Chris Wisniewski Email & Phone Number

San Diego, California, United States

Greater San Diego Area

Oceanside, CA

• Led the implementation and development of the glycan assay from the Prozyme GlykoPrep Instant-AB Glycan kit to the Waters GlycoWorks RapiFluor-MS N-Glycan kit. Evolved the glycan assays from the lab bench to 96-sample.
• Collaborated with Hamilton and Waters on an automated and now mass produced Waters N-Glycan kit.
• Developed an effective UPLC platform SEC analytical method following QbD principles introduced in ICH guidelines Q8, Q8, and Q10. Managed the validation of the method in our on-site QC as well as with a 3rd party.
• Led automation sub-teams for the development of methods of post-ProA purification sample aliquoting and dilution with the purpose of increased throughput, ease of use for downstream testing, and storage.
• Written streamlined protocols for multiple molecules for the following assays: N-Glycan (manual and automated), Reduced and Non-Reduced Capillary Electrophoresis, Ion Exchange and Size Exclusion assays.
• Performed validations for multiple biological assays from initial stage development to end stage GMP implementation.

Greater San Diego Area

I use LIHA and ELISA systems to develop, improve, and transfer diagnostic assays for patient blood samples. HPLC analysis of mobility shift assays by SEC and RP-HPLC. I also produce, qualify, and validate control standards and conjugates for use in the manufacturing process and in the clinical laboratories. Beyond these responsibilities, I am the point of.

Greater San Diego Area

• Develop and perform developmental testing on newly developed mixing skids using no-contact centrifugal pumps and sonic flow meters.
• Research lipid/DNA mixture methods developed per DOE and ANOVA programs.
• Analyze lipid/DNA mixtures for extended study and stability by HPLC and gel electrophoresis for supercoil and open loop percentages.
• Compare and contrast different lipid lots for advanced degradation between separate competing manufacturers.
• Develop autoclaving methods for sonic flow meter sterilization.

La Jolla, CA

• Perform method development on cleaning procedures for 1L and 3L production mixing vessels.
• Assist QC on stability of raw materials for mass production.
• Assist production development teams as first point of contact for purity, concentration, recovery and particulate sizing.
• Research and develop methods for determining good identifiers of drug product from both dirty and cleaned mixing vessels.

Manufacture and purify small, medium, and large scale oligonucleotides in a cGMP environment.Manufactured oligos include: T7, torch, capture, RXL, and blocker.Purify oligos on HPLC units that collected either manually or automatically.Perform quality control on produced oligos mid and post-process for accuracy and allowable purity levels.Independently.

Test manufactured GMP and research-grade peptides at stability time points and the raw materials used in their manufacturing.In-house testing includes: purity by RP-HPLC using Beckman 32 Karat systems, Total Organic Content, Resin Swelling, Moisture Content, and Optical Rotation.Assisted and trained the sites QC-wide application of cGMP regulations.Prepare.

• Perform analytical testing on pharmaceutical drugs for a variety of customers driven by high quality work and results.
• The GMP compliant testing can range from very basic to very complicated methods which are all to be completed on 30 day cycles.
• Certificate of analysis production.
• Analyze drug substance and drug product in compliance with applicable SOPs, protocols, methods, & USP monographs to ensure identity, strength, purity, and quality;
• Perform pharmaceutical analysis in a cGMP and GLP (21 CFR Part 210 and 211 and 21 CFR Part 58) environment
• Responsible for day to day management of multiple projects to ensure quality of results and efficiency of tasks

Worked with Waterborne, asexual animals called Rotifers. PCR and DNA isolation was often used to place new animals into a phylogenetic tree.