Palo Alto, California

Kelly Science and Clinical is the world’s most recognized brand in science and clinical staffing with more than 100 locations in North America, Europe, and the Pacific Rim. Our scientists contribute to the research and development of the next generation of small molecule drugs, biologics and cellular therapies.          

Overview

We are seeking is seeking a Process Development and Manufacturing Scientist IV for one of our clients, a translational laboratory based in Palo Alto, CA that is a purpose-build cGMP facility that supports cellular therapy process development and manufacturing across diverse clinical specialties. The incumbent will support ongoing manufacturing and lead translational development for novel cell-based therapy for use in clinical trials; provide highly specialized technical research, support and expert consultation including innovating and designing solutions for unique process development and product manufacturing activities related to clinical materials manufacturing. Work is to be consistent with principles of current Good Manufacturing Practice cGMP and aligned with the clinical trial investigational phase for treating patients with incurable diseases.

Responsibilities

  • Provide leadership, scientific technical and subject matter expertise to oversee and manage process development and manufacturing activities including planning and implementation of major projects, clinical materials manufacturing activities, process development in translational medicine, services and facilities-related issues.
  • Provide scientific leadership across all functional teams by overseeing and directing project development and management and budgeting oversight; collaborating and liaising with clinical investigators; consulting with and driving solutions for major projects with broad, significant clinical impact based on experience and subject matter expertise.
  • Create new industry standards and best practices; direct and develop technical scientific elements of regulatory filings i.e., chemistry, manufacturing and controls; develop and maintain relationships with vendors to evaluate devices, supplies and materials relevant to process development and manufacturing.
  • Author or co-author articles, presentations, or scientific papers for peer review journals and/or presentation at national/international scientific meetings/conferences.
  • Write, submit and address reviewer comments related to novel methods in process development and manufacturing. Identify research and development funding opportunities.
  • Serve as a liaison to senior management, cross-functional areas, schools and external organizations such as sponsors and government agencies.
  • May manage two or more staff in day-to-day operations for functional area s of responsibility.
  • Responsible for hiring and retaining staff, career coaching, personal development for direct reports and accountable for the performance of employees.
  • Ensure work completion within schedules and constraints. May serve as safety officer; responsible for ensuring implementation of EH&S, fire and city regulations for laboratory safety.

Qualifications

Required:

  • A bachelor’s degree in related scientific field and 6 years relevant experience; or master’s degree and four years of related experience or an equivalent combination of education and experience.
  • Thorough knowledge of the principles of molecular biology, biological process engineering.
  • Demonstrated project management experience.
  • Understanding of principles and compliance with cGMP, raw materials and documentation requirements.
  • Demonstrated cGMP clean room oversight and management.

Preferred:

  • A PhD in a related scientific field.
  • Hands-on experience with iPSCs.

#TJP2021_SPEC



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 (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.

]]

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