Reports to: SVP, Drug Discovery and CMC
Location: Princeton, NJ
PMV Pharma is developing first-in-class p53 regulators for the treatment of cancer. Bringing together leaders in the field to utilize over three decades of p53 biology, PMV Pharma combines unique biological understanding with a pharmaceutical development focus.
PMV Pharma is seeking a highly motivated process chemistry expert to support small molecule CMC efforts. This position requires a hands-on project manager who thrives in a fast-paced dynamic environment with minimal supervision.
- Manage Process R&D, scale-up and manufacturing of drug substance at CMO’s from pre-IND through clinical development
- Evaluate/design robust synthetic routes to successfully deliver drug substance for IND-enabling studies and clinical trials
- As a process chemistry expert, provide input to discovery chemistry team to solve synthetic bottlenecks and make plan for clinical development
- Author/review MBR, specs, SOPs, protocols, and reports for drug substance and drug product manufacturing activities
- Work closely with regulatory affairs to review/author CMC sections in the IND, IMPD and NDA filings
- Serve as the technical CMC expert in regulatory interactions
- Participate in resource and budget planning, risk-assessment, and tracking timelines for API manufacturing
- Ph.D. in Organic Chemistry with at least 15+ years of industry experience
- Strong understanding of modern synthetic methods, analytical chemistry, and cGMP manufacturing
- Strong track record of advancing compounds through multiple stages of clinical development
- Knowledge of current ICH guidelines and regulatory approval process
- Excellent communication, interpersonal, and organizational skills and the ability to effectively work across levels, functions, and with both internal and external stakeholders
PMV provides a competitive medical benefits package, a generous PTO policy, competitive salaries, Employee Stock Purchase Plan, Employee Referral Program, and much more.
How to Apply
To apply, please submit your cover letter and resume to Recruiting@pmvpharma.com or apply through our Online Portal.
PLEASE, NO PHONE CALLS or AGENCIES
PMV Pharmaceuticals is an Equal Opportunity Employer and all applicants will be considered for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran or disability status.