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GMP, Associate Scientist/Eng. II - Bioprocess

Req ID:  4391
Date:  Oct 25, 2019
Location: 

Durham, NC, US, 27710

Personnel Area:  MEDICAL CENTER

School of Medicine:

 

Established in 1930, Duke University School of Medicine is the youngest of the nation’s top medical schools. Ranked tenth among its peers, the School takes pride in being an inclusive community of outstanding learners, investigators, clinicians, and staff where traditional barriers are low, interdisciplinary collaboration is embraced, and great ideas accelerate translation of fundamental scientific discoveries to improve humanhealth locally and around the globe.

 

Comprised of 2,400 faculty physicians and researchers, the Duke University School of Medicine along with the Duke University School of Nursing and Duke University Health System create Duke Health. Duke Health is a world-class health care network. Founded in 1998 to provide efficient, responsive care, the health system offers a full network of health services and encompasses Duke University Hospital, Duke Regional Hospital, Duke Raleigh Hospital, Duke Primary Care, Private Diagnostic Clinic, Duke Home and Hospice, Duke Health and Wellness, and multiple affiliations.

 

GMP, Associate Scientist/Eng. II – Bioprocess

 

Responsibilities

  • Designs experiments, executes and documents GMP activities in compliance with regulatory requirements.
  • Collaborates closely with development teams to provide support for development activities and works diligently with development functions to understand how the production process changes impact product quality.
  • Compiles data and performs analysis and interpretation and draws conclusions regarding progress and results of work, utilizing the data in appropriate decision making; summarizes data, presents results and proposes next steps to advance the GMP program.
  • Writes and reviews technical reports; writes protocols for tech transfer and SOPs for GMP production, and presents data to project teams and larger settings.
  • Manages all materials required for CGMP production, including working with vendors to meet DHVI shipping/delivery/documentation needs, performs investigations which include creation of detailed reports, presentation of trends/risks/and recommendations to wider GMP team / Quality, and negotiates pricing.  Maintains CGMP equipment and facilities, including working with vendors to meet DHVI calibration/repair/documentation needs, performs investigations, and negotiates pricing.  Manages quotation and justification submission documents for grant and contract applications, for GMP facility materials / components / equipment / and services. 
  • Performs root cause analysis for all investigations and implements robust corrective actions in a timely manner.  Uses good documentation practices for all records, adhering to SOPs, and performing audits to ensure compliance.  Trains the GMP team on proper documentation practices and acceptable corrective actions for a GMP compliant organization. 
  • Provides hands-on support for CGMP campaigns, including authoring of batch documents for execution of unit operations, documenting all steps of the process and materials used for campaigns, deviation investigation report authorship for complex upstream and downstream equipment / facility / documentation events. 
  • Provides assistance, including commissioning / qualification / protocol documentation ownership and support, for current and new facility for complex and challenging equipment items, such as dual-use reactors and single use chromatography systems.  Manages timelines and all deliverables included in this scope, such as SOP authorship, calibration requirements, tracking of issues/resolution, and turnover change control documentation closure.
  • Creates and deploys training/SOP/change control documentation as needed.

 

 

Education and Experience Preferences

  • Bachelor's degree in a science, Masters is a plus
  • 4 years relevant experience in the biopharmaceutical industry with experience related to:
  • Understanding of CGMP regulations for Vaccines and/or Biologics
  • GDP experience in an agency-regulated manufacturing environment (clinical manufacturing and/or licensed product manufacturing)
  • Authoring and/or approving controlled documents
  • Implementation of bioprocess unit operations (bioreactor control and operation, Chromatography, TFF filtration, GE Unicorn software) and direct GMP experience
  • Experience in upstream (cell culture, bioreactor operation including scale up) and downstream purification (chromatography, tangential flow filtration, normal flow filtration). 
  • Ability to works independently to develop specific processes or methods
  • Ability to act independently and to problem solve under various conditions
  • Ability to work well in teams and utilize organizational skills to create and maintain tracking systems       
  • Demonstrated ability in solving complex analytical problems with guidance from senior development scientists.
  • Strong oral and written communication skills

 

 

Minimum Qualifications

 

 

Education

Bachelor's degree in a science, engineering, or related field. A Master's degree is preferred.

 

Experience

 

4 years relevant experience in the biopharmaceutical industry or equivalent.

 

Duke University is an Affirmative Action/Equal Opportunity Employer committed to providing employment opportunity without regard to an individual's age, color, disability, gender, gender expression, gender identity, genetic information, national origin, race, religion, sex, sexual orientation, or veteran status.

 

Duke aspires to create a community built on collaboration, innovation, creativity, and belonging. Our collective success depends on the robust exchange of ideas—an exchange that is best when the rich diversity of our perspectives, backgrounds, and experiences flourishes. To achieve this exchange, it is essential that all members of the community feel secure and welcome, that the contributions of all individuals are respected, and that all voices are heard. All members of our community have a responsibility to uphold these values.

 

Essential Physical Job Functions: Certain jobs at Duke University and Duke University Health System may include essential job functions that require specific physical and/or mental abilities. Additional information and provision for requests for reasonable accommodation will be provided by each hiring department.

 


Nearest Major Market: Durham
Nearest Secondary Market: Raleigh