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Stanford University · 2 months ago

Process Development Specialist

Stanford, CA

Full-time

Onsite

Entry, Mid Level

$47.72/hr - $53.23/hr

2+ years exp

Stanford University is seeking a Clinical Process Development & Manufacturing Professional 2 to conduct complex process development and biomanufacturing for clinical materials. The role involves leading biomanufacturing campaigns, coordinating activities with various teams, and ensuring compliance with Good Manufacturing Practice standards.

EducationHigher EducationUniversities

Growth Opportunities

H1B Sponsor Likely

Responsibilities

Lead human clinical materials biomanufacturing campaigns primarily as an operator

Prepare final formulated cellular products for clinical trials within production timelines and manufacturing schedules

Coordinate campaign activities with all functional teams: operations, quality systems, regulatory affairs, and business & administration

Train on biomanufacturing procedures, Batch Records or provide direction during process development activities

Plan and perform complex components of process development for technology transfer, scale-up/scale-out, optimization activities and characterization of new, state-of-the-art technologies in transition and translating pre-clinical, benchtop research into phase appropriate clinical trials

Plan and perform upstream and downstream components of assigned cGMP projects

Identify strategies for innovation in production systems and manufacturing processes

Identify operating excursions and facility deficiencies during manufacturing

Determine deviations and provide recommendations for Corrective and Preventive Action (CAPA) for Batch Records

Develop manufacturing budget including sourcing, identifying and ensuring qualified and verified raw materials for manufacturing; outline overall and per/patient costs for project materials and supplies and hours dedicated to complete all manufacturing steps

Determine need for, devise and revise Standard Operating Procedures and Batch Records

Oversee cGMP grade raw materials acquisition for biomanufacturing

Prepare and submit abstracts for publication in peer-reviewed journals and/or presentation at scientific conferences

Qualification

CGMP clean room experienceAseptic cell cultureBiological scientific backgroundComputer skillsOrganizational skillsCommunication skills

Required

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

Strong biological scientific background

Working experience with aseptic cell culture

cGMP clean room experience

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

Ability to work under deadlines with minimal supervision

Ability to maintain relationships and communicate effectively

Excellent organizational skills and demonstrated ability to complete detailed work

Benefits

Stanford University provides pay ranges representing its good faith estimate of what the university reasonably expects to pay for a position.

At Stanford University, base pay represents only one aspect of the comprehensive rewards package.

The Cardinal at Work website ( https://cardinalatwork.stanford.edu/benefits-rewards ) provides detailed information on Stanford's extensive range of benefits and rewards offered to employees.

Specifics about the rewards package for this position may be discussed during the hiring process.

Company

Stanford University

Glassdoor4.3

Stanford University is a teaching and research university that focuses on graduate programs in law, medicine, education, and business.

Founded in 1885

Stanford, California, USA

10001+ employees

http://www.stanford.edu

H1B Sponsorship

Stanford University has a track record of offering H1B sponsorships. Please note that this does not guarantee sponsorship for this specific role. Below presents additional info for your reference. (Data Powered by US Department of Labor)

Distribution of Different Job Fields Receiving Sponsorship

Represents job field similar to this job

Trends of Total Sponsorships

2020 (12)