Molly J. Clark, PE

Molly Clark is a Chemical Engineer with a broad scope of experience in the pharmaceutical industry ranging from early process development to commercialization, including APIs and drug products, new chemical entities and generics.   

As a representative of emerging pharmaceutical companies, Molly has managed custom manufacturing operations of APIs and drug products, ensuring that development, scale-up, and validation of multi-step small molecule drug processes are performed according to the companies’ technical and quality standards.  This involved identifying, selecting and qualifying appropriate CMO organizations, performing technology transfer, reviewing master and executed batch records, evaluating data, investigating deviations, and witnessing key process steps at the CMO sites.  She has written/edited chemistry, manufacturing, and control documents for DMFs, INDs, NDAs, and foreign registration applications. 

 As a project manager in a CMO, Molly led the laboratory program in developing and optimizing safe, operable, and cost effective processes for the manufacture of intermediates and active pharmaceutical ingredients. She coordinated and prioritized the activities of team members to meet aggressive time tables.  She interacted with customers to assure good communication of needs, expectations, and status.

Molly has served as lead engineer in the design, construction, validation and operation of two major pilot plant API production processes and provided technical support for the scale-up of these processes to commercial scale.

In addition to engineering functions, Molly has served in various Quality Assurance roles which included: establishing quality systems, participating in on-site and internal compliance audits and FDA inspections, training personnel, and determining batch disposition.

Molly received her Bachelor’s degree in Chemical Engineering from Georgia Tech and maintains active status as a Professional Engineer.