Cmc Technical Lead (Chemical Development)
Upper Providence, Pennsylvania, United States
Led matrix teams comprised of CMC line leads to deliver integrated CMC project plans for the development of API and drug product processes, facilitate manufacture & delivery of clinical supplies, progress assets through governance boards, deliver CMC components for regulatory submissions. Led development of robust and scalable chemistry, purification, isolation, API particle formation and formulation processes; developed control strategies and led tech. transfer of processes to pilot… Show more Led matrix teams comprised of CMC line leads to deliver integrated CMC project plans for the development of API and drug product processes, facilitate manufacture & delivery of clinical supplies, progress assets through governance boards, deliver CMC components for regulatory submissions. Led development of robust and scalable chemistry, purification, isolation, API particle formation and formulation processes; developed control strategies and led tech. transfer of processes to pilot plant or commercial manufacturing facilities in support of early development through commercial launch supplies (including oligonucleotide manufacturing) Show less