Director, Cell Culture Development

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 a Director, Cell Culture Development to join the TechOps team. This role will be responsible for managing CDMO(s) to develop/implement processes that enable robust production of Drug Substance (DS) for protein-based biologics. This interdisciplinary position will provide technical leadership in cell culture processes, including scale-up from lab to manufacturing scale. Support of manufacturing campaigns will be critical, including tech transfer, troubleshooting, deviation resolution, and campaign analysis activities. The role will be responsible for advancing clinical assets through clinical development, including development of second-generation processes, resupply, and late phase development as appropriate. The primary focus of this role will be to support late-phase tech transfer, manufacturing, and commercialization activities. Embedded in the Drug Substance Development and Manufacturing team, this position will be a member of an integrated Development, Manufacturing & Supply team, and will collaborate closely with team members involved in drug substance development, device development, analytical development, and supply chain. Key Responsibilities Guide process development of protein production from lab-scale to tech transfer and GMP manufacture at CDMOs (including onsite support when required, such as Person in Plant, inspection support, etc.) Analyze process and manufacturing data to understand and optimize process performance Troubleshoot processes to identify root causes, propose corrective actions, and support resolution of deviations Review and approve master and executed batch records; assist with investigations Author and review internal procedures, reports, and presentations Develop process characterization and validation strategies and documentation Support regulatory activities including submissions and site inspections from preparation through execution Liaise with DP, device development, and clinical supply chain as needed to ensure seamless end to end product delivery and robustness Collaborate cross-functionally with Regulatory to author and support regulatory submissions (IND, IMPD, amendments, IB, BLA, etc.) Develop phase-appropriate product understanding and control strategies using QbD framework Create late-phase development strategy to support potential commercialization. Collaborate closely with colleagues to ensure a seamless, highly integrated TechOps team Along with other TechOps team members, help shape goals and strategic vision for the TechOps organization Ideal Candidate PhD in relevant discipline (e.g., biology, chemistry, biochemistry, bio/chemical engineering, or relevant field) or commensurate years of education and experience 10+ years of biologics development and manufacturing experience Significant experience with cGMPs. Proven track record of advancing assets from pre-clinical through IND and into late phase development Experience with commercialization of biologics, including regulatory expectations for marketing approval Substantial experience leading tech transfer to CDMOs and supporting campaigns Experience with drug product development is preferred Demonstrated aptitude in collaborating cross-functionally with analytical, formulation/DP, manufacturing, and/or supply chain is required Emerging leader with a growth mindset, willing to learn from others, and dedication to promoting a psychologically safe environment Excellent communication skills with an ability to present to a variety of stakeholders and tailor message accordingly Ability to multi-task and keep pace with a fast-moving organization Successfully exhibit Apogee’s C.O.R.E. values: Caring, Original, Resilient and Egoless Availability to participate in calls across multiple international time zones Ability and willingness to travel up to 25%, including domestic and international sites along with mandatory in-person attendance at All Hands meetings typically held twice per year The anticipated salary range for candidates for this role will be $215,000-$230,000. 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. Apogee 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. To review our privacy policy, click here It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.