Sr. Manager, QC Technical Resources

Who we are

At Ferrer we are a group of people who believe in the power of purpose. And our purpose is to make a positive impact in society and bring about change in an unjust world. We are the 24/7 activists fighting for a sustainable planet, equal opportunities for all and a healthy workplace. We reject greenwashing and empty promises - we are about action. That is why in 2022 we became a B Corp company.

Ferrer US (legally Alexza Pharmaceuticals) is part of Ferrer and is an R&D and Manufacturing center located in Fremont, CA. Our focus is to develop technologically advanced, forward-thinking and innovative products for our pipeline based on the Staccato One Breath Technology. We research, develop and manufacture novel, proprietary products for the acute treatment of underserved medical needs.

Job Summary

Provides technical/scientific oversight to the QC Technical Resources group in the areas of method development, method validation, and methods transfer for early development to late stage programs.  Works on complex issues where analysis of situations or data requires an in-depth evaluation of variable factors. Performs focused technical review of cGMP data packets for accuracy, completeness and scientific merit.  Networks with individuals or organizations inside and outside own area of expertise.

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

Why Ferrer?

• Make a positive impact in society
• Participate in volunteering activities
• Grow in a culture of trust, responsibility, and constructive feedback
• Enjoy a flexible working model & collaborative office experience to enable innovation and teamworking
• Make a real difference to the team and to yourself
• Take advantage of opportunities for development & learning
• Discover a range of benefits to support your physical, emotional and financial wellbeing