Contract Director, Developability and Early CMC Development (1-Year, Full-Time, On-Site)
About the Company
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 Contract 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 Director will play a critical role in ensuring efficient candidate selection and optimizing therapeutic candidates for manufacturability, scalability, and regulatory compliance.
Job Description
We are seeking an experienced and motivated Director of Developability and Early CMC Development to join our team on a full-time, one-year contract basis. 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 RCBs and MCBs.
Duties and Responsibilities
Required Skills/Abilities
Full-time, on-site position at PineTree Therapeutics, Cambridge, MA.
Contract Duration:
1 Year (with potential for extension based on performance and business needs).
What We Offer
We seek candidates with a passion for building a creative company culture that is collaborative, multidisciplinary, and committed to make a transformative impact to our industry. To be successful in this role, we look for passion in scientific innovation, adept business skills, and excitement about working in a dynamic startup environment. A demonstrable track record of success in functioning as part of a project team is essential. Pinetree Therapeutics offers highly competitive salaries and comprehensive benefits, including medical and dental insurance, paid time off, and 401(k) with a generous company match.
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.
Recruitment & Staffing Agencies: Pinetree does not accept unsolicited resumes from any source other than candidates. Any resume submitted by an agency in the absence of a signed agreement will automatically become the property of Pinetree, and Pinetree will not owe any referral or other fees with respect thereto.
About the Company
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 Contract 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 Director will play a critical role in ensuring efficient candidate selection and optimizing therapeutic candidates for manufacturability, scalability, and regulatory compliance.
Job Description
We are seeking an experienced and motivated Director of Developability and Early CMC Development to join our team on a full-time, one-year contract basis. 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 RCBs and MCBs.
Duties and Responsibilities
- Supervise and mentor direct reports.
- Manage interactions within cross-functional teams.
- Lead and oversee the early-stage CMC development strategy and execution for monoclonal and multispecific antibody candidates.
- Lead a protein sciences group focused on establishing protein purification, early characterization, and analytics needed to support method transfer to external contract manufacturing organization.
- Design, implement, and manage comprehensive developability and pre-formulation screening, evaluating parameters such as cell productivity, aggregation, glycosylation patterns, post-translational modifications, solubility, stability.
- Provide strategic input into candidate selection based on robust developability assessment outcomes, balancing scientific rigor with resource efficiency, tailored to a small biotech environment.
- Establish fit-for-purpose analytical methods in-house.
- Leverage industry experience to select, engage, and manage external CDMOs effectively, ensuring timely, quality-driven delivery of RCB and MCB.
- 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.
- Collaborate cross-functionally with Discovery, Molecular Biology, and Translational Research teams to ensure seamless transition from research to clinical development.
- Partner with Business Development to pursue new partnerships.
- Develop and manage the operating budget.
- 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.
- PhD or advanced degree in Biochemistry, 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.
- Proven track record in Analytical Method Development and Optimization for physiochemical characterization of biological molecules.
- The ideal candidate should also have knowledge/experience in protein chemistry, in silico modeling and prediction/interpretation.
- Demonstrate significant expertise in biophysical and bioanalytical characterization of large molecules to address potential liabilities such as hydrophobicity, self/self-interaction, colloidal and conformational stability, aggregation propensity, chemical stability and short half-life (PK).
- Demonstrated experience with developability and manufacturability assessment of lead candidate molecules, including stable clone manufacturability assessment.
- Working knowledge with pre-formulation activities is a plus, e.g. excipient screening, solubility, stability testing.
- Experience with stable cell line generation concepts/technology and regulatory requirements.
- Proven track record of successfully managing CRO/CDMO relationships to deliver manufacturing stable cell line, RCB, and MCB.
- Prior experience working in both large pharmaceutical companies and smaller biotech organizations, demonstrating adaptability and efficient resource management.
- Deep understanding of applicable regulatory requirements (FDA, EMA) including current Good Manufacturing Practices and relevant ICH guidelines, that pertain to early-stage CMC activities.
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 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.
- Ability to establish high-level strategies for new drug technologies and apply novel technologies to drug discovery is a plus.
Full-time, on-site position at PineTree Therapeutics, Cambridge, MA.
Contract Duration:
1 Year (with potential for extension based on performance and business needs).
What We Offer
- Opportunity to be at the forefront of oncology research, contributing to the development of next-generation cancer therapies.
- A collaborative, supportive, and inclusive work environment where innovation thrives, and career development is encouraged.
- Competitive compensation package, including comprehensive benefits and opportunities for professional growth.
We seek candidates with a passion for building a creative company culture that is collaborative, multidisciplinary, and committed to make a transformative impact to our industry. To be successful in this role, we look for passion in scientific innovation, adept business skills, and excitement about working in a dynamic startup environment. A demonstrable track record of success in functioning as part of a project team is essential. Pinetree Therapeutics offers highly competitive salaries and comprehensive benefits, including medical and dental insurance, paid time off, and 401(k) with a generous company match.
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.
Recruitment & Staffing Agencies: Pinetree does not accept unsolicited resumes from any source other than candidates. Any resume submitted by an agency in the absence of a signed agreement will automatically become the property of Pinetree, and Pinetree will not owe any referral or other fees with respect thereto.
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