CMC Development
Resume:
MARYELLEN LAVIN, Ph.D.
Paramus NJ 07652
www.linkedin.com/in/maryellenlavin2013
908-***-**** ac2bza@r.postjobfree.com
Pharmaceutical Scientist
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PROFESSIONAL EXPERIENCE
Elite Pharmaceuticals Inc, Northvale NJ 2016-2017
Director Product Development
Direct product development programs. Authored protocols, summary reports, batch records, and product development reports to support Quality by Design ANDA filings.
Consultant CMC Development 2014-2015
Authored IND for a radiolabeled phase 1 study.
Exploring the development of a FDC formulation; authoring IND for the Phase1/2 study
Identifying appropriate technology for the development and commercialization of an IM (1ug/m3 OEL) and IV product.
Investigating Lifecycle Management Qd opportunity for existing BID drug product.
MERCK, Summit, NJ 2009 – 11/2013
Principal Scientist, Product Value Enhancement (PVE) Strategist, Drug Product Development
Contributed to the design of the life cycle management (LCM) process. Motivated generation of LCM ideas of value to the therapeutic areas. Facilitated cross-functional brainstorming sessions to generate innovative product opportunities for proof of concept evaluation.
Worked with Regulatory, Clinical, and Drug Product experts to evaluate the probability of success of ideas generated.
Connected and engaged key LCM stakeholders: early discovery; diversified brands and emerging markets.
Member of the Open Innovation Working Group comprised of members from Merck Consumer Care; Merck Animal Health; and MRL. Initiated Merck Research Laboratories (MRL) first reach into external pharmaceutical brainstorming.
SCHERING PLOUGH, Summit NJ 2002-2009
Principal Scientist, Drug Product Development
Designed a commercial process for manufacture of Posaconazole Oral Suspension.
Appointed CMC Team Chair for Posaconazole Oral Suspension-Managed drug substance and drug product manufacture and supply; clinical study supply; and all regulatory filings.
Development lead for the 1000L CoBall Mill Prior Approval Supplement (PAS) process.
Composed the FDA briefing book.
Established the design space, critical process parameters, critical quality attributes, and critical in process controls.
Managed preapproval inspection (PAI) readiness team.
Authored the PAS. FDA Approval granted 2008
Principal Scientist, Drug Product Development
Managed external life cycle project opportunities.
Directed efforts between Schering Plough and Sheba University (Dr Zvi Ram and Dr Yael Mardor) aimed at developing a formulation for delivery of temozolomide via Convection Enhanced Delivery to brain tumors:
MARYELLEN LAVIN, Ph.D.
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908-***-**** ac2bza@r.postjobfree.com
Collaborated with Dr. William Frey and Dr. Leah Hanson (Alzheimer’s Research Center) to test the hypothesis of nose to brain delivery of temozolomide. Contributed to the design of the animal study protocols.
Collaborated with Alk Abello and Catalent to develop an Orally Dispersible Tablet using their Zydis® technology: Directed the process development batches at Swindon, United Kingdom to the support the BLA filing.
FMC CORPORATION, Princeton, NJ 1994 – 2002
Research Associate Formulations and Process Development
Designed commercially viable products for the Agricultural business and responsible for technical support.
Developed two extruded formulations. Managed these projects from the initial formulation development, through scale up and process development and ultimate commercial production.
Technical support to Formulation Manufacturing Plants: trouble shot production problems; qualified alternate sources of raw materials.
Technical worldwide support of carfentrazone-ethyl product line: Worked with business team to develop a carfentrazone global sourcing strategy & teamed with Asia to extend product line opportunities and advise on manufacturing strategies.
EDUCATION
Ph.D. Yale University (New Haven, CT), Organometallic Chemistry.
B.S Saint Peter's College (Jersey City, NJ), Chemistry
CONTINUING DEVELOPMENT
Clinical Development and Regulatory Affairs Certificate: Courses: Foundations in Clinical Development; Clinical Coordination and Monitoring; Regulatory Affairs, Regulations and Compliance.
MBA program, Rutgers University: 22 credits completed
Operational Excellence Training: Six Sigma Process Improvement Leader
Management Leadership Training; Merck Facilitation Training
Professional Memberships
New Jersey Pharmaceutical Association for Science and Technology (NJPhAST)
American Association of Pharmaceutical Scientists (AAPS)
Addendum of Publications and Patents as well as References are available upon request.
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