The candidate is responsible for the design and implementation of manufacturing process validation for biological vaccine candidates compliant with the current Food and Drug Administration (FDA) regulations and guidance, and the International Committee on Harmonization (ICH) guidance. The candidate is to provide technical expertise to product teams in regards to risk based compliance management for manufacturing, strategic validation of manufacturing processes, equipment, analytical methods, and computer systems. Candidate is responsible for protocol generation, execution, and report writing as well as oversight for staff performing similar activities. Candidate to work in conjunction with team members and stakeholders to anticipate and manage changes to projects, such as but not limited to, technical requirements, business requirements and schedule.
- Responsible for writing process validation master plans, oversight of process validation master plan execution, reviewing and compiling resultant data, writing and compiling validation reports, and maintaining re-validation site requirements.
- Responsible for ensuring all documentation associated with process validation activities is accurate prior to and after execution.
- Act as a validation subject matter expert for resolution of deviations, assessment of change controls and other quality systems.
- Establish process validation approaches for new processes, tech transfer of existing processes in the drug substance and drug product manufacturing areas. Incumbent will liaise with external contract manufacturing drug product partners as needed.
- Maintain process and cleaning operations in a state of compliance via periodic validation reviews and re-validation, as needed.
- Oversee activities related to shipping qualification for process intermediates, drug substance and drug product shipments.
- Oversees the ongoing review of project(s) status; identifies risks. Develops, recommends and implements risk mitigation solutions and implements as appropriate.
- Train company or contract personnel who will be executing validation protocols on how to execute the protocols.
- Required to write technical portions of Requests for Proposals (RFP's) and Scopes of Work (SOW) for subcontract of various efforts associated with process validation. Responsible for the review of Subcontractor's facility, utility, and equipment validation reports.
- Creates and implements schedules, validation budgets, and objectives for projects. Determines need for and impact of changes in scope of project and makes and implements recommendations based on determinations. Gains concurrence, approval, and consensus from stakeholders regarding the various project aspects, adjusts accordingly.
- Support regulatory submission validation sections for new processes, and/or changes to existing processes for various geographies. Act as validation SME during compliance audit inspections and provide responses to regulatory submission questions from agencies.
- Supports manufacturing change controls, investigations, and deviation closure as necessary.
Sanofi pasteur Biologics is an equal opportunity employer M/F/D/V.
- Must demonstrate expert knowledge of CGMPs, FDA/CFR's relevant to CGMP manufacturing and process validation, applied knowledge of biologics manufacturing (from process development through formulation, filling, and finishing of parenteral products).
- Possess demonstrated technical writing, leadership and management skills including excellent planning skills, timeline development skills, and contingency planning skills. Must possess the ability to negotiate with management and customers. It is anticipated that the successful candidate will possess excellent interactive skills, planning skills, presentation skills, and exhibit strategic thought processes
- The candidate must be self-motivated, able to correctly set his/her own priorities for the multiple projects that will be simultaneously managed, and meet project deadlines and budgets. Teamwork and collaboration skills are integral to the position.
- Strong leadership, communication, and organizational skills required.
- Ability to maintain project plans and actions with strong computer skills in MS Project, Word, Excel, and PowerPoint
- Position requires management of direct report(s).
B.S. with at least 15 years or M.S. with at least 10 years of extensive experience in biologics process validation is required, including equipment, analytical method validation and process validation of biologics purified drug substances and final formulated drug substances. A degree in biochemical engineering/biotechnology or related discipline is highly preferred.
Sanofi Pasteur - 2 years ago
Sanofi Pasteur helps you guard against getting sick in the first place. The company is the US unit of Sanofi Pasteur SA, the vaccines...