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Overview:
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 candidate for the position of Senior/Principal Scientist, Biologics Drug Product Development, located in Lilly Technology Center, Indianapolis
Position Summary:
This position is responsible for conducting pre-formulation characterization, formulation of parenteral and novel delivery systems, commercial development studies and technology transfer to manufacturing sites for assigned antibody-siRNA conjugate (ARC), co-formulation product and other projects. The scientist will interact closely with other scientists and may be an integral part of multidisciplinary teams that provide support for product and process development as well as working with Discovery, API development, Analytical Development, Delivery Device and Connected Systems (DDCS), CT Operations and Manufacturing.
Responsibilities:
Independently lead project, including experimental design, execution, and efficient use of data to plan next steps, ability to multi-task and collaborate effectively across CMC functions and with medical, marketing, PK/PD, and toxicology.
Conduct studies to support any manufacture of supplies for GLP studies and needed compatibility testing.
Conduct pre-formulation characterization and formulation studies to develop clinical formulations. Provide support for successful manufacture of clinical supplies.
Good judgment and escalation of technical issues and risks in a timely manner.
Authorship of technical reports and regulatory documents (IND/CTA, BLA/NDA).
Present data at deep dive, formulation and/or other technical forums.
Familiarity of CT and commercial platform processes, working knowledge of CMO operations, as appropriate.
Technology transfer of formulation and/or manufacturing process as appropriate to sites for CT and/or commercial manufacture.
Work effectively with the Bioprocess organization in the definition of the API matrix and in the development of the formulated bulk.
Work effectively with Analytical Development in the definition of Drug Product physical and chemical stability properties as well as coordination of analytical testing support.
Familiarity of API manufacturing process and impact on drug product Critical Quality Attributes.
Conduct commercial development studies collaborating effectively with functions such as Engineering, Statistics, Technical Sciences/Manufacture Sciences and manufacturing sites.
Keep abreast of relevant new technologies / capabilities and regulatory initiatives / requirements. Implement new capabilities, as appropriate.
Support organizational initiatives, as required.
Work effectively with external partners on outsourcing efforts and research collaborations.
Ensure work is aligned with all relevant PR&D Development Quality, regulatory and HSE requirements.
Good laboratory skills and familiarity with formulation, analytical/biophysical techniques and methods capability and hands-on experience with laboratory instruments.
Good communication skills, ability to follow instructions and attention to details, perform sample forecast, retrieve and compile data from appropriate database.
Basic Requirements:
Master’s or Bachelor’s degree in Pharmaceutical Sciences, Chemistry, Biochemistry, or a related discipline, with 3–5 years of biopharmaceutical industry experience in biologics formulation and process development.
Strong background in parenteral liquid and lyophilized formulation and biologics-device combination product development, with deep understanding of stability considerations for parenteral drug products such as antibodies, peptides, and nucleic acid–based therapeutics.
Hands-on experience in the development of antibody–siRNA conjugate (ARC) products is a plus.
Proficiency with standard computer applications and data analysis tools.
Excellent oral and written communication skills, with demonstrated ability to collaborate effectively in cross-functional development teams.
Additional Preferences:
Experience / knowledge of pharmaceutics, chemistry, or biochemistry with understanding of parenteral dosage forms and parenteral drug product stabilities.
Additional Information:
Located in Indianapolis, Indiana, Lilly Technology Center – North
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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
$65,250 - $193,600Full-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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