PETER S. JUNKER

**** ****** ****** 260-***-**** (cell)

Middleburg Heights, 440-***-**** (alt.)

Ohio 44130 acwou8@r.postjobfree.com

OBJECTIVE

A senior level analytical chemist position with a growth oriented company requiring a professional with excellent problem solving, management, and supervisory skills to make a proactive contribution to the company’s product research, development, and profitability.

PROFILE

Personable professional with multiple college degrees. A leader or a team player as projects require. Self motivated and capable of completing tasks with little or no supervision. Flexible and project driven. Has applied expertise in pharmaceutical, environmental, analytical, and academic environments.

SKILLS SUMMARY

● Client Communications ●Teaching & Training ● Tech. Supervision ● Protocol Generation

● Technical Presentations ● R&D Planning ● Project Budgeting ● Report Generation

● Management ● Decision-Making ● Problem-Solving ● Document Review

● QA Auditing ● Safety Auditing ● SOP Generation ● HAZMAT Auditing

● HASP Auditing ● Computer Savvy ● MS Office Proficient ● QC Testing

● IQ/OQ/PQ ● QbR/QbD ● PK/PD Profiling ● Validations

PROFESSIONAL EXPERIENCE

Analytical Chemistry

Over 20 years experience in commercial and academic environments. Particularly experienced in the field of pharmaceutical formulation, testing, and manufacturing.

Extensive knowledge in the application of chromatographic (HPLC, UPLC, GC, TLC), spectroscopic (UV/VIS, IR, FTIR, AAS, AES), electrochemical (CV, NPV, DPV, ASV, SWV), and mass spectroscopic analytical techniques (LC/MS and LC/MS/MS).

Experienced in the use of manual analytical techniques (density, MP, BP, viscometry, stress, TOC, glove-box/vacuum chamber manipulations, sterile manipulations, and general wet chemistry testing).

Expert in the development of many types of test methods (assay, identification, dissolution, drug release profiling, stability testing, impurity testing, in-process testing, parenteral syringeability, drug delivery testing, raw material characterization, finished product testing, cleaning validation, forced degradation testing)

Considerable hands-on technical and practical experience in the repair, maintenance, and upgrade of analytical instrumentation, instrument computer networking, and general computer operations.

Familiar with the analysis and monitoring of environmental substances as per EPA and FDA regulations.

Conversant with procedures for the analysis and evaluation of data using statistical calculations, and with data analysis using computerized model-experiment comparisons.

Management

Excellent communication and interpersonal skills with the ability to lead, train, evaluate, and motivate.

Experienced working within the demands of a 24 hour/day, 7 day/week operation. Considerable experience in dealing with the special problems encountered working unconventional hours.

Able to interact, communicate, and train partners/clients for the purpose of technology transfers between companies.

Has supervised, taught, and trained groups as large as 75, for academic, regulatory, and business purposes.

Documentation

Proficient in the development and generation of scientific and regulatory documentation (SOPs, experimental designs, test methods, validation protocols, qualification protocols, process development protocols, manufacturing batch records, research reports, maintenance protocols, cleaning validation protocols, regulatory submissions, safety procedures, specifications).

Well versed in document control procedures and in chain-of custody requirements when working in a regulated environment.

Well versed in health and safety documentation requirements.

Compliance

Thoroughly familiar with the validation of pharmaceutical test methods for QC/QA use within USP, ICH, and FDA guidelines.

Possesses a working knowledge of the auditing/compliance requirements for FDA, GMP, GLP, OSHA, HAZMAT, and EPA regulations for commercial facilities.

Able to evaluate safety and processing requirements in manufacturing environment.

Able to conduct procedure deviation investigations.

Manufacturing

Experienced in pharmaceutical formulation development, aseptic processing, drug manufacturing process development, sterile processing, process scale-up, and pilot plant design.

Worked with many types of pharmaceutical formulations including liquids, solids, suspensions, lotions, and pastes. Formulations administered as topicals, orals, and parenterals.

Performed Controlled Release (CR) pharmaceutical formulation development, manufacturing process development, scale-up, and pilot plant design. CR formulations based on microsphere technology and liposome technology.

Possesses practical knowledge and experience performing sterile manufacturing and working in sterile environments.

RECENT EMPLOYMENT HISTORY

SUN Pharmaceutical Labs, Inc. Bryan, OH 2009-2016

Generic drug product manufacturing company

Senior Analyst:: Formulations, Analytical Method Development and Validations, QC Testing, Compliance Troubleshooting.

Cleveland BioLabs, LLC Cleveland, OH 2006-2009

Biotech drug discovery company Buffalo, NY

Senior Research Scientist: Formulations and Analytical Method Development for novel

anti-cancer drugs and anti-radiation drugs. PK/PD profiling.

Oakwood Laboratories, LLC Oakwood Village, OH 2002-2006

Controlled release drug development company

Process Development Chemist: Controlled release parenteral formulations, lyophilization, pilot plant, scale-up and analytical development/validation.

EDUCATION

University at Buffalo, State University of New York Buffalo, NY

Master of Arts - Analytical Chemistry 1995

Bachelor of Science - Chemistry 1987

PREVIOUS AFFILIATIONS & CERTIFICATIONS

American Chemical Society 40 hour OSHA/HAZWOPER Asbestos Project Monitor Parenteral Drug Association First Aid/CPR ACS Div. Analytical Chem.

Pittsburgh Conference Respirator Qualification ACS Div. Chem. Ed.

COMPUTER QUALIFICATIONS

● Operating Systems: Windows 9x, Windows2000, Windows XP, Windows 7, Mac OS.

● Utility Software: Microsoft Office (Word, Excel, Power Point, Access, Project), Chemistry Search Software (STN), Lotus Notes, Internet Software.

● HPLC Software: TotalChrom, ChemStation, EzChrom Elite, Empower.

● Mass Spec. Software: MassLynx, Analyst, Xcalibur.

● UV/Vis. Software: WinLab

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