Director Process Development Jobs in Boston, MA (NOW HIRING)

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Summary

The Lilly Bioproduct Research and Development (BR&D) organization is focused on the development and commercialization of parenteral formulations of small molecules and large molecules such as monoclonal antibodies, novel therapeutic proteins and peptides. The organization is also committed to the development of genetic medicines which includes active investments in oligonucleotide development, nanomedicines for tissue specific targeting and other gene delivery strategies. The drug product team is also investing in building new platforms to support complex formulations such as lipid nanoparticles (LNPs), antibody drug conjugates, AAV, and other non-viral vector delivery vehicles.

We are seeking a highly motivated engineer with experience in chemistry, manufacturing and control (CMC) of genetic medicines to drive innovation efforts in the process engineering of genetic medicine programs. This position is a full-time onsite role located at the Lilly Institute of Genetic Medicine in Boston. We are seeking a candidate with hands-on experience in process development of nonviral delivery vehicles, e.g., RNA-lipid nanoparticles, and ideally experience with oligonucleotide drug products. This candidate would collaborate across functions at Lilly's Boston and Indianapolis sites to advance portfolio assets. If you are interested in conducting innovative research, you should consider joining our diverse and high-performing team.

Roles and Responsibilities:

• Build process capabilities for lab scale, early phase clinical scale, and scale up technologies for RNA-LNPs and other parenteral drug products.
• Support the development of portfolio assets (particularly RNA-LNPs), including assessing and mitigating process risks during scale-up through an understanding of in-process and final product critical quality attributes. Anticipate and manage increased workload during scale-up and GMP readiness phases.
• Work with project management and other technical leaders to execute complex tech transfer challenges across sites, including both internal and external manufacturing organizations. Help oversee supply chain readiness and ensure integration of novel excipients into regulatory filing packages.
• Implement processes to deliver drug product material for clinical trials and support generating data required for regulatory filings, including addressing CMC regulatory questions.
• Ensure consistency in technical deliverables and documentation across transfers.
• Partner with analytical colleagues and aid in the transfer and installation of analytical methods to assess developability of portfolio molecules, including familiarity with acquisition and analysis of chromatography methods (e.g., SEC, HPLC, UHPLC methods).
• Cross-Functional Collaboration: Represent the product research & development organization on project teams. Partner with genetic medicines discovery, synthetic chemistry, toxicology, ADME, analytical, and device to support drug delivery, formulation, or process efforts.
• External Engagement: Establish and leverage strategic relationships with academic and industry partners to accelerate and access emerging innovation.
• Innovation: Drive a strong innovation agenda for the team leading to publications, presentations and industry wide influence. Leverage these innovations to advance the Lilly portfolio.
• This is a full-time onsite role (five days per week) in Boston, MA.

Basic Qualifications:

• Ph.D. in Chemical Engineering, Biomedical Engineering, Chemistry, Pharmaceutical Sciences, or a related field.
• 0-5 years of prior experience in nanoparticle formulations, oligonucleotide and/or gene delivery development programs, parenteral formulation, or process development.
• Experience with process development of RNA-lipid nanoparticle and/or oligonucleotide formulations.
• Familiarity with engineering fundamentals towards designing and optimizing manufacturing processes, or drug delivery platforms including RNAs and LNPs.

Additional Skills and Preferences:

• Hands-on experience working with process equipment from lab to pilot scales is preferred.
• Previous experience with regulatory submissions of RNA-based therapies is preferred.
• Self-directed and highly motivated individual who wants to learn new techniques while continually pursuing research and publication goals.
• Excellent communicator (oral and written) with presentation experience, along with a strong publication record.
• Proficient in data analysis and reporting.
• Final job level (Advisor or Senior Advisor) will be based on the selected candidate's experience and qualifications and determined at the hiring manager's discretion.

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Actual compensation will depend on a candidate's education, experience, skills, and geographic location. The anticipated wage for this position is

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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