Associate Director, Technical Operations Quality Control

Responsibilities

• Cook up and oversee Quality Control (QC) activities in support of drug substance and drug product manufacturing.
• Oversee specification development, batch release, and stability program of drug substance and drug product at Contract Manufacturing Organizations (CMOs).
• Provide scientific and technical support to internal and external groups to ensure that products are tested and released in compliance with all applicable regulations.
• Collaborate with Analytical Development team to provide support for method transfer activities.
• Collaborate with Regulatory CMC group to support preparation and QC of regulatory submissions and variations.
• Serve as an SME in support of Travere’s Quality Assurance (QA) PAI readiness activities and Vendor audits.
• Support internal manufacturing team’s comparability assessments for process changes.
• Provide guidance and work with external vendors during OOS, OOT, atypical result investigations and deviations, ensuring final reports are scientifically sound, risk-based, and appropriate CAPAs are implemented, where applicable.
• Serve as a key member of the cross-functional team supporting the corporate goals for clinical development to commercialization of a small molecule drug product for a rare disease indication.

Requirements

• Bachelor’s degree in Chemistry, Biochemistry, or related Life Sciences discipline required. Master’s degree preferred.
• 8+ years of relevant experience in analytical operations, analytical development, or quality control of biologics required. Experience in late-stage drug development preferred.
• Direct knowledge of Dissolution, HPLC, GC, MS, NMR, IR, UV and other relevant analytical methods.
• Broad knowledge and experience within the GMP environment and regulatory affairs.

Additional Skills/Experience

• Driven, intelligent, passionate about making a difference for patients with rare diseases.
• Adaptable to modification and changes to project plans, demonstrating flexibility to implement new strategies and tactics to accommodate these changes.
• Professional experience in a similar role within the biotech or pharmaceutical industry, preferably small molecule pharmaceuticals and biologics.
• Practice team player with strong interpersonal and organizational skills.
• Able to work both independently and in a team environment.
• Strong verbal and written communication skills.
• Excellent decision-making and collaboration skills with strong attention to detail.
• Prominent ability to manage multiple priorities in a fast-paced environment.
• Experience with Veeva/Quality Doc a plus.
• Able to travel 10-20% domestically and internationally.

Total Rewards Offerings

• Comprehensive total rewards offerings that demonstrate our commitment as a diverse, equitable, people-centric, and pay-for-performance organization.
• Benefits: Premium health, financial, work-life and well-being offerings for eligible employees and dependents, wellness and employee support programs, life insurance, disability, retirement plans with employer match and generous paid time off.
• Compensation: Competitive compensation package including a combination of both cash compensation (base pay and short-term incentive) and long-term incentive compensation (company stock), designed to recognize, retain, and reward employees.