Manage data review program

• Review raw data and data summaries provided by contract testing facilities
• Provide timely feedback to testing laboratories regarding necessary corrections to raw data and summaries
• Perform electronic data entry and verification

Manage reference standard and critical reagent program

• Maintain inventory of reference standards and critical reagents at contract testing facilities
• Manage the qualification and requalification of new reference standards and critical reagents

Manage analytical method lifecycle

• Design and maintain the analytical method monitoring program
• Recommend improvements to existing test methods
• Manage the transfer of test methods to contract laboratories including review and approval of protocols and reports
• Participate in the development and validation of new test methods

Initiate and review Quality System records

• Review deviations, OOS/OOT investigations, supplier change notices and change control records as Quality Control subject matter expert
• Author, review and revise Quality Control SOPs
• Manage submission of Quality Control documents into electronic document management system

Support regulatory filings

• Participate in the preparation of regulatory documents (e.g., IND, IMPD, BLA, NDA, MAA) and requests for information including data verification of content
• Participate in the preparation of Annual Product Quality Reviews including data verification of content

• Other duties as assigned

Qualifications/Requirements:

• Bachelor’s degree in biology, chemistry, biochemistry, microbiology, or related field
• 6+ years in pharmaceutical/biopharmaceutical Quality Control / Analytical Science environment; experience with biologics preferred
• Detailed knowledge of analytical techniques and compendial methods used for testing of proteins and small molecules
• Proficiency in GMP analytical data review
• Demonstrated understanding of laboratory investigation methodology for OOT and OOS results
• Demonstrated knowledge of GMP principles and regulatory guidance
• Competent technical writer with expertise in authoring method protocols and reports as well as SOPs and Quality System records (deviations, investigations, change controls)
• Prior use of a LIMS application or electronic database
• Proficient with Microsoft Applications (Word, Excel, Outlook, SharePoint, Teams, etc.)
• Data-driven mindset with eye for detail
• Robust problem-solving abilities
• Capable of maintaining direction while working independently
• Ability to identify and adapt to changing priorities: determine what matters most
• Ability to articulate issues to management in a timely manner
• Self-motivated: ability to interact with a multi-disciplinary remote-based team
• Effective written and verbal communication skills

Preferred Experience, Special Skills and Knowledge:

• Previous partnership with external contract laboratory to coordinate activities between sponsor and service provider
• Prior author of regulatory submissions of IND, IMPD, BLA, NDA, MAA
• Previous contribution to annual product quality review (APQR) process