This is a biopharmaceutical company focused on providing medicines for some of the world's most challenging diseases. We're committed to applying our scientific leadership in cellular metabolism to transform the lives of patients with genetically defined diseases (GDD), encompassing both rare and more common diseases, and mining the extensive potential in the PK platform. We are leading the way in advancing PKR activation for hemolytic anemias, including pyruvate kinase (PK) deficiency, thalassemia and sickle cell disease, and have demonstrated a strong commitment to these patient communities. We continue to foster a productive research engine that yields new insights and potential therapeutic approaches. We're a company that cares about our work, each other, and the people who are counting on us the most. We're inspired to think big and welcome the different perspectives and backgrounds needed to deliver extraordinary results. We're driven to be our best selves, together, so we can reach for the Other Side of Possible.
This team is searching for a dynamic Contractor Process Chemist to join the growing Process Research and Development team. The Senior Scientist / Principal Scientist will be able to follow programs as they proceed through development as supporting the overall drug substance development and manufacturing activities. The successful candidate needs to demonstrate a proven track record of solving technical challenges while supporting GMP manufacturing.
Key Responsibilities
Solve technical issues related to drug substance manufacturing by providing hands-on laboratory support within the chemical development group including process design, optimization, scale-up, process intensification, process characterization, and spike-and-purge studies to bring a clinical phase program to commercial readiness.
Work with external CMO/CRO teams to enhance/support their laboratory experimentation
Author internal technical reports based on in-house laboratory research and provide critical review of similar reports generated at external CMO/CROs
Identify key knowledge gaps and execute plans to ensure process understanding is commensurate with a given program's stage of clinical development
Minimum Requirements
In-depth knowledge of synthetic organic chemistry
MS or PhD in organic chemistry with 5+ years (MS) or 3+ years (PhD) of industry experience
Demonstrated laboratory experience developing processes to produce small molecule pharmaceuticals from early to late-stage development
Ability to navigate and be successful in a fast-paced, highly-matrixed work environment
Effective verbal and written communication skills
Demonstrated experience with organic chemistry instrumentation and interpretation including HPLC, LCMS, GC, NMR and applicable software (ChemDraw, Excel, Word, Powerpoint).
Demonstrated proficiency to manage timelines by effective prioritization to meet project goals
Preferred Qualifications
Working knowledge with DSC, TGA, and XRPD instrumentation and familiarity with Mettler?Toledo equipment are preferred.
Demonstrated scientific contribution to the synthetic community evidenced by presentations and publications
Regulatory writing experience including IND/IMPD/NDA/MAA drug substance quality modules.
Pay Rate: $80-100/Hr *Salary will be commensurate with candidate experience