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Highly accomplished and innovative Technology/Development Leader with years of expertise. Strengths in analytical development, Process Analytical Technology, product development, quality control and quality assurance. An effective manager who previously developed and managed groups of over 30 with operating and capital budgets of over $5MM. SELECTED ACCOMPLISHMENTS Directed and developed PAT program for ISPE 2010 award winning facility for Process and Equipment Innovation. Validated application(s), wrote PAT NDA sections, defended PAT in NDA review and PAI as SME. Represented company in industry input on ASTM E55.02, generated 1 PAT patent.Directed analytical methods development and validation (using internal reources, CRO's and CMO's) for novel excipients, API’s, and medical devices to meet the needs of toxicology(pharmacokinetics /ADME), process or product development, clinical and commercial manufacturing customers. Added Technology & expanded organizations technical ability through personnel development and hiring expertise. Added analytical/process development, QC, micro, stability, QA, environmental, and PAT groups to organizations. Mentored groups from initiation or refocused existing groups in Pharmaceutical and Chemical research and manufacturing organizations.Regulatory Expertise - Initiated / implemented a GMP and GLP program for a drug development company and submitted numerous CMC IND CTD and NDA sections. Managed the reorganization of a GMP compliance program for a bulk pharmaceutical and sterile device manufacturer. Received and responded to customer audits and FDA inspections.Specialties: Technology Leadership - Have successfully led technical programs at the Vice President level for Analytical Development, Quality Control and Quality Assurance and at a Director level for Process Analytical Technology and Chemical Technology.
Self-Employed Consulting Or Contract Only
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Self-Employed Consulting Or Contract OnlyGreater New York City Area
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Technical ConsultingSelf-Employed Remote Consulting Or Contract Only Jan 2019 - Present
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Director Quality ControlIntergel Pharmaceuticals Division International Vitamin Corporation Sep 2011 - Jan 2019Lead all analytical and quality control activities for a soft gelatin capsule manufacturer of dietary supplements, pre-natal multivitamins, RX, and OTC drugs. Directed analytical development; material and product test raw material, in process and finished product testing and release); supplier qualification (analytical and quality system review); and stability programs. Lead analytical development and QC functions during customer and FDA audit/inspection/ due diligence; ANDA filing, review and FDA’s additional requests for information. Directed group of up to 16 departmental budget of ca $2 MM for a site making 1 to 2 billion doses annually
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Director Process Analytical TechnologyMannkind Corporation 2007 - Apr 2011Danbury, Ct, UsInitiated and developed PAT program. Demonstrated applications both onsite and at CMO’s for formulations and novel excipient programs. Established PAT to gain process knowledge of critical process parameters of drying, dissolution, particle formation, condensation, coupling, and hydrolyses reactions. Primarily utilized FTIR, Raman, MS, and FBRM at 0.2 - 4000L scale. Represented company in industry input on ASTM E55.02, generated 1 PAT patent application. •Provided PAT scale-up support to gain process understanding during commercial scale up. Also provided UPLC methods for in-process testing of active & novel excipient during scale-up. •Managed validation of PAT applications in commercial facility. Lead Equipment & Computer validation groups qualifications (writing or editing DS, VRA, UFRS, IOQ, PQ, and TM).•Directed analytical responsibilities for novel excipient pilot facility for transfer of methods to CMO. Development through validation of new HPLC, UPLC, and GC methods (including UPLC/HPLC/GC-MS impurity studies) to support 2nd generation process. -
Director Chemical Process TechnologyMannkind Corporation 2004 - 2006Management of Pilot Plant facility for novel excipient including schedule, plant improvements (capital budget), protocol preparations and executions, training of staff, maintaining facility, facility systems and documentation; responding to pilot plant facility environmental and quality audits. Operating Budget of ca 1.2 million. Technical Team leader/organizer for identification of key suppliers of Insulin and Novel Excipient (Manufactured under a Mannkind Patent).•Successfully demonstrated a 30% yield increase of a condensation reaction at pilot scale and transferred to CMO. •Successfully completed process parameter range studies for a multistep synthesis process at 200 to 1000L scale and transferred to CMO.
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Vice President Quality Control, Quality Assurance And DeviceMannkind Corporation 2000 - 2004Successfully led QA/QC through start up of Danbury facility, expanded QA (from staff of 1 to 5), and QC /Analytical Development (from 1 to 25). Operating budget responsibility of over 4 million. Submitted numerous CMC IND/ CTD/ NDA sections and responded to or participated in response to inquiries. Managed API qualification, pharmacokinetics studies using CRO’s. Participant and departmental lead in numerous cross function teams such as CMC. •Directed design of QC lab and purchase and start up of ca 1.5 million analytical equipment•Successfully led development of initial in-house programs for analytical method validation, stability, and microbiology •Initiated QA system and guided through 2 BPharm inspections of quality systems for a complex dosage form.
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Director Of Quality Control And Quality Assurance (Mannkind)Pharmaceutical Discovery Corporation 1994 - 2000Launched and implemented GMP and GLP compliance programs, including hands on start-up of Analytical Development, QC and QA program for corporation.•Initiated analytical development (ES/LC/MS) including support for: process development; validation and optimization; impurity profiles; plasma and urine method development for chemical entity and metabolites; and stability-degradation products. •Managed and performed hands on formulation development for dry powder inhaler, oral and parental delivery projects through phase 1 clinical studies
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Manager Of Quality Control, Quality Assurance And Analytical Development; Associate ScientistNepera 1984 - 1994Managed all analytical services and functions for organic chemicals, API’s & medical device business. Responsible for analytical group (up to 13 people) performing 40,000 analyses per year on about 10,000 samples per year. Cost effective budget management of over $ 1 million/year salary & operating expense.•Restructured quality assurance, was responsible for the company's GMP compliance program, quality assurance, customer audits and troubleshooting, and FDA, ISO inspections. •Championed and managed an 8% yield improvement on a multimillion kg/yr batch vitamin process. Resulted in a cost savings of 1 million dollars/yr. Demonstrated bench scale continuous process equivalent and obtained kinetics for bimolecular consecutive hydrolyses reaction.•Led a successful 6 month pilot of Continuous De-Ionization technology (similar to electrodialysis) with estimated cost impact $1 to 2 million dollars/year.
Rod Woods Skills
Rod Woods Education Details
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Seton Hall UniversityChemistry Analytical
Frequently Asked Questions about Rod Woods
What company does Rod Woods work for?
Rod Woods works for Self-Employed Consulting Or Contract Only
What is Rod Woods's role at the current company?
Rod Woods's current role is Pharm. Dev and Quality Consultant REMOTE ONLY.
What is Rod Woods's email address?
Rod Woods's email address is rw****@****ail.com
What is Rod Woods's direct phone number?
Rod Woods's direct phone number is +191485*****
What schools did Rod Woods attend?
Rod Woods attended Seton Hall University.
What skills is Rod Woods known for?
Rod Woods has skills like Analytical R&d, Quality Management, Business Development, Analytical Method Validation, Process Analytical Technology, Quality Control, Strategic Thinking, Spectroscopy, Gas Chromatography, Hplc, Team Building, Team Leadership.
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