Program Manager, Research & Development
R&D | Santa Ana | CA
We are seeking an individual to plan, manage and coordinate R&D projects in a new product development program to ensure that overall program goals are met. Lead large, complex product development efforts for multiple projects aimed at developing and manufacturing GMP-grade cell culture media, reagents and devices used for the production of biotherapeutics (e.g. monoclonal antibody therapies and vaccines), regenerative medicine therapies (including stem cell therapy), and assisted reproductive technologies (ART). Responsible for all new product development activities from Concept through Product Launch, as well as tracking and reporting on post-launch activities.
- Coordinating and reporting on all project activities according to project scope, timelines and budget.
- Coordinating and managing routine new product development team meetings.
- Reporting project status to the new product development committee (NPC) consisting of a senior level management team that manages the product portfolio.
- Maintaining knowledge of technologies appropriate for managing the development process for new products.
- Working across departments (cross-functionally) with key team members to gather customer requirements for design input.
- Working with the finance and marketing core team members to develop the financial analysis for projects, and to gather information justifying each product’s potential for commercial success.
- Working with the operations team to efficiently and effectively transfer products from R&D to manufacturing.
- Communicating effectively with R&D management, commercial (sales and marketing), quality, regulatory, manufacturing, finance, and legal.
- Working to ensure that the project teams stays on track to deliver on objectives, meet timelines and stay within budget.
- Ability to influence across departments without direct authority.
- Providing needed administration support to all R&D new product development projects.
- Communicating externally with regulatory agencies, notified bodies, competent authorities, collaborators, vendors, beta-site testers, and customers on an as needed basis.
- Position requires substantial independent judgment, creativity and self-motivation.
- B.S. in Cell Biology, Biochemistry, Biotechnology, Chemistry or equivalent.
- Master’s Degree in a technical field or MBA is desirable.
- 10+ years relevant experience in industry or academic environment.
- 6+ years in Program Management in New Product Development utilizing a formal phase-gate process with demonstrated success.
- Strong understanding and practical knowledge of Design Control including, but not limited to, design input, design output, verification and validation process, drug master files, risk assessments, technology transfer from R&D into manufacturing, and producing quality products that meet customers’ needs.
- Experience in a regulated industry such as medical devices is highly preferred.
- Strong understanding of GMP and GLP is highly preferred.
- Understanding of cell culture media business environment is preferred.
- Understanding of cell culture techniques, technologies, concepts, practices and procedures is desirable.
- Ability to build collaborative relationships and facilitate a collaborative environment.
- Ability to work with team to address challenges, trouble-shoot and deliver on action items.
- Experience in technology licensing and contract negotiation is preferred.
- Highly proficient in Microsoft Excel, Word, PowerPoint, Outlook, and Microsoft Project (or equivalent software).
- Excellent verbal, written, electronic communication, and oral presentation skills are required.
- Ability to communicate and interact at all levels from senior management to staff level.
- A Program Management certification such as a PMP certification is desired.
- Experience in hiring and directly managing employees is desirable.
To Apply: Please send resume to: firstname.lastname@example.org. Please put R&D Program Manager 122818 in the subject line.
Principals only. No recruiters please.
FUJIFILM Irvine Scientific is an equal opportunity employer. All qualified candidates will receive consideration for employment without regard to race, color, religion, sex including sexual orientation and gender identity, national origin, disability, protected Veteran status, or any other characteristic protected by applicable federal, state, or local law.