Developmental Scientist

Location
Bethesda, Maryland, United States
Posted
Nov 22, 2018
Ref
4
Hotbed
BioCapital
Required Education
Doctorate/PHD/MD
Position Type
Full time
The Clinical Monitoring Research Program (CMRP) provides quality assurance and regulatory compliance support to the National Cancer Institute's (NCI's), Center for Cancer Research (CCR), Surgery Branch (SB).

Key Roles/Responsibilities:
  • Provide support and advisement to the development of the T Cell receptor gene therapy protocols.
  • Establishes, implements and maintains standardized processes and assesses performance to make recommendations for improvement
  • Provides support and guidance to the cellular therapy or vector production facilities at the NIH Clinical Center engaged in the manufacture of patient specific therapies
  • Manufactures cellular therapy products for human use
  • Develops and manufactures lentiviral and/or retroviral vectors
  • Prepares technical reports, abstracts, presentations and program correspondence concerning assigned projects through research and analysis of information relevant to government policy, regulations and other relevant data and monitor all assigned programs for compliance
  • Provides project management support with planning and development of project schedules and deliverables, tracking project milestones, managing timelines, preparing status reports and monitoring progress ensuring adherence to deadlines
  • Serves as a leader/mentor to administrative staff and prepares employee performance evaluations
  • Develops and implements procedures/programs to ensure effective and efficient business and operational processes
  • Ensures that internal budgets, schedules and performance requirements are met
  • Monitors workflow and timelines to ensure production operations are on schedule and adequate raw materials and supplies are available
  • Ensures all activities are in compliance with applicable federal regulations and guidelines and proper testing/validation activities have been scheduled and conducted
  • Participates in planning facility or operations modifications, upgrades and renovations
  • Performs technical audits of outsourced contractors in conjunction with Quality Assurance and or Quality Control
  • Assists in the evaluation and selection of staff, planning and coordination of training, assigning of tasks and scheduling workloads and evaluating overall performance

BASIC QUALIFICATIONS
  • Possession of a Doctoral degree in a field related to biomedical research/scientific discipline Foreign degrees must be evaluated for U.S. equivalency
  • A minimum of five (5) years of progressively responsible job-related experience. This includes working in a laboratory developing lentiviral and/or retroviral vectors for gene therapy and hands on experience with development/manufacturing of cellular therapies for human use
  • Experience in cellular therapy manufacture or vector production
  • Ability to develop and maintain manufacturing operations under cGMP compliance
  • Possess knowledge of production-related principles of biopharmaceutical development and production processes
  • Working knowledge of cGMPs as they relate to biopharmaceutical manufacturing
  • Capable of ensuring quality control and fiscal planning
  • Must be able to obtain and maintain a security clearance

PREFERRED QUALIFICATIONS
  • Proficiency in Microsoft Office® Products
  • Familiarity with interactive databases quality assurance, quality systems, auditing, metrics analysis, cancer

Equal Opportunity Employer (EOE) | Minority/Female/Disabled/Veteran (M/F/D/V) | Drug Free Workplace (DFW)