Senior Director, Process Development

Landmark Bio translates groundbreaking research into life-changing medicines. We provide development, manufacturing, and regulatory capabilities to help early-stage life science innovators rapidly progress advanced therapies from bench to clinic. Launched in 2021, and based in Watertown, Mass. Landmark Bio is an unprecedented venture bringing together the best of industry, academia and research hospitals to accelerate life sciences innovation. 

We are seeking a highly motivated and team-oriented professional with entrepreneurial spirit to join our company! This is an exciting opportunity for a well-qualified candidate to join a rapidly growing company focused on turning today’s cutting-edge research into tomorrow’s breakthrough therapies.

Responsibilities

·         Lead a process development team to develop clinical and commercial manufacturing processes for cell and gene therapies. 

·         Recruit, develop and retain an engaged and motivated workforce with diverse and complementary skillsets.

·         Manage technology transfers from our clients to the Landmark Bio process development lab and internally from Process development to GMP manufacturing.

·         Provide leadership and management support for activities to drive a fast paced, highly efficient learning culture.

·         Author, review, and provide technical expertise from reports to regulatory submissions, building a culture of data integrity.

·         Manage the compilation and presentation of data to clients and/or Landmark Bio stakeholders and management.

·         Work directly with our clients in academia or industry.

Minimum Qualifications

·         Ph.D. in biology, cell biology, chemical or biomedical engineering or a closely related field with +15 yrs. Biotech or Pharmaceutical Industry experience specifically in the development of cell and gene therapy products with 10+ years of management experience.

·         Experience translating pre-clinical work into GMP processes for cell and gene therapies.

·         Experience related to the development and technical transfer of GMP processes for cellular therapies.  Experience with multiple cell types (eg. CAR-T/TCR, iPSC and/or NK) highly preferred.

·         Experience related to the development and technical transfer of GMP processes for novel viral vectors (e.g. AAV and Lentivirus) and/or extracellular vesicles.

·         Knowledge of FDA, EMA and ICH regulations, industry standards and quality control principles.

·         Highly skilled in statistical methods, and design of experiments.

·         Ability to communicate and collaborate with internal and external stakeholders.

·         Ability to work effectively in a collaborative team environment.

·         Self-driven, independently motivated, data driven and excellent problem-solving capabilities.

Landmark Bio is an Equal Opportunity, Affirmative Action employer. Minorities, women, veterans, and individuals with disabilities are encouraged to apply.