We have been retained  to hire the Head of Technical Development for a new Stealth-mode CDMO specializing in Antibody drug conjugates.  In this role you will be an executive leader for the organization, impacting technical strategy, operations, people and culture.  Your primary duties will be leading and overseeing the development, optimization of bioprocesses and analytical methods tailored to client needs.

This role will ensure that all development activities meet the highest standards of technical capabilities, quality, and regulatory compliance, and are aligned with client requirements. The ideal candidate will have a strong background in both microbial fermentation and mammalian cell culture, preferably with Antibody Drug Conjugate (ADC) experience. Additionally, the candidate should have excellent leadership skills, and a proven track record of driving innovation and continuous improvement initiatives in a CDMO setting.

Key Responsibilities:

• Oversee the upstream, downstream, analytical and conjugation development activities.

• Develop innovative approaches and best-in-class capabilities to accelerate CMC timeline for clients while maintaining high quality deliverables.

• Lead a team of scientists and engineers, providing guidance, mentorship, and performance management.

• Collaborate with senior management to align development goals with the company’s overall objectives and industry needs.

• Oversee scope and work flow development to meet client specifications.

• Lead process validation and technology transfer activities.

• Manage multiple development projects simultaneously, ensuring customer satisfaction.

• Develop project plans, timelines, and budgets, and track progress against these metrics.

• Serve as the primary point of contact for clients on development projects, ensuring clear communication and alignment with client objectives.

• Work closely with cross-functional teams, including R&D, Quality, and Manufacturing, to ensure seamless integration of new processes.

• Communicate technical development strategies and progress to stakeholders at all levels of the organization

• Prepare and present technical reports, proposals, and presentations to clients, conferences and internal stakeholders.

Qualifications:

• Ph. D in Science or Engineering with a minimum of 10 years of experience in biological development, with at least 5 years in a leadership role within a CDMO or similar setting.

• Strong knowledge of microbial fermentation and mammalian cell culture.

• Conjugation experience is strongly preferred.

• Knowledgeable in protein purification and analytical method development.

• Experience with data mining, data processing and statistical data analysis.

• Proven track record of successfully managing and delivering complex projects.

• Excellent leadership, communication, and interpersonal skills.

Competencies:

• Strategic Thinking: Ability to develop and implement long-term strategies

• Leadership: Strong leadership skills with the ability to inspire and motivate a team.

• Client Focus: Excellent client management skills with the ability to understand and meet client needs.

• Problem-Solving: Excellent analytical and problem-solving skills.

• Project Management: Strong project management skills with the ability to manage multiple projects simultaneously.

• Communication: Excellent verbal and written communication skills.

• Adaptability: Ability to adapt to changing priorities and work in a fast-paced environment.