Manufacturing Associate - Intermediate in Boulder, CO at Volt

Date Posted: 1/17/2020

Job Snapshot

  • Employee Type:
    Contingent
  • Location:
    Boulder, CO
  • Job Type:
  • Duration:
    48 weeks
  • Date Posted:
    1/17/2020
  • Job ID:
    209556
  • Contact Name
    Volt Branch
  • Phone
    970-494-2000

Job Description

Shift Hours: 6:00am to 4:30pm; Tuesday - Friday

As a Manufacturing Associate, you will check and schedule resources to ensure on-time delivery. Your scientific knowledge and background will be leveraged through your review of formulation documents and active ingredient dilution to ensure that products are manufactured to specification.  

Key responsibilities include:

- Actively involved in the manufacturing of oligonucleotide APIs in a GMP environment.

- Actively involved in aspects of technology transfer and scale-up of oligonucleotide manufacturing processes delivered from Manufacturing Technical Services into Manufacturing.

- Write and revise standard operating procedures according to regulatory and procedural guidelines.

- Work with Validation and Engineering personnel to validate new equipment and facilities.

- Work with Manufacturing Management and Quality to resolve manufacturing problems including drafting quality documentation (CAPA, deviation, change control, etc.).

- Maintain, calibrate, and trouble shoot critical process equipment.

Qualifications 

  • 1+ years of related experience in a pharmaceutical manufacturing environment preferred but not required
  • Previous knowledge of oligonucleotide synthesis, purification, UF, conjugation, and lyophilization is advantageous
  • Detail oriented and can perform technical duties following standard operating procedures and general laboratory safety rules
  • Ability to work both independently and in a team setting on a variety of projects and use individual discretion to meet required project objectives and deadlines
  • Excellent math, documentation, communication and operational trouble shooting skills
  • Mechanically inclined
  • Ability to work as a successful member of a team working to establish priorities, scheduling, and procedures that collectively will meet department goals and project deadlines
  • Ability to work in a clean room environment
  • Previous experience in a FDA regulated manufacturing environment highly desired