Sr. Scientist Technical Services/Manufacturing Science API-EM

BioSpace; Indianapolis (IN); On-site; USD 68,000 - 174,000; Full time

Benefits offered by this job

401(k)

Pension

Vacation benefits

Medical, dental, vision benefits

Flexible benefits

Life insurance

Well-being programs

Job summary

Lilly seeks an API-EM Scientist to support biologics manufacturing through external contract manufacturers, ensuring performance aligns with global quality standards. The role requires cross-functional collaboration with development, QC/QA, and site management to maintain compliant processes.

The position emphasizes regulatory understanding, documentation rigor, and the ability to drive continuous improvement in a 24/7 manufacturing environment in Indianapolis, IN.

Qualifications

• 3+ years of hands-on experience in pharmaceutical manufacturing and knowledge of regulatory expectations.
• Authorized to work in the United States on a full-time basis; sponsor unlikely.
• Technical expertise to support biologics manufacturing and external contract manufacturers.

Responsibilities

• Provide technical oversight for biologics manufacturing processes.
• Lead resolution of technical issues, including control strategy.
• Communicate effectively with internal and external partners.
• Build relationships with development and central technical organizations.
• Document process descriptions, measures, and specifications with justification.
• Ensure processes are compliant, in control, and validated or qualified.
• Assess validation data to demonstrate process capability.
• Drive continuous improvement across the network.

Skills

Biotech/pharmaceutical manufacturing

Regulatory compliance knowledge

Data management

Cross-functional collaboration

Education

Bachelor's degree in Biotech/Biochemistry/Biology/Pharmacy/Engineering

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.

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 TS/MS (Technical Services / Manufacturing Science) Scientist will provide technical and scientific expertise within a dynamic external manufacturing environment. The Scientist is 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 team members and site management.

The candidate will be responsible for supporting ongoing manufacturing at our External Partners through tasks such as process monitoring, response to issues, and improvements where necessary. A strong understanding of manufacturing principles and Lilly systems is required to ensure those same standards are applied to the external contract manufacturers.

This is a Biologics (Mabs, Recombinant Enzymes, ADC) position. 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.

Responsibilities

• Provide technical oversight for biologics manufacturing processes, leveraging a strong technical foundation and previous experience supporting these processes.
• Leads resolution of technical issues including those related to control strategy and manufacturing.
• Employ excellent communication skills to manage internal and external relationships.
• Build and maintain relationships with development and central technical organizations.
• Ensure proper characterization of processes and products and ensure effective documentation of the process description, measures, acceptable ranges, and specifications (and the justification of these measures, acceptable ranges, and specifications).
• Ensure that processes are compliant, capable, in control, and maintained in a validated or qualified state.
• Understand, justify and document the state of validation with data that evaluate the capability of the manufacturing process to meet its stated purpose.
• Influence and implement the network technical agenda and drive continuous improvement.
• Maintaining biologic processes in a state of compliance with US and global regulations
• Understanding the scientific principles required for manufacturing intermediates and drug substances, including the interaction of the process and equipment.
• Operate with ‘Team Lilly’ in mind

Basic Requirements

• Bachelors in scientific disciplines of Biotech, Chemistry, Biochemistry, Biology, Pharmacy, or Engineering (Biotech/Biochemistry strongly preferred)
• 3+ years of demonstrated hands on working experience and proficiency 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, 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

• Strong understanding of regulatory requirements and their application in a manufacturing environment
• Proficient in data management practices across manufacturing operations
• Demonstrates adaptability, a collaborative mindset, and a positive attitude toward change
• Proven ability to effectively communicate and influence across diverse technical and business teams
• Skilled in managing and delivering complex, cross-functional initiatives
• Demonstrated project management expertise with a track record of coordinating and executing multifaceted projects

Additional Information

• Some travel (<25%) is required
• 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. Relocation assistance will be provided.

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 $67,500 - $173,800

Benefits

• 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)

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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