Analytical Chemist

Mark R Whight

*** *** ** *** *****, NC ***** Phone: 919-***-**** Email: ****.*.******@*****.***

Senior Analytical Scientist/Project Leader

Accomplished, respected, Analytical Scientist with an extensive knowledge in developing products through

IND/NDA. Well-established background in analytical HPLC/GC method development, method validation,

instrumentation, stability, GMP’s, GLP’s, and regulatory filings, pertaining to drug substance/intermediates and

formulated products. Very effective communication and teamwork skills, excellent problem solver with a high

attention to detail.

Skills

HPLC/GC Method development and full ICH validation.

Stability studies and protocols, methods, developing specifications for release and end of life.

Solid knowledge base of a wide range of analytical equipment and techniques.

Transfer of processes to manufacturing sites, pre-approval inspections, and regulatory filings.

Professional Experience

Self Employed (2010 to 2014)

● Car restoration business specializing in Volkswagen buses and pre-1970 Chevrolets.

● Restoration of old houses using primarily recycled and reclaimed building materials.

GlaxoSmithKline – Ware UK and RTP, NC, USA (1982 to 2009)

Principal Scientist (2001 to 2009)

Primary responsibility: Analytical Project Leader for development of a small volume parenteral (SVP) product.

● Developed and validated complex HPLC methods along with hydrodynamic chromatography and size exclusion methods.

Coordinated technology transfer and performed analyst training at international manufacturing site.

● Developed and validated a procedure and GC assay to determine the amounts of the plasticizer, DEHP, extracted from

administration sets used in the clinic.

● Developed and validated a technique to determine the impact of oxygen in the headspace resulting in a change in the

manufacturing process that extended product shelf life.

● Authored technical reports, regulatory submissions (IND), stability protocols, methods, and defined specifications.

Collaboration with other Departments:

● Conceptualized and developed a headspace GC method for determining the leak rate of 134a from metered dose inhalers

that provided significant time and cost savings over the USP methodology. Adopted as an in-process control by the

manufacturing site.

● Provided analytical support for the development of a combination product that included a controlled substance. Worked

closely with formulators to develop multiple tablet formulations that successfully extended Cmax of the drug in patients

during clinical studies.

● Maintained, developed applications, and provided Departmental training on Agilent 6890 Gas Chromatograph and ANTEK

Chemiluminescence Nitrogen Detector.

Research Scientist (1996 to 2001)

Primary responsibility: Analytical Project Leader on the development a Class IV API (Avodart®).

● Provided analytical method development, validation and stability testing on five intermediates and final drug substance.

● Performed technology transfer and performed analyst training at international manufacturing site.

● Performed analytical method development, validation, and support for toxicology dosing solutions

● Supervised and mentored the work of two associate scientists.

● Authored technical reports, regulatory submissions (IND/NDA), stability protocols, methods, and defined specifications.

-Continued-

Mark R Whight

107 1st St Haw River, NC 27578 919-***-**** ****.*.******@*****.***

Collaboration with other Departments:

● Provided product development and analytical support for the soft-gelatin capsule formulation in CAPMUL ® – including

development of a 2-stage enzyme dissolution method and a HPLC gradient impurities method that resolved all impurities

from the complex excipient matrix.

● Developed an in-vitro API dissolution assay for a 5-alpha reductase inhibitor that predicted the in-vivo performance of drug

substance batches in toxicological studies. Utilized as an in-process control for API particle size.

● Applied capillary electrophoresis to the analysis of GSK compounds and comparator products to provide a more efficient

alternative to established HPLC methods of analysis.

Scientist (1993 to 1996) Associate Scientist (1990 to 1993)

Primary responsibility: Analytical Team Member for Zofran® Injection and Imitrex® Tablets.

● Developed HPLC methods, coordinated and performed stability testing on various product formulations and was a key

member of project teams that worked on NDAs for Zofran ® Injection and Imitrex® Tablets.

● Provided analytical method development and validation of toxicology formulations for an early development compound in

support of clinical programs that resulted in successful approvals.

● Developed and validated a flame atomic absorption spectroscopy method that determined amounts of silicon oil

administered to patients using Zofran® Injection and Ventolin® inhalers in response to FDA deficiency letters.

Collaboration with other Departments:

● Developed Departmental procedures for determining heavy metals using inductively coupled plasma emission

spectroscopy for new chemical entities.

● Co-developed and put into practice a department-wide, CFR-compliant, loose-leaf notebook system that increased

productivity in recording and reviewing experiments.

● Routine testing of inhaled products (June 1992 – January 1993 Secondment to GSK Ware, UK)

Associate Scientist (1982 to 1990 GSK Ware, UK)

Primary responsibility: Analytical support for a department of 60 Synthetic Research Chemists.

● HPLC, GC and CE method development, preparative HPLC, chiral separations of novel compounds .

Education & Training

Bachelor of Science with Honors in Applied Chemistry Hatfield University – Hertfordshire, UK. Graduated 1988 (Obtained

while working full time)

Trained in GMP/GLP, OOS/OOT procedures, Handling Class IV compounds and controlled substances, Change Control,

Dissolution, Stability and Document Databases, Word, EXCEL, Powerpoint, Agilent Chemstation, LEAP Headspace

analyzer software, Drylab, Statistica, Documentum.

Awards

CEO Award for significant contribution to Imitrex® Tablet NDA

CEO Award for significant contribution to Dutasteride BPH IND

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