1+ months

R&D Project Manager

Kelly Services
Santa Ana, CA 92702
**Kelly Services is currently seeking a** **R&D Project Manager** **for a Direct Hire role in Santa Ana.**

**Job Title** : **R&D Project Manager**

Pay: $125 134k depending on experience

***Must be Six Sigma certified**

**Job Function:**

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.

**Job Duties:**

1. Coordinating and reporting on all project activities according to project scope, timelines and budget.

2. Coordinating and managing routine new product development team meetings.

3. Reporting project status to the new product development committee (NPC) consisting of a senior level management team that manages the product portfolio.

4. Maintaining knowledge of technologies appropriate for managing the development process for new products.

5. Working across departments (cross-functionally) with key team members to gather customer requirements for design input.

6. Working with the finance and marketing core team members to develop the financial analysis for projects, and to gather information justifying each products potential for commercial success.

7. Working with the operations team to efficiently and effectively transfer products from R&D to manufacturing.

8. Communicating effectively with R&D management, commercial (sales and marketing), quality, regulatory, manufacturing, finance, and legal.

9. Working to ensure that the project teams stays on track to deliver on objectives, meet timelines and stay within budget.

10. Ability to influence across departments without direct authority.

11. Providing needed administration support to all R&D new product development projects.

12. Communicating externally with regulatory agencies, notified bodies, competent authorities, collaborators, vendors, beta-site testers, and customers on an as needed basis.

13. Position requires substantial independent judgment, creativity and self-motivation.


+ B.S. in Cell Biology, Biochemistry, Biotechnology, Chemistry or equivalent.

+ Masters 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.


**Why Kelly** **** **?**

Kelly Science & Clinical is your connection to premier scientific and clinical companies looking to hire talented people just like you. Every day, we match science professionals with dream jobs that fit their skills and interestsits the way we think job searching should be. Nearly 100 percent of our science recruiters have a professional background/education in science, so we know a thing or two about the science market and how to get you noticed.

**About Kelly** ****

At Kelly, were always thinking about whats next and advising job seekers on new ways of working to reach their full potential. In fact, were a leading advocate for temporary/nontraditional workstyles, because we believe they allow flexibility and tremendous growth opportunities that enable a better way to work and live (plus, did we mention we provide a ton of benefits ?). Connecting great people with great companies is what we do best, and our employment opportunities span a wide variety of workstyles, skill levels, and industries around the world.

Kelly is an equal opportunity employer committed to employing a diverse workforce, including, but not limited to, minorities, females, individuals with disabilities, protected veterans, sexual orientation, gender identity. Equal Employment Opportunity is The Law. (
Posted: 2021-08-23 Expires: 2021-10-07

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R&D Project Manager

Kelly Services
Santa Ana, CA 92702

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