Palo Alto, California

Director of Quality Control - Cell Therapy, Palo Alto, CA

Direct Hire

Seeking a Director of Quality Control to ensure compliance with all Federal and State regulations governing the manufacturing of cell and gene therapy products for Phase I/II clinical trials conducted under Investigational New Drug (IND) applications. The Director will oversee the quality control activities related to process development, manufacturing and release testing of products and novel analytical development and assay testing; will ensure facilities and manufacturing operations are conducted according to current Good Manufacturing Practices (cGMP); will provide training and certification for manufacturing and quality control staff; will control distribution, tracking and archiving of clinical materials and provide validation support for all equipment and processes essential to the production of biotechnical products.

 

Duties include:

• Provide strategy and vision; make decisions that establish objectives for the overall direction or operation of a significant project(s) or area(s).
• Manage staff of a large science, engineering, and/or technical research area, which includes recruiting, hiring, developing, evaluating and setting priorities; manage business, technical, and educational activities for direct reports including managers and technical experts.
• Identify, clarify, and resolve issues with strategic impact and substantial significance, which spam multiple areas, using advanced technical and professional knowledge requiring broad discretion and judgment.
• Collaborate with others on the direction of activities relevant to long-term objectives. Develop strategies to ensure effective achievement of objectives.
• Develop policies and procedures as they relate to academic or program activities.
• Implement, evaluate and maintain quality control standards to ensure program success.
• Establish, oversee and manage financials and schedule for large programs and/or multiple projects.
• Recommend the adoption of emerging technologies and the development of new methods and approaches.
• Negotiate with internal departments and external agencies with authority to commit resources and effort.
• Serve as a liaison to senior management, cross-functional areas, schools and external organizations such as sponsors and government agencies.
 

DESIRED QUALIFICATIONS:
• PhD and 8+ years of industry (or equivalent) experience in a biologics cGMP compliant work environment.
• Record of publication of scientific findings in peer reviewed journals
• Experience in Immunology, Oncology, Cell and Gene Therapy desirable; experience in Analytical Development

EDUCATION & EXPERIENCE (REQUIRED):

Bachelor's degree and eight years of relevant experience or combination of education and relevant experience. Advanced degree may be required.

KNOWLEDGE, SKILLS AND ABILITIES (REQUIRED):
• Experience leading, managing, motivating and developing technical staff.
• Experience leading complex scientific, engineering or technical research projects or programs.
• Detailed understanding of relevant business and technical knowledge and problem resolution.
• Ability to synthesize and articulate technical and scientific methodologies, specifications, and information.
• Knowledge of emerging technologies, trends, methodologies, and resource management principles.
• Demonstrated ability to work and communicate effectively with others.
• Exceptional customer relationship and consensus building skills.
• Ability to influence and establish effective working relationships in a diverse environment.
• Ability to resolve complex issues quickly and make decisions that meet university objectives in a collaborative culture.

 



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 interests—it’s 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, we’re always thinking about what’s next and advising job seekers on new ways of working to reach their full potential. In fact, we’re 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. 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.

]]

Palo Alto, California

Why Kelly - Since 2011 we have placed over 16,000 Veterans

Need More?

Kelly applies targeted recruiting initiatives to the Veterans population (in all stages of transition) by aligning customer defined requirements with military skills and experience.  The transition from military to civilian life can be stressful and complex for veterans, and our staff is trained to assist in this transition.  Unlike our competition, Kelly places these resources without geographic or industry constraints, offering our customers and our employees greater flexibility.  Kelly has a wide variety of local opportunities, for Veterans and their spouses, within our workforce solutions as well as national recruiting programs on behalf of our customers.  Kelly’s leading placement opportunities for Veterans are within Information Technology, Engineering, Science, Light Industrial and Call Center.

Our specially trained Veteran recruiters are armed with a number of tools to help Veterans obtain roles that match their potential including skill translation tools, leading Veteran- centric job boards and Veteran/spouse social media networks, among others.

Through Kelly’s vast branch network, we are closely located to the majority of major military installations across the United States.  Kelly recruiters participate in onsite and virtual military career fairs as well as advertise through local and national Veteran job boards.  In recent years, over 150 Kelly branches have worked directly with their local military installations to recruit spouses and transitioning personnel.  These teams not only engages with transitioning talent from local bases, but also have a strong focus on Veterans in areas where the military has identified high Veteran unemployment. This approach ensures that military talent is engaged and shared across the centralized military recruiting team and documented in a centralized database, so that other Kelly locations can benefit from hiring or relocating this valuable pool of talent.

Our focus on military recruiting is a win on multiple levels. Kelly gains top talent with the skills needed to excel; our clients receive the benefit of that talent to help them compete in an ever challenging business landscape; and Veterans receive gainful employment in line with their skills and abilities to ease the transition to the next phase of their lives.

A People Company, Staffing the World

Kelly founded the temporary staffing industry in 1946, and has maintained a leadership position through the years based on a valuable premise: we invest in people. Today that focus benefits our customers wherever they operate around the globe - in a growing number of specialized fields. And we’ll continue to meet the evolving challenges of workforce flexibility with staffing solutions tailored to your precise business needs, both locally and worldwide.

Similar jobs