Michael Heberlein Email & Phone Number

San Diego, Ca, Us

San Diego, California, United States

Utilize GMP & IND-enabling strategies to create and develop drug formulations for preclinical and human clinical oral drug candidates.Manage transfer of formulation projects to the GMP manufacturing team and collaborate with process engineers and analytical chemists.Manage project timelines and planning of experiments following service agreements to meet client expectations. Write up technical reports and communicate results and strategy with management and clients.Spearhead training on physical characterization techniques and concepts.Formulation Techniques: spray drying, blending, encapsulation (profill), suspensions, solutions, wet/dry fluid bed granulation, tablet compression, coating, milling, disintegration.Analytical techniques: PXRD, mDSC, TGA, PLM, HPLC, DVS, DLS, SEM, PION/Disso (SSKD, LLPS), Osmolality, Rheometer.

La Jolla

As a member of the Molecular Pharmaceutics Group - Define and implement screening and characterization strategies to provide solid form and formulation risk assessments of preclinical drug candidates within the Oncology therapeutic area.• Participate on multidisciplinary project teams and collaborate with colleagues to define and implement formulation design, crystallization, polymorph and salt screening activities according to project timelines.• Conduct solid state physical and chemical characterization of small molecules (active pharmaceutical ingredients, inhibitors, degraders).• Prepare formulations (solutions, suspensions, nano-suspensions) for in vivo PK/PD, Efficacy, & Toxicology studies from early-stage development to candidate selection phase.• Conduct small scale formulation development and stability studies and write up toxicology formulation transfer documents for pre-clinical safety studies.• Perform pharmaceutical profiles for post-CAN compounds which include: pKa determination, lipophilicity LogP/D, pH solubility, and chemical stability experiments. • Transfer and prepare HPLC analytical methods to examine degradation profiles and potency of novel drug candidates and formulations.• Championed the effort to incorporate Single Particle Analysis Technology via “The Solubility Company” into the MP workflow.• Write up technical documents for solid form nominations, general pharmaceutical profiles, and early candidate evaluations.• Member of Communications Team, Science Influence Team, & Capital Team.Analytical Instrumentation:• Proficient in PXRD, TGA, TGA-IR, DSC, PLM, PLM-HS, HPLC/UPLC, DVS, NMR, UV Vis, PSD (Zetasizer), Aqualab.• Knowledge of SEM/EDX, Pion-disso apparatus, HPLC-MS, Raman Spectroscopy.

Greater San Diego Area

• Group leader that facilitated the hiring, training, and growth of multiple scientists to meet the needs of the client. • Organized and coordinated a 5S of the client’s lab and inventory system (saved $90,000 on repurposed lab supplies and shortened workflow times leading to improved efficiency).• Utilized wet chemistry techniques to grow single crystals, scale up/isolate drug substances, and perform salt and polymorph screening. Prepared solution/suspension formulations and conducted solid-state characterization experiments.• Collaborated with colleagues and clients on project teams to effectively communicate experimental observations and plan for activities to maintain project timelines.• Developed and maintained close working relationships with a variety of clients; inherently providing consistent high-quality service.

General Chemistry and Organic Chemistry Laboratory Teaching Associate and Tutor

Worked in Clinical Trials Department

Basketball & Softball Referee for intramural basketball and softball games.

Researched Cell Molecular Neurobiology and assisted in publishing a research article. Performed experiments to test a newly discovered intracellular Ca2+ modulator (cADPR).

Bachelor Of Science, Major In Chemistry & Minor In Biology

Activities and Societies: American Chemical Society, UCI Chemistry Club, Student Homeless Outreach ClubRelevant Coursework: Medicinal.

Inorganic Chemistry

Activities and Societies: American Chemical SocietyGraduate Student Researcher Department of Chemistry, SDSU Principal Investigators: Dr..

Neurobiology, Swedish Language, Scandinavian Culture & Society

Study Abroad Program (EAP)