Sr. Manager - Chemistry and Device at Eli Lilly and Company

Durham, North Carolina, United States

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Not SpecifiedCompensation

Senior (5 to 8 years)Experience Level

Full TimeJob Type

UnknownVisa

PharmaceuticalsIndustries

Requirements

Bachelor (4-year college) degree in a life or applied science (Chemistry preferred)
At least five years of relevant, hands-on experience working within a GMP laboratory
Able to provide on call support, as required

Responsibilities

Lead a team of laboratory personnel supporting routine device, water, and drug product testing
Schedule and plan laboratory testing, laboratory data review, and laboratory project support activities
Oversee or assist in the onboarding of laboratory instrumentation and equipment, including authoring/reviewing/executing change controls and related actions, authoring/reviewing IQ/OQ/PQ protocols and reports, authoring/reviewing/approving standard operating procedures and training materials, and working with/overseeing certified service providers during instrument installation/repair
Provide oversight of personnel learning plans, including assigning training courses, developing/maintaining departmental training matrices, and scheduling training for managed personnel
Utilize technical and regulatory expertise to assist in inspection/audit related activities, laboratory investigations, and continuous improvement initiatives
Provide support to cross-functional quality control teams, such as microbiology and environmental monitoring, as needed
Proactively lead a team of laboratory analysts
Effectively manage departmental workload, including collaboration with other laboratory leadership on scheduling, prioritization of projects/testing/deliverables
Communicate with other laboratory leaders to ensure effective cross-shift communication
Provide technical and administrative leadership within the laboratory team, cross-functionally, and across sites, as required
Author and/or approve investigations/deviations, CAPAs, and change controls, as required
Lead and manage relationships with contract personnel, as required
Provide support for internal and external auditing processes, including acting as a key presenter and tour lead for managed areas
Coach and develop team, including one-on-one meetings, performance management, and development plans
Support other laboratory personnel within microbiology and environmental monitoring teams with escalations and problem resolution

Skills

QC Chemistry

Device Testing

Water Testing

Drug Product Testing

Laboratory Management

IQ/OQ/PQ

Change Controls

SOP Authoring

Laboratory Instrumentation

Training Management

Regulatory Expertise

Audit Support

Laboratory Investigations

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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