Monika Springer, M.S.

Transitioned and joined the research and development department specializing in biologics development, specificially the R&D group that developed the number 1 drug in the world, Humira. Quickly became an expert and then the analytical scientific project lead and lab manager for a promising biologic in the treatment of patients with c-Met positive metastatic non-small cell lung cancer.

Key Achievements:

• Hit the ground running upon the transition to a new scientific specialty, from small molecule drug product development to the biologics development. Due to the ability to adapt, learn quick and lead a novel expertise, was awarded the opportunity to lead a complex, phase II biologic asset within 8 months of joining the group.
• Was able to quickly exemplified top tier managerial skills and was concurrently awarded the opportunity to lead a team of scientists that directly reported to me the directly supported in activities assigned and reviewed by me.
• The drug product asset that I was the lead for, received “roadrunner” status in the R&D pipeline at AbbVie quickly following, received "Breakthrough Therapy" designation by the FDA in early .
• Successfully designed and met all aggressive timelines in support of an accelerated submission while maintaining the deliverables for drug product, drug substance and the monoclonal antibody intermediate while juggling goals, initiatives and managing direct reports
• Manages 4 direct reports, mentors a scientist in a contract role while leading a group of 1-4 PPD scientists that are hired to support at the high points of project deliverables.
• Grew the analytical biologics organization by scouting, interviewing and hiring 6 scientists with a successful culture built on diversity.
• Designed and implemented 47 studies while and managed previously set up stability studies required for successful multi-market approvals following local, quality, ICH and regulatory guidelines.
• Extensive experience working with in cross-functional and global CMC (Chemistry, Manufacturing and Controls) team with counterparts across multiple time zones across Europe (Germany and Italy) and sites at both coasts (Worcester, Massachusetts and Redwood City, California). Example: Successfully managed and co-validated all stability indicating analytical methods with the Operations QC lab in Worcester, Mass.
• Expert in technical writing of documents spanning from validation protocols, to data investigations of GMP material to submission documents. Primary author of the analytical section of the Biologics License Applications (BLA) being drafted in preparation of scientific team and management review.
• Recipient of the 2022 CMC team recognition for the coveted AbbVie “Astound Award” for the successful completion of the process performance qualification (PPQ) campaign for a complex biologic drug substance across all commercial supply chain networks. The cross-functional team across sites and organizations worked tirelessly the past year to manage accelerated “road runner” timeline goals and execute on a highly complex strategy. The global team exemplified commitment and proactive communication, planning, and risk-mitigation removed barriers and maintained schedule adherence and a successful end-to-end campaign.
• Successful design and cross functional collaboration and completion of a clinical commercial in-use stability study in R&D that spanned months of active support of multiple scientists (3 process engineers, 3 analytical chemists and 2 project leads) in prepararation for commercialization and approval of CSTD’s (Closed System Transfer Device) use for current clinical trials.
• Successful collaborated with regulatory affairs to create a filing strategy to accelerate BLA technical writing for a quicker submission to the FDA and agencies across the globe for current asset.

Joined the R&D community of immunotherapy drug product design and development portfolio at AbbVie in a high paced, collaborative group to deliver a top tier asset to compliment historical performance, since the Blockbuster asset in immunotherapy was quickly coming off of patent. I served in progressively more responsible leadership roles, including Associate Research Scientist (2014-2016), Research Scientist (2016-2018), Research Scientist II (2018-2020), which I served as the Analytical Project lead for the now approved immunological asset Rinvoq. Monika stood out in the R&D field due to her high ambition, attention to detail, energetic/extroverted attributes and her aggressive pursuit of top tier science. These qualities largely contributed to the success of a major asset in the AbbVie portfolio. The asset was approved in 2019 and currently holds 6 FDA approved indications which produces a net revenue of $695 million.

Key Achievements:

• Understands and achieves business goal even when faced with technical adversity. When novel technology (PrepEngine) was implemented by her in the final weeks of the Rinvoq NDA preparation, Monika went on the road to ensure the receiving labs in S&T and Ops QC received face to face training. Monika shared some of the team's success with this innovation during AbbVie’s R&D 2017 poster session.
• Developed all stability indicating methods for Rinvoq and successfully trained high ranking colleagues, crossfuntional colleagues in Operations in both the Science and Technology departments onsite, as well as in Ireland and the Quality group, located at a separate AbbVie campus.
• when technical issues arose at the proposed commercial manufacturing facility in Sligo, Ireland, Monika traveled to the site within a days notice. The trip was successful and proved that all controls were in place for the successful transfer of the novel science and technology,
• Technical writing – Primary author of analytical sections of the NDA and received zero questions from the FDA upon review.
• Managed and evaluated data and successfully released over 60 lots of investigational new drug product batches to supply one of the largest global clinical trial.
• Independently designed a matrix of registration stability studies across multiple dosage forms, 4 different packaging containers and multiple storage conditions following pharmaceutical guidelines in support of MMA (Multi-Marketing Approval) submission filings.
• Trained and educated scientist on theory and technical and routine use of analytical instrumentation (High Performance Liquid Chromatography, Dissolution, Gas Chromatography, Size Exclusion Chromatography, Capillary Electrophoresis, Protein Content determination via SoloVPE, Osmolarity, Hydrophobic Interaction chromatography, Free Drug Analysis for Antibody Drug Conjugates, Dissolution and Imaged Capillary Isoelectric Focusing)
• Evaluated and implemented new technologies and laboratory techniques to improve quality and robustness of sample analysis. (Shaking vs Prep-engine sample preparation in the 11th hour of submission preparation for stability indicating tests concerning a late stage asset.

Worked extensively in the lab in developed and providing stability indicating analytical methods and authored and executed analytical method validation experiments for pharmaceutical generic formulations in the fields of oncology, anesthesia, and critical care therapy. Simultaneously supported several complex projects, meeting all pertinent milestones.

Key Achievements:

• Expanded technical toolbox in analytical chemistry by developing stability indicating methods for the determination of purity, potency, degradation products, process impurities using state of the art instrumentation (Ultra-High Performance Chromatography, Karl Fischer, ETc)
• Independently developed 6 methods and independently wrote and executed 6 validation protocols
• Actively participated in laboratory safety committee and was nominated as Captain of the Lab Safety Audit Committee in January 2014.
• Responsible for all stages of product development including on-site monitoring of stability lots, protocol authoring and data reports.
• Responsible for providing data and scientific justifications in responding to FDA response letters, along with writing test methods, protocols and final reports for active pharmaceutical ingredients and drug product studies.

Assisted and collaborated with a team of healthcare providers, primarily with Doctors of Optometry, as well as, Medical Doctors, specializing in Ophthalmology, in a fast paced eyecare clinical setting as a clinical optician. Worked extensively with clinical eyecare instrumentation corneal topographers, retinal imaging cameras, ocular tonometer and autorefractors) in aid of providing comprehensive eye exams among several clinical locations in the Chicago-land area. Served as a liaison between the doctors and the patients/customers to ensure relationship-based eye care in reach of top-tier customer/patient service.

Key Achievements:

• Developed high customer satisfaction skills and ratings/recognitions in assisted patients and csutomers by tailoring their personal eyewear needs with their aestheic and prescriptions needs provided by the clinicains.
• Obtained a large clientele that specifically made appointments to see me when getting a new refraction and selecting new eyewear due evolving a sense of trust which was fuided by educating all patients and customers about optimal eyewear satisfaction.
• Expert in troubleshooting and resolving any problems/vision issues with new glasses and was the “go-to” person in solving complicated vision issues concerning patient eyewear.
• Independently increased eye exam efficiency (reduced eye exam time by replacing the old technology of “air puff” tonometry) by independently introducing the handheld rebound tonometer and training all staff to utilize it in routine eye exams.
• Interviewed, trained, and mentored new staff in both the clinical and eye lab setting.
• Performed patient work ups, ancillary testing and orders and dispenses contact lenses to support operational efficiency.
• Established operational priorities in the clinic, worked independently and proceeded with objectives without supervision.
• Calibrated seg heights, vertex and pupillary distance and pantoscopic tilt to customize eyeglass to the specificity of the patient to ensure perfect fit and in hand thrived on helping others and create pleasant and memorable optometry visits.
• Acted as an eyecare expert and achieved great customer service recognition by effectively educating patients of all ages on proper care and transportation of spectacles as well as care and insertion and removal of contact lenses.