Mary A. Tawfilis

** *** ******

EAST BRUNSWICK, NJ 08

732-***-****

ad4rjy@r.postjobfree.com

SUMMARY

Senior Scientist/ Research Scientist with extensive experience across R&D including formulation, scale up and validation, technical support and troubleshooting manufacturing problems. Developed various types of solid dosage forms, including IR, CR (modified, sustained) tablets, capsules and pellets. Experienced with film, enteric and sugar coating processes. Generated numerous products and process development documents. Analyzed scientific data, evaluated manufacturing processes to ensure robustness and high quality of the products. Contributed toward development of many successful brands and generic drugs.

TECHNICAL SKILLS / EXPERTISE

Machines: Operation and trouble-shooting of

High Sheer Mixer Collette, Niro-Fielder, TK Fielder 200L

Dryer Glatt Fluid Bed Drier, Gruenburg Oven

Compactor Alexanderwerk Roller Compactor 120, Fitzpatrick IR 220 Chilsonator

Compression Manesty, Fette, Kilian, Stokes, Korsch XL100, Piccola, Minipress, Carver

Coater GCX-1000, LDCS, Compulab 24/36

Encapsulation Bosch 2500

Milling / mixing Fitz Mill, Comil, V-Blenders, Double Cone Mixer

Pellets Nica: Extruder E140, Spheroniser S450

X-Ray Machine Faxitron

Texture Analyzer TA XT Plus

Moisture Analyzer Computrac MAX-2000, Metrohm 832 Karl Fisher Thermoprep

Particle Size Analysis ATM Sonic Sifter

Powder Rheometer FT-4

Computer Windows Microsoft Office including Word, Excel, Power Point & Outlook,

Software Application Minitab, JMP 10, Discoverant and Sample Manager Systems

PROFESSIONAL EXPERIENCE

Organon/Merck (Net2Source) 9/2023 – Present

Process Engineer – III (Senior), External Manufacturing, Non Sterile Drug Product

Acting as a technical interface with the external partners in the area of process support to resolve production issues. Providing guidance on process optimization, technology transfers, investigations, process improvement and change control.

F. Hoffmann La Roche Ltd 5/2021 – 5/2023

Roche Molecular System, Branchburg, NJ

Senior Technical Writer, Design Transfer & Technical Support Department (DTTS)

Participate in process validation activities to support new products lunches and any changes of existing validated processes for regulated on-market products.

Prepare/review validation plans, protocols and final reports for bulk reagents and production intermediates such as Oligonucleotides (synthesis & purification), Control Stocks and Enzymes.

Analyze data and develop validation strategies in harmony with industry guidelines and SOPs.

Manage multiple completing timelines and priorities, and work in a cross-functional team.

Utilize the following systems: Smart sheet, Share1, Trackwise, Diadoc, SAP and Google drive.

Lupin Inc. Somerset, NJ 10/2019 – 6/2020

Senior Technical Writer, Technical Transfer Department

Generated protocols and final reports for hold time study batches.

Supported the technical operations by analyzing data and providing conclusions as part of technical reports/documents.

BRISTOL-MYERS SQUIBB (Aerotek/HireGenics), New Brunswick, NJ 9/2012 – 2/2018

Consultant, Manufacturing Science & Technology - Drug Product - Technical Operation

Collaborated with peers, managers, R&D teams and manufacturing sites in the technical transfer activities of oral solid dosage forms to manufacturing sites (at BMS or external manufacturing). Optimized and troubleshooted manufacturing processes during development to launch for robust execution of the products manufacturing.

Supported technology transfer related activities from development to launch for drug products (DPs) at BMS manufacturing sites (or external manufacturing) according to BMS directives, ICH, FDA and regulatory guidelines.

Performed physical testing on solid dosage forms.

Collected, analyzed and presented scientific data that derived from experimental, LTSS, TT, PJ, PV and commercial batches using Minitab statistical software application.

Monitored the manufacturing processes of DP at BMS and contract sites.

Contributed in discussions of ideas, applications and suggestions, to reach the manufacturing technology (MT) goals.

Generated performance qualification (PQ) of equipment, MBRs, protocols, final reports, for placebo, experimental and TT/stability batches.

Participated in the investigations of hard gelatin stability problems.

TEVA PHARMACEUTICALS (TECH USA), Pomona, NY 5/2011 – 8/2012

Technical Writer, R&D Process Engineering

•Generated process development reports of Pre-validation official batches.

•Reviewed sequence of the process development from scientific records.

•Compiled the data and circulated the reports for approval, to support the regulatory filings.

PFIZER (formerly WYETH), Pearl River, NY 3/2006 – 7/2010

Research Scientist II, Pharmaceutical Science, R&D of Solid Formulation

Developed stable dosage forms of CR formulations of new molecular entities. Designed and performed the experiments. Evaluated the scientific data. Generated manufacturing procedure for clinical batches, technical reports, regulatory submission and patent documents. Supported the technical transfer team.

•Participated in the development of bio adhesive film, bi-layer tablets and tablet in tablet development techniques. Analyzed the new scientific data.

•Designed and performed experiments for developing new controlled release tablets, documented in a new patent “Direct Compression Unification Titration Technology (DC-UTT) for a Idiosyncratic Consistent Conjugated Equine Estrogen Tablet Formulation” (Docket No: AM103538).

•Designed and performed experiments for developing new modified release tablets and pellets formulations of new product.

•Supported a new manufacturing process for validation batches of coating the high and low doses of Premarin New Process.

•Implemented pilot batches of coating process with my team members using Glatt GCX-1000 and Compulab 36, evaluated the findings, generated the report, and input the information into the company’s documental system.

•Drafted and revised “Investigational Clinical Production Direction (ICPD) documents for clinical manufacturing procedure in compliance with the company’s established SOPs.

•Established and drafted drug product specifications in compliance with the pharmacopeias requirements of current USP/NF, PH.Eur. and JP, for the final products, comparators, excipients and intermediates in order to support clinical studies or regulatory filings.

•Collaborated with scientists, analytical team members, quality and compliance, regulatory group, and other service groups to get the work done on time.

PHARMACEUTICAL FORMULATION INC., Edison, NJ 4/1997 – 8/2005

Formulated / reformulated generic composition of numerous OTC and RX tablets/capsules. Designed and performed the experiments. Managed scale up, technical transfers and process optimization activities. Generated the MBRs and SOP documents. Conducted trouble shooting the manufacturing problems. Evaluated new sources of API and excipients. Investigated and drafted the reports for the unsuccessful production batches.

Senior Scientist, R & D ( 2003-2005)

•Developed generic formulation of the following brands: Bayer Children’s Aspirin Chewable 81 mg (cherry flavor), Tylenol Sinus severe congestion, Motrin IB tablets and caplets, and Benadryl Allergy/Sinus Headache caplets.

•Reformulated Ibuprofen Rx products of 800 mg, 600 mg, and 400 mg within SUPAC levels.

•Led the operations of three validation batches and one stability batch.

•Drafted master batch records, SOP documents and trained scientists and operators.

•Participated in troubleshooting of manufacturing problems.

•Investigated failed production batches to define the root cause and improved the processes.

•Evaluated new sources of API, including: cimetidine, naproxen sodium, and ibuprofen.

•Reviewed and signed validation and product annual reports.

Scientist, R & D (1998-2003)

•Developed the generic formulations of the following brands: Rennie Tablets (antacid/England), Women’s Tylenol Caplets, Benadryl Ultra Tablets, Caffedrine Caplets, Clor-Trimeton Allergy Tablets, Coricidin HBP/Cough & Cold Tablets, and Citrucel Caplets.

•Reformulated the generic forms of the following brands: Tylenol Children’s Cold Tablets, Midol Max Strength PMS Caplets, Excedrin PM Tablets, Sudafed Sinus Headache Tablets, Coricidin HBP/Max Strength Flu Tablets, and Doan’s PM Caplets.

•Generated master batch records and technical documents.

•Led the operation of stability and validation batches in compliance with cGMP.

•Qualified alternate source of excipients and active ingredients for cost reduction.

•Collaborated with QC/QA, regulatory affairs, purchasing, production managers, engineers, marketing, and outside vendors to resolve problems and coordinate activities.

Technical Service Formulator, R & D (1997-1998)

•Formulated/reformulated generic formulations and processes for the following brands: Fibercon, Unisom PM (Pfizer)/Tylenol PM caplets, Arthritis Pain Formula caplets (Medtech), Extra Strength Tylenol Gel tabs, Tylenol Sinus Gel tabs, Tylenol Allergy Sinus Gel tabs, Tylenol PM Gel tabs, Tylenol Severe Allergy caplets, Tylenol Severe Congestion Caplets, Benadryl Allergy Sinus Headache Caplets, and Sudafed Sinus Non Drowsy caplets.

•Generated the master batch record in compliance with the company’s established SOPs.

•Technical transferred the new products to commercial batch size.

•Managed the operations of three validation batches for the new products.

•Qualified alternate sources of excipients.

EDUCATION

BS, Pharmacy, Cairo University, Egypt

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