Director, Process Chemistry (API Phase III to NDA Stage) - San Francisco Bay Area - East Bay, CA | Biospace
Get Our FREE Industry eNewsletter

Director, Process Chemistry (API Phase III to NDA Stage)


San Francisco Bay Area - East Bay, CA
Posted Date:
Position Type:
Full time
Job Code:
Required Education:
Bachelors Degree
Areas of Expertise Desired:
Chemical Engineering, Chemistry, CMC, Development, Engineering, Manufacturing, Manufacturing/Production, Obstetrics, Organic Chemistry,

Job Description

- Process chemistry project leadership role within a fast-paced East Bay pharma that has several late stage NDA-track small molecule drug candidates.
- Late-stage API process chemistry role that requires a broad spectrum of chemical development and organic synthesis API-focused hands-on project leadership skills.
- Requires an organic chemist or chemical engineer well-versed in downstream (Phase II to NDA stage) process chemistry with hands-on expertise in complex organic molecule API synthesis, route development, purification, and characterization.  
* Reports to a tech-savvy exec who appreciates independence and creative problem solving skills.
* Must be well versed in GMP-compliant late stage API manufacturing.
* Will act as the lead process chemist and main point of contact managing CMO partners---this includes managing tight timelines for API batch or NDA batch studies within defined budgets, troubleshooting technical issues, independently reviewing and approving batch records, overseeing tech transfer, and issuing regular reports.
* Entails use of exceptional organization and communication skills including the ability to collaborate effectively with diverse disciplines.  


- PhD, MS, or BS (depending on level of expertise) with emphasis on organic chemistry or chemical engineering  
- A minimum of 6 years’ pharmaceutical industry hands-on technical leadership experience in cross-functional collaboration and technical leadership to drive API process development scale-up and manufacturing---including project design and execution---for GMP-compliant phase III to NDA-stage manufacturing of active-pharmaceutical-ingredients (APIs), aka, drug substances.
- Technical project leadership skills in late stage [Phase II-to-NDA scale] small molecule API manufacturing.  
- Expertise must include hands-on experience in late-stage process development, process optimization, process validation, scale-up, GMP-compliant API manufacturing, and CMO selection and management.
- Thorough knowledge of global cGMP compliance requirements and proven strategic leadership skills in optimizing API-focused, late-stage process chemistry projects.  
- Strong interpersonal and communication skills--including ability to write well, to communicate with diverse disciplines and to present complex information in a cogent manner.
- Demonstrated ability to work well in a small company environment.
- Ability to travel possibly up to 30% of the time.
- Use link provided or, preferably, email resume directly to using job code API-dr in the subject line.
* organic chemistry chemical engineering cGMP manufacturing statistical DOE “design of experiments” nucleosides “drug substances” API NDA IND synthesis “route development”  scale-up purification characterization “process development” “process chemistry”