Sr.Principal Engineer-TSMS Project Management at Eli Lilly and Company

Suzhou, Jiangsu, China

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Not SpecifiedCompensation

Senior (5 to 8 years), Expert & Leadership (9+ years)Experience Level

Full TimeJob Type

UnknownVisa

Pharmaceuticals, HealthcareIndustries

Requirements

Bachelor's degree or above in pharmaceutical, chemistry or chemical engineering or related fields
Above 8 years’ experience in pharmaceutical industry, with capital project or greenfield management practical experience
Familiar with GMP knowledge and practices with relevant experiences
Effective leadership skills
Strong teamwork and collaboration
Very strong communication skills and networking skills
Solid English communication skills
Good computer skills
Prefer strong aseptic drug product process knowledge and validation experience

Responsibilities

Lead TS/MS-led or contributed projects/initiatives for Suzhou site, such as post-OQ, process validation for Line 2 Cartridge Filling Project, dual source localization materials/components supply projects, yield optimization, and other site/flow team initiatives
Lead development of post-OQ strategies, timelines, and preconditions for key systems/equipment (e.g., formulation system, filling line, cleanroom, autoclave, parts washer), benchmarking best practices from other sites
Coordinate multi-functional teams internal and external to TS/MS, manage resources, and ensure project milestones (e.g., FAT, IOQ support, onsite activities)
Organize and support PQ and PV activities, including VMP, PQ/PV protocols and reports (e.g., cleaning validation, sterilization validation, EMPQ, AFPT, APS planning)
Support tech transfer activities, commercialization, regulatory filing, and GMP inspection/certification
Support PP team on product tech transfer and commercialization
Proactively coordinate and resolve issues across functions to meet project milestones and take corrective actions to mitigate delays
Manage and collaborate with SA, PP, VA teams to utilize resources efficiently and meet business demands flexibly
Support training and knowledge transfer to develop people’s skills, capability, and capacity
Build a capable and sustainable project team, develop and manage team members’ PM programs, training, and development to retain key talents
Support global project management, train and prepare team members for STA/LTA, and accept delegations from supervisor

Skills

Project Management

Process Validation

Operational Qualification

Supply Chain Localization

Yield Optimization

Technology Transfer

Commercialization

Cross-functional Coordination

Resource Management

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.

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