Early Phase Formulation Scientist Job in Indianapolis 46225, Indiana Us
For more than 130 years, Lilly has been dedicated to meeting the health care needs of people in the United States and around the world. We address these needs primarily by developing innovative medicines—investing a higher percentage of our sales in research and development than any other major pharmaceutical company. If you are interested in being considered for employment with a “Best in Class” Pharmaceutical company, please review the following opportunity:
Early Phase Formulation Scientist
The Preformulation group within Pharmaceutical Sciences supports small molecule development efforts from Lead Optimization through Product Decision, providing physical chemistry, pharmaceutics, and solid state chemistry expertise to program teams and to CMC teams in development. The Candidate will be responsible for performing Preformulation studies to enable Candidate Selection (CS), formulation and process development of small synthetic molecules. The Candidate will be expected to network regularly with Discovery Chemistry, ADME, Toxicology, the VTeam, and Formulation Development as well as with various groups within Preformulation
KEY OBJECTIVES/DELIVERABLES:
- Preclinical and Clinical dosage form development:
- Provide formulation support for Pre-CS to POC activities by developing and characterizing formulations for ADME, pharmacology, and Toxicology studies.
- Influence excipient selection for dosage forms by understanding properties, advantages and limitations to use.
- Support development of the first in human clinical formulations, manufacturing processes, and partner in the selection of primary packaging for use in clinical trials.
- Interface between Preformulation, Formulation and clinical site for clinical dosage form development and manufacture.
- Maintain technical expertise within solid oral dosage form development to engage in scientific discussions with the team members and manufacturing personnel.
- Collaborate with Lilly partners, Quality, and other study team members to resolve/escalate specific issues when necessary.
- Work independently, with guidance in only the more complex situations.
- Compound Characterization
- Determine physical-chemical properties of drugs, including solubility, dissolution, solid-state characterization, compressibility, and BCS classification.
- Knowledgeable regarding the proper use, trouble-shooting and maintenance of laboratory instrumentation.
- Develop and maintain relationships with salt screening/physical characterization group.
- Effectively work within a scientifically-diverse team to provide a comprehensive pharmaceutical data package for lead optimization and candidate selection.
- Delivery of Enabling/alternate routes of administration:
- Develop solubilization techniques for class II compounds.
- Understand the characteristics/importance of properties governing in vivo performance Influence the design and contribute to the strategy for selection of enabled dosage form.
- Work closely with scientists in Formulation Development to ensure that a robust strategy is established for commercialization prior to FHD
- Communication/Information Management
- Document (notebook, reports, and database), evaluate and interpret Preformulation and Formulation data.
- Communicate results, both written and oral, to customers, colleagues and Preformulation staff.
- Actively listen and respond to customer needs. Communicate, develop best practices, and build relationships using cross-functional teamwork.
- Compliance
- Responsible for understanding and complying with all corporate good research practices and local standards of operating procedures. Candidate ensures compliance with corporate policies.
MINIMUM REQUIREMENTS:
- Bachelors Degree in Chemistry or Pharmaceutical Sciences discipline
- Must have at least 3 years previous work experience in one or a combination of the following areas:
o Clinical Trial/Development dosage form manufacture
o FHD dosage form manufacture or supply, i.e., experience with or working understanding of GMP manufacture of FHD dosage forms
o Specialized formulation delivery (e.g. Solid Dispersions,Lipids, Liposomes, Nanoparticles) - Qualified candidate must be legally authorized to be employed in the United States. Lilly does not anticipate providing sponsorship for employment visa status (e.g., H-1B or TN status) for this position.
ADDITIONAL SKILLS/PREFERENCES:
- Good general knowledge of emerging drug delivery technologies
- Dosage form development for global markets
- Working knowledge of equipment for solid oral dosage form manufacture
- Demonstrated success ineffective interpersonal and communication skills.
- Demonstrated strong leadership, teamwork, and influence are necessary.
- Strong problem-solving skills, including strategic and creative thinking.
- Experience and success in self-managing priorities and multi-tasking projects.
- Excellent written communication skills.
- Computer skills (e.g.Excel, Word, PowerPoint, Symyx eLN).
OTHER CONSIDERATIONS:
- Some international travel may be required.
Lilly credits its exceptional employees for its successes, and knows the key to ongoing achievement lies in attracting and retaining the best people. A company rich in heritage, Lilly employs individuals, conducts research and markets products worldwide. By providing for the unmet needs of our customers through a continuous stream of innovation, we will outgrow all competitors.
Lilly earns consistent and wide recognition for creating an exceptional work environment while maintaining our highly regarded reputation in the Pharmaceutical Industry and Community. The following is a selection of awards and recognition Lilly has received in recent years:
Awards and Recognition
ELI LILLY AND COMPANY IS AN EQUAL OPPORTUNITY EMPLOYER