My client a leading Pharmaceutical company now require an Associate Director Process Validation - Biologics to join their expanding team.
The Associate Director Validation - Biologics will represent my client’s quality organization in the day to day support and oversight of technical transfer, validation, GMP production and operations at contract manufacturing and packaging including storage and distribution for all clinical and commercial products.
This is a permanent role based in Dublin City Centre which will come with a strong salary and benefits package. There will be some flexibility on working from home.
Responsibilities of Associate Director Process Validation - Biologics
- Lead Validation input for the Biologics programs for my client and CMO partners.
- Maintain, manage, and enhance Validation Master Plan for the Biologics Program
- Ensure that Validation approach meets commercial and clinical phase appropriate requirements of US/EU and OUS regulatory territories
- Provide expertise and guidance in interpreting existing and emerging regulations, agency guidelines and internal policies to assure compliance as relates to Validation
- Collaborate with cross-functional teams to provide Validation leadership for Biologic Drug Substance and Drug Product manufacturing
- Represent Validation on Technology Transfer Teams
- Provide Validation and technical input to Biologic Drug Substance and Drug Product CMC Product Teams
- Provide support to the Senior Director Quality, (Development & External) and act as designee where required, including CMC support /representation.
- Provide Validation representation, guidance, leadership, and direction to CMO’s, Process Development, and External Operations teams for both Biologics Drug Substance and Drug Product clinical and commercial.
- Provide technical and Validation expertise for product quality decisions and project team decisions
- Provide on-going validation support to External Partners (CMOs) in resolving validation related issues
- Evaluate proposed process changes and improvements, assesses validation impact and provides a “calibrated” technical review of change control requests, deviations and Master Batch Record changes
- Participate, as a Subject Matter Expert at CMO audits
- Support investigations associated with major deviations
- Author, review and / or approve documents (SOPs, deviations, CAPAs, change controls, etc.)
- Review and approve product lifecycle documentation for biologics program generated (Development Reports, Risk Assessments, Control Strategy, Specification and Validation Acceptance Criteria Documentation)
- Review and approve Validation documentation generated by CMOs
- Provide QA oversight for regulatory submission for Biologic products
- Provide SME input for Supplier Quality audits
- Provide QA oversight of technology transfer for Biologics products
- Provide input into negotiation of quality agreements with Biologic contract organizations
- Master’s or Bachelor’s degree in biology, biochemical / chemical engineering, pharmaceutical science, or related field
- Minimum of 8+ years of progressive industry experience in the area of Biologics Validation to include a minimum of 4+ years leadership/ management experience
- Experience in implementation of Validation Approach to support production of clinical trial materials for Biologic Drug Substance and Drug Product manufacturing, technical transfer, and Validation
- Experience in supporting regulatory audits (FDA, EMEA, PMDA, etc.) in support of pre-approval and general inspections
- Experience with Validation Oversight experience of Contract Manufacturing Organizations
- There will be US travel involved, I can explain more on the pattern
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The RFT Group, BioPharmaceutical Division specialize exclusively in the recruitment of scientists, engineers and executives for the biotechnology, pharmaceutical and medical device sectors.
For more information please contact John at The RFT Group / www.rftgroup.ie / 01 2302400 or click apply below