Senior Advisor, Manufacturing Science and Technology

About the role

We are seeking an exceptional Senior Advisor, Manufacturing Science and Technology, to join our team. The candidate will manage external manufacturing activities for Orna’s proprietary lipid manufacturing and pipeline support to circular RNA and lipid nanoparticle candidates.

Responsibilities

• Primary responsibility for technical and operational management of manufacturing operations for custom raw materials (Lipids) through their development lifecycle.
• Support drug substance (DS) and drug product (DP) manufacturing for preclinical and clinical studies, enabling seamless transition to commercial supply.
• Provide guidance and direction for manufacturing strategy, goals, budgets, and other operational activities to ensure timely delivery.
• Integrate internal and external team activities into the manufacturing operations and present plans and progress to the Leadership Team as needed.
• Manage CDMOs for manufacturing operations, tech transfers, investigations/OOS, and batch documentation reviews.
• Responsible for identification and selection of CDMOs for cGMP manufacture for Orna’s portfolio development programs.
• Resolve any issues impacting timelines or other critical deliverables, communicate potential impact(s) to management and other key stakeholders, and assist in mitigation plans.
• Author regulatory and technical documents for regulatory submissions in support of custom raw materials (Lipids) manufacturing and serve as subject matter expert in regulatory interactions.

Requirements

• PhD, Master’s, or Bachelor’s degree in chemistry, life sciences, engineering, or related field with the following years of relevant industry experience: PhD 6+ years, Master's 9+ years, or Bachelor’s 12+ years.
• Experience with Lipid or excipient manufacturing and scale-up is required.
• A minimum of 7+ years of manufacturing operations experience in the biopharmaceutical/pharmaceutical industry covering RNA/LNP modalities.
• Good understanding of tech transfer, cGMP manufacturing and regulatory requirements for RNA and LNP modalities.
• Experience working with cross-functional product development teams, including Research & Development, QA, Pre-clinical and Safety, Regulatory Affairs, and other groups.
• Experience with authoring and reviewing early and/or late-stage regulatory filings is required.

Additional Preferences

• Strong leadership skills, including demonstrated ability to work with a cross-functional team, and to influence at all levels of an organization.
• An entrepreneurial approach to develop new, innovative ideas that will drive growth within the Manufacturing organization.
• Develop effective and efficient working relationships with both internal and external partners.
• Available to travel if/when needed.
• The ability to effectively plan and implement stage-appropriate change management and set realistic goals to ensure timely and successful completion.
• Strong analytical and problem-solving skills are necessary along with great attention to detail.
• Excellent oral and written communication skills, including presentation to effectively communicate key updates/challenges to the program team.
• Detail oriented, self-motivated, and excited to take on new challenges.