Senior Technical Product Lead

If you are unable to complete this application due to a disability, contact this employer to ask for an accommodation or an alternative application process. Senior Technical Product Lead Full Time Professional COSTA MESA, CA, US Salary Range: $155,000.00 To $175,000.00 Annually Overview: The Senior Technical Product Lead will drive product and project leadership within a drug product contract manufacturing organization (CMO). This role supports programs from initial facility fit assessment and technology transfer through client interaction, process improvements, validation, and commercial manufacturing. The Senior Technical Product Lead will be part of the MS&T (Manufacturing Science & Technology) group, leading client interactions, internal project management, and technical and business process improvements. This position is fully on-site at our facility in Costa Mesa, CA. Key Responsibilities: NewProductIntroduction: Lead and contribute toproposal writing and review. Conductfacility fit assessmentsfor new manufacturing programs, including risk assessments, failure mode analyses, and process impact evaluations. Overseetechnology transferactivities between development and manufacturing. Translateprocess development reports into manufacturing batch records and SOPs. Provide hands-onmanufacturing process trainingas part of technology transfer. Project Management: Develop and leadprocess improvementprojects. Implementsystems for improved GMP planning, scheduling, and execution. Oversee the lifecycle management of clinical and commercial programs. Develop and manage comprehensive project plans, sharing key deliverables with internal and external stakeholders. Serve as aprimary client liaison, ensuringhigh-quality contract manufacturing services. Act as a technical interface between internal teams and client partners. Quality & Compliance: Supportroot cause investigationsandCAPA (Corrective and Preventive Actions) implementation. Author and managechange controlfor internal and client-related projects. Driveoperational excellencein collaboration with Manufacturing by identifying and implementingprocess improvements. Qualifications: Bachelor’s Degree in Sciences or Engineeringor equivalent experience. 8 years of experience supporting biotech or pharmaceutical manufacturing operations. Experience with aseptic operations and drug product manufacturing is required. 5 yearsof experience inproject managementwithin a biotech, pharmaceutical, or CMO setting. Strong understanding ofGMP regulations and compliancewithin manufacturing facilities. Ability toanalyze and improve manufacturing process data. Excellentwritten and verbal communication skills(technical writing ability required). Ability to workcross-functionally within internal and external teamsto drive project success. Self-motivated, adaptable, and comfortable in a fast-paced contract manufacturing environment. Able to manage multiple projects simultaneously, ensuring on-time delivery and customer satisfaction. #J-18808-Ljbffr ADP, Inc.