Apogee Therapeutics - Associate Director, Analytical Development
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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 • O.R.E. • 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.
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.
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 • E-Verify Participation: As part of the I9 verification of authorization to work in the US, Apogee participates in E-Verify. To learn more about E-Verify please review this poster.
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