Stephen Takach Email & Phone Number

Bedford, MA, US

Bedford, MA, US

► Served as Project Manager and guided Research group for 2+ years in early stage development to create a novel pharmaceutical product for a Phase 1 clinical evaluation► Process scale up from benchtop manufacturing of 20-50 single-use units per batch to 500 units per batch► Led a team of 3 Engineers that wrote cGMP protocols, batch records, standard.

Bedford, MA, US

► Led the Product Validation for Dextenza that supported the New Drug Application submitted to the FDA in 2015► Led the Development Team for FDA Non-Significant Risk Clinical Trials that supported the clinical evaluation of a pharmaceutical product► Executed 6 sets of DOE's that determined Critical Process Parameters (CPP's) and Critical Quality Attributes.

Bedford, MA, US

► Transitioned to R&D group and was R&D lead for Phase 1 OUS clinical evaluation and 3 Placebo clinical evaluations including one Non-significant risk study in the US► Successfully delivered clinical material for all programs listed above balancing multiple formulation changes and multiple programs running simultaneously

Bedford, MA, US

► Completed IQ's, OQ's, and PQ's on multiple pieces of manufacturing equipment ► Worked closely with R+D group in development of 2nd-generation ocular sealant, ensuring the product was easily manufactured at a reasonable cost

Fridley, Minnesota, US

► Developed new manufacturing processes and supported existing processes for proprietary hyrdrogel technology► Worked as a core team member to launch PMA and 510(k) medical devices► Performed studies and implemented new equipment to scale-up low volume processes and reduced waste up to 60%

Marlborough, MA, US

Peabody, MA, US

North Reading, MA, US

Master'S, Mechanical Engineering - Mechanics And Design

Bachelors, Mechanical Engineering

Mechanical Engineering