Expert Details
HPAPIs, Pharmaceutical
ID: 737213
Illinois, USA
Key Strengths:
- Project/Program Management
- Regulatory Filing (CMC/DMF)
- R&D Management & Strategic Planning
- Process Validation/QbD
- Outsourcing
- Drug Development
- Amino Acids & Carbohydrates
- Oncology High Potency API
- Parenterals and Oral Solids
- ICH Q7 API cGMP Manufacturing
Education
| Year | Degree | Subject | Institution |
|---|---|---|---|
| Year: 1993 | Degree: Postdoctoral Research Associate | Subject: Organic Synthesis via Chiral Metal Complexes | Institution: University of Colorado, Boulder |
| Year: 1992 | Degree: Ph.D. | Subject: Chemistry | Institution: University of Colorado, Boulder |
| Year: 1987 | Degree: B.S. | Subject: Chemistry | Institution: University of Wisconsin, Madison |
Work History
| Years | Employer | Title | Department |
|---|---|---|---|
| Years: 2014 to Present | Employer: Undisclosed | Title: Director | Department: Process R&D |
Responsibilities:Leader of the Process Chemistry, Kilo Lab, and Project Management activities in the R&D organization.To ensure that all company goals are achieved, direct and prioritize the process R&D and project management activities of team members for internal development and external contract manufacturing projects. • Technical liaison for international (Europe, US, China, and India) business development team • Technical director of activities for all API CDMO commercial manufacturing and clinical phase development projects. • Senior Leadership Team member for key decisionables with Chairman, VP’s, and Board of Directors. • R&D capital expansion lead for lab upgrades and future design buildout to accommodate new technologies such as linker-toxins for ADC manufacture and safe handling of highly potent API’s • Process development team lead for high purity, multicompendial excipients (trehalose, plant-derived galactose, sucrose, maltose, mannitol, amino acids) used in protein stabilization and cell culture media for the world’s top-selling biologics/biosimilars • Strategic planning for new product pipeline and implementation of new platform technologies, based on QbD principles, including continuous improvement initiatives, Design of Experiment, FMEA, and JMPbased statistical analysis. • Due diligence and evaluation of new external product development partners, including analytical labs and manufacturing facilities • Negotiation of Supply Agreements and NDA’s with customers and corporate contract attorneys • Development of cost models and author of research proposals and requests for quote • Project manager of internal cross-functional teams (Sales & Marketing, Engineering, QA, Procurement, Legal, Operations) as well as CRO’s and CDMO’s for both internal and external R&D and manufacturing tech transfer projects • Recruitment of new hires for R&D team expansion • Lead technical author of international drug substance CMC (Module 3) filings for API’s and excipients • R&D subject matter expert for intellectual property assessments, including reviewing FDA Orange Book data and competitive landscape. • ICH Q3D elemental impurities risk assessments for commercial API’s and excipients • Maintenance of SafeBridge certification for high potent API R&D and manufacturing operations • Market assessments (including IQVIA data analysis) of generic oncology API’s (injectable and oral solid dosage form) for new drug substance development opportunities • Subject matter expert for FDA and customer quality audits • 5S trained and certified team lead for sustainability and operational efficiency efforts • SWOT analyses of existing product portfolio and new business ventures |
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| Years | Employer | Title | Department |
| Years: 2007 to 2013 | Employer: Ferro Pfanstiehl, Inc. | Title: Manager | Department: Process Chemistry |
Responsibilities:Leader of the Project Management and Process Development activities for a chemistry staff of four senior Ph.D.’s and three product development technicians• Program manager for API chemical development, process validation, CMC/NDA support and manufacturing of generic and contract API’s (clinical and commercial nucleoside analogs) o Directed R&D and production activities for No. 1 revenue-generating API manufactured at Pfanstiehl under exclusive Supply Agreement with large pharma company • Utilized stage-gate principles to manage customer expectations while maintaining focus on safety, quality, delivery, and cost containment • Managed department budget and authorized monthly project deliverable invoices • Introduced reverse-phase chromatographic purification and lyophilization technologies for small molecule drug conjugate isolation • Attended conferences and trade shows (CPhI, Informex, AAPS, ChemOutsourcing, PepTalk) to meet directly with customers and contractors in support of new business development efforts • Developed purification technology for isolation of plant-based carbohydrates • Collaborated with enzyme engineering teams for downstream processing of biotransformation broths • R&D lead on Material Review and Process Validation Boards that oversee site-wide quality systems including documentation, change control, corrective and preventative actions (CAPA), Out of Spec (OOS) investigations, and non-conforming material reports (NCMR) • Established strategy and aligned resources for successful project execution |
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| Years | Employer | Title | Department |
| Years: 2004 to 2006 | Employer: Ferro Pfanstiehl Labs | Title: Senior Scientist | Department: |
Responsibilities:• Teamed with high potency manufacturing operations for process validation batches of an FDA fast-track approved drug for the treatment of pediatric leukemia• Coordinated efforts of analytical method validation, quality control, process engineering, and quality assurance groups to produce cGMP clinical supply batches of an Hsp90 (heat shock protein 90) inhibitor for use in Phase II/III clinical trials • Supported production of sodium and potassium lactate USP solutions • Upgraded manufacturing routes and DMF’s for internal production of two generic oncology API were originally approved 25+ years ago • Project manager and technical chemistry lead for the manufacture of two parenteral, nanosuspension formulation Phase II/III oncology API’s • Co-authored supporting regulatory filings for late-phase clinical trial materials and commercial product NDA annual updates |
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| Years | Employer | Title | Department |
| Years: 2001 to 2004 | Employer: Albany Molecular Research, Inc. | Title: Senior Research Scientist II | Department: |
Responsibilities:Managed 5−10 major research programs per year, with a team of two senior-level Ph.D. and two experienced BS chemists.• Led a research team in 29-step chemical synthesis of a complex tetrasaccharide, establishing significant development time and cost savings compared to an enzymatic route • Designed both solution- and solid-phase pilot plant-scale procedures for the convergent synthesis of a novel octapeptide • Utilized preparative HPLC and Biotage chromatography (Flash 75/150 and 400 systems, including normal and reverse phase columns), LC-MS, HPLC, GC, GC-MS, IR, polarimetry, and advanced NMR spectroscopy to isolate and fully characterize compounds • Presented all project communications to internal senior management and external customers |
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| Years | Employer | Title | Department |
| Years: 1995 to 2001 | Employer: Monsanto Company (NSC Technologies Division) | Title: Senior Research Scientist | Department: |
Responsibilities:Coordinated international and domestic outsourcing efforts for amino alcohol and chiral auxiliary production, including on-site supervision, technology transfer, and communication with off-site R&D teams.• Pioneered the first manufacturing route to an Evans chiral auxiliary used to produce the cholesterol drug Zetia (ezetimibe). • Authored technical transfer packages for both domestic and international production • Designed and evaluated non-patent infringing routes to key, advanced chiral intermediates required for the generic production of the ACE inhibitors Lotensin (benazepril), Prinivil (lisinopril), and Monopril (fosinopril) |
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| Years | Employer | Title | Department |
| Years: 1994 to 1995 | Employer: Monsanto Company (NutraSweet Division) | Title: Research Scientist | Department: |
Responsibilities:Conducted first proof of concept lab experiments and process optimization activities for neotame, the follow-on artificial sweetener to NutraSweet (aspartame).• Led chemical development efforts in producing amino acid (natural and unnatural) derivatives as pharmaceutical intermediates. Seven previously commercially unavailable amino alcohol-derived compounds were produced at a multi-kg scale. • Developed a safe and cost-effective route to reduce amino acids to amino alcohols at 2,000- gallon scale. |
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Career Accomplishments
| Associations / Societies |
|---|
| (Conferences and memberships) Research and Development, Roche Colorado Peptide Symposium, American Chemical Society, SOCMA |
| Publications and Patents Summary |
|---|
| 12 research papers and book chapters in peer-reviewed chemistry publications. CPhI, Informex, AAPS, ChemOutsourcing, PepTalk, Monsanto Fellow’s Symposium, Organic Process |