Sign In
 [New User? Sign Up]
Mobile Version

Manager, Drug Development

kaleo


Location:
Richmond, Virginia 23219
Date:
06/09/2017
2017-06-092017-07-09
Job Type:
Employee
Job Status:
Full Time
kaleo
  •  
  • Save Ad
  • Email Friend
  • Print
  • Research Salary

Job Details

The Manager, Drug Development is responsible for overseeing the analytical, formulation, and manufacturing drug development activities necessary to achieve and maintain marketing approval for the Company's products. This person's responsibilities include:

  • Development of the drug constituent component of the Company's products including primary container closure selection, formulation development, analytical methods development and validation, manufacturing process development and transfer, study protocol and report development, review and approval;

  • Ensuring identity, strength, purity, and quality of the drug constituent component of the Company's products; and,

  • Ensuring data from drug development studies are complete, credible, and suitable for submission to Regulatory Authorities.

  • Oversee and participate in formulation studies to assess new product feasibility.

  • Develop formulations and manufacturing processes for pilot, registration, and commercial batches.

  • Prepare pharmaceutical development reports for regulatory submission.

  • Design and characterize new formulations, and ensure that they can be transferred into existing drug products manufacturing site for scale-up.

  • Direct compounding of lab batches and design stability studies to determine optimal drug product shelf life.

  • Collaborate with Quality, Supply Chain and Manufacturing, Product Development, and Regulatory Affairs departments to coordinate pilot, registration and commercial batches.

  • Oversee analytical method development, validation, method transfer, and stability studies for raw materials and finished drug products.

  • Oversee feasibility studies, method development, and method validation for various analytical methodologies (e.g. HPLC, GC, MS, UV).

  • Oversee manufacturing process development (i.e. batch record review, equipment specifications, component specifications, product filter requirements, etc.).

  • Establish specifications, compounding records, and various technical protocols/reports including CMC drug substance and drug product sections for FDA submissions.

  • Periodically review ongoing drug product quality testing results and provide drug product subject matter expertise to help identify trends for investigation and participation in those investigations.

  • Identify and implement pharmaceutical innovations over the lifecycle of the products.

  • Manage CROs and CMOs associated with the above activities including the establishment of timelines and associated budgets for these activities.

Additional Responsibilities:

  • Prepare periodic status reports and openly communicate the status of programs to other team members.

  • Conduct periodic teleconferences with development partners to ensure key members of the Company and external development team are well informed, engaged, and on task.

  • Assist in review and update of the NDA and Development GANTTs and budgets on a periodic basis to ensure all development programs are on schedule and within budget.

  • Assist in Regulatory program planning meetings for each major Development initiative to confirm strategies, plans, roles, responsibilities and timelines.

Requirements

  • Advanced (MS or PhD) degree in Life Science and a minimum of 6 years experience.
  • BS degree in a Life Science and a minimum of 12 years experience.

  • Biopharmaceutical experience in drug product and regulatory development including formulation development, analytical development, manufacturing process development, and parenteral manufacturing preferred.

  • Knowledge of regulatory guidelines for GLP and GMP compliant studies.

POSITION QUALIFICATIONS:

  • Must have the ability to manage multiple complex projects and resolve complex issues.

  • Must possess excellent supervisory, interpersonal, leadership, and project management skills.

  • Must possess confidence and be able to communicate with all levels of personnel.

  • Must have a strong understanding of the biopharmaceutical industry.

Featured Jobs[ View All ]