Experience

Aclaris Therapeutics, Inc.

• United States
• Pharmaceutical Manufacturing
• 1 - 100 Employee

• Director of Analytical Sciences

  • Nov 2022 - Present

  Responsible for oversight of all company outsourced analytical development activities including method development, validation and technology transfer for starting materials, intermediates, API and drug products by providing operational, scientific, and technical leadership for all development programs, including early to mid-staged clinical development assets, as well as compounds transitioning from discovery to early development. Responsible for oversight of all company outsourced analytical development activities including method development, validation and technology transfer for starting materials, intermediates, API and drug products by providing operational, scientific, and technical leadership for all development programs, including early to mid-staged clinical development assets, as well as compounds transitioning from discovery to early development.



Mallinckrodt Pharmaceuticals

• Ireland
• Pharmaceutical Manufacturing
• 700 & Above Employee

• Sr. Research Manager

  • Feb 2017 - Nov 2022

  • Hired, mentored and developed employees. Provided effective leadership and technical guidance to team members of all levels, and conducted performance reviews.• Participated in product development project teams as CMC lead or functional area representative. Provided comprehensive project analysis to senior management in the form of reports and presentations. • Established, managed and led the CMC development plan for drug substances and drug products from clinical through commercial development utilizing internal and external resources (CMO’s/CRO’s).• Directed/oversaw contract manufacturing and testing operations for the company’s drug substances and drug products. Acted as primary liaison with contractor(s) on assigned projects. • Reviewed and approved master batch records from all manufacturing activities, analytical release testing, stability studies and investigations. Guided external operations through tech transfer, process and method development, optimization, qualification and validation. • Worked with Quality and Regulatory, develop SOPs and guidelines and ensure that all company policies were adhered to and all external manufacturing activities comply with relevant regulations. • Prepared CMC regulatory filing sections (domestic and international).• Served as key member of Mallinckrodt-academia collaborations in drug discovery that involves identification and selection of drug candidates. Show less

• Research Manager / Group leader

  • Dec 2003 - Feb 2017

  • Led group activities involving analytical method development, validation and transfer, and unknown identification for drug substances and products in support of regulatory submissions (NDAs/ANDAs/BLAs). Prepared CMC documentation pertaining analytical development for the filings and responses.• Explored new analytical technologies for effective support of product development and manufacturing activities; responsible for successful implementation of several new technologies (UPLC, LC/MS, DART, IMS, FL, CAD and ELSD).• Successfully led an analytical team in a multi-year project to explore new technologies to address FDA’s concerns about genotoxicity of Mallinckrodt’s products that impacts multi-million sales of APIs. • Provided due diligence for the organization to make informed decisions on new business acquisition, technology transfer, and API supplier selection. Conduct audit of CROs/CMOs. Show less

• Sr. Analytical Research Chemist

  • Aug 2002 - Dec 2003

  • Responsible for development/validation of analytical methods for the analysis of drug substances and drug products, and transfer them to corporate manufacturing plants, contract labs and/or contract manufacturing facilities. • Served as core team member for multi-functional product development teams, while representing analytical CMC.



Akorn Inc.

• Decatur, Illinois Area

• R&D Supervisor (05/01–08/02), R&D Scientist (07/98 – 05/01), ,

  • Jul 1998 - Aug 2002

  • Lead 4-5 chemists in developing and validating analytical methods to support FDA and foreign regulatory submissions of new injectable and ophthalmic products, with emphasis on HPLC, GC, IC, AA and ICP; Prepare analytical portion of CMC section for regulatory filings and responses. • Prepare, review and approve technical documentation, including SOPs, method validation protocols and reports, specifications of drug substances and drug products, and technology transfer. • Oversee the purchase and IQ/OQ/PQ of analytical instruments. • Conduct investigations and prepare reports on OOS/OOT and non-compliance of cGMP, GLP and company SOPs and prepared deviation reports. Show less



Conair Inc.

• Rantoul, IL.

• Chemist

  • Sep 1997 - Jul 1998

  • Develop methods; perform physical and chemical testing of personal care products using HPLC, GC, UV, IR, etc. • Perform calibration and maintenance of analytical instruments. • Develop methods; perform physical and chemical testing of personal care products using HPLC, GC, UV, IR, etc. • Perform calibration and maintenance of analytical instruments.



University of Florida (Tropical Research and Education Center)

• Homestead, Florida Area

• Chemist

  • Mar 1997 - Sep 1997

  • Led the effort in setting up an analytical lab for processing and testing of agriculture samples • Acquired and set up analytical instrument including HPLC and elemental analyzer • Performed physical and chemical testing of various agriculture samples including soil, water and plants. • Led the effort in setting up an analytical lab for processing and testing of agriculture samples • Acquired and set up analytical instrument including HPLC and elemental analyzer • Performed physical and chemical testing of various agriculture samples including soil, water and plants.



Dept. of Chemistry, Rutgers Univ.

• Piscataway, NJ.

• Postdoctoral Research Associate

  • May 1996 - Mar 1997

  • Conduct research on characterization and quantitation of trace metals in various materials with emphasis on ICP/MS and HPLC-ICP/MS. • Maintain and supervise undergraduate students the use of analytical instruments. • Conduct research on characterization and quantitation of trace metals in various materials with emphasis on ICP/MS and HPLC-ICP/MS. • Maintain and supervise undergraduate students the use of analytical instruments.