Summary Affinivax has an exciting new opportunity to join the QA team as a Senior Manager.
In this role you will have internal and external responsibilities to support on-going projects to ensure that Affinivax is compliant with all applicable rules and regulations.
This is a unique opportunity for an individual to work in a clinical stage Quality department and gain experience in many areas of Quality Assurance.
Your Role You will be responsible for batch disposition and Release Functions including: MBR Approval Perform GMP batch record review CoA review and approval Material disposition Interaction with CMOs regarding matters of Quality Assurance and review and release of all chemicals used internally Negotiate quality agreements with all CMOs and applicable suppliers.
Ensure quality agreements are consistent with Affinivax procedures and requirements.
Responsible for review and approval of specifications for Components, Raw Materials, Drug Substance, and Drug Product.
Approve stability protocols for GMP material and review and approval of final stability reports.
Perform audits of CMOs and critical material suppliers as defined in internal procedures.
Review and approve analytical method qualification/validation documents.
Additional duties and responsibilities as required.
Your Background Bachelor’s degree, or advanced degree in Chemistry, Biology, Engineering, or related field.
10 years of industry experience (5 years of QA experience) in biopharma.
Experience with biologics (bacterial fermentation preferred).
Experience with Good Documentation Practices including Batch record review.
Experience with review and disposition of clinical materials for human use.
Knowledge of regulatory requirements for early phase biologics.
Able to respond to changing priorities and expectations in a fast-paced environment.
Ability to foster effective relationships with vendors and colleagues.
Excellent communication, written, and presentation skills for interfacing with internal and external organizations.
Experience performing audits of CMOs and suppliers.
Strong collaboration skills.
Ability and desire to work in a fast-paced environment.
Ability to think through the process, and accurately apply and adapt regulatory standards.
Able to understand the QA function in a start-up entity and the ability to make decisions on a go/no go basis.
The ability to work effectively within a variety of situations and adapt to changes in job demands.
Pursues tasks with energy, drive, and initiative; even in a fast-paced environment.
Comfortable in a results-driven, highly accountable environment, where you can make an impact.
Builds productive working relationships across key groups at Affinivax.
Ability to handle multiple responsibilities simultaneously and still meet high quality and timelines under pressure.