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:New Product Introduction:- Lead and contribute to proposal writing and review.
- Conduct facility fit assessments for new manufacturing programs, including risk assessments, failure mode analyses, and process impact evaluations.
- Oversee technology transfer activities between development and manufacturing. Translate process development reports into manufacturing batch records and SOPs.
- Provide hands-on manufacturing process training as part of technology transfer.
Project Management:- Develop and lead process improvement projects. Implement systems 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 a primary client liaison, ensuring high-quality contract manufacturing services. Act as a technical interface between internal teams and client partners.
Quality & Compliance:- Support root cause investigations and CAPA (Corrective and Preventive Actions) implementation.
- Author and manage change control for internal and client-related projects.
- Drive operational excellence in collaboration with Manufacturing by identifying and implementing process improvements.
Qualifications:- Bachelor's Degree in Sciences or Engineering or equivalent experience.
- 8 years of experience supporting biotech or pharmaceutical manufacturing operations. Experience with aseptic operations and drug product manufacturing is required.
- 5 years of experience in project management within a biotech, pharmaceutical, or CMO setting.
- Strong understanding of GMP regulations and compliance within manufacturing facilities.
- Ability to analyze and improve manufacturing process data.
- Excellent written and verbal communication skills (technical writing ability required).
- Ability to work cross-functionally within internal and external teams to 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.
