Developability and Early CMC Development

Pinetree Therapeutics, Inc; Cambridge (MA); Vor Ort; USD 180.000 - 240.000; Vollzeit

Zusammenfassung

PineTree Therapeutics in Cambridge, MA, seeks a Director of Developability and Early CMC Development to lead analytical method development, developability assessment, and cell line development for monoclonal and multispecific antibodies. You will oversee CRO/CDMO collaborations, guide candidate selection, and drive IND readiness in a fast-growing biotech environment.

The role requires senior scientific leadership, experience with analytical and purification technologies, and a track record of

Qualifikationen

• PhD or advanced degree in Biochemistry, Chemistry, Biotechnology, or related field.
• 10+ years in advancing biologics from late research to CMC development.
• Proven ability to design and optimize analytical and purification methods.
• Experience managing CRO/CDMO relationships for manufacturing cell lines.

Aufgaben

• Lead early CMC developability strategy for monoclonal and multispecific antibodies.
• Collaborate with Discovery, Molecular Biology, Translational Research teams.
• Oversee analytics, purification, and cell line development workflows.
• Manage CRO/CDMO relationships, timelines, and budgets.
• Author IND-CMC sections and communicate progress to leadership.

Kenntnisse

Leadership

Analytical methods

Cross-functional

Communication

IND submissions

Ausbildung

PhD in Biochemistry/related

Tools

UPLC-MS

LC-MS

RP-HPLC

HIC-HPLC

CEX-HPLC

Jobbeschreibung

Developability and Early CMC Development

25.12.31

Director, Developability and Early CMC Development (Full-Time On-Site)

Location: PineTree Therapeutics, Cambridge, MA Job Type: Full-Time Employee

Start Date: Immediately

About PineTree Therapeutics: PineTree Therapeutics is an innovative biotech company pioneering multispecific degrader antibodies to revolutionize cancer treatment. Our proprietary platform is designed to target and degrade membrane-bound and extracellular proteins, offering a new approach to overcoming drug resistance in oncology. We are advancing a robust preclinical pipeline and actively preparing for translational and early clinical development.

To support our rapid growth, we are seeking a Director to provide scientific and strategic leadership in early CMC development. This individual will oversee the development of late-stage drug candidates with analytical and developability screening and cell line development. Working on-site, the right candidate will play a critical role in ensuring efficient candidate selection and optimizing therapeutic candidates for manufacturability, scalability, and regulatory compliance.

Position Overview: We are seeking an experienced and motivated Director of Developability and Early CMC Development to join our team. This position will play a critical role in the early-stage assessment of monoclonal and multispecific antibodies coming out of the Discovery pipeline and advancing them to cell line development. The ideal candidate will have extensive experience in analytical method development, developability assessment, lead selection, and expertise in managing internal resources alongside external CROs to establish the cell line development.

Supervisory Responsibilities:

• Supervise and mentor direct reports.
• Manage interactions within cross-functional teams.

Key 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, 10aggregation, 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.

Qualifications:

• 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.
• 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.

Required Skills/Abilities:

• 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 Skills:

• Ability to establish high-level strategies for new drug technologies and apply novel technologies to drug discovery is a plus.

Location:

Full-time, on-site position at PineTree Therapeutics, Cambridge, MA.

Pinetree is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person’s race, color, gender, age, religion, national origin, ancestry, disability, veteran status, genetic information, sexual orientation or any characteristic protected under applicable law. Pinetree will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law.