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Head of Process Development, Delivery

2 months ago

Norwood, United States Moderna Full time

The Role:

Please make an application promptly if you are a good match for this role due to high levels of interest. Moderna is seeking a veteran biotechnology leader with deep experience in the development of biopharmaceutical manufacturing processes to assume the Head of Process Development, Delivery role. This critical position is responsible for leading a diverse and high-functioning team of scientists and engineers to develop manufacturing processes for the company’s portfolio of lipid nanoparticle drug delivery systems; the role is also responsible for synthetic process development for Moderna’s portfolio of custom-synthesized small molecules. Reporting to the Senior Vice President, Technical Development, this role is critical to advancing novel drug delivery technology from Research to the clinic and on to late phase development and commercialization as a member of the Technical Development Leadership Team the role also plays a significant role across the function. Here’s What You’ll Do: Technical leadership and innovation: Using a deep understanding of scientific and engineering principles and extensive experience in bioprocessing, biomanufacturing, and the development of biological products, lead the development of manufacturing processes for both lipid particles for nucleic acid delivery and a variety of small molecule components. Experience with manufacture of nanoparticles and small molecules is highly desirable. As an innovative scientist or engineer, you have a track record of developing novel solutions for a wide variety of complex technical challenges, with substantial experience in design of experiments, quality by design, and statistical principles for process development. You have substantial knowledge of regulatory requirements related to biopharmaceutical process development and manufacturing.

Leadership and management skills: You have substantial experience leading and organizing large scientific and engineering teams, including strategic planning, resource allocation and management, and budgeting. You

obsess over learning , and drive a team culture of innovation. You drive productive decision making,

removing viscosity

to encourage collective action and leading imaginative solution development. You are skilled at developing talent at all levels, including managing other leaders. You have experience translating broad corporate and department objectives into a compelling technology vision and concrete action plans; and can manage a complex and rapidly changing portfolio of development projects.

Communication and collaboration: You have outstanding communications written and oral communication skills, including the ability to convey complex technical information to a variety of audiences, from executive management to health care authorities. You are a preferred partner, and drive a culture of collaboration across functions, including with research, quality and regulatory affairs.

Here's What You'll Bring to the Table: PhD in Chemical Engineering or Chemistry

Minimum of 15 years of experience in the biopharmaceutical industry, with extensive experience in process development of complex products.

Experience with process development for both small molecules and biologics, ideally including: route scouting and optimization, process optimization and scaleup for small molecules

experience with particulate drug delivery systems such as lipid or polymeric nanoparticles, microparticles

Outstanding written and oral communication skills

Extensive experience with team leadership of medium and large teams, including leading other leaders.

Thorough understanding of pharmaceutical regulatory requirements and best practices. Experience communicating complex technical strategies in regulatory documentation.

Thorough understanding of quality systems in the pharmaceutical industry; ability to define best practices for compliance in a development setting.

Broad understanding of and ability to operate effectively across the CMC function.

Proven ability to work collaboratively across functions, including leadership of cross functional teams (for example, with Research, Quality, Regulatory Affairs, Supply Chain).

Ability to effectively manage a complex portfolio of technical projects, including the development of complex research plans and dynamic realignment of timing and resources enable the

pursuit of multiple options in parallel

Ability to

act with dynamic range , maintaining simultaneously a strong detail orientation and deep knowledge of technical activities and a strategic view of department priorities.

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