- Bring an extensive knowledge of oligonucleotide development to SMDD and use this expertise to grow internal capabilities through coaching, mentorship, and leadership.
- Possess fluent knowledge in modern synthetic organic and nucleic acid chemistry methods with the drive to challenge existing methods, define new manufacturing technologies, and apply those to deliver a portfolio.
- Demonstrate a deep expertise and demonstrated capability with utilization of modern synthetic organic and process chemistry techniques to address key CMC challenges.
- Identify scientific projects/process improvements where solutions are developed through interactions with diverse talent across the larger organization.
- Exhibit a high learning agility with the ability to understand and exploit new scientific concepts and methods across multiple fields; be able to apply these takeaways to a portfolio of small molecule, oligonucleotide, and synthetic peptide, and other emerging synthetic modalities.
- Possess solid understanding in unit operation design, process modeling, process equipment selection, and scale-up methodologies; build and apply groundbreaking technology and novel platforms within a time constrained environment.
- Lead a cross-disciplinary team to evaluate and refine new manufacturing routes, manufacturing technologies, and practices to deliver an exciting portfolio.
- Provide technical leadership in the scale-up and demonstration of new chemical processes in development and commercial scale equipment; collaborate in technology transfer activities to CRO/CMO organizations and internal Lilly manufacturing nodes to ensure processes are technically robust, well developed and characterized, and safe.
- Design experimental laboratory plans in support of route and process design, definition, optimization, and technology transfer objectives.
- Ability to integrate process (and property design) data based on a fundamental understanding of the underlying physical processes.
- Apply advancements in technology (PAT) and modeling platforms to understand and lead experimental protocols.
- Plan and lead short term and long-term development activities; develop and/or review technical agendas and timelines for project work; advise resource allocation to accomplish projects according to plans, communicate progress and propose changes in timeline, objectives, or direction.
- Collaborate across internal CMC networks (Drug Product Delivery, Project Management, Quality, Manufacturing, and Regulatory) to implement and deliver material and information for clinical trials and regulatory submissions.
- Possess deep understanding of the external global regulatory climate and emerging requirements; ability to address key CMC regulatory questions that enable clinical studies and support marketing authorization applications.
- Embrace diversity in thoughts, background, and experiences through supervision, mentoring, and development of a diverse scientific staff to deliver solutions. Encourage team members to take initiative and accountability to achieve goals and draw out and encourage others to share knowledge on challenging technical issues.
- Actively collaborate and exhibit influence in the external scientific environment and demonstrates an ability to recognize and integrate external innovation across the Lilly synthetic portfolio.
- Ph. D. in organic chemistry or a related field with 5+ years of pharmaceutical product development experience OR MS in Organic Chemistry or related field with 15+ years demonstrated experience.
- Experience within the pharmaceutical sector is preferred; however, other proven experience may meet expectations. Prior experience in active ingredient development and associated formulated product is acceptable. Relevant industrial sectors would include agrochemicals, nutraceuticals, specialty chemicals, and personal care products. Experience with developing chemical processes the form mid-development cycle (proof of concept) to product commercialization.
- Experience with nucleic acid chemistry, oligonucleotide synthesis, and conjugation chemistry.
- Experience with technical transfer of processes into manufacturing operations.
- Experience with authoring regulatory submissions and responding to regulatory questions.
- Established external reputation and strong publication record.
- Knowledge and experience with management of a technical project and ability to build ideas for future work plans.
- Experience with modern analytical techniques and process analytical technologies (PAT).
- Experience with modeling and simulation tools, data analytics, and predictive analytics.
- Ability to transform ideas into marketable products and processes.
- Demonstrated leadership capabilities, good communication skills and a sustained tendency for collaboration.
- Ability to prioritize multiple activities and handle ambiguity.
- Ability to influence others to promote a positive work environment.
- Travel: 5-10% as part of regular interaction with the SMDD team in Indianapolis
- Position Location: Boston, MA; SMDD located at the Lilly Institute for Genetic Medicine
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Director - Chemistry - Genetic Medicines (SMDD) - Boston, United States - BioSpace
Description
Job DetailsAt Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We're looking for people who are determined to make life better for people around the world.
The Synthetic Molecule Design and Development (SMDD) organization is responsible for the development of synthetic drug substances and drug products from the pre-clinical phase through commercialization. Our scientists and engineers develop innovative technical solutions to advance an exciting portfolio that includes small molecules, synthetic peptides, oligonucleotides, and other emerging therapeutic modalities. By cultivating a hardworking, culturally diverse workforce that exhibits deep technical expertise, SMDD delivers on these responsibilities and helps bring the next generation of life-changing medicines to patients.
Our SMDD team is looking for experienced and creative candidates to lead synthetic molecule development at the early phase interface with our Lilly Genetic Medicines (LGM) discovery team located in Boston, MA. This technical, lab-based role will emphasize identification of emerging synthetic needs across the LGM portfolio, development, and execution of research plans with a cross functional team to help accelerate programs and facilitate technical transfer to the early phase clinical supply team located in Indianapolis. The scientist will collaborate with a growing team comprised of chemists, analysts, and engineers aimed at development and optimization of existing methods and exploration of novel synthetic approaches to oligonucleotides and their conjugates as well as oligonucleotide purification, isolation, and formulation. The position presents an opportunity to work closely with the LGM team and will be co-located at the new Lilly Institute for Genetic Medicine in Boston, Seaport. As part of SMDD, this role also provides connectivity to the diverse technical expertise, experience, and resources from the SMDD development group in Indianapolis, IN. Candidates for this position will also provide oversight for external R&D and tech transfer to other functions within Eli Lilly as necessary.
Responsibilities
Top candidates for this position will be expected to:
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