PineTree Therapeutics Inc · 13 hours ago
Director, Developability and Early CMC Development (Full-Time On-Site)
Cambridge, MA
Full-time
Onsite
Director/Executive
10+ years expPineTree Therapeutics is an innovative biotech company pioneering multispecific degrader antibodies to revolutionize cancer treatment. We are seeking a Director to provide scientific and strategic leadership in early CMC development, overseeing the development of late-stage drug candidates and ensuring efficient candidate selection for manufacturability and regulatory compliance.
BiotechnologyMedicalOncologyTherapeuticsWellness
Hiring Manager
Michael Smith
Responsibilities
Establish fit-for-purpose analytical/purification methods to support multivalent therapeutic antibodies, ADC or protein/antibody fusion lead screening and further development in leveraging both proprietary (in-house) technologies and external (CRO/partner) capabilities to accelerate lead identification and candidate advancement
Executing purification and analytical utilizing modern equipment to support the programs at early discovery or late-stage development including UPLC-MS, LC-MS, RP-HPLC, HIC-HPLC, CEX-HPLC and different affinity chromatography et al
Provide strategic input into candidate selection based on robust developability assessment outcomes, balancing scientific rigor with resource efficiency, tailored to a small biotech environment
Collaborate cross-functionally with Discovery, Molecular Biology, and Translational Research teams to ensure seamless transition from research to clinical development
Lead and oversee the early-stage CMC development strategy and execution for monoclonal and Multivalent antibody candidates to the IND submission
Design, implement, and manage comprehensive developability and pre-formulation screening, evaluating parameters such as cell productivity, aggregation, glycosylation patterns, post-translational modifications, solubility, stability
Establish and optimize workflows, ensuring alignment of internal processes with industry best practices
Manage relations with external CDMOs for CMC activities including process transfers, problem resolution, timeline management, and budget oversight
Author key sections of IND applications related to CMC
Communicate effectively with senior management and external partners regarding CMC strategies, progress, and risk management
Fostering a culture of innovation, teamwork, and continuous performance improvement
Qualification
Required
PhD or advanced degree in Biochemistry, Chemistry, Biotechnology, (bio)chemical Engineering, or a related scientific discipline
10+ years of experience in advancing biological molecules from late research to CMC development, specifically focused on monoclonal and multi-specific antibody therapeutics
Demonstrated hands-on expertise in designing, optimizing, and validating analytical and purification techniques to support the screening and development of multivalent therapeutic antibodies. Skilled in leveraging both proprietary (in-house) technologies and external (CRO/partner) capabilities to accelerate lead identification and candidate advancement
Proven track record in Analytical Method Development and Optimization for physiochemical characterization of biological molecules
Strong interpersonal and communication skills, with the ability to clearly articulate strategies and scientific rationale to diverse stakeholders
Managerial or supervisory experience is mandatory
Excellent organizational, analytical, and problem-solving abilities
Deep and hands-on expertise in Analytical method development is mandatory
Experience with formulation screening and optimization
Experience in IND submissions and early-phase regulatory interactions
Familiarity with various mammalian expression systems and technologies, especially CHO cell-based production
Experience with novel antibody formats such as multispecific antibodies or antibody-drug conjugates (ADCs)
Team player and builder with excellent coaching skills
High degree of integrity, professionalism, and dedication to exceptional quality
Preferred
Working knowledge with pre-formulation activities is a plus, e.g. excipient screening, solubility, stability testing
Good to have experience in protein/antibody biophysiological characterization such as CE-SDS, cIEF, DSC…
Good to have experience with stable cell line generation concepts/technology and regulatory requirements
Good to have experience of successfully managing CRO/CDMO relationships to deliver manufacturing stable cell lines, RCB, and MCB
Good to have experience working in both large pharmaceutical companies and smaller biotech organizations, demonstrating adaptability and efficient resource management
Ability to establish high-level strategies for new drug technologies and apply novel technologies to drug discovery is a plus
Company
PineTree Therapeutics Inc
Pinetree Therapeutics is an award-winning, pre-clinical stage biotechnology company based in Cambridge, Massachusetts.
11-50 employees
H1B Sponsorship
PineTree Therapeutics Inc has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2024 (1)
2022 (1)
2021 (1)
2020 (2)
Funding
Current Stage
Growth StageTotal Funding
$87.5MKey Investors
DSC Investment,Northern Star Partners,STIC InvestmentMassachusetts Life Sciences Center
2025-10-28Series B· $47M
2024-07-30Series A· $17M
2022-09-27Grant
Leadership Team
Ho-Juhn Song
CEO/Founder
Recent News
2026-01-14
2025-11-01
Company data provided by crunchbase