NAVAL BAJWA, Ph.D.

**** ****** *****, ******* *****, IL 60089

765-***-****

acz2vp@r.postjobfree.com

HIGHLIGHTS

Excellent track records of success as an individual contributor and as a Project Manager

Strong leadership, interpersonal and managerial skills, and ability to work with people at different levels

Experience with submission of NDA files and variations / label updates for on-market IV products

Extensive hands on experience with FDA regulations (21 CFR, cGMP, GLP, GDP), ICH guidelines, USP and EP compliance, DMF content, therapeutic product dossiers, software cybersecurity processes and risk documents

Proficient in authoring, reviewing / approving, handling of controlled cGMP documents; experienced in manufacturing and quality document compilation i.e. QTPPs, BPRs, validation documents, APRs, change control management, CAPA, NCR, HACCP etc

Experience with CCDS / CCSI, SmPC, USPI, PIL, CTD and CMC section of Regulatory files

Led activities of chemists and engineers team on the technical transfer and start up support of API manufacturing operations

Supported parenteral nutrition product portfolio and Base IV solutions portfolio within Baxter as SME/PDO

CERTIFICATES

Regulatory Affairs Certificate Program (RAPS): Pharmaceuticals. April, 2017 – Present

oCourses completed:

Role of the Regulatory Professional

Pharmaceuticals: Definition and Lifecycle

Global Regulatory Strategy for Pharmaceuticals

Ethics

FDA Law and Regulations

Chemistry, Manufacturing and Controls

Project Management for Regulatory Professionals

EXPERIENCE

Product Design Owner / Research Scientist I: Baxter International, Round Lake, IL. March, 2015 – March 2017. Responsible for providing technical support (PDO/SME) to a family of therapeutic products (IV) produced and distributed globally; led global projects impacting Parenteral Nutrition and Base IV solutions portfolio

oExtensive hands on experience with FDA regulations (21 CFR, cGMP, GLP, GDP), ICH guidelines, USP and EP compliance, DMF content, therapeutic product dossiers, software cybersecurity processes and risk documents.

oProficient in authoring, reviewing / approving, handling of controlled cGMP documents; experienced in manufacturing and quality document compilation i.e. QTPPs, BPRs, validation documents, APRs, change control management, CAPA, NCR, CMC sections of Regulatory files e.g. manufacturing process and controls, specifications, analytical method validation, stability data and container closure system sections for Drug Product.

oExperience with submission of NDA files and variations / label updates for on-market IV products.

oExperience with CCDS / CCSI, SmPC, USPI, PIL, CTD and CMC section (Module 3) of Regulatory files

oFamiliar with regulatory submission process (NDA, ANDA, variations, labeling updates, IND). Experience with electronic file submission database e.g. BaxEdge.

oSupported parenteral nutrition product portfolio and Base IV solutions portfolio within Baxter as SME/PDO; experienced with sterile injectable products (terminal sterilization; aseptic filling); familiar with container closure systems (semipermeable flexible containes, glass bottles, two chamber and three chamber IV products).

oParticipated as SME/PDO in cross-functional project teams (PM, QA, Sterility assurance, RA, QC, Manufacturing, container engineering, stability operations, analytical, statistical, toxicology and R&D) focused towards tech transfer of manufacturing processes from one site to another as part of capacity expansion / geographic expansions and new product launches; authored QTPP, R&D stability studies; provided CMC sections for Regulatory submissions.

oLed several non-conformances (NCRs) and CAPAs; strong knowledge and experience of using Trackwise (TW8); experienced in using DMAIC methodology for CAPA investigations.

oStrong knowledge of change control process - managed change controls and supplier notification of changes as change owner (in TW8 system); performed PDO/SME assessments for process and product changes with global impact.

oExperience with product risk documents and Event Based Risk Reviews; worked with cross functional teams (Medical Affairs; QA; Risk Management) towards creation of risk documents (e.g. RACT, PRTT, etc.); conducted periodic risk reviews for IV products; participated in Field Alert Reports (FARs) compliation; provided input for Field Corrective Actions (FCAs); worked with complaint handling teams and QA for assessing and addressing recurrent complaints.

Project Manager: Evonik Corporation, Lafayette, IN. July 2011 – February 2015. Led activities of chemists and engineers team on the technical transfer and start up support of API manufacturing operations; Delivery commitment met “on time in full (OTIF)” for projects assigned.

oManaged multiple custom manufacturing projects within regulated cGMP environment; tracked project status, deliverables, scope and schedules throughout the project and maintained open communication with customers; facilitated problem solving and decision making.

oProficient in manufacturing document compilation i.e. BPRs, APRs, validation documents (process and cleaning), change control management, CAPA, NCR, HACCP, CMC sections of Regulatory files e.g. manufacturing process and controls, specifications, analytical method validation, stability data and container closure system sections for API /Drug Substance.

oInternational assignment to lead technical transfer activities of a product from Evonik, Wuming site (China) to Evonik, Tippecanoe site (U.S.).

oExperienced in evaluation of RFQs (Requests for Quotes) from external customers. Successfully evaluated several RFQs. Worked with cross-functional teams to ensure efficient and realistic evaluation of new proposals in a timely manner.

oExperience with FDA, Environmental (DEA, Title V air, TSCA, FIFRA etc.), Halal and Kosher audits.

oExtensive experience with GLP, cGMP, GDP and ISO.

Post Doctoral Research Fellow: Synthetic Organic / Medicinal Chemist, University of Michigan, School of Medicine, and Department of Pathology. September 2009 – June 2011. Studies towards synthesis of potent small molecule Mcl-1 (myeloid cell leukemia-1) inhibitors as new molecularly targeted therapies of cancer.

Post Doctoral Research Associate: Synthetic Organic Chemist, General Motors R & D, Warren, MI. September 2008 – August 2009 (employed through Optimal CAE Inc., MI). Synthesized novel porous Metal Organic Frameworks (MOFs) and micro porous polymers for hydrogen storage application in fuel cells.

EDUCATION

Ph.D., Synthetic Organic Chemistry, University of Alabama 2008.

Dissertation: Studies towards the total synthesis of the biologically active natural product aigialomycin D and development of two novel methodologies.

M.Sc (Hons. School) with distinction, Organic Chemistry, Panjab University, Chandigarh, (India) 2004.

Dissertation: Studies towards asymmetric synthesis of -8-oxo protoberberine alkaloids.

B.Sc (Hons. School), Chemistry, Panjab University, Chandigarh, (India) 2002.

SKILLS AND RELATED WORK EXPERIENCE

Trained in Lean and Six Sigma; data analysis, DMAIC tools, Minitab and JMP software.

Proficient in using Project Management tools e.g. Microsoft Project, GANTT charts etc.; experienced Sharepoint user.

Experienced team player; extensive experience of working in global environment and leading global projects; proficient in using telecommunting tools e.g. Instant Messaging, webex, emails etc.

Excellent leader and communicator.

Taught undergraduate lab sections for 4 years.

Extensive experience in mentoring undergraduate, graduate and industrial researchers.

PRESENTATIONS AND PUBLICATIONS

Nikolovska-Coleska, Z.; Bajwa, N.; Liao, C.; Lei, M. “Small molecule inhibitors of Mcl-1 and uses thereof.” Patent No. WO2013149124.

Bajwa, N.; Liao, C.; Lei, M.; Nikolovska-Coleska, Z. “Small molecule Mcl-1 inhibitors” two manuscripts in preparation.

Bajwa, N.; Liao, C.; Nikolovska-Coleska, Z. “Inhibitors of the anti-apoptotic Bcl-2 proteins: a patent review.” Expert Opinion on therapeutic patents 2012, 22(1), 37.

Bajwa, N.; Jennings, M. P. “Chapter 6 - A Chemo- and Diastereoselective Ring Closing Metathesis Macrocyclization Approach to the Total Syntheses of Aigialomycin C and D.” Strategies and Tactics in Organic Synthesis, Vol. 8, Burlington: Academic Press, 2012, pp 153-169.

Bajwa, N.; Jennings, M. P. “Efforts towards total synthesis of the biological active natural product aigialomycin D.” Presentation paper ORGN 502, 235th ACS National Meeting and Exposition, New Orleans, LA, April 6-10, 2008.

Bajwa, N.; Jennings, M. P. “An Efficient 1,2-Chelation Controlled Reduction of Protected Hydroxy Ketones via Red-Al” J. Org. Chem. 2008, 73, 3638.

Bajwa, N.; Jennings, M. P. “Syntheses of epi-Aigialomycin D and deoxy-Aigialomycin C via a diastereoselective ring closing metathesis macrocyclization protocol.” Tetrahedron Lett. 2008, 49, 390.

Bajwa, N.; Jennings, M. P. “Efficient and Selective Reduction Protocols of 2,2-Dimethyl-1,3-benzodioxan-4-one Functional Group to Readily Provide both Substituted Salicylaldehydes and 2-Hydroxy Benzyl Alcohols.” J. Org. Chem. 2006, 71, 3646.

Bajwa, N.; Jennings, M. P. “Efficient and Selective Reduction Protocols of 2,2-Dimethyl-1,3-benzodioxan-4-one Functional Group to Readily Provide both Substituted Salicylaldehydes and 2-Hydroxy Benzyl Alcohols.” Poster, Division of Organic Chemistry, ACS 231st National Meeting and Exposition, Atlanta, Georgia, March 28th, 2006.

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