Remote Associate Director, Biologics Analytics & Operations

Travere Therapeutics; Salt Lake City (UT); On-site; USD 150,000 - 195,000; Full time

Benefits offered by this job

Premium health benefits

Retirement with employer match

Generous PTO

Life insurance

Disability insurance

Work-life programs

Job summary

Travere Therapeutics is seeking an Associate Director of Technical Operations to lead analytical method development, validation and transfer for biologics in a cGMP environment. The role requires collaboration with Quality, Regulatory and external CDMOs/CROs to ensure compliant product development and release.

The ideal candidate has a deep background in HPLC/CE-SDS/cIEF, ELISA and LC-MS, with 8+ years in biologics analytics and strong project management skills.

Qualifications

• B.S. in chemistry or related Life Sciences; MS preferred.
• 8+ years in analytical development of biologics, preferably late-stage.
• Knowledge of HPLC, CE-SDS, cIEF, potency bioassays, LC-MS, ELISA.
• Experience with data review and external CDMOs/CROs

Responsibilities

• Manage method development, validation, and transfer for biologics.
• Oversee specification setting at CDMOs/CROs.
• Author/review validation protocols/reports and SOPs.
• Manage reference standard program for substances and products.
• Review batch records and CoAs.
• Assist in investigations and root-cause analyses.
• Contribute to regulatory submissions for analytical packages.
• Providetechnical support to ensure compliant manufacturing/releases.

Skills

Interpersonal skills

Organizational skills

Verbal and written communication

Education

B.S. in chemistry/biochemistry/pharmaceutical sciences

M.S. degree preferred

Tools

HPLC

CE-SDS

cIEF

ELISA

LC-MS

Peptide mapping

Lyophilized products knowledge

Job description

Travere Therapeutics is seeking an Associate Director of Technical Operations to lead analytical method development, validation and transfer for biologics in a cGMP environment. The role requires collaboration with Quality, Regulatory and external CDMOs/CROs to ensure compliant product development and release.

The ideal candidate has a deep background in HPLC/CE-SDS/cIEF, ELISA and LC-MS, with 8+ years in biologics analytics and strong project management skills.