CenterWatch

1+ months

Process Development Manufacturing Scientist

Kelly Services
Palo Alto, CA 94301
Process Development Manufacturing Scientist, Palo Alto, CA



Direct Hire opportunity



**MUST HAVE: Experience with induced pluripotent stem cells



This position will join a stellar team of PDM Scientists and will provide highly specialized technical research, support and expert consultation including identifying, innovating and designing solutions for unique process development and 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. This position entails work under Biosafety Level 2 (BSL2) and current Good Manufacturing Practice (cGMP) level conditions and adherence to corresponding requirements.


Duties include:


Lead development activities for new processes and procedures for first-in human clinical materials development including design of process scale-up and scale-out, closed systems and engineering runs to meet clinical materials requirements.

Lead clinical materials manufacturing campaigns; responsible for oversight and coordination of junior staff in conducting all activities related to manufacturing; lead decision-making when collaborating with functional teams: operations, regulatory affairs, quality systems, business & administration; maintain regular reporting to functional manager.

Develop methods for, perform and supervise manufacturing of clinical materials according to cGMP standards in Biosafety Level 2 (BSL2), cGMP-level work conditions and adherence to corresponding requirements.

Develop standard operating procedures (SOPs), Batch Records and product specifications. Critically assess experimental data, provide interpretation of results, and ensure data quality and integrity. Present data to functional manager and collaborative groups to support product and process specification.

Author or co-author of manuscripts for publication in peer-reviewed journals. Remain current on literature and standard industry practices by attending scientific meetings/conferences.

Provide support for regulatory filings including drafting Chemistry, Manufacturing and Controls (CMC) section of Investigational New Drug (IND) Regulatory Filing.

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 a liaison to senior management, cross-functional areas, schools and external organizations such as sponsors and government agencies.

May serve as safety officer; responsible for ensuring implementation of EH&S, fire and city regulations for laboratory safety.


*- Other duties may also be assigned



DESIRED QUALIFICATIONS:


EDUCATION & EXPERIENCE (REQUIRED):


Bachelor's degree in related scientific field and four years of related experience, or Masters degree and two years of related experience or an equivalent combination of education and relevant work experience.


KNOWLEDGE, SKILLS AND ABILITIES (REQUIRED):

Excellent understanding of scientific principles

Working experience with aseptic cell culture

cGMP clean room experience

Excellent computer skills and ability to learn quickly and master computer programs, databases and scientific applications

Ability to work independently, maintain relationships and provide ongoing reporting to functional management

Excellent organizational skills and demonstrated ability to complete detailed work.






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



With Kelly, youll have access to some of the worlds highest-regarded scientific organizations
providing you with opportunities to work on todays most challenging, research-intensive, and relevant
projects. Our connections can lead you to innovative scientific pursuits youll be proud to help
advance. We work with 95 of the Fortune 100 companies, and found opportunities for more than 9,000
scientific professionals last year.


You pursued a career in science to fuel your quest for knowledge and your desire to make the world
a better place. Let Kelly fuel your careerconnect with us today.




**AboutKelly Services** ****



As a workforce advocate for over 70 years, we are proud to directly employ nearly 500,000 people around the world and have a role in connecting thousands more with work through our global network of talent suppliers and partners. Revenue in 2017 was $5.4 billion. Visit kellyservices.com and connect
with us on Facebook , LinkedIn and Twitter .


Kelly Services is an equal opportunity employer including, but not limited to, Minorities, Females,
Individuals with Disabilities, Protected Veterans, Sexual Orientation, Gender Identity and is
committed to employing a diverse workforce. Equal Employment Opportunity
is The Law.

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Posted: 2019-07-03 Expires: 2019-08-29

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Process Development Manufacturing Scientist

Kelly Services
Palo Alto, CA 94301

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