Sr Manager, QC Technical Resources

Responsibilities

• Provide guidance and development of QC Technical Resources staff in the areas of scientific knowledge of different analytical applications and analytical techniques to current industry standards. Provide mentorship in order to develop and challenge the QC Technical resources staff.

• Oversee QC Technical Resources team as they perform method feasibility and method validations for early phase through late stage development programs. Ensure analytical methods are ready for transfer to approved contract laboratories.

• Oversee internal transfer of analytical methods to QC for method validations of early development programs. Ensure analytical methods are appropriate for transfer into QC, and validated phase appropriately in QC.

• Oversee transfer of late stage analytical methods to designated laboratories as part of reproducibility of methods.

• Write method transfer protocols and reports as required.

• Lead technical discussion of methods to external and internal personnel to ensure successful and efficient method transfer.

• Assess commercial analytical test methods on a periodic basis for significant change that would require supplemental method validation.

• Work with Regulatory Affairs to assess the regulatory impact for required changes.

• Review data packages for scientific merit, regulation compliance and Good Documentation Practices. Data review includes but not limited to, QC testing data supporting product release, incoming material testing; stability studies, and qualification/validation/verification related studies and laboratory equipment logbooks.

• Perform timely data review with a high focus on data technical quality to ensure accuracy, completeness, cGMP compliance of QC test data according to material and drug product specifications and study protocols.

• Review existing QC SOPs related to method validation and method transfer to ensure the documents reflect current regulatory requirements for all marketed regions. Revise or create new QC SOPs as needed.

• Verify data transfer, calculations, and documented information such as reagent expiry, instrument calibration, logbook entries, standards, controls, etc. in data packages are present, complete, and accurate

• Verify that all analysis performed followed cGMP requirements and support existing product/material stability trends.

• Maintain data integrity of computerized files to support all documentation systems.

• Assist in various compliance related activities related to both internal and external audits.

• Lead lab investigation related to method validations to perform root cause analysis and deviation reporting.

• Complete training for test methods in timely manner.

• Act as Subject Matter Expert during Health Authority Inspections. Ensure inspection readiness of the labs.

• Write CMC sections for analytical methods in regulatory filings.

• Other duties as assigned

Skills Required

• Must be highly organized, detail oriented, capable of multi-tasking, and able to collaborate with individuals in a matrix environment

• Able to maintain detailed and accurate records

• Excellent communication skills both written and oral

• Motivated and flexible to work in a dynamic group

• Must work with a balance of both speed and accuracy

• Capable of working independently

• Ability to remember and accurately follow detailed instructions

• Experience with computer software such as WORD, EXCEL, etc.

• Experience in statistical programs such as JMP or Minitab

Education and Experience

• BS degree in scientific area or equivalent

• 10+ years of pharmaceutical, medical device or other FDA regulated experience

• Knowledgeable in FDA Guidance, ICH Guidelines, and ISO certifications

• Advanced knowledge of analytical methods and testing using QC related instrumentation

• Advanced knowledge of GMPs, safety regulations and data integrity

• Experience with eQMS such as Empower and OpenLab a plus

• Experience in Health Authority inspections a plus

• Experience in analytical method transfers to different marketed regions

Physical Requirements

• Prolonged periods of sitting at a desk and working on a computer

• Potentially prolonged periods standing

• Must be able to lift up to 15 pounds at times

• Must be willing to travel

The annual base salary for this role starts at $180,000. Individual title and pay may vary based on additional factors, including, but not limited to, job-related skills, experience, and relevant education or training consistent with applicable law. The initial salary range is just one component of the Company's total compensation and benefits package, which includes, but is not limited to, discretionary bonus; life, health, accident and disability insurance; and a 401(k) plan