Christopher Hofer Email & Phone Number

Greater Indianapolis

• Supports the Regulatory Program Teams in planning, budgeting, and implementation of a program of work to achieve regulatory strategy objectives.
• Leads translation of regulatory strategy into actionable plans for obtaining and maintaining product registrations.
• Ensures key study/task information has been captured in the regulatory plan of work to enable timely study initiation.
• Supports evaluation of unplanned studies and activities agreed by the Regulatory Leaders and affected function.
• Manages effective regulatory program implementation (study timelines, submission milestones) through active monitoring and intervention.
• Works to proactively anticipate and mitigate foreseeable challenges to submission milestones.

Greater Indianapolis

• Managed projects required for global product-chemistry registration in the areas of physical properties, analytical methods, and batch analysis of active ingredient and formulated products.
• Designed and implemented product specifications.
• Actively participated on global, cross-functional teams (Manufacturing, R&D, Regulatory, Supply Chain) to communicate project progress and timelines.
• Developed, validated, and executed analytical methods in the laboratory and worked directly with Contract Research Organizations to provide required data.
• Initiated, coordinated, and issued reports needed for registration and re-registration of end use products and active ingredients.
• Acted as Study Director to plan, write protocols, and carry out analytical studies in support of registration and development.

Indianapolis, Indiana Area

• Manage projects required for global product-chemistry registration in the areas of physical properties, analytical methods, and batch analysis of active ingredient and formulated products.
• Design and implement product specifications.
• Actively participate on global, cross-functional teams.
• Develop, validate, and execute analytical methods in the laboratory and work directly with Contract Research Organizations to provide required data.
• Initiate, coordinate, format according to requirements, and issue reports needed for registration and re-registration of end use products and active ingredients.
• Act as Study Director to plan, write protocols and carry out analytical studies in support of registration and development.

Indianapolis

- As Study Director, plan and write protocols, conduct and report GLP studies in support of product registration.- Manage the time and technical projects of laboratory technicians in the conduct of studies, data collection, and reporting.- Represent the function as a member on cross-functional teams, and communicate progress of projects and timelines to.

- Operated and calibrated GCMS and LCMS. - Participated in improvement of analytical methodologies.- Performed the initial analysis and interpretation on data from analytical instrumentation.- Reviewed quality control material to ensure data is acceptable and within limits. - Manually posted or checked auto-posting of QC and specimen results into LIMS..

Solid state characterization using various techniques including x-ray powder diffraction, DSC/TGA, HPLC, VTI, raman spectroscopy and birefringence microscopy.

Combination of logistics and supply chain responsibilities. Controlled entire plant’s productive material inventory as well as scheduled railcars/trucks and resolved shipment issues.

Certificate, Executive Certificate In Business Of Life Sciences

Completed certificate program in the business of life sciences.

Bachelor Of Science, Chemistry

Deans List

Bachelor Of Arts, History

Activities and Societies: Baseball, Phi Delta ThetaDeans List