Method Development Manager

Austin, TX

Title: Method Development Manager

Reports to: Chief Scientific Officer


Position Summary:

The Method Development Manager provides all analytical aspects of product development, including technical oversight and execution of internal and external analytical development programs. This position reports to Chief Scientific Officer and will closely collaborate with the Director of Research & Development, Director of Manufacturing, and MSAT Manager.


Responsibilities:

Collaborate with R&D, Manufacturing, Commercial, and Operations teams by providing the following roles and responsibilities:

  • Define, manage, and execute analytical assay development strategy to encompass all aspects of testing active ingredients, raw materials, in-process (intermediate) and finished product testing using a variety of instruments, including HPLC/UPLC-DAD, HPLC/UPLC-MS, HPLC/UPLC-MS/MS, GC-MS, GC-MS/MS, and GC-FID
  • Ensure all analytical method development complies with ICH, AOAC, and applicable compendia and FDA/ICH regulatory guidance
  • Author, review, and manage method development protocols, SOPs, qualification, and validation protocols/reports to satisfy appropriate quality assurance and regulatory guidelines
  • Serve as subject matter expert and leverage industry knowledge in analytical chemistry and method development for employees and customers.
  • Attend R&D, MSAT, Manufacturing, and operations meetings as needed
  • Manage project plans, timelines, and deliverables associated with analytical method development
  • Manage and execute method development, qualification, validation, and transfer activities compliant with GMP and non-GMP guidelines
  • Provide and oversee routine sample analysis for newly developed methods to support internal and external processes and formulation activities
  • Analyze and interpret analytical data and provide conclusions to R&D, MSAT, and Manufacturing departments
  • Collaborate with Manufacturing, MSAT, and Quality Assurance to draft and review material specifications for GMP and non-GMP Manufacturing
  • Continue to identify and adopt new analytical methodologies to keep the organization competitive and industry leader
  • Work closely with R&D, Manufacturing, Analytical, and Quality Assurance Team (QAT) team to lead and resolve technical investigations and process issues and facilitate CAPAs as needed
  • Work with Lab Manager to transfer and qualify analytical methods into ISO/IEC 17025:2017 regulated environment for high throughput testing
  • Maintain and troubleshoot analytical instruments as needed
  • Train existing and new employees on new development methods and collaborate with quality assurance and third-party auditors


Requirements, Critical Skills, and Knowledge:

  • Ph.D. in a scientifically relevant field such as analytical chemistry; a master’s degree may be considered depending on experience
  • A minimum of 5 years experience in the pharmaceutical industry with knowledge of analytical method development chemistry and its applications towards product development, including but not limited to small molecules, amino acids, proteins, and volatiles (solvents, terpenoids)
  • Significant proficiency and proven experience in analytical development using techniques such as HPLC/UPLC and GC with a variety of detection, including DAD/PDA, MS, MS/MS, FLD, CAD
  • Working experience and knowledge of Thermo Fisher/Chromeleon are a plus
  • Extensive knowledge in GMP, ICH, USP, AOAC, and other regulatory guidance about method development, qualification, and validation required
  • Experience in the routine maintenance and troubleshooting with HPLC/UPLC and GC instruments
  • Experience working with formulation teams with knowledge of product development is preferred
  • Strong listening and speaking skills and ability to communicate at all levels within organizations
  • Must be able to think critically and strategically
  • Quick ability to conceptualize complex subjects and demonstrate understanding to all levels of employees, including associates to senior leadership
  • The breadth of analytical development experience from early workflows to later stages of commercialization and technology transfer is highly preferred


Working Conditions:

  • May require periodic hands-on learning, teaching, and execution of analytical development activities
  • This position requires heavy lifting (25 lbs. or more), exposure to potentially hazardous chemicals and active pharmaceutical ingredients
  • Extensive computer and phone usage, including Microsoft Office, Teams, Outlook, Visio, Excel, PowerPoint, Zoom, OneDrive, Minitab
  • 10-20% travel may be required
  • Must be able to work independently and collaboratively on complex projects
  • May require periodic evening, weekend, and holiday work, as necessary, to meet company deadlines



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