Senior Director, Process Development

Landmark Bio is dedicated to translating cutting-edge research into life-changing therapies. Headquartered in Watertown, Massachusetts, the company was founded by leading academic institutions, research hospitals, and industry partners to accelerate the development, manufacturing, and commercialization of advanced therapies. Driven by the compelling science and transformative potential of genetic medicine, Landmark Bio offers deep drug development expertise and integrated end-to-end solutions to support its partners. The company also serves as a collaborative platform to advance next-generation manufacturing technologies for novel modalities. Following its acquisition by Artis BioSolutions in 2025, Landmark Bio continues to operate as a distinct entity.  Learn more at www.landmarkbio.com. 

 

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.

·         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.

·         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.

It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law may be subject to criminal penalties and civil liability.

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