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.

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).

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

Associate Director, Analytical Development

Key skills