Associate Director, Quality Control – Analytical Sciences
Apogee Therapeutics
full-time
Posted on:
Location Type: Remote
Location: United States
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Salary
💰 $165,000 - $185,000 per year
Job Level
About the role
- Support the harmonization of QC analytical methods across internal laboratories, external vendors, and contract testing organizations.
- Partner with global and cross-functional teams to ensure successful implementation of harmonized methods.
- Support method transfers, validations, and comparability studies, ensuring adherence to regulatory and quality requirements.
- Provide technical oversight to vendors and contract laboratories, including troubleshooting and resolution of method-related issues.
- Author and review regulatory submissions (e.g., INDs, BLAs, MAAs) and support technical documentation, ensuring clarity, accuracy, and compliance with global guidelines.
- Generate and review technical documents, including protocols, reports, and method lifecycle documents.
Requirements
- Advanced degree in a relevant discipline (e.g., analytical chemistry, biochemistry, microbiology or related field)
- 7+ years of analytical development & quality control experience with complex biologics spanning early and late-stage development (GMP experience required)
- Expertise/competence in several relevant analytical techniques such as HPLC, spectrophotometry, mass spec, ELISA, bioassay and microbiology
- Strong understanding of global regulatory requirements (e.g., FDA, EMA, ICH) as they relate to analytical development, QC testing, and method validation
- Hands-on experience supporting regulatory submissions (INDs, IMPDs, BLAs/NDAs, or equivalents), including preparation, review, and response to analytical sections
- 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
- Position requires up to 30% travel including mandatory in-person attendance at Apogee All Hands meetings typically held twice per year
Benefits
- 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
- We provide competitive time off, including three weeks PTO, two one-week company-wide shutdowns a year and dedicated paid sick leave
- 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
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard skills
analytical developmentquality controlHPLCspectrophotometrymass spectrometryELISAbioassaymicrobiologymethod validationGMP
Soft skills
communicationcollaborationindependencemulti-taskingproblem-solving