Director of Vector Manufacturing – Lentivirus, AAV, Retrovirus

Published
October 7, 2021
Location
Atlanta, GA
Category
Job Type

Description

Growing CDMO seeks an experienced Director of Vector Manufacturing. Ideal candidates will have experience with Lentivirus, AAV and/or Retroviral vectors

This Jobot Job is hosted by: Hunter Prater
Are you a fit? Easy Apply now by clicking the "Apply on company site" button and sending us your resume.
Salary: $200,000 - $250,000 per year

A bit about us:

Our client is is focused on supporting the demands of the current and future gene and cell therapy manufacturing market—making viral vector production accessible to both early-stage, growth-oriented companies and well-established industry leaders.

Why join us?

Paid vacation days, amount based on tenure, and paid sick time

  • 8 observed holidays + 1 floating holiday
  • 401(k) plan with company match up to 6% of salary, vested immediately
  • Choice of five healthcare plans
  • FSA and HSA programs
  • Dental & vision care
  • Employer-paid basic term life/personal accident insurance
  • Voluntary disability, universal life/personal accident insurance
  • Annual Bonus
  • RELOCATION ASSISTANCE AVAILABLE

Job Details

Our client is actively seeking a Director of Vector Manufacturing to join a Lentiviral vector manufacturing CDMO located in Fishers, IN. The Director of Vector Manufacturing will manage the viral vector manufacturing processes including responsibility for the planning, on-time execution, and delivery of quality product. The role is also responsible for the training and development of the Manufacturing team and continuous improvement of the Manufacturing processes. As part of routine operations, this individual will need to work with the cross-functional teams, including Engineering, Facilities, EHS, Quality Assurance, IT, HR, Process Development, and Quality Control to support site operations. The Director of Vector Manufacturing is a motivated individual who can thrive in a fast-paced environment.
REPORTING RELATIONSHIPS: Manage the Manufacturing supervisors and oversee the Manufacturing team
ESSENTIAL JOB FUNCTIONS

  • Hire, lead, and develop the Manufacturing team to meet group objectives successfully
  • Provide leadership, coaching, and mentoring to the Manufacturing organization across multiple shifts
  • Plan and execute manufacturing activities on time
  • Deliver product on time to clients, including review of Manufacturing records and investigations
  • Monitor and report on area performance, identifying opportunities for improvement and implementing process improvements
  • Implement highest standards of compliance with quality systems into the day-to-day activities and maintain compliance with all applicable guidelines and regulations
  • Identify and mitigate risks in Manufacturing operations that could negatively impact product and personnel safety
  • Partner with business development for evaluation of potential business opportunities, assessing project plans and their feasibility
  • Manage process tech transfer activities from Process Development into Manufacturing
  • Work with Quality Assurance to establish the Manufacturing System (as defined in FDA 6 systems) for viral vector Manufacturing
  • Participate in client management and report Manufacturing status and progress directly to clients
  • Act as the Manufacturing system subject matter expert for client and regulatory audits

KNOWLEDGE, SKILLS, AND EXPERIENCE

  • Degree in Biology, Chemistry, or Engineering
  • 10+ years of experience in biopharmaceutical Manufacturing and aseptic processing
  • Expertise in protein or gene therapy vector purification and Manufacturing
  • 5+ years of related experience in a GMP setting
  • 5+ years of leadership experience
  • Experience using single use systems is preferred
  • Expertise in aseptic processing is preferred
  • Experience with optimizing, scaling, and tech transferring Manufacturing processes
  • Excellent communication skills, written and verbal
  • Ability to handle multiple priorities simultaneously
  • Demonstrated interpersonal skills to build relationships, act as change agent, and adapt to rapidly changing organizational and business needs
  • Ability to thrive in a quickly changing, CDMO environment where flexibility and teamwork is essential
  • Flexibility in problem solving

PHYSICAL DEMANDS

  • Ability to function in a rapidly changing environment & handle multiple priorities
  • Willingness to occasionally work nights and weekends is required
  • Ability to work in an environment that requires aseptic gowning
  • While performing the duties of this job, the employee is frequently required to stand; walk; sit; use hands to finger, handle, or feel; reach with hands and arms; and talk or hear. The employee is occasionally required to climb or balance; and stoop, kneel, crouch, or crawl. The employee must frequently lift and/or move up to 10 pounds and occasionally lift and/or move up to 25 pounds. Specific vision abilities required by this job include close vision, and ability to adjust focus.

Interested in hearing more? Easy Apply now by clicking the "Apply on company site" button.

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