Associate Director, Analytical Development
Apogee Therapeutics
full-time
Posted on:
Location Type: Hybrid
Location: Boston • United States
Visit company websiteExplore more
Salary
💰 $175,000 - $195,000 per year
Job Level
About the role
- Design, develop, and implement analytical methods for the testing and characterization of biologics programs including monoclonal antibodies and other biologics modalities. The work will include partnership with contracted partners and/or internal analytical capabilities.
- Design, manage and execute experiments to support developability screening, upstream/downstream process development, process transfer, formulation studies, product characterization and comparability studies.
- Develop and execute analytical strategies with other stakeholders in support of the product and analytical method lifecycle, ensuring compliance with safety, quality, and regulatory requirements.
- Demonstrate technical excellence in method development and analytical characterization/comparability of biologics; build strong partnerships and collaborations internally and externally.
- Collaborate with cross-functional teams, including process development and R&D, to support project goals and timelines.
- Analyze and interpret complex data sets, providing clear and actionable insights and recommendations.
- Prepare technical reports, presentations, and documentation to communicate findings and progress to stakeholders.
- Author and review analytical sections of IND, IMPD, BLA, and MAA submissions.
- Stay current with industry trends, advancements to continuously improve analytical capability, methodologies and practices.
Requirements
- PhD in Analytical Chemistry, Biochemistry, or related field, with a minimum of 7 years of relevant industry experience in an analytical development role, preferred.
- Demonstrated expertise in managing analytical development initiatives for monoclonal antibodies and other biologic modalities, encompassing method development, product quality assessment, characterization, and comparability studies.
- Deep expertise in several analytical techniques such as mass spectrometry, H/UPLC (SEC, IEX, RP, HILIC,), electrophoresis (CE-SDS, icIEF) and/or biophysical methods. Experience in ELISA, bioassay and potency assays is preferred.
- Experience in working with external contract organizations (CDMO, CRO, etc.) to deliver key analytical deliverables.
- Strong problem-solving skills and the ability to lead, design, troubleshoot, and conduct complex experiments.
- Excellent communication skills with an ability to collaborate effectively across functional lines.
- Strong organizational and project management skills, with the ability to manage multiple projects simultaneously.
- Familiarity with regulatory requirements and guidelines (e.g., FDA, ICH) related to analytical development and comparability
- Successfully exhibit Apogee’s C.O.R.E. values: Caring, Original, Resilient and Egoless
- Ability and willingness to travel up to 35% for company-wide meetings as well as Tech Ops team meetings.
- This hybrid role requires approximately two days per week onsite at our laboratory in Boston (Seaport area).
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 & Tools
analytical methodsmethod developmentproduct quality assessmentcharacterization studiescomparability studiesmass spectrometryH/UPLCelectrophoresisELISAbioassay
Soft Skills
problem-solvingcommunicationcollaborationorganizational skillsproject managementleadershiptroubleshootingdata analysisinsight generationpresentation skills
Certifications
PhD in Analytical ChemistryPhD in Biochemistry