Associate Director, QC & Technical Operations (Remote)

Travere Therapeutics; Detroit (MI); On-site; USD 150,000 - 195,000; Full time

Benefits offered by this job

Premium health benefits

Retirement plans with employer match

Generous paid time off

Job summary

Travere Therapeutics is looking for an Associate Director, Technical Operations QC to manage Quality Control activities in compliance with GMP standards. This role involves providing technical leadership and collaboration across multiple departments for the commercialization of therapies targeting rare diseases.

The ideal candidate will have extensive experience in the pharmaceutical industry, particularly in quality control and regulatory compliance. The commitment to patient-focused values is essential in this fast-paced environment.

Qualifications

• 8+ years of relevant experience in analytical operations, analytical development, or quality control of biologics required.
• Direct knowledge of applicable analytical methods is crucial.
• Broad knowledge and experience within the GMP environment and regulatory affairs.

Responsibilities

• Coordinate and lead Quality Control (QC) activities in support of drug manufacturing.
• Oversee specification development and batch release.
• Collaborate with internal and external groups to ensure compliance with regulations.
• Provide guidance during investigations of deviations and ensure CAPAs are implemented.

Skills

Analytical operations

Quality control of biologics

Regulatory affairs

Communication skills

Teamwork

Education

Bachelor's degree in Chemistry, Biochemistry, or related Life Sciences

Master's degree preferred

Tools

HPLC

GC

MS

NMR

IR

UV

Job description

Travere Therapeutics is looking for an Associate Director, Technical Operations QC to manage Quality Control activities in compliance with GMP standards. This role involves providing technical leadership and collaboration across multiple departments for the commercialization of therapies targeting rare diseases.

The ideal candidate will have extensive experience in the pharmaceutical industry, particularly in quality control and regulatory compliance. The commitment to patient-focused values is essential in this fast-paced environment.