Product Development Medicinal Chemistry

Karen Linda Privateer, M.A.

Brooklyn, NY *****

617-***-**** *************@*****.*** LINKEDIN

EDUCATION

University at Buffalo, Buffalo, NY

•Master of Arts in Biological Sciences

Hofstra University, Hempstead, NY

•Post-Baccalaureate Certificate Program in Natural Sciences

Drexel University, Philadelphia, PA

•Bachelor of Science in Biology

SKILLS

●Experience in Drug Product Development.

●Understanding of investigations, Deviations and CAPA management in a regulated pharmaceutical industry.

●Experience with commissioning and qualifying new equipment facilities, utilities and maintaining equipment systems in qualified/validated conditions per standard policies and procedures.

●Supports validation deliverables such as validation plans and change controls.

●Synthesizes, designs, and purifies allosteric inhibitors, indolinones.

●Manages CAR-T, Viral Vector, and molecules/samples for operations of clinical/nonclinical studies to ensure company deliverables are met and objectives are achieved under limited guidance.

●Performs characterization on intermediates and final compounds such as Mass Spectrometry, H NMR, 13C NMR, and HPLC.

●Responsible for review of clinical/non-clinical study protocols and associated study document as it pertains to biospecimen management.

●Trains associates and provides leadership and guidance to others within the group.

●SME support for technology, SME support for technology transfers, and SME technical input in support of GMP manufacturing.

●Manufactures Chimeric Antigen Receptor Therapy (CAR-T) for five treatments.

●Knowledge of Single Use mixing tanks (XDMs) and Single Use Bioreactors (XDR)

●Proficiently able to perform upstream cell culture operations as well as downstream operations.

●Participates in team efforts to maintain functional operations in a regulated environment.

●Knowledge of aseptic techniques, culturing cells and ability to regulate assays to support portfolio projects.

RESEARCH EXPERIENCE

University at Buffalo, Buffalo, NY October 2022-January 2024

David E. Heppner, Ph.D. Lab, Medicinal Chemistry; Graduate Student

Synthesis, design, and purification of novel EGFR inhibitors.

Receptor inhibition and biological characterization of mutant selection and kinase potency.

Rational and iterative drug design.

Legend Biotech, Somerset, NJ February 2022-August 2022

Material Sciences and Technology, Technical Development; Viral Vector Scientist / Lead

Acts as technical upstream lead for lentiviral and retroviral platform development.

Designs, executes, and interprets, upstream, viral process development experiments.

Authors and reviews technical documents, protocols, and reports.

Analyzes, organizes, and presents data in a clear and concise manner.

Maintains laboratory notebooks and prepare protocols and reports in a compliant manner.

Works closely with internal and external partners to evaluate, develop, tech transfer and implement new process technologies related to viral manufacturing.

Contributes to technical documents in support of regulatory filings.

Provides technical SME input to GMP lentiviral manufacturing.

Bristol-Myers Squibb, Warren, NJ August 2020-February 2022

Manufacturing Operations, CAR-T; Senior Manufacturing Associate

•Presentation of reports on special projects.

•Evaluated and updated laboratory procedures and methodologies.

•Directed involvement team.

•Production of blood-element lot through cell culture, harvest and cryopreservation.

•Balanced and measured in-process specimens.

•Followed schedule with special attention to punctual, internal production logistics.

•Documented production data in a clear and concise manner per GDP requirements.

•Edited and revised batch records and SOPs.

•Authored CAPAs and deviations.

•Performed multiple weekly presentations for meetings on Safety.

•Performed weekly 6S audits on assigned lab with team members.

•Collaborated in a team based, cross-functional environment to complete production tasks per schedule.

Bristol-Myers Squibb (Tech Data Service), Summit, NJ Summer2019 (Short term)

Drug Product Development; Vendor Readiness Support-Sr. Specialist

●Arranged early development and organization of relationships with Contract Research/Contract Manufacturing Organization to ensure productive and beneficial relationships.

●Focused on the development and optimization of robust clinical manufacturing processes for drug products.

●Monitored and compiled relevant metrics and reported vendor performance.

●Set up and prepared business meetings with internal engineering groups.

●Orchestrated data mining for various clientele for a few engineering groups within DPD.

Vedanta Biosciences, Cambridge, MA May 2018- August 2018 Manufacturing; Manufacturing Associate

●Manufactured drugs substance and drug product in a cGMP environment.

●Performed inoculations in anaerobic chamber and scaled up to wave bioreactor.

●Experienced with fermentation, crossflow filtration, and lyophilization.

●Collaborated with Quality Assurance for Manufacturing-associated deviations, CAPAs and change controls.

General Electric Health Care (Artech), Marlborough, MA December 2016-February 2018

Manufacturing; Manufacturing Engineer II ● Supervised night operations, processes, and building facilities.

●Experienced with quantitative analysis and automation.

●Knowledge of large scales aseptic processes, purifications operations, and chromatography.

●Basic statistics & mathematical skills.

●Regularly generates experimental data and carries out cell culture experiments.

●Faithfully recorded experiments in both batch record format and in electronic notebook. ● Experienced with sampling for bioburden, endotoxin, and retain.

●Troubleshoot as well as built and constructed lines to successfully complete procedures.

●Independently able to provide leadership in successfully training fellow colleagues during overnight shifts.

●Activated cGMP Biomanufacturing equipment in cleanroom environment.

●Collaborated with engineers, team leads, supervisors, and managers to improve quality, and process efficiency.

●Routine tasks included training on cGMP manufacturing operations, operation, and monitoring of cell culture and/or purification equipment and reviewing cGMP documentation.

Amgen (US Tech Solutions), Cambridge, MA April 2016- October 2016

Drug Substance Process Development; Associate Lab Support Technician Effectively used process automation systems to operate production processes (Delta V.).

●Demonstrated ability to independently develop, document, and trouble shoot laboratory instruments of high levels of complexity.

●Daily monitoring of seed cultures including sampling and in process assays (cell counting).

●Scaling up of seed culture and performed cell passaging.

●Demonstrates ability to troubleshoot basic mechanical operations.

●Performed water function testing and ability to build gas lines.

●Operated manual, semi-automated, and automated equipment in support of routine process development.

●Experienced with sampling tissue culture, and small-scale procedures as well as other scaling up procedures. ● Experienced with equipment commissioning and functional testing after movements.

Genzyme (Pro-Unlimited), Allston, MA October 2014-March 2015

Cell Culture Operations; Manufacturing Associate I Experienced with LIM system, quantitative analysis, and automation.

●Daily monitoring of cultures and bioreactor processes including sampling and in process assays.

●Hands on expertise on cell culture and diverse biological and biochemical techniques.

●Provided sampling from a two-bottle sampler and facilitated aseptic technique.

●Familiarity with cell counting and viability.

●Performed sampling for TOC, Conductivity, Endotoxin, and Bioburden testing.

●Effectively supported in clean in place (CIP), pressure holds, steam in place (SIP) of process equipment.

●Monitored upstream operations as well as proficiently test and build hydrophobic and hydrophilic filters.

●Familiarity with mixing caustic solutions for the preparation of a soak tank.

EXPERIENCE

Massachusetts General Hospital, Boston, MA November 2011-August 2014 MGH Churchill Surgical Service, Patient Service Coordinator II

MGH (Bulfinch Temps) Cancer Center, Phone Coordinator

MGH (Bulfinch Temps) McLean Hospital, Staff Assistant Belmont, MA

●Effectively triaged, scheduled, and directed patients to the appropriate clinics by thoroughly reading through discharge notes, operative notes, and notes in the CAS system.

●Proficiently problem solved and reviewed complex information with patients.

●Utilized electronic system to process financial transactions, such as billing and cash payment processing.

McLean Hospital (Randstad) Belmont, MA August 2011-November 2011

Health Information Services/Medical Records; Coordinator Analyst/Correspondence Tech

Verified the appropriate time sensitive confidential requested electronic and paper medical records.

●Processed Medical Records via IDX and Meditech MCZ for patients all over the United States and Global.

●Retrieved and sent out admit notes, outright discharge letters, neurology consult or psychological reports, labs, treatment plans, initial assessments, or detachments notes.

Harvard Vanguard Medical Associates, Needham, MA March 2010 -August 2010

Customer Service/Clinical Lab; Business Information Systems Assistant/Lab Processor

Verify results for accuracy of Molecular & PCR HPV Identification Reports, Anti-Nuclear AB, and Endocrine Lab.

●Centrifuged PT INR and Gold Top tubes and regulated hundreds of specimens from 15 HVMA locations.

●Aliquoted Vitamin B12 and Lactate specimens.

●Processed lab specimens for Chemistry, Hematology, COAG, Urinalysis, Glyco, and Microbiology.

●Data entry for Test Data such as Pending Lists, Research Project, and other Miscellaneous projects.

●Sent out Normal Letters concerning either a negative Pap Smear or occult bloods to physicians or patients to ensure that test results are communicated to the patient.

●Verified results for accuracy of Molecular & PCR HPV Identification Reports, Anti-Nuclear AB, and Endocrine Lab.

Beth Israel Deaconess Medical Center, Boston, MA November 2008-August 2010

Operations Administration; Customer Service Review Coordinator

●Typed up reviews based on the various ambassador’s and scheduler’s performance levels according to the levels of Professionalism, Alertness, Friendliness, and Comfort of six lobbies in the East and West Campus lobbies of BIDMC.

●Supervised schedulers over the phone and then coached them based on their customer service performance and emailed Supervisors, Directors, and editor on the customer service level of the Waiting Room or Practice.

Willow Laboratories and Medical Center, Lynn, MA March 2007-November 2007

GC/MS Laboratory; Laboratory Technician ● Experience with small molecule analysis.

●Knowledge of therapeutic area.

●Confirmation drug testing as outlined in standard protocol outline.

●Proved positive drug screening results were accurate by using Gas Chromatography/Mass Spectroscopy in house toxicology lab.

●Performed chemical extractions, assays, elusions, and column chromatography.

GE Health Financial Services (Kelly Services Inc.) Boston, MA January 2006- September 2006 Documentation Department Receptionist/Operator

●Prepared terminated or non-terminated files for scanning and conducted UCC Filling via database.

●Operated the switchboard for the GE community within and outside of MA.

●Collected and sorted incoming mail for various departments.

AWARDS

Bravo Award, Bristol Myers Squibb Warren, NJ 2022

Bravo Award, Bristol Myers Squibb Warren, NJ 2021

Certificate of Achievement, Neiman Marcus Boston, MA 2014

VOLUNTEER WORK

Seneca Babcock Food Pantry, Buffalo, NY September 2022- Present ● Helps clients shop for food.

●Organizes food and food deliveries.

●Assists with set-up and break down of food pantry.

Boston Center for Pregnancy Choices, Boston, MA June 2015- Present ● Operates Baby Boutique and assists with client inspiration, shopping and donations.

●Assists with events/fundraisers such as Sanctity for Human Life, Love 5k Races, and Love Galas.

●Served as Cleaner, Receptionist & Hotline Counselor- effectively aids women in crisis.

Brigham and Women’s Hospital Boston, MA September 2008-August 2010 ● Transported patients for Central Transport Systems ● Discharged patients: post-partum and hospital. ● Performed round trips for the blood blank.

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