Michael Heberlein Email and Phone Number
👋About Me:Pharmaceutical Scientist with industry experience, specializing in solid-state characterization, formulation development, and analytical techniques. Proficient in designing and implementing screening and characterization strategies to assess solid form and formulation risks for novel drug candidates. Experienced with a large array of instrumentation. Motivated individual contributor capable of leadership and collaboration within a multi-disciplinary environment. 🔬 Expertise:Specializing in material science characterization, analytical development/techniques, formulation development, and solid-state experiments for small molecules. 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.Skills & Techniques: Polymorph screening, Salt Screening, Solution/Suspension/Nanosuspension formulations, HPLC method transfer and development, particle size analysis, pKa determination, lipophilicity LogP/D, pH solubility, physical and chemical stability, thermal analysis, crystallinity determination, single crystal growth, amorphous materials, hydration/dehydration kinetics, thermodynamic solubility, biorelevant media solubility, elemental analysis, potency determination, degradation profiling, hygroscopicity, purity. 🚀 Professional Journey:My professional journey began as a Graduate Student Researcher at SDSU/UCSD, where I delved into the synthesis of microporous solids, metal-organic frameworks and water oxidation catalysts. This laid the foundation for my interest in inorganic chemistry and ultimately led to my discovery of the need for solid form characterization of active pharmaceutical ingredients within the pharmaceutical industry.As a Scientist at Pfizer, I've been instrumental in defining and implementing screening strategies, preparing formulations for critical studies, and initiating the adoption of innovative technologies with external vendors such as Single Particle Analysis via “The Solubility Company”.Excited to start my new role as an Oral Formulation Development Scientist at Catalent Pharma Solutions. Looking forward to connecting with anyone wanting to discuss science and/or any potential future clients with formulation development needs.
Catalent Pharma Solutions
View- Website:
- catalent.com
- Employees:
- 8864
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Product Development Scientist 3Catalent Pharma Solutions Apr 2024 - PresentSan Diego, California, United StatesUtilize 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.
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Pharmaceutical ScientistPfizer Apr 2019 - Feb 2024La JollaAs 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. -
Crystallization Scientist, Group LeaderEurofins Lancaster Laboratories Pss Jan 2017 - Apr 2019Greater 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.
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Teaching AssociateSan Diego State University Sep 2012 - May 2016General Chemistry and Organic Chemistry Laboratory Teaching Associate and Tutor -
Laboratory AssociateQuest Diagnostics Apr 2012 - Jul 2012Worked in Clinical Trials Department -
Referee At The Anteater Recreation CenterUc Irvine Jan 2008 - Jun 2008Basketball & Softball Referee for intramural basketball and softball games. -
Lab Research AssistantUc Irvine Jun 2007 - Jun 2008Researched Cell Molecular Neurobiology and assisted in publishing a research article. Performed experiments to test a newly discovered intracellular Ca2+ modulator (cADPR).
Michael Heberlein Education Details
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Inorganic Chemistry
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Lund UniversityNeurobiology, Swedish Language, Scandinavian Culture & Society
Frequently Asked Questions about Michael Heberlein
What company does Michael Heberlein work for?
Michael Heberlein works for Catalent Pharma Solutions
What is Michael Heberlein's role at the current company?
Michael Heberlein's current role is Pharmaceutical Scientist | Formulations, Materials Characterization, Analytical Development.
What schools did Michael Heberlein attend?
Michael Heberlein attended Uc Irvine, San Diego State University-California State University, Lund University.
Who are Michael Heberlein's colleagues?
Michael Heberlein's colleagues are Elías Trotta, Si Ping Ou Yang, Chad Odgers, Sierra Hamlett, Jayne S., Tamara Hussain, Russell Hunter.
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Mike Heberlein
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Mike Heberlein
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Mike Heberlein
Minneapolis, Mn4gmail.com, aol.com, juno.com, russellreynolds.com3 +151733XXXXX
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