Specification Lead, Quality Operations

The Position

This position resides within the Integrated Quality Operations team and serves as the owner of the specification lifecycle for Arrowhead's product portfolio, from early phase clinical development, through late phase clinical, and commercial supply. The Specification Lead is responsible for the creation, review, approval, revision, periodic review, and version control of specifications for intermediates, drug substance, drug product, and finished goods, and for ensuring that there is agreement on and justification that the acceptance criteria are phase-appropriate, justified, tighten appropriately as programs progress, and remain aligned with filed commitments and compendial requirements. The Specification Lead works closely with Analytical and Process Development, Quality Control, CMC, Regulatory Affairs, Manufacturing, and Supply Chain.

Responsibilities

• Serve as the Quality owner of the specification lifecycle for intermediates, drug substance, drug product, and finished goods across clinical and commercial programs.
• Author, review, and route specifications for approval, and maintain version control, effective dating, and distribution within the electronic document management system.
• Ensure acceptance criteria are phase-appropriate and scientifically justified, working collaboratively with Analytical and Process Development, Quality Control, CMC, and Regulatory Affairs as criteria are established and tightened from early phase through process validation and commercial supply.
• Maintain alignment between approved specifications and registered or filed commitments (IND/CTA/IMPD and NDA/BLA/MAA), and ensure specification changes are assessed for regulatory impact and filing requirements prior to implementation.
• Maintain alignment with compendial requirements (USP, Ph. Eur., JP), monitor compendial forecasts and revisions, and support the assessment of the impact of monograph and general chapter changes on specifications and associated test methods.
• Lead periodic review of specifications on the defined cycle, including verification of current test methods, references, acceptance criteria, and regulatory and compendial alignment.
• Own specification change controls, including impact assessment, coordination of downstream actions (test method and procedural document updates, certificate of analysis templates, batch record and label updates), and verification of implementation.
• Maintain the specification index and ensure traceability between specifications, test methods, reference standards, and material and product codes.
• Support new program onboarding and technical transfer by establishing initial specifications for new materials, intermediates, and products.
• Track and report specification program metrics, including on-time completion of periodic reviews, open specification change controls, and record aging.
• Maintain inspection readiness for the specification program and serve as the subject matter expert for specification related questions during audits and health authority inspections.
• Write, review, update, and issue applicable Procedural Documents governing specification creation, revision, periodic review, and compendial monitoring.
• Collaborate with, and provide quality support for, other departments (Analytical Development/QC, CMC, Regulatory Affairs, Manufacturing, Supply Chain, Project Management, etc.).
• Maintain knowledge of current compliance expectations and regulations pertaining to specifications and analytical testing (e.g., 21 CFR Parts 210/211, ICH Q1A(R2), Q2(R2), Q3A/Q3B, Q3C/Q3D, and Q6A/Q6B, and USP/Ph. Eur. compendial requirements).
• Other duties consistent with the position as assigned from time to time.

Requirements

• Bachelors Degree in Chemistry, Biology, Engineering, or a related scientific field
• 5+ years of pharmaceutical or biotechnology experience in Quality Assurance, Quality Control, or Analytical Development, including direct experience with specifications and analytical test methods.
• Demonstrated experience authoring, revising, and approving specifications for raw materials, drug substance, and/or drug product.
• Working knowledge of compendial requirements (USP, Ph. Eur., JP) and their application to specifications and test methods.
• Working knowledge of analytical methods and data sufficient to evaluate acceptance criteria, reporting conventions, and method suitability.
• Experience with change control and document control within a GMP environment.
• Working knowledge of US and international GMP regulations and ICH guidance applicable to investigational and commercial products, including phase-appropriate acceptance criteria.
• Excellent attention to detail and demonstrated ability to manage a high volume of controlled documents accurately.
• Excellent communication skills and ability to work with diverse professionals across quality, analytical, regulatory, and manufacturing functions.
• Highly motivated team player willing to contribute to a growing pharmaceutical organization.
• A detail-oriented self-starter who endeavors to anticipate and resolve problems and seeks opportunities to grow their role and responsibilities at Arrowhead.

Preferred

• Advanced degree in a science field.
• Experience supporting an NDA/BLA/MAA submission, including preparation or justification of specifications.
• Experience managing specifications through the transition from early phase into late phase and commercial supply.
• Experience with compendial change monitoring and assessment of monograph and general chapter revisions.
• Experience configuring or verifying specifications within LIMS and/or ERP systems.
• Experience applying statistical evaluation of manufacturing and analytical data to support setting of acceptance criteria.
• Experience with sterile/parenteral drug product and with oligonucleotide, peptide, or biologic modalities.
• Experience with electronic quality management and document control systems (e.g., Veeva Vault, TrackWise, MasterControl).
• Additional Quality/Regulatory related certification desired, such as CQA, CQE, RAC, etc.