Dr. Karmarkar has over thirty years of leadership experience at analytical instrumentation and pharmaceutical companies. At Lachat Instruments (now a Danaher-Hach company), he led development of ion chromatography and flow injection analysis instrumental techniques. During his 16 years of career at Baxter Healthcare, he led analytical development global teams on validation and transfer of hundreds of methods for excipients, drug substance, drug products at in-process, release, stability testing, and cleaning validation. He has worked on small molecule and peptide drug products terminally sterilized and aseptically filled, in syringes, vials, and flexible containers. His areas of expertise include establishing analytical controls, Analytical Quality by Design (AQbD), CMC development, reference standards, authoring and review of 3.2.S and 3.2.P CMC sections for IND, IMPD, NDA, MAA, 505(b)(2), ANDA, PAS submissions, data integrity, root cause analysis & resolutions of CAPAs and OOS.
As Director, Program Management at Baxter, Dr. Karmarkar led global teams (US, Europe, and Asia) to direct turn-around of a non-productive, international CRO relationship with about 200 FTEs into it becoming one of the best CRO relationships within Baxter routinely delivering millions of dollars in cost savings through implementation of key strategies in clarity of work, simplify the complex, building trust, empowerment, and continuous improvement. He is valued for clear and concise presentations to senior management.
As an independent consultant, Dr. Karmarkar has provided analytical and CMC leadership to oncology injection and emulsion drug products by a startup and mid-size Pharma, authoring and review of 3.2.s and 3.2.p sections for oral dosage NDA/MAA submission by a large Pharma, compliance issue resolution for a mid-size Pharma, IND-CMC authoring for a regenerative medicine company, technology transfer for a mid-size Pharma, and Analytical Center of Excellence conceptualization for a large Indian CRO.
As Director, Program Management at Baxter, Dr. Karmarkar led global teams (US, Europe, and Asia) to direct turn-around of a non-productive, international CRO relationship with about 200 FTEs into it becoming one of the best CRO relationships within Baxter routinely delivering millions of dollars in cost savings through implementation of key strategies in clarity of work, simplify the complex, building trust, empowerment, and continuous improvement. He is valued for clear and concise presentations to senior management.
As an independent consultant, Dr. Karmarkar has provided analytical and CMC leadership to oncology injection and emulsion drug products by a startup and mid-size Pharma, authoring and review of 3.2.s and 3.2.p sections for oral dosage NDA/MAA submission by a large Pharma, compliance issue resolution for a mid-size Pharma, IND-CMC authoring for a regenerative medicine company, technology transfer for a mid-size Pharma, and Analytical Center of Excellence conceptualization for a large Indian CRO.
Shreekant Karmarkar, Ph.D.