Director of Bioconjugation

Company Description 

Veranova is a global leader in the development and manufacturing of complex active pharmaceutical ingredients (APIs) for pharma and biotech customers. With deep technical expertise and impressive flexibility, we develop solutions and processes that support and accelerate innovation.

Job Description

The Director of Bioconjugation will lead the bioconjugation efforts within the Contract Development and Manufacturing Organization (CDMO) in the pharmaceutical and biotech sectors. This individual will oversee the development, optimization, and manufacturing of bioconjugates, including antibody-drug conjugates (ADCs), fusion proteins, and other targeted therapies. They will work closely with clients, cross-functional teams, and external partners to ensure the successful translation of bioconjugate therapies from preclinical stages to commercialization.

Key Responsibilities / Accountabilities

• Leadership and Strategy: Lead and manage the bioconjugation team, providing strategic direction for the design, development, and manufacturing of bioconjugates. Develop a long-term vision and roadmap for the bioconjugation capabilities within the CDMO, aligning with client needs and market trends.
• Project Management: Oversee multiple bioconjugation projects, ensuring they are executed on time, within budget, and meet quality standards. Act as the key point of contact between clients and internal teams, providing updates and managing expectations.
• Bioconjugation Technology Development: Drive the development of new bioconjugation technologies and methods, focusing on improving efficiency, scalability, and product quality. Stay abreast of the latest trends, scientific advancements, and regulatory requirements in the field.
• Collaboration with Clients: Serve as the primary technical liaison for clients involved in the development and manufacturing of bioconjugates. Provide expert advice on bioconjugation strategies, optimizing conjugation chemistry, and ensuring robust production processes.
• Regulatory and Compliance Oversight: Ensure that bioconjugation processes comply with regulatory guidelines (e.g., FDA, EMA, ICH) and internal quality standards. Oversee the preparation of regulatory documentation, including CMC (Chemistry, Manufacturing, and Controls) sections for INDs and CTDs.
• Process Development and Optimization: Lead the scale-up and transfer of bioconjugation processes from laboratory to manufacturing scale. Identify and address challenges related to conjugation efficiency, stability, purification, and final product characterization.
• Team Development and Training: Build and mentor a high-performing bioconjugation team. Provide guidance on best practices in conjugation technologies and facilitate professional development opportunities for team members.
• Cross-Functional Collaboration: Work closely with other departments, including analytical development, formulation, quality assurance, and regulatory affairs, to ensure seamless integration of bioconjugation processes into broader drug development timelines.
• Technology Transfer and Commercialization: Oversee the transfer of bioconjugation processes to clients’ commercial manufacturing sites or internal GMP facilities. Provide technical expertise and troubleshooting support during commercialization phases.
• Budget and Resource Management: Manage resources, staffing, and budgets related to bioconjugation activities. Ensure efficient use of materials and technologies to meet project goals within the defined financial parameters.

Qualifications

• Ph.D. or Master’s degree in Biochemistry, Molecular Biology, Pharmaceutical Sciences, Chemical Engineering, or a related field.
• Minimum of 10 years of experience in the pharmaceutical/biotech industry, with at least 5 years in a leadership role focused on bioconjugation, ADCs, or related therapeutic modalities.
• Strong knowledge of bioconjugation chemistries (e.g., linker technologies, payload conjugation, site-specific conjugation).
• Hands-on experience in process development, optimization, and scale-up of bioconjugation processes.
• Expertise in cGMP manufacturing processes, regulatory requirements, and IND/CMC documentation.
• Proven ability to manage cross-functional teams and client relationships.
• Excellent leadership, communication, and interpersonal skills.
• Strong problem-solving and decision-making abilities, with a track record of driving scientific innovation and process improvements.
• Ability to manage multiple projects simultaneously, with a focus on timelines, quality, and client satisfaction.
• In-depth knowledge of bioconjugation-related regulatory guidelines, including FDA, EMA, and ICH.
• Familiarity with laboratory automation and high-throughput screening technologies is a plus.
• Ability to work in a fast-paced, client-driven environment while maintaining a strong focus on quality and compliance.
• Strategic mindset with the ability to navigate complex challenges and drive solutions in collaboration with internal and external stakeholders.
• Strong business acumen, with the ability to contribute to strategic planning, budgeting, and resource allocation for bioconjugation projects.

Additional Information

All your information will be kept confidential according to EEO guidelines.

Veranova is an Equal Opportunity Employer. It is the policy of Veranova to provide equal employment access and opportunity to all persons regardless of age, race, color, national origin, religion, sex, sexual orientation, gender identity and/or expression, physical or mental disability, genetic information, citizenship, marital status, veteran status, or any other characteristic protected by federal, state, or local law.

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