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Aliada Therapeutics is a pioneering biotech company located in Boston, with a focused vision of advancing next-generation CNS therapeutics for patients. Aliada is driven by a seasoned team with collaborative experience and success across neurologic and biologic drug development. At the core of Aliada’s innovation lies a proprietary Modular Delivery (MODEL) platform, capable of transporting large molecule therapeutics across the blood-brain barrier (BBB). The platform, originally engineered at Janssen (Edavettal et al. 2022), includes a toolkit that enables tailoring of exposure and therapeutic functionality, including two distinct BBB-receptor targets (TfR and CD98) and a design that can accommodate a variety of therapeutic cargoes including antibodies, oligonucleotides, and enzymes. Aliada is applying the MODEL platform to multiple targets and modalities, with its most advanced program, ALIA-1758 entering a Phase 1 SAD clinical study. We are looking to build our team with colleagues who are intellectually curious, driven, accountable, and collaborative.

Role Summary

Aliada Therapeutics is currently searching for a Senior Director of Protein Chemistry CMC. This key resource will lead the strategic build of the CMC team driving innovation and developing forward-looking strategies for the development and commercialization of next-generation products.

Responsibilities:

· Lead a team of CMC scientists working with cross-functional R&D partners to develop therapeutic biologic candidates from early development through BLA approval.

· Accountable for the success and overall CMC quality of the diverse Aliada portfolio projects including multi-specific antibodies, enzyme fusions, and antibody-oligo conjugates.

· Provide strong functional technical leadership and ensure timely completion of all functional deliverables including reports and applicable quality and regulatory documents.

· Responsible for the Module 3 content of global filings, and high-quality CMC dossiers.

· Key member of teams that participate in communication and meetings with global Health Authorities along the development continuum.

· Reviews contracts with Third Party CDMOs, CROs, and consultants. Develops a budget in collaboration with R&D senior leadership and stays within the approved funding.

· Critically evaluates and integrates formulation, drug substance, drug product, analytical control strategy and device inputs to an overarching CMC strategy that

aligns with corporate business objectives and current regulatory / compliance requirements.

· Recruit and develop top talent to create and maintain a productive team of highly skilled scientists and project leaders. Establish and maintain an environment that ensures retention of key talent through continued development opportunities and recognition of key accomplishments.

· Ensures compliance with regulatory, health, safety, and environmental requirements. Is always informed of trends and breakthrough developments in the global technical, regulatory and compliance arena and industry practices.

Skills and Requirements:

· Ph.D. or MS Degree in Pharmaceutical Sciences, Chemistry and/or Chemical Engineering preferred. 12+ years of related industry experience required.

· Demonstrated in-depth technical expertise in formulation and drug substance/product process development of biologics, including process scale-up from pilot plants to large-scale facilities.

· Experience with bioconjugation and devices preferred.

· Proven experience in the generation of relevant sections of IND and BLA filing.

· 8+ years of experience in technical leadership role that includes experience managing people with demonstrated ability to build and develop a high performing team.

· Self-motivated leader with exceptional influencing, partnership, and collaboration skills to solve scientific and business problems and drive results within a matrix environment.

· Understanding of industry best practices & trends to challenge status-quo and drive change.

· Knowledge of the cGMP practices and compliance requirements.

· Excellent written, presentation, and verbal communication skills with ability to interact professionally and effectively with internal and external constituents.

If you are interested in exploring work opportunities at Aliada, please submit your resume noting your specific position interest to: careers@aliadatx.com. For more information on Aliada, please visit our website at https://aliadatx.com.

Aliada is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, disability, age, sexual orientation, gender identity, national origin, veteran status, or genetic information. Aliada is committed to providing access, equal opportunity, and reasonable accommodation for individuals with disabilities in employment, its services, programs, and activities.

Applicants must be authorized to work for ANY employer in the U.S. We are unable to sponsor or take over sponsorship of employment Visa at this time.

Employment agencies are an important component of our talent acquisition strategy, and we value the partnerships we have built with our preferred vendors. We will not accept unsolicited resumes from employment agencies for any employment opportunity.

All resumes submitted by search firms to any employee at Aliada or directly to hiring managers in any form without a signed agreement between the parties will be deemed unsolicited in nature, and no fee will be paid in the event the candidate is hired as a result of the referral or through other means.