CHRISTOPHER MAHN SAN DIEGO, CA ***** 858-***-**** ac02rc@r.postjobfree.com

SCIENTIST, DRUG PRODUCT DEVELOPMENT

Preclinical through Phase 2 CMC Regulatory

I aim to use my passion for drug development and scientific discovery to work in a close-knit team to develop nascent technology for proof of concept testing. As a dynamic blend of scientist and project manager with 10+ years experience, I effectively manage multiple complex development projects and facilitate group success through a combination of excellent scientific work, clear communication, and collaboration. I thrive in fast-paced organizations and especially enjoy the challenge of driving diverse responsibilities to positive outcomes. CORE COMPETENCIES

Program/Project Management Data Analysis & Interpretation

Process Development Formulation Development

CFR/FDA/GxP/ICH Guidelines Regulatory Compliance

Experimental Design Analytical Chemistry

Pharmaceutical Manufacturing Quality Systems

KEY ACHIEVEMENTS

• Designed and executed 15+ projects for multiple therapeutic targets with phase-specific strategies for process development, manufacturing, formulation, and analytical development to achieve CMC objectives for national/international clients

• Implemented an internal workflow process to identify critical path items to functional leads that resulted in the completion of numerous IND-enabling projects (>90% on-time and on-budget)

• Managed potential risks by identifying and proffering solutions to stakeholders resulting in the elimination of project delays

• Led injectable business unit to contribute 22% and 31% of overall revenues in its first two years Principal – CM Consulting (January 2017 – present) Left prior role to start consulting and bring scientific and technical expertise to clients in need of regulatory-driven solutions to drug product development challenges.

• Designed preclinical development plans for a small molecule drug product through the 505(b)(2) pathway providing both risk-averse and risk-tolerant timelines

• Worked with biopharmaceutical project team to integrate regulatory requirements and tasks and create a realistic, actionable timeline

• Collaborated with management to develop high-level strategies to accomplish specific corporate objectives Senior Scientist, Program Manager – IriSys, LLC (December 2014 – December 2016) Moved into a leadership role based on demonstrated scientific and technical expertise and sound judgment. Responsible for managing the new aseptic manufacturing unit and leading client drug development programs from concept to product.

• Adapted relevant ideas from scientific literature to successfully develop drug products across a range of liquid dosage forms for various routes of administration (oral, subcutaneous, intramuscular, intravenous)

• Designed studies and led research efforts in process, formulation, analytical, and manufacturing development to overcome technical challenges and meet project objectives

• Provided project and technical leadership in formulation development, analytical characterization, and process development for projects involving nanosuspension/nanoparticle technology

• Utilized project management tools to improve GMP manufacturing operation efficiency through improved planning and resource utilization

• Interpreted and implemented regulatory requirements for aseptic manufacturing of injectable drug products and passed FDA and California FDB inspections

• Implemented effective communication strategies with team members across functional groups and external CROs to improve integration of project activities

• Actively managed projects to control project scope and facilitate discussions with clients and senior leadership regarding contract modifications

• Provided strong client support; authored development and technical reports, meeting agendas and minutes, led progress meetings, and collaborated in high-level strategy discussions

• Worked with junior scientists to improve critical thinking skills Senior Research Associate, Project Manager – IriSys, LLC (August 2014 – December 2014) Given increased scientific and technical responsibilities and tasked with the management of a translational project in collaboration with The Scripps Research Institute and ChemDiv to develop a targeted liposomal drug product and establish proof-of-concept.

• Critically evaluated scientific literature to design appropriate experiments and incorporate Quality By Design

(QbD) principles to achieve development objectives

• Developed a robust, scalable manufacturing process by incorporating research-based manufacturing methodologies during process development

• Developed and optimized a novel reverse-phase HPLC method to assess manufacturing purity and quantification of ligand in drug product

• Designed multiple novel assays to characterize liposome drug product and illustrate in vitro performance

• Integrated in-house development activities with CROs to evaluate formulations and meet aggressive deadlines

• Collaborated on patent application

Research Associate – IriSys, LLC (June 2014 – August 2014) Hired as a bench scientist to provide analytical expertise in topical and oral liquid formulation development projects.

• Influenced oral liquid product design by demonstrating oxidative instability of various flavor/color agents

• Solved viscosity stability problem in a topical product by researching and optimizing manufacturing process

• Optimized common assays for topical and oral liquid drug products Graduate Researcher, Staff Research Associate III, Researcher – UCSD (2003 - 2014) Began research career and held various positions that developed broad, foundational knowledge in scientific research and project management.

• Managed a diverse scope of projects including multi-disciplinary research projects, research expeditions, and federal grant applications

• Solved significant technical challenges using analytical and engineering problem-solving skills

• Developed and executed a broad range of analytical assays for characterization of complex samples

• Authored and contributed to 15+ peer-reviewed publications and presentations

• Collaborated with scientists internally and on multi-national projects to achieve research objectives

• Mentored and trained junior scientists

EDUCATION

Marine Chemistry and Geochemistry (Ph.D. Candidate) - University of California, San Diego B.S. Earth Science, Chemistry - University of California, San Diego AREAS OF INTEREST

Rare/Orphan Disease, Pediatric, & Neonatal Drug Development R&D evaluation of novel technology

TECHNICAL TRAINING

Project Management Professional Certificate (expected in July 2017) - Project Management Institute Leading People & Teams Specialization - University of Michigan Biofuels Science – Analytical Chemist Certificate Program - University of California, San Diego Extension

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