Michelle Howard Sparks, Phd Email & Phone Number

Newton, Ma, Us

New York, Ny, Us

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Lead R&D Groups relating to Formulation, Device Design and Preclinical strategy.

CMC lead responsible for development, manufacturing and supply/sourcing of all drug product, device and clinical trial components in preparation for approval and commercialization. Progressing NCE candidates (oral and parenteral) from nomination through commercial readiness. Provided strategic CMC input and corporate growth strategy from IPO to commercial launch planning. Worked closely with Quality to build Quality Systems for Combination Drug-Device development. Worked closely with Regulatory Affairs to support CMC related FDA, EMA and MHRA filings and interactions for Orphan Drug indication.

Daresbury, Cheshire, Gb

Cambridge, Ma, Us

Lead Formulation Group within the Pharmaceutical Technology Research and Development Lab Division, including a staff of 14 formulation development scientists in the development of oncology products. Responsible for ensuring departmental direction, achievement of goals and HR needs. Lead efforts toward the integration of global systems within CMC functions across Oncology, Immunology and Respiratory Therapeutic Areas. Served as Global CMC Lead for Oncology based therapeutic area. Responsible for maintaining business relationships with key CMO partners. Responsible for departmental budget, FTE resource planning, and progression of discovery candidates from First in Man through Phase III dosage form development, validation and commercialization.

Silver Spring, Md, Us

Lead strategic and operational planning for global drug development efforts, including oversight of drug substance, drug product, pre-clinical testing, formulations and manufacturing.

Malvern, Pa, Us

CMC product lead responsible for all stages of NDA formulation and analytical development through validation. Authored, reviewed and created strategic direction within the CMC component of NDA regulatory submissions. Managed development activities with key partners organizations. Created NDA development plans.

Malvern, Pa, Us

Selected and managed tech transfer R&D and commercial products between domestic and international manufacturing sites. Managed budgets, timelines and development activities with key partner organizations to ensure no commercial supply interruptions. CMC product lead on Phase III development projects and commercial products. Authored CMC sections. Responsible for staff mentoring and development. Created Cost of Goods and ROI analysis for portfolio valuations.

Malvern, Pa, Us

Technical team leader responsible for pre-formulation, formulation, and process development of Schedule II narcotics. Lead tech transfer of NDA products to Phase I/II CMO. Managed pre-clinical and clinical supplies.

Nashville, Tn, Us

Doctor Of Philosophy (Ph.D.), Medicinal Chemistry

B.S, Biology

Pre-Professional

Education record