JobWatch

1+ months

Process Development and Manufacturing Scientist IV

Kelly Services
Palo Alto, CA 94301
**Kelly Science and Clinical** is the worlds 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 bachelors degree in related scientific field and 6 years relevant experience; or masters 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 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. (https://www.dol.gov/ofccp/regs/compliance/posters/ofccpost.htm)

Categories

Posted: 2021-07-23 Expires: 2021-10-23

Before you go...

Our free job seeker tools include alerts for new jobs, saving your favorites, optimized job matching, and more! Just enter your email below.

Share this job:

Process Development and Manufacturing Scientist IV

Kelly Services
Palo Alto, CA 94301

Join us to start saving your Favorite Jobs!

Sign In Create Account
Powered ByCareerCast