Associate Director, Analytical Development

We are seeking an Associate Director, Analytical Development to join our team in Analytical Development and Quality Control. This newly created position is a highly collaborative leadership and technical position based in our Research and Development lab in Boston.

You will manage and lead Analytical Development activities to support early to late phase programs, including monoclonal antibodies and other biologics modalities. These activities include supporting developability screening studies, method development, non-GMP analytical characterization, comparability and R&D sample testing. In this role you will be an important member of the Tech Ops team, managing multiple activities in parallel at various stages of drug development.

Key Responsibilities

• 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.

Ideal Candidate

• 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).

The anticipated salary range for candidates for this role will be $175,000 – $195,000 /year. 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.