Scientist, Dissolution & Biopharmaceutical Modeling

At Lilly, the work is demanding because patients are waiting. We unite caring with discovery to help make life better for people around the world, knowing that every decision, every detail, and every day matters. Headquartered in Indianapolis, Indiana, our over 50,000 employees around the globe take on complex challenges to discover and deliver life-changing medicines, strengthen how health is understood and managed, and support the communities we serve. This is hard, urgent, selfless work—but it’s work worth doing. If you’re driven by purpose and ready to bring your best to work that truly matters for patients, we invite you to join us.

Organization and Position Overview:

At Lilly, Synthetic Molecule Design and Development (SMDD) is involved in key activities for the development of synthetic active pharmaceutical ingredients from pre-clinical phases through commercialization of drug substances and drug products. Our scientists and engineers develop key technical and business solutions across the portfolio using their deep technical expertise to accelerate testing of clinical hypothesis and overall drug development. SMDD delivers on these responsibilities by recognizing diverse talent and cultures are necessary to bring the next generation of life changing medicines to patients.

Candidates should have hands-on experience in analytical chemistry and/or pharmaceutical sciences, including exposure to techniques such as spectroscopy, chromatography, formulation development, or biopharmaceutics. They should be motivated to continue building their skills and deepen their understanding of molecular properties, product and process design, and product performance in order to support drug product development from early research through commercialization.

Responsibilities

• Developing analytical methods and conducting experiments to aid early clinical formulation development to enable drug delivery of a broad range of synthetic drug molecules.

• Collaborating with formulation scientists to design experiments and guide selection and characterization of formulations for pre-clinical and early clinical drug candidates.

• Partnering with biopharmaceutical modeling scientists, analytical chemists, pharmaceutical scientists, and engineers to identify the appropriate drug form, formulation, and process characteristics that provide the desired drug product performance.

• Identifying and mitigating technical risks for the performance and production of clinical and commercial drug products.

• Operating, maintaining, and troubleshooting automated dissolution systems, including hardware and instrument control software.

• Overseeing instrument qualification, calibration, and preventive maintenance of dissolution equipment, and partnering with vendors and laboratory support groups to resolve instrument issues and minimize downtime.

• Investigating atypical dissolution results and data anomalies  and implementing appropriate corrective and preventive actions.

• Executing with attention to safety, quality, regulatory, GLP/GMP, and legal requirements for all activities.

• Authoring key regulatory documents demonstrating appropriate understanding of product performance control strategy and biopharmaceutics risk mitigation for clinical trials product commercialization.

• Embrace diverse thought, background, and experience to deliver innovative solutions.

• Possess strong communication (oral, written), organizational, and leadership skills.

• Engaging and influencing the external scientific community to foster collaborations for innovation and to advance Lilly’s internal portfolio.

Basic Requirements:

• B.S. in Chemistry, Biochemistry, Pharmaceutical Science, or other directly related discipline (e.g., Material Science)
• Understanding of analytical techniques and methods for characterizing physicochemical properties of drug molecules and performance of drug products (e.g., HPLC, UV, NIR, dissolution)
• Strong leadership, supervisor, teamwork, communication and writing skills.
• Qualified applicants must be authorized to work in the United States on a full-time basis. Lilly will not provide support for or sponsor work authorization or visas for this role, including but not limited to F-1 CPT, F-1 OPT, F-1 STEM OPT, J-1, H-1B, TN, O-1, E-3, H-1B1, or L-1.

Additional Skills/Preferences:

• Career experience relevant to the position is strongly preferred.

• Demonstrated experience with development, validation, and transfer of analytical methods, especially dissolution, UV-Vis and HPLC.

• Hands-on experience operating and troubleshooting automated dissolution systems, including autosamplers, fraction collectors, online UV/fiber-optic analysis and hardware/instrument control software.

• Knowledge of biopharmaceutics and pharmacokinetic principles, formulation development and pharmaceutical material sciences, and drug product factors impacting in vivo performance and manufacture

• Basic understanding of regulatory aspects pertaining to development and clinical testing of drug products

Other Information:

• This position will be on our LTC-N Campus in Indianapolis, IN
• Travel:  0-10%

Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form (https://careers.lilly.com/us/en/workplace-accommodation) for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response.

Lilly is proud to be an EEO Employer and does not discriminate on the basis of age, race, color, religion, gender identity, sex, gender expression, sexual orientation, genetic information, ancestry, national origin, protected veteran status, disability, or any other legally protected status.

Our employee resource groups (ERGs) offer strong support networks for their members and are open to all employees. Our current groups include: Africa, Middle East, Central Asia (AMECA), Black Employees at Lilly (BE@Lilly), Chinese Culture Network (CCN), EnAble, Evolve, Lilly Indian Network (LIN), Organization of Latinx at Lilly (OLA), Pride (LGBTQ+ Allies), Veterans Leadership Network (VLN) and Women’s Initiative for Leading at Lilly (WILL).

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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