Associate Director- Quality Control & Analytical Development

Job Title: Associate Director- Quality Control & Analytical Development

Job Number: 33803

Location: Remote, 

Job Description

The Associate Director– Quality Control & Analytical Development will oversee technical and operational aspects of analytical method development, characterization, and Quality Control across the company's pipeline. This individual will be an important member of the TechOps team, managing multiple parallel activities at all stages of product development. This role will report to the Senior Vice President of Quality Control and Analytical Development.

Responsibilities

• Manage analytical method development, characterization and Quality Control testing at contract testing labs and CDMOs
• Develop phase-appropriate methods for drug substance/drug product characterization and release testing, including qualification and validation activities
• Oversee stability studies and comparability programs
• Author or review study protocols and reports
• Work with Quality Assurance to help build and maintain a robust QC infrastructure
• Execute strategies for moving products from early to late stage and commercial development
• Work closely with Manufacturing & Development partners within Apogee TechOps, as well as external stakeholders, to execute analytical development and Quality Control activities according to program needs

Required Skills

• Advanced degree in a relevant discipline (e.g., analytical chemistry, biochemistry or related field)
• 10+ years of analytical development & quality control experience with complex biologics spanning early and late-stage development
• Expertise/competence in several relevant analytical techniques such as HPLC, spectrophotometry, mass spec, ELISA, and cell-based bioassays
• Excellent communication skills with an ability to collaborate effectively across functional lines
• Ability to work independently and multi-task in a fast-moving organization
• Availability to participate in calls across multiple international time zones
• Successfully exhibit Apogee’s C.O.R.E. values: Caring, Original, Resilient and Egoless
• Ability and willingness to travel up to 25%