Stephen Levine Email & Phone Number

Remote staff management for pharmaceutical clients. Identifying, hiring, and management of pharmaceutical staff on assignment at various clients.

CMC Product Development for Pharma IND, NDA, and aNDA products. Formulation Development and Process Engineering. Organizational management. Manage and direct teams of scientists and development lab activity, chemists work on method development and prototype analysis, and quality personal, to develop and manufacture drug products and prepare quality systems for audit readiness. Liaison work with CDMOs and virtual companies.Business Development and Pharma Sales Support for CDMO and ingredient products. Tech to Tech sales support and liaison for R&D, QA, Clinical Supplies, Scale-up, and Manufacturing. Nutritional Supplement Product Development: Formulation and Process Development work. Paper and bench top formulation, process development, scale-up; manage development activities. Draft labels and product specifications. Tech to Tech sales support and liaison for R&D, QA, and Manufacturing.Innovative products for Pharma and Nutra markets. Drug product, Nutraceutical Product, and Exciptient Product Development. Process Development. Project Management. cGMP transfer, Sales, QA, and Manufacturing Support. Laboratory and Staff Management. Systems Development (Quality systems, Organizational systems). Strategic Corporate Growth Direction and Development, Personnel identification, selection, management, mentoring, organization, and succession planning. cGMP transfer, scale-up, and product launch support. Sales, QA, and Manufacturing Support and Troubleshooting (OOS and OOT investigations), etc.

Manage group of senior formulation scientists, formulation scientists, and technicians in contract development of dosage forms and clinical trial materials for Phase I and II clinical trials. Focus on managerial oversight directing of project managers.* Manage pharmaceutical product development groups of senior scientists, project managers, formulation scientists, etc. (12 reports)* Mentor direct reports to increase expertise, cGMP understanding and compliance, to develop project management and customer service skills, instill confidence, and promote empowerment, and high productivity* Team management including mentoring reports in interpersonal skills* Risk analysis and mitigation; mentoring reports in the same* Proactive, insightful, and informed decision making* Oversee and train project management activities performed by direct reports* Project Management responsibilities for the most complex projects encompassing pre-formulation, drug product formulation, analytical method development and validation, scale-up, pilot batches, cGMP manufacturing for Phase I, II, IIb, and IV clinical trial materials, batch release, tech transfer* Project Management for formulations and analytical work performed overseas in Asia involving off-hours communications and managerial support* Scheduling of staff, laboratory equipment, and facilities to maintain an efficient work environment and ensure project timelines are met* Manufacture most solid, semi-solid and non-sterile liquid dosage froms* Implement effective systems to ensure organization of raw materials, electronic and hard copy data, technical literature, and time-tracking data * Lead and oversee corporate technical publishing efforts; 25 posters in five years* Spport technical sales for pharmaceutical development and clinical projects* Write proposals and interact with clients though the proposal revision process

Manage a group of senior formulation scientists, formulation scientists, and technicians to develop new excipients, primarily for polymer based coating systems, including controlled release and color matching* Recruited and trained staff for Technical Services, Pharmaceutical Services, and Contract Manufacturing (40+ people)* Project Management on the grand scale of conceiving, developing, commercializing, transferring, and manufacturing a 1,000+ SKU project line of Advantia film coatings for ISP (now Ashland)* Technical design, laboratory development, and process validation for the global development, launch, and product support of the Advantia coating platforms and products including Advantia Prime (immediate release), Advantia Performance (enteric), and Advantia Preferred (all with option for custom color matching)* Launched Quality By Design value added excipient platforms using design of experiments and statistical analysis and optimization* Managed color matching activities and initiated the development of an auto-color matching data base system* Directed technical services, development, optimization, and technical sales support and technical publishing efforts for internal excipient lines and other novel development work (13 AAPS posters in 2 years)* Manage method development for physical characterization testing* Oversee generation and revision of quality systems documentation* Coordinated and developed the training material for hands-on advanced coating training courses for ingredient vendors, equipment manufacturers, and several “Big Pharma” companies and led training workshops both domestic and international* Provided technical transfer and commercial manufacturing and consulting technical support for production equipment installations, new product launches, and general troubleshooting of commercial pharmaceutical operations

Develop complex dosage forms for all type of solid dosage forms, semi-solids, and non-sterile liquids.* Managed pharmaceutical drug product and excipient development group including 5 scientists and 5 technicians* Started and established a technical services group from the ground up: from drafting job descriptions and recruiting to training, teaching, managing, mentoring and empowerment* Headed coating platform development using design of experiment and extensive coating and film characterization including method development* Staff Management for pharmaceutical development and clinical manufacturing, packaging, and release* Project Management for complex pharmaceutical development and clinical manufacturing projects from pre-formulation through cGMP Phase IIb clinical manufacturing, packaging, and batch release* Oversee API characterization and interact with manufacturer for release* Established and maintained project management link between Emerson Pharmaceutical International product development scientists and a joint venture partner analytical laboratory and chemists* Supported quality systems development and implemented cultural change in corporate transition from R&D-only facility to cGMP and with Clinical Trial Material manufacturing* Worked with intellectual property patent attorneys on expert witness lab trails, affidavits, and legal depositions* Served as lead coating instructor for Emerson Science Center tableting courses* Provided consulting support to Commercial Manufacturing operations both Pharmaceutical and Neutraceutical

Develop dosage forms and litigation support.* Lead numerous pharmaceutical development projects covering preformulation through technical transfer to manufacturing sites* Developed numerous types of solid dose product formulations and processes including extrusion/spheronization, roto-granulation, chewable tablets and gum, effervescent tablets, orally disintegrating tablets, enteric and sustained release; dry, high-shear, and fluid bed granulations* Worked with analytical equipment and methods including dissolution, UV/Vis spectrometry, FTIR, DSC; physical characterization equipment, including disintegration and other compaction profile tablet characterization instruments; analytical sieving and other powder characterization instruments; rheology, texture and surface analysis, film characterization, and colorimetry* Worked extensively with numerous types of specialty coating systems, applications, and processes, including organic solvents, hydro-alcoholic, pseudo-latex, pH dependant and pH independent controlled release, coating of powders and beads, taste and odor masking, moisture barrier coating, drug layering/loading of beads and tablets, hard and soft gelatin capsule coatings, and tradition and rapid sugar coating* Supported initial and ongoing efforts to transition facility to pharmaceutical cGMP compliance for the manufacture of Clinical Trial Materials* Drafted and executed Equipment Qualification documents and SOPs* Conducted lab trails and provided testimony for expert witness intellectual property cases* Provided technical support for color matching and specialty coating systems

Final and in-process QC analysis.

Final and in-process QC analysis.

Education record

M.Div., Pastoral Ministry

Bachelor Of Applied Science (Basc), Applied Human Anatomy & Physiology