Stanford Diabetes Research Center supported cell manufacturing and process development specialist

📁
Research
📅
88745 Requisition #

Stanford University is seeking a Clinical Process Development & Manufacturing Professional 2 to independently conduct major portions of complex process development and clinical materials biomanufacturing consistent with principles of current Good Manufacturing Practice (cGMP) and aligned with the clinical trial investigational phase for treating patients with incurable diseases

 

Duties include:

  • 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.


*-The job duties listed are typical examples of work performed by positions in this job classification and are not designed to contain or be interpreted as a comprehensive inventory of all duties, tasks, and responsibilities. Specific duties and responsibilities may vary depending on department or program needs without changing the general nature and scope of the job or level of responsibility. Employees may also perform other duties as assigned.

 

DESIRED QUALIFICATIONS:

  • Previous laboratory experience and previous employment in and cell therapy manufacturing or process development facility.

 

EDUCATION & EXPERIENCE (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. 


KNOWLEDGE, SKILLS AND ABILITIES (REQUIRED):

  • 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.


CERTIFICATIONS & LICENSES:

None


PHYSICAL REQUIREMENTS*:

  • Frequently sit, grasp lightly, use fine hand manipulation, repetitive pipetting, perform desk-based computer tasks, and lift, carry, push, and pull objects up to 15 pounds. 

* - Consistent with its obligations under the law, the University will provide reasonable accommodation to any employee with a disability who requires accommodation to perform the essential functions of his or her job.


WORKING CONDITIONS:

  • May require working in close proximity to blood borne pathogens.
  • Ability to work under deadlines and meet/ exceed unpredictable manufacturing schedules.
  • Position may at times require the employee to work with or be in areas where hazardous materials and/or infectious diseases are present. 
  • Position requires working in a cGMP clean room environment. 
  • Position may work with viruses: lentiviruses, adeno-associated viruses, and/or retroviruses.
  • Position may work with human embryonic stem cells (hESCs).
  • Employee must perform tasks that require the use of personal protective equipment, such as safety glasses and shoes, protective clothing and gloves, and possibly a respirator. 
  • May be exposed to high voltage electricity, radiation or electromagnetic fields, lasers, noise > 80dB TWA Allergens/Biohazards/ Chemicals, and confined spaces, working at heights.
  • May require extended or unusual work hours based on clinical manufacturing requirements and business needs. May be required to stay at work until product is released.


WORKING STANDARDS:

  • Interpersonal Skills: Demonstrates the ability to work well with Stanford colleagues and clients and with external organizations.
  • Promote Culture of Safety: Demonstrates commitment to personal responsibility and value for safety; communicates safety concerns; uses and promotes safe behaviors based on training and lessons learned.
  • Subject to and expected to comply with all applicable University policies and procedures, including but not limited to the personnel policies and other policies found in the University’s Administrative Guide, http://adminguide.stanford.edu/.

 

WHY STANFORD IS FOR YOU:

Imagine a world without search engines or social platforms. Consider lives saved through first-ever organ transplants and research to cure illnesses. Stanford University has revolutionized the way we live and enrich the world. Supporting this mission is our diverse and dedicated 17,000 staff. We seek talent driven to impact the future of our legacy. Our culture and unique perks empower you with:

 

Freedom to grow. We offer career development programs, tuition reimbursement, or audit a course. Join a TedTalk, film screening, or listen to a renowned author or global leader speak.
A caring culture. We provide superb retirement plans, generous time-off, and family care resources.
A healthier you. Climb our rock wall, or choose from hundreds of health or fitness classes at our world-class exercise facilities. We also provide excellent health care benefits.
Discovery and fun. Stroll through historic sculptures, trails, and museums.
Enviable resources. Enjoy free commuter programs, ridesharing incentives, discounts and more.

 

Stanford is an equal employment opportunity and affirmative action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, protected veteran status, or any other characteristic protected by law.

My Submissions

Track your opportunities.

My Submissions

Similar Listings

School of Medicine, Stanford, California, United States

📁 Research

School of Medicine, Stanford, California, United States

📁 Research

School of Medicine, Stanford, California, United States

📁 Research

Global Impact
We believe in having a global impact

Climate and Sustainability

Stanford's deep commitment to sustainability practices has earned us a Platinum rating and inspired a new school aimed at tackling climate change.

Medical Innovations

Stanford's Innovative Medicines Accelerator is currently focused entirely on helping faculty generate and test new medicines that can slow the spread of COVID-19.

Technology

From Google and PayPal to Netflix and Snapchat, Stanford has housed some of the most celebrated innovations in Silicon Valley.

Advancing Education

Through rigorous research, model training programs and partnerships with educators worldwide, Stanford is pursuing equitable, accessible and effective learning for all.

Working Here
We believe you matter as much as the work

Group Dance Class In A Gym
Nora Cata Portrait

I love that Stanford is supportive of learning, and as an education institution, that pursuit of knowledge extends to staff members through professional development, wellness, financial planning and staff affinity groups.

Nora Cata

School of Engineering

Students Working With A Robot Arm
Philip Cheng Portrait

I get to apply my real-world experiences in a setting that welcomes diversity in thinking and offers support in applying new methods. In my short time at Stanford, I've been able to streamline processes that provide better and faster information to our students.

Philip Cheng

School of Medicine

Students Working With A Robot Arm
Denisha Clark Portrait

Besides its contributions to science, health, and medicine, Stanford is also the home of pioneers across disciplines. Joining Stanford has been a great way to contribute to our society by supporting emerging leaders.

Denisha Clark

School of Medicine

Students Working With A Robot Arm
Laura Lind Portrait

I like working in a place where ideas matter. Working at Stanford means being part of a vibrant, international culture in addition to getting to do meaningful work.

Laura Lind

Office of the President and Provost

Getting Started
We believe that you can love your job

Join Stanford in shaping a better tomorrow for your community, humanity and the planet we call home.

  • 4.4 Review Ratings
  • 89% Recommend to a Friend
  • 90% Approve of President

View All Jobs