Experience

Emalex Biosciences
• United States
• Biotechnology Research
• 1 - 100 Employee
• Director, Drug Product Development

  • Apr 2023 - Present


Radius Health, Inc.

• United States
• Pharmaceutical Manufacturing
• 100 - 200 Employee

• Executive Director, Neuroscience CMC Operations and Supply Chain

  • Feb 2021 - Oct 2022

  Worked to build out CMC team for global RAD011 asset. Named Head of Manufacturing and Analytical activities for RAD011 and represented CMC to key stakeholders (i.e., QA, regulatory, clinical, finance, and PV). Assumed oversight of CDMOs for drug substance, drug product, packaging and labeling, distribution, and analytical with multiple global vendors for RAD011. Drove technology transfers for both drug substance and drug product manufacturing, as well as associated methods. Led development and maintained budget allocated for RAD011 manufacturing activities. Show less



Novan, Inc.

• United States
• Pharmaceutical Manufacturing
• 1 - 100 Employee

• Vice President Product Operations, Supply Chain, Facilities Management

  • Nov 2018 - Feb 2021

  Hand-selected as Head of Supply Chain, Manufacturing, Facility, Procurement, and Analytical for all four company assets. Planned, implemented, and maintained budget for all of supply chain, manufacturing, facility, and analytical in collaboration with finance and company goals. Ensured regulatory filings contained current information for CMC sections with regulatory. Worked with R&D to aid in QbD experiments and new potential container closure options. Established and maintained relationships with all CMO vendors to ensure strong supply chain. Assumed primary accountability for company production of multi-formulations for clinical and non-clinical drug products and API. Oversaw procurement to include sampling and release testing of drug product raw materials. Managed all operational, safety, and environmental aspects and standards of physical plant. Drove data integrity gap assessment and execution of remediation plan for all operational equipment. Worked with PHMSA to gain clearance for API to ship. Gained certification of facility DHS to allow on-site storage of toxic chemical in large amounts. Show less

• Director of Analytical Services and Supply Chain

  • May 2018 - Nov 2018

  Oversaw day-to-day activities of analytical laboratory and ensured manufacturing maintained raw materials as requested. Collaborated with QA and manufacturing to streamline sample turnaround times and release of product. Worked with R&D to ensure testing of samples in a timely manner. Facilitated project management for vast majority of vendors and partners. Maintained active leadership involvement alongside QA on all new and implemented change controls. Trained and mentored six scientists in validation, method transfer, and qualifications. Show less

• Associate Director, Quality Control and Inventory Control

  • May 2017 - May 2018

  Served as head of QC and raw-material procurement. Managed delivery of analytical results for drug substance, drug product, raw materials, and intermediates from QC in timely manner while keeping production on track. Oversaw purchase, testing, and release of all raw materials used in manufacturing of drug substance and drug product. Negotiated contracts with third-party vendors for pricing and storage of raw materials. Established new and measurable procedures with contract warehouse for sample materials. Revised SOPs for workflow efficiencies for inventory control group. Created and developed stability evaluation team. Show less

• Quality Control Manager

  • Jul 2015 - May 2017

  Named quality control department head. Authored SOPs to ensure business compliance. Acted as laboratory lead for design and relocation plan of new facility. Assisted in MasterControl implementation to digitize methods, specifications, and SOPs. Responsible for gathering and presenting data to Specification Committee for drug substance, drug product, intermediates, and raw materials.

• Senior QC Chemist

  • Jan 2015 - Jul 2015

  Coached and trained all new employees. Led document writing and contributions for IND and NDA submission processes. Drafted and authored selected standard operating procedures. Evaluated, launched, and implemented Empower 2 to aid in identification of data integrity gap. Developed and implemented training regimen for new analytical chemist (both in QC and R&D).



Mayne Pharma

• Australia
• Pharmaceutical Manufacturing
• 400 - 500 Employee

• Quality Control Manager, Raw Materials

  • 2014 - 2015

  Supervise work flow for Laboratory Supervisors, Senior Analytical Chemists, Analytical Chemists and other laboratory personnel. Manage and create lab work schedule for 12 scientist in the Raw Materials lab. Responsible for the release of compendial (USP/EP/JP) excipients for both internal and external clients. Writing Analytical Standards for new incoming materials. Interaction with clients on specific projects, Writing and revising Standard Operating Procedures, Author OOS/OOT documents, analytical procedures, validation documents, Certificate of Analysis, Analytical Reports and other portions of regulatory submissions as directed. Ensure that all work is accurate, precise, properly documented, and performed within GMP guidelines, Installation Qualification/Operational Qualification of Instruments. Evaluation and Acquisition of Laboratory Instrumentation. Forecast Equipment and Personnel needs based on product forecast. Ensure achievement of laboratory, group and company goals Show less

• Quality Control Manager, Finished Products and APIs

  • 2013 - 2014

  Supervise work flow for Senior Analytical Chemists, Analytical Chemists and other laboratory personnel. Responsible for training new employees. Manage and create lab work schedule for 15 scientist in QC lab. Writing Documents for IND/NDA Submissions. Identification and trending of Release and Stability data for Commercial products. Preparation of Annual Product Review, Chemistry Section. Interaction with clients on specific projects. Writing Standard Operating Procedures. Stability Program Management. Author OOS/OOT documents, analytical procedures, validation documents, Certificate of Analysis. Analytical Reports and other portions of regulatory submissions as directed. Ensure that all work is accurate, precise, properly documented, and performed within GMP guidelines. Installation Qualification/Operational Qualification of Instruments. Evaluation and Acquisition of Laboratory Instrumentation. Member of the Compendial Harmonization Committee. Forecast Equipment and Personnel needs based on product forecast. Show less

• Laboratory Supervisor | Senior Analytical Chemist | Analytical Chemist

  • 2006 - 2013



Pitt Community College

• United States
• Higher Education
• 300 - 400 Employee

• Chemistry Instructor

  • 2010 - 2013

  Delivered lectures and demonstrated experiments to college students as per approved curriculum. Maintained weekly lesson plans. Motivated students to achieve their academic goals. Provided advice to students on attendance and behaviors. Maintained student attendance and progress reports. Worked positively with students and faculty. Delivered lectures and demonstrated experiments to college students as per approved curriculum. Maintained weekly lesson plans. Motivated students to achieve their academic goals. Provided advice to students on attendance and behaviors. Maintained student attendance and progress reports. Worked positively with students and faculty.