Radius Health, Inc. is seeking an experienced Process Development Chemist with a proven track record of sustained laboratory achievement and innovation to join our CMC group.
The incumbent will be alongside other CMC, Research, and Clinical within the company’s investigational drug RAD1901 team. Currently, the investigational drug RAD1901 is in Phase 2 development for the Vasomotor indication, and in Phase 1 development for breast cancer indication.
Essential duties and responsibilities:
Manage Contract Manufacturing Organizations (CMO) for GMP manufacturing of APIs.
Working in close collaboration with CMO;
Develop processes suitable for controlling the quality of bulk API as required by cGMP, ICH and FDA regulations as well as the bulk attributes conducive to successful formulation development.
Develop optimized synthetic route to manufacture GMP API from early development through Phase III and commercial.
Apply fundamental chemistry and engineering principles to solve challenges in preparation and process development of APIs from milligrams to kilogram manufacturing scales
Serve as an API development representative on a multidisciplinary CMC or program teams.
Having a good understanding of how impurities are formed, tracked and purged throughout the subsequent processing.
Demonstrates excellent verbal communication skills and interpersonal skills.
Demonstrates collaborative communication and problem solving spirit.
Work closely with Quality Assurance, Quality Control, Regulatory Affairs and Supply Chain Planning groups for the management of manufacturing schedules, resolution of technical issues, batch record review and batch release/disposition activities.
5-10 years of relevant industry experience in a pharmaceutical CMC/GMP environment.
3-5 years’ experience working for chemical/pharmaceutical manufacturing/process development organizations in a cGMP environment or working with cGMP contract manufacturing organizations.
Experience with CMC issues encountered in API development is highly desirable.
Experience in managing CRO/CMOs for the manufacture of GMP APIs.
Excellent laboratory skills and knowledge of organic synthesis and purification techniques.
Proficient in the use and interpretation of standard analytical instrumentation including, NMR, GC, HPLC, LCMS, IR, DSC, TGA, XRD.
Track record in developing and scaling-up innovative, safe and effective processes for the manufacture of intermediates and APIs.
Experience with regulatory documentation such as IND/IMPD filings.
MS or PhD in Organic Chemistry or related scientific discipline.Link here. Best wishes to those interested.
BS degree with extensive industry experience.