Job details

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. A public benefit company, our work advances emerging technologies, demonstrates therapeutic potential, and improves human health.

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.

Average salary estimate

$175000 / YEARLY (est.)

min

max

$150000K

$200000K

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What You Should Know About Senior Director, Process Development, Landmark Bio

Are you ready to make a real impact in the biotech world? Landmark Bio in Watertown, MA, is on the lookout for a passionate Senior Director of Process Development to join our vibrant team. Our mission is to translate groundbreaking research into life-changing medicines, and we need your expertise to help us achieve that goal! As the Senior Director, you'll lead a dynamic process development team, focusing on creating clinical and commercial manufacturing processes specifically for cell and gene therapies. You'll have the unique opportunity to recruit and cultivate a diverse workforce, fostering an engaged and motivated environment. Your role will include overseeing technology transfers from our clients and managing the transition from process development to GMP manufacturing. We believe in a fast-paced, efficient learning culture – and your leadership will be instrumental in driving that. With your extensive background in biotech, you'll author and review critical reports and regulatory submissions, ensuring data integrity is at the forefront of our operations. As you work closely with our clients, both in academia and industry, you'll bring your expertise to the table and help shape the future of therapeutic development. Join us and play a key role in developing novel therapies that improve human health today and tomorrow. If you're self-driven, motivated, and eager to tackle challenges, we can’t wait to see how you’ll contribute to our mission at Landmark Bio!

Frequently Asked Questions (FAQs) for Senior Director, Process Development Role at Landmark Bio

What are the main responsibilities of the Senior Director, Process Development at Landmark Bio?

The Senior Director, Process Development at Landmark Bio is responsible for leading a team to develop clinical and commercial manufacturing processes for cell and gene therapies. This role includes recruiting and nurturing a skilled workforce, managing technology transfers, providing leadership for a learning culture, and ensuring technical expertise in regulatory submissions all while collaborating with clients in academia and industry.