Associate Director, Quality Control – Analytical Sciences

DirectorDirectorFull TimeRemoteTeam 51-200H1B No SponsorCompany Site LinkedIn

Location

United States

Posted

61 days ago

Salary

$165K - $185K / year

Postgraduate Degree7 yrs expEnglish

Job Description

• 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.

Job 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