Development Product

Renu L. Kapoor

**** ******** **** *****, ** ***** 732-***-**** ***********@*****.***

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Citizenship Status: citizen

US

Experience Summary:

Pharmaceutical Scientist with over 10 years of pharmaceutical product development and

commercialization experience. Expertise in scale-up, process technology transfer and product

validation. Highly proficient in a wide variety of dosage forms including solids, ointments,

transdermals and oral suspensions. Proven leadership with cross-functional groups in

development, coordination and manufacture of preclinical and clinical supplies supporting

worldwide product registrations. Worked successfully with obal Regulatory Team to support

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execution of regulatory strategy reat ability to identify problems, gather and analyze

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information, draw conclusions, and recommend solutions. Self motivated and detail oriented,

can work independently as well as in a team environment. Skills in prioritization, problem

solving, organization, decision-making and time management. Highly proficient in written and

oral communications. Well versed in 21CFR and regulatory guidance. Expertise in cGMP and

.

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Professional Experience:

Merck Animal Health ummit, NJ, S Dec 2002 – Dec 2013

Scientist:

● Key member in development (IND to NDA) of an oral suspension and a transdermal drug product.

● Independently executed studies supporting formulation and process development. Conducted

technology transfer and full scale demonstration and validation lot manufactures for multiple

transdermal solution and oral suspension products. Worked efficiently with international

manufacturing sites.

● Participated in regulatory meetings and activities including dossier development, drug submissions,

and FDA correspondence.

● Reviewed and verified production Records including protocols, reports, processes and data.

● Performed inspections and audits of research laboratory and production sites to ensure safety and

GMP compliance of the facilities.

● Independently planned and executed strategies for formulation development and solved complex

problems.

● Independently developed manufacturing process and order of addition for transdermal solution to

ensure product homogeneity and stability.

● Completed US registrations and PAI preparation resulting in product approvals and launches.

● Served as a central point of contact after the Principal Formulation Scientist. Represented the

formulation development group and served as a subject matter expert (SME) with government

agencies, e.g. FDA during PAI or in responding to deficiencies to submitted NDA applications.

● Managed and updated databases and tracking systems to reflect the status of CMC submissions.

● Coordinated and Managed the regulatory aspects of drug life cycle review process from initial

submission through approval to post approval.

Facilitated meetings with cross functional groups and managed the regulatory review of

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Abbreviated new Drug Applications (ANDAs).

● Completed formulation development, scale up and technology transfer to third party manufacturer

for a dermal pour on product for bovine and an otic and oral suspension for canine.

● Used analytical and scientific approaches in resolving issues or problems.

● Served as a key Pharmaceutical Sciences Team member. Conducted problem solving activities

and efforts to ensure timely deliverables. Ensured obligations were met in compliance with FDA

and ICH guidelines.

● Maintained effective communication with cross functional groups to ensure that all the data and

documentation required for IND submission are current and valid.

● Proficient in both written and oral communications. Authored US and EU CMC sections,

pharmaceutical development reports, protocols (IQ/OQ), technical reports and standard operating

procedures (SOPs).

● Prepared reports for IND submissions.

● Prepared replies by conducting studies and research to correspond with FDA questions regarding

NDA submissions.

● Prepared reports of findings in support of product development and studies related to regulatory

actions.

● Prepared memoranda, briefings and other background material as requested by subordinates and

management.

● Reviewed, evaluated, and responded to inquiries involving Food, Drug and Cosmetic Act laws and

regulations.

● Presented projects to the division globally at meetings and at weekly group review meetings

● Achieved on time IND filing by educating team on various chapters of CMC section, serving as a

key member in negotiation of process parameters with regulatory officials and contributing to CMC

sections.

● Managed and controlled the lab DEA cabinet containing controlled substance. Trained staff on

drug handling and storage of controlled substances.

● Reviewed and authorized reports/documents such as product development reports, batch records,

data, master formulas and other key documents/reports.

● Organized and procured materials and equipment for execution of batches for clinical studies.

● Served as the SME for Out of Specification (OOS) incidents that were reported to the group.

● Communicated safety policies, plans and programs to the group.

Conducted investigations regarding discrepancies of drug product and collected evidence to

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support appropriate administrative and regulatory actions.

● Communicated the interpretation of regulations, policies and procedures to the group.

● Planned and coordinated the execution of investigations and inspections. Prepared reports and

other documentations to support investigative findings and recommendations. Reported findings to

upper management.

● Performed evaluation of inspection reports using regulations and policies to ensure consistency

with guidelines as applied to the Food, Drug, and Cosmetic Act.

● Conducted regulatory inspections and investigations to ensure manufacturing processes were in

compliance. Reviewed and evaluated inspection reports and provided guidance to the drug

manufacturing plant.

● Conducted regular investigation to ensure consistency with Good Manufacturing Practices and

efficacy of quality controls

● Reviewed, evaluated, and responded to a variety of inquiries involving Food, Drug and Cosmetic

Act laws and regulations.

● Provided updates on new technology related to product development, regulatory programs and

regulations. Interpreted FDA regulatory issues and communicated to the group regarding

compliance.

National Starch and Chemical Company Bridgewater, NJ, Jul 1999 Dec 2002

Staff Chemist:

● Carried out detailed and specific phases of assigned research and development tasks.

● Key liason to facilitate rapid response to customer product inquiries. tively participated in all phases

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of product development from formulation to scale up for commercial food packaging adhesives.

● Performed analyses of products using modern experimental design techniques and various

quantitative and qualitative methods/equipment.

● Utilized Design of Experiments (DOE) techniques to optimize experimental efficiency.

● Worked successfully with the Technical Service group in such matters.

Education:

Bachelors in Sciences in Biology Kean University, NJ

Honors and Publications:

● National Starch and Chemical Co. Performance Award 2002

● Reactivatable Adhesives US 200******** A1 2003

● Hot melt Adhesive and Use thereof US 200********-****

References vailable upon request.

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