Steven Luedecke
Saint Louis
Summary
Demonstrated success in pharmaceutical products while efficiently and smoothly running professional chemistry laboratories. Sound judgment, critical thinking skills and work ethic. Knowledgeable about upholding data integrity standards and abiding to cGMP and ISO standards.
Overview
11
11
years of professional experience
1
1
Certification
Work History
Senior Chemist
Nomax Inc.
08.2022 - Current
- Provide testing and oversight support to QC laboratory via extensive quality testing background, such as HPLC, GC, ICP-OES, Perkin Elmer FTIR, Agilent UV-Vis instruments
- Documentation review and evaluation is ongoing and varies with demand.
- Additional support is given to current chemists and analysts regarding SOP testing, USP-NF, ASTM, and ISO testing; as well as instrument preventive maintenance and calibration.
- Daily collaboration with production environments both liquid and solid dosage formulations
- Managing QC responses and assistance related to in-process improvements as well as root cause analysis and solutions implementation in deviation situations.
- Responsible for QC analysis and customer, vendor, and regulatory agency responses for drug, nutraceutical, and medical device products.
- Active responsibilities with internal and external audits, ISO, cGMP, FDA, and ASTM standards
- Providing relevant response and documentation to management related to FDA and customer audit requests / inquiries.
- Additionally, responsibilities include testing of raw materials, stability materials, finished goods, reagent procurement, chemical inventory status, and hazardous waste documentation and intermittent disposal through external third part
- Improved product quality by developing and optimizing chemical formulations for various applications.
- Enhanced laboratory efficiency with streamlined processes and optimized equipment utilization.
- Mentored junior chemists, fostering a collaborative and supportive work environment.
- Led safety training initiatives, educating staff on best practices for handling hazardous chemicals.
Chemist III (Pharmaceutical R&D)
Sensient Colors
09.2015 - 08.2022
- Managed junior scientists within the R&D laboratory while providing technical, developmental, and sales support to regional sales account managers.
- Responsible for laboratory purchases, maintenance schedules, and external service arrangements with outside contractors.
- Advanced experience regarding method development across multiple analytical devices.
- Proficient with Agilent HPLC, Waters HPLC, H.P
- GC, Agilent GC(Headspace), UV/Vis, DMA 4500 Densitometer, Rotary Evaporator, Auto Titration, as well as various other laboratory equipment.
- Competent of FDA, EPA, DEA regulations and standard operating procedures outlined by USP, EP, JP, in pharmaceutical laboratory as well as when speaking with outside customers and agencies.
- Advanced Microsoft Office competency as well as direct customer support and communication.
- Supported GM and Technical Director regarding laboratory purchases, ROI projects, and laboratory equipment and supplies.
- Direct support to production and planning environment, related to production processes, environmental and commercial savings potentials, and operator development.
- Developed novel coating system, deemed by organization as patent worthy, patent application submitted, pending.
- Founding member of sites ESG team, Environmental, Safety, Green initiates, as a founding member throughout the company, multiple strategies have been created to reduce landfill waste, reduce carbon footprint, increased use of recyclable materials, and increase safety of employees.
- Enhanced product quality by developing and optimizing chemical processes and procedures.
- Increased laboratory efficiency by implementing new software programs for data analysis and management.
- Collaborated with interdisciplinary teams to solve complex problems in product development and scaleup.
Chemist II (Pharmaceutical)
Bayer Corps.
01.2015 - 09.2015
- Analyze and provide quantitative results for production, stability, and special project samples from various pharmaceutical production lines, engineering batches, and cleaning verification samples.
- Understanding and use of various laboratory equipment such as HPLC, GC, ICP, UV-VIS, FTIR, Near-IR, DSC, using different techniques necessary for active ingredients, heavy metals, contaminants and other pertinent materials identification.
- Competent of FDA, EPA, DEA regulations.
- Submitted a RISE initiative that focused on cutting cost related to finished product testing while increasing profits for both the company and the customer.
Chemist (Production and R&D)
Albaugh LCC (US Facility)
01.2013 - 12.2014
- Analyze and provide quantitative results for production samples from various agro-chemical production lines and assist lab manager in the development of new product.
- Write and review laboratory data and method validation protocols and reports.
- Competent in the use of HPLC, GC, Viscometry, Karl Fischer, Titration Chemistry, Wet Chemistry, Flash Point Analysis, Cross Contamination Analysis, Waste Water Analysis.
- Customize product colorization per customer specifications through dye mixing.
- Advanced experience with MS Excel, Word, and Outlook
- Utilized on a daily basis for data analysis, recording, and timely communication with other departments.
- Communicate effectively with manufacturing personnel to offer batch adjustments.
- Nominated for inclusion on the ISO 9000 team to help organize and improve performance and safety at the facility while acquiring ISO 9000 certification.
- Independently responsible for entire lab during high demand portion of the year; maintained a high level of accuracy, precision, and professionalism when working various evening and overnight shifts
- Flexibility to work overtime as needed.
- Work with management team to prepare for division expansion to future facility
- Includes space planning, procurement of instrumentation for new laboratory, and training of additional lab personnel.
- Perform preventive maintenance and calibration activities on analytical instrumentation.
- Author, review and modify SOPs and other lab documents as necessary.
Education
Bachelor of Science - Biology & Chemistry
University of Missouri - Kansas City
12.2011
Skills
- Analytical chemistry
- Polymer chemistry
- Physical Chemistry
- Method validation
- Laboratory Management
- Product Development
- Specification Development
- Professionalism
Areas Of Interest
- Analytic Chemistry (with Lab)
- Microbiology (with Lab)
- Biochemistry
- Water Chemistry
- Organic Chemistry (with Lab)
- Environmental Chemistry
- Physics (with Lab)
- Virology
- Immunology
- Environmental Philosophy
- Vertebrate Biology
- Invertebrate Biology
- Human Anatomy and Physiology
- Social and Political Philosophy
Volunteer Experience
Boys and Girls Club, 20
Certification
- HAZ-MAT Certified Shipping Training - Dec. 2019 - Dec. 2023
Timeline
Senior Chemist
Nomax Inc.
08.2022 - Current
Chemist III (Pharmaceutical R&D)
Sensient Colors
09.2015 - 08.2022
Chemist II (Pharmaceutical)
Bayer Corps.
01.2015 - 09.2015
Chemist (Production and R&D)
Albaugh LCC (US Facility)
01.2013 - 12.2014
Bachelor of Science - Biology & Chemistry
University of Missouri - Kansas City
Similar Profiles
Paul WebbPaul Webb
Patient Transporter at Veterans Affairs Medical CenterPatient Transporter at Veterans Affairs Medical Center
Gage NalleyGage Nalley
Membership Services Representative at UMSL Recreation and Wellness CenterMembership Services Representative at UMSL Recreation and Wellness Center
Harper EdigerHarper Ediger
Substitute teacher at Kelly EducationSubstitute teacher at Kelly Education
Davion HowardDavion Howard
Assistant Manager at MNG 2005 IncAssistant Manager at MNG 2005 Inc
Domenico Rotella Senior_CHEMISTDomenico Rotella Senior_CHEMIST
Senior Chemist at SayboltSenior Chemist at Saybolt