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Senior Director, Quality Control Analytical Sciences
Senior Director, Quality Control Analytical SciencesApogee Therapeutics • Milwaukee, WI, US
Senior Director, Quality Control Analytical Sciences

Senior Director, Quality Control Analytical Sciences

Apogee Therapeutics • Milwaukee, WI, US
[job_card.30_days_ago]
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  • [job_card.full_time]
[job_card.job_description]

Senior Director, Quality Control Analytical Sciences

We are seeking a Senior Director, Quality Control (QC) Analytical Sciences, to lead QC Analytical Sciences across Apogee's pipeline. This individual will be an important leader driving the TechOps and CMC Regulatory strategy, reporting to the VP of Analytical Development and Quality Control.

Key Responsibilities

  • Lead QC Analytical Sciences team, responsible for QC activities for all pipeline programs including strategies for phase-appropriate method qualification, validation, and transfer for drug substance, drug product, and drug-device combination testing; in-process / release / stability testing; specification justification and maintenance; shelf-life management; and critical documentation
  • Partner with new and existing external QC testing labs and CDMOs, managing relationships and all relevant activities in collaboration with TechOps Program Management, Quality Assurance, and Manufacturing
  • Develop analytical regulatory strategies and prepare relevant Module 3 regulatory documents
  • Contribute to a mature QC infrastructure, implementing processes and procedures to support the development of therapeutic candidates in a GMP-compliant manner
  • Monitor data trends, troubleshoot QC method performance, and investigate OOT / OOS results

Ideal Candidate

  • PhD in relevant discipline (e.g., analytical biochemistry or relevant field)
  • 15+ years of QC experience with complex biologics, particularly monoclonal antibodies, spanning late-stage development and commercialization
  • Proven people leader with a growth mindset, willing to learn from others, and dedication to promoting a psychologically safe environment
  • Excellent communicator with an ability to present to and be understood by a variety of stakeholders and tailor message accordingly
  • Experience with regulatory filing preparation and messaging across global jurisdictions
  • Deep knowledge and understanding of relevant global regulatory guidance and requirements
  • Ability to keep pace with 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 30%

    • The anticipated salary range for candidates for this role will be $245,000-$260,000. The final salary offered will depend on several factors, which may include, but is not limited to relevant years of experience, educational background, and geography.

    A great culture, grounded in our C.O.R.E. values : Caring, Original, Resilient and Egoless

    Opportunity to work in a fast-paced, highly dynamic environment where you help shape the culture and company, wear multiple hats, and learn quickly

    Market competitive compensation and benefits package, including base salary, performance bonus, equity grant opportunities, health, welfare & retirement benefits

    Flexible PTO

    Two, one-week company-wide shutdowns each year

    Commitment to growing you professionally and providing access to resources to further your development

    Apogee offers regular all team, in-person meetings to build relationships and problem solve

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