Sr. Scientist Technical Services/Manufacturing Science API-EM at Eli Lilly and Company

Indianapolis, Indiana, United States

Apply Now

Not SpecifiedCompensation

Senior (5 to 8 years)Experience Level

Full TimeJob Type

UnknownVisa

Pharmaceuticals, BiotechnologyIndustries

Requirements

Bachelor's 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
Working knowledge of regulatory expectations
Strong understanding of regulatory requirements and their application in a manufacturing environment (preferred)
Proficient in data management practices across manufacturing operations (preferred)
Demonstrates adaptability, a collaborative mindset, and a positive attitude toward change (preferred)
Proven ability to effectively communicate and influence across diverse technical and business teams (preferred)
Skilled in mAb processes (preferred, based on context)

Responsibilities

Provide technical oversight for monoclonal antibody manufacturing processes, leveraging a strong technical foundation and previous experience supporting these processes
Lead 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
Maintain mAb 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 the process and equipment
Operate with ‘Team Lilly’ in mind

Skills

cGMP

API Manufacturing

Technical Services

Manufacturing Science

Large Molecule

mAb

Process Monitoring

Process Improvement

Regulatory Compliance

Cross-functional Collaboration

Eli Lilly and Company

Develops and delivers prescription medicines globally

About Eli Lilly and Company

Eli Lilly and Company is a global pharmaceutical company that focuses on discovering, developing, and delivering medicines to improve health. The company has a long history of scientific achievements, including the creation of insulin, the first life-saving treatment for diabetes. Lilly's operations involve extensive research and development to create new medications and enhance existing ones, ensuring they are safe and effective. Their products are primarily prescription medicines sold to healthcare providers for various medical conditions, including diabetes, cancer, and pain management. What sets Lilly apart from its competitors is its strong commitment to ethical practices and the protection of its products from counterfeiting. The company's goal is to enhance lives through innovative medical solutions while maintaining high standards of quality and ethics.

Indianapolis, IndianaHeadquarters

1876Year Founded

$1,180.1MTotal Funding

IPOCompany Stage

Biotechnology, HealthcareIndustries

10,001+Employees

Risks

Competition from Novo Nordisk's Ozempic may impact tirzepatide's market share.

Potential construction delays in Indiana could affect GLP-1 drug production timelines.

Regulatory challenges may hinder Kisunla's expansion in new Alzheimer's markets.

Differentiation

Eli Lilly's rich history includes the first life-saving insulin treatment.

Lilly's strategic partnerships enhance its position in neurodegenerative disease treatments.

FDA approval of Zepbound opens new therapeutic markets for sleep disorder treatments.

Upsides

Lilly's $9 billion complex in Indiana boosts GLP-1 drug production capacity.

Kisunla's approval in China expands Lilly's Alzheimer's treatment market in Asia.

Collaboration with EVA Pharma enhances Lilly's reputation as socially responsible.

Land your dream remote job 3x faster with AI

Try Jobo Free