Tbwa Chiat/Day Inc
Associate Director of Cell Line Development Bothell, Washington, United States
Tbwa Chiat/Day Inc, Bothell, Washington, United States, 98021
Associate Director of Cell Line Development
Bothell, Washington, United States Company Overview Immunome is a clinical-stage targeted oncology company committed to developing first- and best-in-class targeted therapies designed to improve outcomes for cancer patients. We are advancing an innovative portfolio of therapeutics, drawing on leadership that previously played key roles in the design, development, and commercialization of cutting-edge targeted cancer therapies, including antibody-drug conjugate therapies (ADCs). In addition to a portfolio of discovery-stage ADCs, our pipeline includes AL102, a gamma secretase inhibitor which is currently in a Phase 3 trial for treatment of desmoid tumors, as well as IM-1021, a ROR1 ADC, and IM-3050, a FAP-targeted radioligand, both of which are the subject of INDs expected to be submitted in the first quarter of 2025. Position Overview We are seeking a highly experienced and innovative Associate Director of Cell Line Development to lead and manage the cell line development activities for our pipeline. This role is responsible for overseeing the development and optimization of mammalian cell lines used in the production of biologics. The successful candidate will collaborate cross-functionally with teams in R&D, process development, manufacturing, and regulatory affairs to ensure the efficient generation and characterization of high-quality, stable cell lines that meet clinical and commercial production and regulatory standards. Responsibilities Lead the cell line development team, setting strategic goals, timelines, and priorities to support pipeline projects and process optimization. Drive innovation in cell line development technologies, such as expression systems, gene transfection and amplification, and host cell engineering. Ensure proper characterization of cell lines, including expression levels, genetic stability, and product quality (e.g., glycosylation patterns, aggregation, and post-translational modifications). Collaborate closely with Discovery Research to design and select the appropriate candidates with optimized productivity, stability, and product quality. Lead activities in generating and maintaining master and working cell bank inventories across a portfolio of engineered cell lines. Ensure compliance with regulatory requirements and quality guidelines for cell line development, including ICH Q5A/B/D and FDA/EMA guidance. Oversee the generation of comprehensive documentation (SOPs, protocols, reports) to support regulatory submissions and technology transfer. Maintain awareness of emerging trends in cell line development, biologics production, and regulatory expectations, and incorporate them into the company’s strategy. Mentor, coach, and develop a team of scientists and technical staff to foster a high-performance culture. Manage resource allocation, budgets, and timelines for the cell line development function. Qualifications Ph.D. or Master’s degree in Cell Biology, Molecular Biology, Biochemistry, Biotechnology, or a related field. Minimum of 7 years of experience in cell line development for biopharmaceutical production. Previous leadership experience is strongly preferred. Proven track record in developing and optimizing cell lines for monoclonal antibodies and recombinant proteins. Experience with regulatory submissions and interfacing with health authorities (FDA, EMA). Knowledge and Skills Strong expertise in mammalian cell culture (e.g., CHO, CHO-K1, CHO-DG44, CHO-S). Proficiency in modern techniques such as gene editing, flow cytometry, automation, and high-throughput screening. Familiarity with quality by design (QbD) principles, and cell line characterization tools (e.g., NGS, proteomics, flow cytometry). Knowledge of GMP standards, regulatory guidelines, and experience supporting IND, BLA, or MAA filings. Strong leadership and people management skills. Excellent communication and cross-functional collaboration abilities. Strong problem-solving skills with a solution-oriented approach. Ability to manage multiple projects and prioritize effectively in a fast-paced environment. Washington State Pay Range: $171,000 - $196,000 USD E/E/O Immunome, Inc. is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all employees.
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Bothell, Washington, United States Company Overview Immunome is a clinical-stage targeted oncology company committed to developing first- and best-in-class targeted therapies designed to improve outcomes for cancer patients. We are advancing an innovative portfolio of therapeutics, drawing on leadership that previously played key roles in the design, development, and commercialization of cutting-edge targeted cancer therapies, including antibody-drug conjugate therapies (ADCs). In addition to a portfolio of discovery-stage ADCs, our pipeline includes AL102, a gamma secretase inhibitor which is currently in a Phase 3 trial for treatment of desmoid tumors, as well as IM-1021, a ROR1 ADC, and IM-3050, a FAP-targeted radioligand, both of which are the subject of INDs expected to be submitted in the first quarter of 2025. Position Overview We are seeking a highly experienced and innovative Associate Director of Cell Line Development to lead and manage the cell line development activities for our pipeline. This role is responsible for overseeing the development and optimization of mammalian cell lines used in the production of biologics. The successful candidate will collaborate cross-functionally with teams in R&D, process development, manufacturing, and regulatory affairs to ensure the efficient generation and characterization of high-quality, stable cell lines that meet clinical and commercial production and regulatory standards. Responsibilities Lead the cell line development team, setting strategic goals, timelines, and priorities to support pipeline projects and process optimization. Drive innovation in cell line development technologies, such as expression systems, gene transfection and amplification, and host cell engineering. Ensure proper characterization of cell lines, including expression levels, genetic stability, and product quality (e.g., glycosylation patterns, aggregation, and post-translational modifications). Collaborate closely with Discovery Research to design and select the appropriate candidates with optimized productivity, stability, and product quality. Lead activities in generating and maintaining master and working cell bank inventories across a portfolio of engineered cell lines. Ensure compliance with regulatory requirements and quality guidelines for cell line development, including ICH Q5A/B/D and FDA/EMA guidance. Oversee the generation of comprehensive documentation (SOPs, protocols, reports) to support regulatory submissions and technology transfer. Maintain awareness of emerging trends in cell line development, biologics production, and regulatory expectations, and incorporate them into the company’s strategy. Mentor, coach, and develop a team of scientists and technical staff to foster a high-performance culture. Manage resource allocation, budgets, and timelines for the cell line development function. Qualifications Ph.D. or Master’s degree in Cell Biology, Molecular Biology, Biochemistry, Biotechnology, or a related field. Minimum of 7 years of experience in cell line development for biopharmaceutical production. Previous leadership experience is strongly preferred. Proven track record in developing and optimizing cell lines for monoclonal antibodies and recombinant proteins. Experience with regulatory submissions and interfacing with health authorities (FDA, EMA). Knowledge and Skills Strong expertise in mammalian cell culture (e.g., CHO, CHO-K1, CHO-DG44, CHO-S). Proficiency in modern techniques such as gene editing, flow cytometry, automation, and high-throughput screening. Familiarity with quality by design (QbD) principles, and cell line characterization tools (e.g., NGS, proteomics, flow cytometry). Knowledge of GMP standards, regulatory guidelines, and experience supporting IND, BLA, or MAA filings. Strong leadership and people management skills. Excellent communication and cross-functional collaboration abilities. Strong problem-solving skills with a solution-oriented approach. Ability to manage multiple projects and prioritize effectively in a fast-paced environment. Washington State Pay Range: $171,000 - $196,000 USD E/E/O Immunome, Inc. is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all employees.
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