Job #               #3093
Job Type:         Full-time, On-site
Location:         Greater Boston area

Position Summary:
We are seeking an experienced and motivated Director (Sr. Director), Early CMC Development and Development Assessment to join our client’s team in the Greater Boston area.  This position will play a critical role in the early-stage assessment of monoclonal and multi-specific 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 multi-specific 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:

• The 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 in the Greater Boston area

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*Our activities, as well as those of our client, are conducted to not discriminate against any applicant because of his/her race, color, religion (creed), gender, gender expression, age, National origin (ancestry), disability, marital status, or sexual orientation. This is an unofficial document prepared by CMCPositions.com to provide basic information concerning the position.   The company we are conducting this search for has the official job description.