Senior Process Chemist

BioSpace has been engaged to help our client find and hire an experienced Process Chemist to join a team of dedicated professionals involved in Active Pharmaceutical Ingredient (API) research, development and manufacture on location at their California site. The candidate that we recruit will ultimately be responsible for developing safely scalable processes for manufacture of existing API’s, as well as new medicines to benefit patients worldwide. These manufactures will be implemented in our Kilo Lab, Pilot Plant and Commercial Manufacturing facilities. The position requires the individual to provide technical leadership in performing synthetic chemistry experiments for understanding, developing and validating process chemistry for new and/or established products and projects, characterizing reaction products utilizing appropriate methodology and maintaining laboratory records in accordance with cGMP practices and requirements. We believe that the long-term success of our organization depends first and foremost on recruiting and retaining the highest quality personnel, as well our cooperative cross-functional working thanks to our relatively small size of around 70 staff at this location, albeit with ongoing investment and growth and with strong supporting financial security. We enjoy world class facilities with state of the art analytical equipment which our scientists use for effective and efficient process design. Apart from this breadth of analytical equipment, we also have a variety of other process tools to aid in developing safe, scalable, robust processes. We encourage diversity along with close and cooperative project team collaboration on each and every project.

Requirements: 

M.Sc. degree in chemistry with at least 7 years of relevant work experience in the synthesis and manufacture of active pharmaceutical ingredients and/or Ph.D. degree in chemistry with at least 3 years of relevant work experience in the synthesis and manufacture of active pharmaceutical ingredients. Hands-on experience in the development and scale-up of a variety of synthetic organic transformations at multi-kilogram scale. Practical experience in the techniques and procedures of synthetic organic chemistry including spectroscopy, chromatography, handling air-sensitive agents, etc. Excellent interpersonal skills with an ability to work as part of a multi-disciplinary team, with the ability to manage, prioritize and coordinate activities with cross-functional departments. Self-motivated with strong organizational and time management skills. Hands-on experience with a variety of analytical spectroscopic equipment such as HPLCs, GCs, for organic reaction analysis. Clear writing and communication skills. Demonstration of previous project managerial experience and team leading experience. Ideally has a working knowledge of cGMP principles and the ability to apply them. Experience with a range of chemical calculations. Computer literacy including practical experience with Excel, Word, Powerpoint, Outlook, Chemdraw or equivalent software. A careful observer dedicated to maintaining comprehensive experimental records including diligent lab notebook recording of work. Demonstration of understanding the mechanisms of reactions and reaction kinetics as a predictor of control and scale up. A working knowledge in the use of factorial experimental design software to aid process optimization is preferred

Responsibilities:  

Develop and validate new process chemistry or evaluate and validate established process chemistry for synthetic organic chemical manufactures. Scale-up of new products from gram quantities to multi-kilo to tonnage scale manufacture in our Kilo Lab, Pilot Plant and Commercial Products Facilities. Take on Project Leader responsibilities and management of workload vs. project timelines to complete projects on time, within budget and achieving the desired quality. Generate insights into chemical reactions and procedures under development. Obtain scale-up kinetic and thermodynamic experimental data defining controlling variables by performing periodic removal, quenching (if required) and analysis of aliquots. Conduct thorough literature reviews to identify and assess feasibility of proposed route(s) of synthesis. Write and present development reports to upper management and clients. Verbal interaction with clients to discuss scientific results. Prepare novel compounds and characterize them using modern spectroscopic tools (IR, NMR (1H, 13C,1-D,2-D), UV-Vis, MS). Generate gram quantities of high-purity samples of key intermediates, most often by chromatography, recrystallization, sublimation, and/or fractional distillation. Maintain laboratory records in accordance with accepted good laboratory practices, SOPs, and regulatory requirements. Teach and mentor junior staff with possibility of supervisory management role. Assist with the preparation/review of regulatory and controlled documentation. Adhere to current Good Manufacturing Practices (cGMP).  Actively support the Environmental, Health & Safety programs of the organization to ensure employee, plant and community safety and security