John R. Biddescomb

*** ****** ****** *********, ** 07071

Home Phone: 201-***-**** Cell Phone: 201-***-****

ad20ju@r.postjobfree.com

SUMMARY OF QUALIFICATIONS

Scientist/Laboratory/ Formulation/ Development Technician in the OTC Medical Device and Vitamin/Nutritional Supplement products industry who has advanced product prototypes from proof of principle to full development and scale-up to product launch using Operational Excellence (OE) tools. Extensive experience in solid dosage forms and tableting (denture cleanser tablets/nutritional supplements). Aligns work to meet project goals by taking on a project leadership role along with team management and communicating any changes or challenges that could affect advancement of projects to market launch. Develops and builds relationships with colleagues and collaborate within project teams and trains and provide guidance to colleagues on expert systems. Working knowledge of 510K filings and Medical Device regulations. Highly skilled in Product Stability testing/management: Control, monitor, track, recording and updating of all stability data, setting up studies for new products. Performed laboratory testing on raw materials, intermediate and finished products and prepared specifications for finished products. Proficient in the use of document management systems and repositories and Laboratory Notebook. Initiated and tracked, and monitored electronic review and approval/signatories of various documents through systems such as Product Research, AS400 and Documentum for Deviations, Non-Conformances, Raw Material, Finished/Bulk Product Specifications, Formulation Sheets, Batch Manufacturing Records.

PROFESSIONAL EXPERIENCE

NATUREX, INC. SOUTH HACKENSACK, NJ 2021 – Present

Laboratory Technician – Research & Development

Preparation of Specifications for Finished Products and Raw Materials

Change Control – Prepare/Monitor Change Controls from Initiation to Closure, updating of specifications in electronic database

Perform investigations of laboratory data and perform laboratory testing to determine feasibility of proposed changes

NATURE”S BOUNTY COMPANY, LEONIA, NJ 2016 – 2020

Scientist – Technical Services

Evaluation and Resolution of Vitamin/Nutritional Supplement Formulations (tablets and capsules) to improve product quality through formula review, process changes, blending changes.

Preparation of amendment documentation for said changes.

Performance of trial batches, and if successful, on to full scale batches.

Initiation of online deviations and non-conformance requests

JOHN R. BIDDESCOMB PAGE 2

Preparation and monitoring of Change Controls from Initiation to Closure, updating of online formulation repository (Product Research)

Trending of Non Conformances and performance of Root Cause Analysis for formulas with a history of similar manufacturing issues

GLAXOSMITHKLINE, Parsippany, NJ 2014 – 2015

Production Operator – GMP Operations/New Product Development

Assisted in scale up activities (Pilot batches) and process optimization for products (solids, semi-solids) to move forward to clinical/human use testing and market launch stability.

Operated various pieces of manufacturing equipment including tablet presses (Piccola, Compacta, Stokes, Courtoy). Granulation equipment (GMX, V-Blender, Glatt Fluid Bed).

Operated milling equipment (Fitzmill, Quadro mill). Mixers (Ribbon Blender, V-Blender, Hobart Mixers, Tumble Blender).

GLAXOSMITHKLINE, Parsippany, 2012 – 2014

Consultant – GMP Operations/New Product Development

Assisted in scale up activities (Pilot batches) and process optimization for products to proceed to clinical/human use testing and market launch stability.

Coordinated activities for the reduction of outstanding samples (pending testing, validation and approval) in LIMS

Completed training on LabWare (LIMS Administration 1 V2).

Assisted in sensory evaluations of various products, for attributes including taste, texture, fragrance, visual perceptions.

Assisted in preparation of R&D documentation (Specifications, formulation sheets, stability studies, manufacturing instructions, toxicology assessment reports).

GLAXOSMITHKLINE, Parsippany, NJ 2001 – 2011

Formulation/Development Technician, New Product Development

Manufactured lab scale prototype solid and semisolid formulations (evaluation of various polymers) in the early proof of concept/principle phase of projects (Denture/Oral Care – Denture Cleanser Tablets, Mouthwash, Denture Adhesives). Tested in-vitro formulations to ensure product performance (shear, hang time for adhesive and cleaning evaluation for cleansers). Prepared R&D and commercial documentation (specifications, stability studies, batch manufacturing records, Tox submissions) from laboratory to full scale.

Coordinated and performed scale up activities (Pilot batches) and process optimization for formulations to proceed to clinical/human use testing and market launch stability.

Set up new product specifications and tests on LIMS for the Dental Group.

Tracking, monitoring, coordination of Stability studies. Performing stability testing on various products. Test results documented and entered into the LIMS system.

JOHN R. BIDDESCOMB PAGE 3

Introduced product innovations and reduced costs as representative of R&D on multi-function project teams.

Identified and partnered with raw material suppliers to evaluate innovative and cost effective new technologies.

Selected to train new hires and colleagues on the use of in-vitro testing equipment and document management systems.

R&D Lead for project management in new product development and packaging innovations.

Recognized with Team Spirit Awards for on time completion of project tasks.

Member of GlaxoSmithKline First Aid Team

BLOCK DRUG COMPANY (acquired by GlaxoSmithKline in December, 2000) 1982 – 2000

Scientist C (Junior Scientist) (1993 – 2000)

Formulated solid, semisolid, powders, liquids, creams and evaluated polymers for various oral care products.

Coordinated and monitored/performed stability study programs.

Conducted in-vitro testing of formulations to ensure product performance (shear, hang time for denture adhesive and cleaning evaluation for denture cleansers).

Prepared documentation (specifications, stability study requests, batch manufacturing records, product/process deviations/modifications) from laboratory to full scale.

Laboratory Technician, Dental Research (1987 – 1993) formulated solid, semisolid, powders, liquids, creams, and polymers.

Manufactured lab scale and pilot scale prototype denture care formulations

Laboratory Technician, Consumer Research (1982 – 1987)

Performed market research studies and compiled results on experimental products in order to gauge consumer acceptance.

Conducted sensory evaluations of various products and package types (toothpastes, denture cleansers, denture adhesives, household products) evaluating product characteristics such as taste, fragrance, texture, visual perception.

TECHNICAL SKILLS

Equipment: Tableting experience with various types of Tablet Presses {Stokes, Manesty, Piccolo, Carver Press, Beta}, Fluid Bed Granulator, Powder Blenders { V-Blender

and Ribbon Blender, Brabender Extruder} and Mixers { Tumble Mixer, Hobart, Speedmixer,} Milling equipment {Tri-homo, Fitz, Roto}

JOHN R. BIDDESCOMB PAGE 4

Methods: Formulation development, batch manufacture, stability testing, in-vitro and in-vivo testing, sensory and consumer testing of prototype formulations.

Systems: LIMS, Documentum, Trackwise (Change Control)

REFERENCES

1.Stephanie Calafat - Manager R&D Technical Services at Naturex/Givaudan (my immediate supervisor). Mobile: 917-***-****

2.Mukeshkumar Ray – Principal Scientist at Nature’s Bounty (my immediate supervisor). Tel: 201-***-**** Mobile: 908-***-****

3.Kimberly Biedermann – Former VP Technical Services at Nature’s Bounty. I also worked with her at GlaxoSmithKline for many years. Tel: 973-***-****

4.Carmen Mercado – Former Documentation Group Manager at Nature’s Bounty, Mobile: 954-***-****

5.David Estrada – Former Manufacturing Supervisor at Nature’s Bounty. I also worked with him at GlaxoSmithKline for many years. Mobile: 201-***-****

6.Thomas Abraham – Former co-worker at GlaxoSmithKline. Tel: 732-***-****

EDUCATION AND PROFESSIONAL DEVELOPMENT

MONTCLAIR STATE COLLEGE

95 credits toward B.S. in Chemistry

Toastmasters (Improvement of Public Speaking Skills) 2008-2014

American Chemical Society 2006-Present

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