Job Description
About Apogee Therapeutics
Founded in 2022, Apogee Therapeutics, Inc. (Ticker: APGE) is a well-funded, Nasdaq listed company that offers the opportunity to work in a fast-paced, highly dynamic environment. At Apogee, you can actively contribute to shaping the company culture, take on various roles and responsibilities, and grow professionally.
Apogee Therapeutics is a clinical-stage biotechnology company advancing novel biologics with potential for differentiated efficacy and dosing in the largest I&I markets, Apogee’s antibody programs are designed to overcome limitations of existing therapies by targeting well-established mechanisms of action and incorporating advanced antibody engineering to optimize half-life and other properties. Zumilokibart (APG777), the company’s most advanced program, is being initially developed for the treatment of atopic dermatitis (AD), which is the largest and one of the least penetrated I&I markets, as well as asthma. With four validated targets in its portfolio, Apogee is seeking to achieve best-in-class efficacy and dosing through monotherapies and combinations of its novel antibodies. Based on a broad pipeline and depth of leadership and expertise, the company believes it can deliver value and meaningful benefit to patients underserved by today’s standard of care.
We are a fast-paced company committed to building an exceptional culture, founded on our C.O.R.E. values: Caring, Original, Resilient and Egoless and a commitment to refusing to stop at “good enough”.
If this sounds like you, keep reading!
Role Summary
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: C aring, O riginal, R esilient and E goless
- 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.
What We Offer
- 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.
A pogee Therapeutics is proud to be an Equal Opportunity employer. All qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected Veteran status, age, or any other characteristic protected by law.
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