Overview:Orna Therapeutics, Inc., a wholly owned subsidiary of Eli Lilly and Company, is an innovative biotechnology startup based in Watertown, MA, committed to developing groundbreaking therapies for diseases that current approaches cannot address. With our pioneering circular RNA technology, developed at MIT, we are at the forefront of advancing the next generation of RNA therapeutics. Our state-of-the-art expression and delivery platform positions us to tackle complex diseases, including B cell-driven autoimmune disorders, B cell malignancies, sickle cell disease, and beyond.
Position Summary: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. Primary responsibilities include working with internal stakeholders and third-party vendors to plan external manufacturing activities. This role will also ensure timely delivery of materials and acting as the primary liaison with external suppliers, logistics providers, and test/manufacturing partners. The ideal candidate will have extensive experience working with a variety of CDMOs for cell and gene therapy or nanoparticle applications and working with internal R&D, CMC and other teams. Furthermore, the candidate will possess strong oral and written communication capabilities, demonstrate excellent organization, collaboration, and interpersonal skills, and be adept at problem solving in a fast-paced environment.
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.
Basic 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
Additional Information:Physical Demands/Travel:The physical demands of this job are consistent with a lab environment
Travel: ~10%
The physical demands here are representative of those that must be met by an employee to successfully perform the essential functions of this job.
Work Environment:This position's work environment is in a office environment.
The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job.
*To perform this job successfully, an individual must be able to perform the role and responsibilities satisfactorily. The requirements listed above are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
Actual compensation will depend on a candidate's education, experience, skills, and geographic location. The anticipated wage for this position is
$141,000 - $228,800
Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance). In addition, Lilly offers a comprehensive benefit program to eligible employees, including eligibility to participate in a company-sponsored 401(k); pension; vacation benefits; eligibility for medical, dental, vision and prescription drug benefits; flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts); life insurance and death benefits; certain time off and leave of absence benefits; and well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities).Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion and Lilly's compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees.
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