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SENIOR DIRECTOR, PROCESS DEVELOPMENT

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Posting Details

Posting Details

Reference Number 40-26899
Posted Job Title SENIOR DIRECTOR, PROCESS DEVELOPMENT
School Name Perelman School of Medicine
Org DM-Gene Therapy Program
Posted to the Web 09/28/2017
Posted Job/Salary Grade 030
Employment Type Exempt
Hours N/A
Position Type Full Time
Position Schedule 8-5
Months 12
Position Length Contingent Upon Funding
Position End Date
University Overview

The University of Pennsylvania, the largest private employer in Philadelphia, is a world-renowned leader in education, research, and innovation. This historic, Ivy League school consistently ranks among the top 10 universities in the annual U.S. News & World Report survey. Penn has 12 highly-regarded schools that provide opportunities for undergraduate, graduate and continuing education, all influenced by Penn’s distinctive interdisciplinary approach to scholarship and learning.

Penn offers a unique working environment within the city of Philadelphia. The University is situated on a beautiful urban campus, with easy access to a range of educational, cultural, and recreational activities. With its historical significance and landmarks, lively cultural offerings, and wide variety of atmospheres, Philadelphia is the perfect place to call home for work and play.

The University offers a competitive benefits package that includes excellent healthcare and tuition benefits for employees and their families, generous retirement benefits, a wide variety of professional development opportunities, supportive work and family benefits, a wealth of health and wellness programs and resources, and much more.

School/Center Overview

The Perelman School of Medicine at the University of Pennsylvania is the oldest and one of the finest medical schools in the United States. Penn is rich in tradition and heritage and at the same time consistently at the forefront of new developments and innovations in medical education and research. Since its founding in 1765 the School has been a strong presence in the community and prides itself on educating the leaders of tomorrow in patient care, biomedical research, and medical education. http://www.med.upenn.edu/

Duties

The Gene Therapy Program (GTP) is entering a new era of unprecedented opportunity with the great potential to reshape the face of medicine as we know it. Our discoveries have set the stage for successful treatments and possibly even cures for devastating genetic diseases.

The laboratory of Dr. Jim Wilson, at GTP of the University of Pennsylvania, has been a leader in the development of innovative vector technology for close to three decades. We have emerged as the ‘go-to’ organization for public and private partners, who want to participate in the gene therapy space. Currently, we are positioned to lead another round of vector innovation and establish pre-clinical and clinical proof-of-concept in therapeutic applications of in-vivo genome editing.

Our Vector Core is a state-of-the-art facility which provides vector-related materials and services in support of basic and translational research worldwide, producing vectors in support of IND-enabling research, conduct GLP assays, oversee CMO’s in vector production and is expanding to conduct state-of-the art process development.

Due to major growth, the Vector Core is looking for a new Senior Director of Process Development (SD-PD) to be responsible for the development of scalable upstream and downstream processes suitable for GMP vector production in support of early to late phase clinical trials and commercialization.

Reporting to the Executive Director, Vector Operations (EDVO) of GTP, as the (SD-PD), you will oversee the development of scalable vector production processes relevant to commercial scale manufacturing. You will be responsible for the transfer of manufacturing processes/technology internally as well as to contract manufacturing organizations (CMOs) and manage the production of clinical vector at CMOs; engage with corporate sponsors as needed to partner on process development, optimization and process transfer; and participate in the establishment of GMP vector manufacturing capabilities at Penn.

The preferred candidate will have industry experience in overseeing manufacturing of biologics, developing manufacturing processes suitable for clinical translation and in managing production activities at CMOs.

Qualifications
  • The minimum of a Master’s Degree in Bioengineering, Biology, Biochemistry and 5-7 years of industry experience in process development, or an equivalent combination of education and experience, are required. PhD strongly preferred
    * Minimum of 5 years of supervisory experience required
    * Extensive knowledge of biologics manufacturing, FDA regulations (GLP and GMP)
    * Experience in interactions with outside vendors, e.g. CMOs, CROs
    * Self-starter but also a strong desire to contribute and work collaboratively to achieve goals
    * Success in roles requiring execution of multiple tasks while responding to multiple priorities
    * Highly functioning, detail-oriented, and analytical candidate who can think strategically
    * Excellent oral/written communication skills required
Affirmative Action Statement

Penn adheres to a policy that prohibits discrimination on the basis of race, color, sex, sexual orientation, gender identity, religion, creed, national or ethnic origin, citizenship status, age, disability, veteran status, or any other legally protected class.

Special Requirements
Quick Link http://jobs.hr.upenn.edu/postings/31656

Posting Supplemental Questions

Required fields are indicated with an asterisk (*).

  1. * How did you hear about this employment opportunity?
    • Jobs@Penn
    • Contacted by a Penn Recruiter
    • Referred by a Penn Employee
    • Referred by a friend or family member
    • Higher Education Recruitment Consortium (HERC)
    • Inside Higher Ed
    • Indeed.com
    • Other Internet Advertisement
    • Linkedin
    • Twitter
    • Other Social Media Site
    • Professional Affiliation/Trade Website
    • Diversity Association/Publication Website
    • Heard about it at a conference or career fair
    • Apple One
    • Recruitment and/or staffing agency
  2. * What is your highest level of education completed?
    • Less than high school education
    • High School Diploma or GED
    • Vocational or Technical School
    • Associate's Degree or Two Year College
    • Bachelor's Degree
    • Master's Degree
    • PHD/MD/JD or equivalent doctoral degree
  3. * How many years of experience do you have related to this position?
    • 0 to 1 Year
    • 1 to 2 Years
    • 2 to 3 Years
    • 3 to 5 Years
    • 5 to 7 Years
    • 7 to 10 Years
    • Over 10 Years

Applicant Documents

Required Documents
  1. Resume
Optional Documents
  1. Cover Letter