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Managing Director, Process Development (Cellular Therapies)

Company: Rutgers University
Location: New Brunswick
Posted on: September 15, 2020

Job Description:

Managing Director, Process Development (Cellular Therapies) Below you will find the details for the position including any supplementary documentation and questions you should review before applying for the opening. To apply for the position, please click the Apply for this Job link/button.

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Recruitment/Posting Title Managing Director, Process Development (Cellular Therapies)

Job Category

Department Cancer Institute of New Jersey

Overview

Rutgers Cancer Institute of New Jersey Vision, Mission, and Core Values:

Our vision is to be a statewide, national and world leader of scientific discovery, transdisciplinary engagement, translation, patient care and education that improves outcomes for cancer patients and populations. We will accomplish this by conducting innovative basic, clinical and population research and cutting-edge patient-centered care that expands our understanding of the etiology and biology of cancer; facilitates the rapid translation of laboratory-based discoveries into human studies; develops new approaches and interventions for cancer prevention that decrease cancer incidence and mortality; and develops new and better therapies to decrease suffering and mortality from cancer.

Core Values:

Curiosity and Discovery, Integrity, Collaboration, Respect and Caring, Perseverance.

Posting Summary

Rutgers, The State University of New Jersey is seeking a Managing Director for the Cancer Immunology and Metabolism department at Rutgers Cancer Institute of New Jersey ( CINJ ).

The Managing Director, Process Development (Cellular Therapy) is to initiate and run a shared service for cellular and immunotherapy development. This position is responsible for working with collaborating laboratories to transfer, develop, and implement methodologies for the production of translational products and projects. This position will lead the process development team.

Supervision Received: Under general supervision of the CoDirector of the MacMillan Center for Immunology and Metabolism.

Among the key duties of this position are the following:

Directs the daily activities of the process development laboratory.

Manages a group of highly trained technicians that comprise the process development team.

Generates Chemistry, Manufacturing, and Control ( CMC ) documents for Investigational New Drug Applications (INDs).

Generates validation plan for new products.

Supervises validation experiments for new products.

Position Status Full Time

Daily Work Shift

FLSA Exempt

Grade 35S

Annual Minimum Salary 105361.000

Annual Mid Range Salary 139980.000

Annual Maximum Salary 174600.000

Standard Hours 37.50

Union Description Non-Union

Payroll Designation PeopleSoft

Information about the benefits provided to Rutgers employees can be found at: http://uhr.rutgers.edu/benefits/benefits-overview

Seniority Unit

Terms of Appointment Staff - 12 month

Position Pension Eligibility ABP

Minimum Education and Experience

Ph.D. in Biomedical Science, Biology, Chemistry, Engineering or related field.

Five (5) years in scientific research with five (5) years of experience in supervising/managing cellular therapies labs, cGMP facilities, in vitro cell culture, related analytical labs, experimental and clinical trials studies, and FDA IND submissions.

Experience in participating and leading cross-functional/matrix project teams.

Required Knowledge, Skills, and Abilities Knowledge of cGMP, GCP , FDA , FACT , and AABB .

Knowledge of laboratory and regulatory requirements in cellular therapy related research.

Working knowledge of IRB and regulatory approvals and developing FDA IND submissions.

Working knowledge of Materials and Technology Transfer including transitioning of research techniques into cGMP production methods and start-up of existing or new processes at internal and external manufacturing facilities.

Knowledge of Microsoft Suite (Word, Excel, PowerPoint, Visio) and general analytics.

Demonstrated ability to work in a fast-paced environment supervising multiple projects and activities simultaneously.

Possesses personal leadership qualities that inspire trust, respect, credibility, and confidence of peers and colleagues and takes the organization to a higher level.

Knowledge of Stem Cell literature and experience in science-based cGMP manufacturing, demonstrated innovative thinking.

Well-developed interpersonal skills; experienced communicator, ability to provide clear and logical presentation of complex strategic issues.

Demonstrated ability to manage people and to assign work effectively based on staff skills.

Proven ability to design and implement studies with direct translation.

Resilient, energetic, and enthusiastic, responding constructively to challenging new ideas and inputs.

Strategic thinking: innovating with informed, sharp, and objective practical purpose, experienced in detailed analysis, interpretation, and reporting.

Strong interpersonal skills and networking.

Ability to develop productive relationships with academic scientists and research/business executives in the biotechnology, pharmaceutical, and medical device industries.

Proven ability to maintain effective oversight of a project and schedule progress to predetermined milestones, experience in developing and monitoring detailed budgets.

Demonstrated ability to handle pressure and ambiguity; comfortable with the pressure to excel and ability to maintain focus in situations of ambiguity and uncertainty.

Effective oral and communication skills.

Computer literate with proficiency and working knowledge of database and reporting tools such as Microsoft Word, Excel, Access, and PowerPoint.

Preferred Qualifications Physical Demands and Work Environment

Special Conditions

Posting Number 20ST1606

Posting Open Date

Special Instructions to Applicants

Regional Campus Rutgers Biomedical and Health Sciences (RBHS)

Home Location Campus Downtown New Brunswick

Supplemental Questions Required fields are indicated with an asterisk (*).

* Do you have a Ph.D. in Biomedical Science, Biology, Chemistry, Engineering or related field? Yes

No

* Do you have five (5) years in scientific research with five (5) years of experience in supervising/managing cellular therapies labs, cGMP facilities, in vitro cell culture, related analytical labs, experimental and clinical trials studies, and FDA IND submissions? Yes

No

* Do you have working knowledge of cGMP, GCP, FDA, FACT, and AABB, laboratory and regulatory requirements in cellular therapy related research as well as IRB and regulatory approvals and developing FDA IND submissions? Yes

No

* Are proficient in Microsoft Office Suite applications? Yes

No

Required Documents Resume/CV

Optional Documents Cover Letter/Letter of Application

It is university policy to provide equal employment opportunity to all its employees and applicants for employment regardless of their race, creed, color, national origin, age, ancestry, nationality, marital or domestic partnership or civil union status, sex, pregnancy, gender identity or expression, disability status, liability for military service, protected veteran status, affectional or sexual orientation, atypical cellular or blood trait, genetic information (including the refusal to submit to genetic testing), or any other category protected by law. As an institution, we value diversity of background and opinion, and prohibit discrimination or harassment on the basis of any legally protected class in the areas of hiring, recruitment, promotion, transfer, demotion, training, compensation, pay, fringe benefits, layoff, termination or any other terms and conditions of employment. For additional information please see the Non-Discrimination Statement .

In compliance with the Americans with Disabilities Act (ADA) and the New Jersey Law Against Discrimination (NJLAD), if you have a disability and would like to request an accommodation with regard to your access to and/or your participation in the application and selection processes (for example, the online application process or interviews), please call 848-932-4444 or e-mail us .

Rutgers University is an equal access/equal opportunity institution. If you have trouble accessing this page because of a disability, please contact us at 732.745.7378 or via email at OneSource@Rutgers.edu .

For technical assistance with the applicant tracking system (login, filling out your application, resetting your password, etc.) please contact the ROCS Help Desk at 848-932-4444 or ROCS@hr.rutgers.edu .

To learn more about Rutgers University’s commitment to diversity and inclusion on its campuses, click here .

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Keywords: Rutgers University, New Brunswick , Managing Director, Process Development (Cellular Therapies), Other , New Brunswick, New Jersey

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