- Established small pharma with significant pipeline of NDA-track small molecule drug candidates seeking API-focused technical leader to direct process chemistry and CMC activities to ensure GMP-compliant technical transfer to CMOs of drug substance analytical methodologies and manufacturing processes.
- Will manage scale-up, manufacturing, and process validation of late-clinical to commercial stage APIs.
- Will bring leadership expertise in key areas of process development, process validation, quality by design, scale-up, and manufacturing.
- In collaboration with cross functional teams, will lead GMP chemical development and manufacturing processes by applying superior decision-making skills and up-to-date knowledge of current regulatory standards.
- Through interpersonal and project-leadership skills, will interact effectively with cross functional groups to lead successful mid to late stage CMC project operations and activities.
- Will draft well-written CMC registrations and CMC sections of INDs.
- Will ensure compliance of CMC project activities in accordance with GMP, FDA, and other regulatory standards.
- a PhD in chemistry or related field [or a non-PhD with equivalent industry seasoning] with proven expertise in strategically planning and implementing CMC projects for mid to late stage (clinical to commercial stage) APIs.
- Seven-plus years of pharma industry experience leading CMC activities and process chemistry activities that include tech transfer to CMOs of drug-substance analytical methods and manufacturing processes.
- Technical strengths and leadership expertise in key areas of process development, process validation, QbD, scale-up, manufacturing, and selection and supervision of CMOs.
- Experience managing cGMP-compliant manufacturing and process validation for mid-to-late stage (clinical to commercial stage) active pharmaceutical ingredients (APIs).
- Experience independently leading GMP chemical development and manufacturing processes.
- Advanced decision-making skills and up-to-date knowledge of GMP, FDA, and other current regulatory standards.
- Hands-on experience reviewing and finalizing master batch records and production records and troubleshooting deviations and out-of-specification (OOS) results.
- Demonstrated seasoning and collaboration skills working effectively with cross functional groups.
- Demonstrated advanced communication skills for concise written and oral reporting and successful drafting of CMC registrations and CMC sections of INDs.
- Ability to travel internationally up to 25%
Use link provided or email your resume directly to email@example.com - Use the following job code in your subject line: DirCMC-API