Senior Scientist – Manufacturing Science

100 Eli Lilly and Company; Indianapolis (IN); On-site; USD 66,000 - 172,000; Full time

Benefits offered by this job

Bonus program

Travel opportunities (up to 20%)

Job summary

Lilly is seeking a Senior Scientist – Manufacturing Science in Indianapolis to support the API External Manufacturing portfolio, including raw materials, intermediates, enzymes and bulk drug substances.

You will execute experiments, modeling and data analysis to improve process control, yield, purity and productivity, and set up lab-scale studies to troubleshoot and optimize manufacturing. Domestic and international travel up to 20% is required.

Qualifications

• Bachelor's degree in Biochemistry, Organic Chemistry, Chemical Engineering, Physical Chemistry, Bioanalytical Chemistry, or Analytical Chemistry.
• 3+ years of relevant industrial experience in API Manufacturing, TS/MS, Quality Control, Quality Assurance, or Development.
• Authorized to work in the United States on a full-time basis; Lilly will not sponsor work authorization or visas for this role.
• Familiarity with cGMP manufacturing environment is preferred.

Responsibilities

• Understand the scientific principles for manufacturing intermediates and bulk drug substances.
• Execute technical projects to improve process control, yield, and productivity.
• Prepare technical documents such as reports, change controls, regulatory submissions, deviation investigations, validation protocols, and summary reports.
• Develop and monitor metrics in real-time to assess process variability and capability.
• Validate process and cleaning state documentation with data.
• Ensure accurate instructions and PFD describe process and control strategy for manufacturing steps.
• Provide support to internal and global process teams.
• Ability to independently set up and execute chemical reactions.
• Ensure experiments are well designed with clear objectives.
• Analyze data and document results.
• Apply safe laboratory practices and CHP requirements.
• Write technical reports and documents.

Skills

3+ years relevant industrial exp

Laboratory experimentation

Data analysis

Education

Bachelor's degree in Biochemistry, Organic Chemistry, Chemical Engineering, Physical Chemistry, Bioanalytical Chemistry, or Analytical Chemistry

Job description

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.

Job Description: The Senior Scientist – Manufacturing Science provides the technical support required to achieve the reliable and compliant manufacture of the API External Manufacturing (API EM) portfolio which includes raw materials, intermediates, enzymes and bulk drug substances.

The Senior Scientist – Manufacturing Science executes technical projects (experimental, modeling and/or production data analysis) to improve and optimize process control, yield, purity, and/or productivity. In addition, the Senior Scientist – Manufacturing Science should be capable and technically independent in setting up and executing a variety of experiments at the laboratory scale and conduct research on manufactured product for process improvements and troubleshooting in the TS/MS laboratory.

Key Objectives/Deliverables

• Understand the scientific principles required for manufacturing intermediates and bulk drug substances, including the interaction of the chemistry and equipment.
• Execute technical projects (experimental, modeling and/or production data analysis) to improve process control, yield, purity, and/or productivity.
• Provide technical support for preparation of relevant technical documents, as required, such as: technical reports, change controls, regulatory submissions, deviation investigations, validation protocols and summary reports, processing records, procedures, PFDs, VMPs, etc.
• Develop and monitor established metrics in real-time to assess process variability and capability.
• Understand, justify and document the state of validation (process and cleaning) with data that evaluate the capability of the manufacturing process to meet its stated purpose.
• Ensure that an accurate instruction set (tickets & procedures) and PFD describe the process as performed and the control strategy for the discrete manufacturing steps.
• Provide support internal and joint process teams and to the global and local PLOT teams.
• Ability to independently set up and execute various chemical reactions.
• Ensure that experiments are well designed with clear objectives.
• Ability to analyze data and ensure appropriate documentation.
• Utilize safe laboratory practice and adhere to CHP requirements.
• Write technical reports and documents.

Basic Requirements

• Bachelors degree in scientific disciplines of Biochemistry, Organic Chemistry, Chemical Engineering, Physical Chemistry, Bioanalytical Chemistry, Analytical Chemistry.
• 3+ years of relevant industrial experience in any of the following discipline such as API Manufacturing, TS/MS, Quality Control, Quality Assurance, or Development.
• 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 Preferences

• Demonstrated basic knowledge in small molecule API Manufacturing.
• Familiarity with cGMP manufacturing environment and terminology.
• Excellent analytical, interpersonal, written and oral communication skills.
• Ability to work independently as well as part of a team.
• Ability to prioritize activities.
• Good judgment and flexibility.

Other Information

• Complete learning plan for API EM TS/MS Scientist.
• No certifications required.
• Tasks require entering manufacturing areas which require wearing appropriate PPE.
• Domestic and international Travel (variable, can approach 20%).

Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions.

Compensation

The anticipated wage for this position is $66,000 - $171,600.

Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance).

Benefits

• Actual compensation will depend on a candidate’s education, experience, skills, and geographic location.
• 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.

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).

#WeAreLilly At Lilly we strive to ensure our employees are part of a team that cares about them and our shared purpose of making life better for those around the world. How do we do this? We continue to look for ways to include, innovate, accelerate and deliver while maintaining integrity, excellence and respect for people. We hope that you seek to join us on our journey as we create medicine and deliver improved outcomes for patients across the globe!