SUMMARY OF QUALIFICATIONS
PhD medical writer with over 10 years of experience in drug development.
- Experienced in writing regulatory documents, grants, and GMP documents.
- Led and collaborated with multifunctional international project teams.
- Lead writer for health authority responses, investigator brochures, briefing books, and clinical study reports.
- Experienced in communicating project goals and progress through detailed Excel timelines, PowerPoint presentations, and written reports.
- Broad scientific experience including nucleic acid complexes, enzymology, drug-antibody conjugates, oral peptide therapies, and traditional small molecule therapies.
- Led projects in various stages of development from research phase to late phase clinical, in formulation and analytical.
Medical Writer and Consultant
- Write and edit documents to support regulatory submissions in collaboration with global client teams.
- Develop plain language web content for health education.
- Lead internal task force to create shareable content on topics of interest to the industry.
- Provide internal training on biologics and statistics.
- Responsible for analytical development of clinical drug substance and orally administered clinical supplies.
- Authored analytical specifications, stability protocols and reports, validation protocols and reports, method transfer protocols and reports, and CMC sections of IND/IMPD and IB.
- Co-developed global analytical training academy to roll out best practices and QbD principles across Novartis.
- Performed analytical analysis to support clinical supply development of oral protein therapies.
- Developed scalable streamlined process for antibody-drug conjugation reaction and purification, developed “plug and play” lyophilized formulation for antibody platform.
- Authored GMP documents, including SOP, CoA, MSS, and batch records.
- Led project as co-PI for SBIR Phase I grant, supervised BS scientist.
Industrial pre-doctoral internship
- Screened inhibitor compounds against enzyme mutants to evaluate factors that influence drug potency.
Ph.D., Chemistry, University of Michigan, Ann Arbor
National Institutes of Health Chemical Biology Interface Training Grant Fellow
- Examined catalytic mechanism of metalloenzyme farnesyltransferase through transient kinetics and spectroscopy, investigating transition state and role of active site residues in the laboratory of Carol Fierke.
- Assisted with a grant proposal, writing research portions, and received funding from National Institutes of Health.
Graduate Student Instructor
- Taught Introduction to Biochemistry to 20 undergraduate students, leading discussion classes, writing quizzes, and grading assignments.
B.S., Chemistry with Honors, University of North Carolina, Chapel Hill
Analyzed oxidative cleavage of 2′-substituted DNA by ruthenium compounds in the laboratory of H. Holden Thorp.
PROFESSIONAL AFFILIATIONS AND CERTIFICATES
American Medical Writers Association (AMWA) Essential Skills Certificate
AMWA Carolinas Chapter Social Media Director
Pickett J. Augmenting medical writing with artificial intelligence and natural language generation. AMWA Journal. 2020;Spring:30-32. [Conference Report]
Pickett JS, Vakil R, Kuemmell A, McGill R, LoBrutto R. Circular dichroism: Applications to formulation development. PDU Journal (internal publication) 2011;1(1):1-7.
Pan C, Valente JJ, LoBrutto R, Pickett JS, Motto M. Combined application of high resolution and tandem mass spectrometers to characterize methionine oxidation in a parathyroid hormone formulation. J. Pharm. Sci. 2010;99(3):1169-1179. doi: 10.1002/jps.21901
Sapra P, Stein R, Pickett J, Qu Z, Govindan SV, Cardillo TM, Hansen HJ, Horak ID, Griffiths GL, Goldenberg DM. Anti-CD74 antibody-doxorubicin conjugate, IMMU-110, in a human myeloma xenograft and in monkeys.Clin. Cancer Res. 2005;11(14):5257-5264. doi: 10.1158/1078-0432.CCR-05-0204
Pickett JS, Bowers KE, Fierke CA. Mutagenesis studies of protein farnesyltransferase implicate aspartate beta 352 as a magnesium ligand. J. Biol. Chem. 2003;278(51):51243-51250. doi: 10.1074/jbc.M309226200
Pickett JS, Bowers KE, Hartman HL, Fu HW, Embry AC, Casey PJ, Fierke CA. Kinetic studies of protein farnesyltransferase mutants establish active substrate conformation. Biochemistry 2003;42(32):9741-9748. doi: 10.1021/bi0346852
Tobin DA, Pickett JS, Hartman HL, Fierke CA, Penner-Hahn JE. Structural characterization of the zinc site in protein farnesyltransferase. J. Am. Chem. Soc. 2003;125(33):9962-9969. doi: 10.1021/ja035927o
Chehade KA, Kiegiel K, Isaacs RJ, Pickett JS, Bowers KE, Fierke CA, Andres DA, Spielmann HP. Photoaffinity analogs of farnesyl pyrophosphate transferable by protein farnesyl transferase. J. Am. Chem. Soc. 2002;124(28):8206-8219. PMID: 12105898
Farrer BT, Pickett JS, Thorp HH. Hydride transfer in oxidation of nucleic acid sugars: electronic effects of 2′-substituents on activation of the 1′-C-H bond by oxoruthenium(IV). J. Am. Chem. Soc. 2000;122(4):549-553. doi: 10.1021/ja991967+
Pickett, J. The Times They Are a Changin’: Managing Change in Every Role (Conference Roundtable) AMWA Medical Writing and Communication Conference, Oct 20-22, 2020
Novartis 10th Annual Science and Technology Day (internal conference), East Hanover, NJ, May 19, 2011:
Pickett JS, Vakil R, Kuemmell A, Use of circular dichroism to investigate food effect for PTK796. (Analytical poster winner)
Pickett J, LoBrutto R. Analytical QbD Academy.
Pickett JS, Interdonato M, Muentener R, Marcella F, Agyilirah G, Teelucksingh J, Vrettos J, Jain P, Desai R. Quality culture in TRD: PHAD US, QA US, and Reg-CMC US.
Novartis 8th Annual Science and Technology Day (internal conference), East Hanover, NJ, Feb. 24, 2009:
Pickett JS, Ghosh A, Valente J, Mulligan D, Singh R, LoBrutto R. Use of L-methionine to prevent solution-mediated oxidation of PTH134.
Allenspach C, Valente J, Pickett JS. Incompatibility of ionic superdisintegrants and evaluation of a new excipient grade for PTH134.
Allenspach C, Valente J, Pickett JS. LEAN formulation screening of PTH134 using the compaction simulator. (Formulation poster winner)
Valente J, Pan C, Allenspach C, Pickett, JS. Chemical reactivity between therapeutic peptides and an oral delivery agent.
McGill R, LoBrutto R, Pickett JS, Valente J, Taneja V. APP018/APL018: Unraveling the mystery of analysis for non-covalent vs. covalent aggregates for proteins/peptides.
Pan C, Valente J, LoBrutto R, Pickett JS, Motto, M. Combined application of high resolution and tandem mass spectrometers to characterize methionine oxidation in a parathyroid hormone formulation.
Protano C, Valente J, Singh R, D’Altrui E, Erz K, Pickett JS. HPLC separation of low dose peptides from an excess of functional excipient.
Pickett JS, Bowers KE, Hartman HL, Fierke CA. Alternate binding modes important for catalysis in protein farnesyltransferase. Poster presented at: Protein Lipidation, Signaling, and Binding Domains, FASEB SRC; July 20-25, 2002; Tucson, Arizona.
Pickett JS, Bowers KE, Scholten J, Fierke CA. Determinants of Farnesyltransferase Inhibitor Potency. Poster presented at: Midwest Enzyme Chemistry Conference (MECC); September 23, 2000; Chicago, Illinois.
- volunteered 3-5 times a week with 4th to 6th-grade robotics students at Triangle Math and Science Academy
- introduced them to Lego Ev3 hardware components and programming
- mentored them in their science project for FLL season
- 2017 season: taught the team about the impact of nutrient pollution on the water supply
- 2018 season: explored deep space travel, grew sprouts in Martian regolith
- 2019 season: interfaced with NC State Department of Geospatial Analytics to explore drones
- organized and supervise field trips
- provided support for First Lego League, line-follower, and sumo-bot tournaments
- Created a simple annual Thanksgiving drop-off food drive for my neighborhood.
- Collect and deliver food donations for the drive for Western Wake Crisis Ministry.
- As of 2020, the food drive has collected over 1330 pounds of food for those in need.
Coupon Book Sale Co-Chair
Salem Elementary School
- Coordinated distribution of 700 coupon books for fundraising.
- Designed and distributed paper and electronic marketing materials for the sale.
- Collected and recorded funds for deposit according to PTA guidelines.
- Organized recovery of unsold books.
- Raised over $8000 for PTA in 3 months.