Jake Warnke Email & Phone Number

Seattle, Washington, United States

Support stability activities for vaccine products from early-stage development through Phase 3, culminating in BLA filing and commercial manufacturing. Design, plan, execute, and coordinate stability studies on development and clinical batches, summarize and analyze results, author protocols and reports. Collaborate closely with many cross-functional teams (quality, regulatory, process development, analytical, clinical), and play an integral part in guaranteeing the quality, safety, and adherence to regulatory standards for vaccine products.

Louisville, Colorado, United States

Multidisciplinary background with a strong focus on CMC analytical development and product characterization. I played a direct role in supporting the advancement of 31 different biopharmaceutical products, spanning pre-clinical through postmarket approval, for 20 innovator client companies.Contributed to method transfer, development, qualification; full product characterization in support of BLA and IND filings; variant and impurity characterization; stability, forced degradation, and process comparability programs; formulation development; structure elucidation.Served as the point of contact for several large, multifaceted programs that required strong organizational and project management abilities. Supported 4 BLA submissions, including 1 approved therapy. Program manager and client point of contact for 1 BLA involving a bioconjugated mAb.Technical Background: HPLC (SEC, HILIC/HIC, RP, IEX) and electrophoresis (CE-SDS, icIEF) separation techniques; mass spectrometry (N- and O-glycan, intact/reduced mass, peptide and disulfide map); biophysical secondary (FUV CD, FTIR), tertiary (NUV CD, DSC), and higher order structure (MALS, SV-AUC, DLS) characterization; bioassay potency (alphascreen), protein quantification (BCA), and limited exposure to cell-based assays; particle characterization (MFI); automation (Biomek 4000); GLP safety (BSL 1-2) and quality practices.

Louisville, Colorado

Louisville, Colorado

Golden, Co

The purpose of this research was to demonstrate how electrospun polymer scaffolds can be further manipulated to address current problems facing cell proliferation in the application of bone tissue engineering. Polymers such as polylactic acid have many inherent properties for tissue engineering, however such scaffolds are hydrophobic and mechanically weak, limiting their applications in biological systems. Hydroxyapatite, a natural composite of calcium and phosphorous, was studied as a method for improving scaffold strength and biocompatibility. The effect of time, temperature and reactant concentration on the hydrothermal synthesis of hydroxyapatite nanoparticles was experimentally determined in order to better understand how these particles form and develop. A procedure for investigating the mechanical properties of electrospun polymer scaffolds was then examined. Although there is a vast amount of research into the physical characteristics of certain polymers, very often there is little information into the actual method of investigation. As such, effort was taken to explore the current procedures for mechanically testing polymer scaffolds, and from that a methodology for future analysis was developed.

Golden, Co

This six week course was designed to introduce students to advanced chemical methods across the field. Emphasis was placed on communication-style reports and group presentations.

Colorado School Of Mines

Students for Sensible Drug Policy (SSDP) is an international grassroots network of students who are concerned about the impact drug abuse has on our communities, but who also realize that the War on Drugs is failing our generation and our society. We aim to get students involved in the political process, pushing for sensible polices that achieve a safer and more just future, while fighting against the counterproductive Drug War. We strive to honestly educate the community and incorporate harm reduction techniques; particularly those that directly affect students and youth. As chapter president, I was responsible for coordinating events, running student meetings and remaining in direct contact with the SSDP Foundation and members of the community.

Golden, Co

Graded +50 labs for the introductory biology students each week. Labs consisted of basic biological applications: PCR, Gel Electrophoresis, Microscopy, Genetics, etc.

Golden, Co

Worked with Professor Allison Caster at CSM to create exercises for the Principles of Chemistry students. Exercises consisted of: Effective Nuclear Charge, Lewis Structures, a Symbaloo organizing center for student to use, and a very basic "What's In an Atom" exercise. I also contributed towards lecture and helped students by answering questions.

Bachelor’S Degree, Biochemistry

Diploma