Eli Lilly and Company→
Scientist, Dissolution & Biopharmaceutical… at Eli Lilly and… · US
Entry LevelOn-siteFull-timeUS, Indianapolis IN$65k–$169k/yr
Skills
analytical chemistrypharmaceutical sciencesspectroscopychromatographyformulation developmentbiopharmaceuticshplcuv spectroscopynir spectroscopydissolution testingpharmacokineticsregulatory complianceglpgmpdrug product performance characterization
Job Description
Summary: Eli Lilly and Company is a global healthcare leader headquartered in Indianapolis, Indiana, dedicated to improving lives through innovative medicines. The Scientist in Dissolution & Biopharmaceutical Modeling will develop analytical methods for early clinical formulation development and collaborate with various scientists to ensure effective drug product performance.
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
- 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 and 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
Required Qualifications:
- B.S. in Chemistry or Pharmaceutical Science, or other 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)
- Hands-on experience in analytical chemistry and/or pharmaceutical sciences, including exposure to techniques such as spectroscopy, chromatography, formulation development, or biopharmaceutics
- Strong communication (oral, written), organizational, and leadership skills
- Ability to execute with attention to safety, quality, regulatory, GLP/GMP, and legal requirements for all activities
- Ability to author key regulatory documents, demonstrating appropriate understanding of product performance control strategy, and biopharmaceutics risk mitigation for clinical trials and product commercialization
- Ability to embrace diverse thought, background, and experience to deliver innovative solutions
- Ability to engage and influence the external scientific community to foster collaborations for innovation and to advance Lilly's internal portfolio
Preferred Qualifications:
- Industry, research or internship experience relevant to the position is strongly preferred
- Strong leadership, supervisor, teamwork, communication and writing skills
- 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
- General understanding of techniques and instrumentation used in characterization of pharmaceutical drug products, especially dissolution and other product performance tests
Required Skills: Analytical Chemistry, Pharmaceutical Sciences, Spectroscopy, Chromatography, Formulation Development, Biopharmaceutics, HPLC, UV Spectroscopy, NIR Spectroscopy, Dissolution Testing, Pharmacokinetics, Regulatory Compliance, GLP, GMP, Drug Product Performance Characterization
Benefits: Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance)., 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, Well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities)
Benefits
Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance).
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
Well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities)