such as OSHA, EPA, and FDA
• Previous supervisory experience
• Administrative management experience in a scientific laboratory or API research/development project
• Ability to communicate effectively both in verbal and written forms in an interdisciplinary environment
• Coaches, mentors, train, supervise and develop scientific staff on process development issues including process safety, scale up, equipment and operational issues
• Detailed understanding of cGMP, chemical operation and process safety, and safety regulations; assume specific responsibilities for departmental operations, policies, as needed