Senior/Principal Scientist – Peptide Technical Services & Manufacturing Science (TS/MS), API Ex[...]

Eli Lilly and Company; Indianapolis (IN); Sur place; USD 66 000 - 171 600; Plein temps

Avantages offerts par ce poste

Some travel

On-site in Indianapolis

Some off-shift work

Résumé du poste

Eli Lilly and Company in Indianapolis, IN, is seeking an API-EM Senior or Principal Scientist to join the TS/MS team. The role provides technical support across peptide and oligonucleotide processes in an external contract manufacturing setting, with focus on transfer, monitoring, and issue resolution to uphold global quality standards.

Candidates should have a chemistry/biochemistry/biology/engineering background and 3+ years in pharmaceutical manufacturing, with strong problem-solving skills

Qualifications

• Bachelor’s degree in a scientific discipline is required.
• 3+ years of pharmaceutical manufacturing experience and regulatory knowledge.
• Authorized to work in the United States full-time; visa sponsorship is not provided.

Responsabilités

• Provide technical oversight for peptide and/or oligonucleotide manufacturing processes.
• Lead resolution of technical issues related to control strategy and manufacturing.
• Communicate effectively with internal and external stakeholders and perform investigations.
• Build relationships with development partners and central technical organizations.
• Document process descriptions, measures, NORs/PARs, and ensure regulatory compliance.

Connaissances

Regulatory understanding

Cross-functional collaboration

Analytical thinking

Problem solving

Formation

Bachelor’s degree in Chemistry/Biochemistry/Biology/Pharmacy/Engineering

Outils

GxP data analytics tools

Description du poste

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 Overview

Join the energetic and growing Active Pharmaceutical Ingredient – External Manufacturing Organization (API‑EM) that delivers a diverse portfolio of medicines essential to our patients around the world. The API‑EM Senior or Principal Scientist will join the Technical Services/Manufacturing Sciences (TS/MS) team who work within a dynamic external manufacturing environment to provide technical support and scientific expertise across Peptides and Oligonucleotides (TIDES). The Senior/Principal Scientist acts as an SME responsible for providing technical support to achieve the reliable and compliant manufacture of API drug substance at external contract manufacturing groups to predetermined global quality standards. This person interacts daily with a wide variety of people, primarily external partners, process team members and site management.

The candidate will be responsible for technical transfer, process stewardship, process monitoring and will demonstrate a proactive attitude to issue resolution. A strong understanding of manufacturing principles and Lilly systems is required to ensure those same standards are applied to the external contract manufacturers. The incumbent would preferably possess an investigative mindset and be skilled at critical thinking with a preference for collaborative working.

The position requires knowledge of cGMPs, applicable global regulatory manufacturing guidance, and the corporate/industry standards. The position requires working cross‑functionally within the site and other functions to deliver on technical objectives.

Key Objectives/Deliverables

• Provide technical oversight and stewardship for peptide and/or oligonucleotide manufacturing processes.
• Lead resolution of technical issues including those related to control strategy and manufacturing.
• Employ excellent communication skills to manage internal and external relationships, perform effective investigations and disseminate actionable outputs.
• Build and maintain relationships with development partners and central technical organizations.
• Ensure proper characterization of processes and ensure effective documentation and justification of the process description, measures, acceptable ranges, and specifications. Experience with advanced data analytics to ensure that Proven Acceptable Ranges (PAR) and Normal Operating Ranges (NOR) align with process capability.
• Ensure that processes are compliant, capable, in control, and maintained in a validated or qualified state through process monitoring. Identify any leading signals of process weakness from yield/quality standpoint and proactively resolve/escalate.
• Understand, justify and document the state of validation with data that evaluate the capability of the manufacturing process to meet its stated purpose.
• Initiate deviation records and ensure on‑time closure of open records with appropriate CAPAs and effectiveness checks in place. Demonstrate a structured approach to problem solving and investigation.
• Support regulatory submissions with technical input as required, author and review annual reports to regulatory agencies and maintain awareness of regulatory best practices.
• Influence and implement the network technical agenda and drive continuous improvement with appropriate change controls in place.
• Maintain peptide/oligonucleotide processes in a state of compliance with US and global regulations.
• Understand the scientific principles required for manufacturing intermediates and drug substances, including the interaction of chemistry and equipment.
• Operate with ‘Team Lilly’ in mind – including coaching and mentoring of peers and other scientists.

Basic Requirements

• Bachelor’s in a scientific discipline of Chemistry, Biochemistry, Biology, Pharmacy, or Engineering (Chemistry or Biochemistry strongly preferred).
• 3+ years of demonstrated experience with pharmaceutical manufacturing and working knowledge of regulatory expectations.
• 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.

Additional Preferences

• Knowledge and experience with regulatory requirements.
• Enthusiasm for changes, team spirit and flexibility.
• Ability to influence and communicate to diverse groups on business, or technical issues within the site and function.
• Proficiency in delivering complex tasks and/or tasks that are cross‑functional.
• Demonstrated project management skills and ability to coordinate complex projects.

Additional Information

• Some travel.
• Some off‑shift work (night/weekend) may be required to support 24/7 operations.
• This position is located onsite in Indianapolis, IN and is not approved for remote work.

We welcome and encourage applicants with disabilities to apply. 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.

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 $66,000 – $171,600.

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; life insurance and death benefits; certain time off and leave of absence benefits; and well‑being benefits such as an 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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