Sr. Director - API Manufacturing Quality Control at Eli Lilly and Company

Houston, Texas, United States

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Not SpecifiedCompensation

Senior (5 to 8 years)Experience Level

Full TimeJob Type

UnknownVisa

Pharmaceuticals, HealthcareIndustries

Requirements

Bachelor’s degree in relevant field (STEM preferred)
10+ years of supporting complex analytical testing (mass spec, bioassay, protein characterization)
5+ years of supervisory/leadership experience
Additional preferences:
Knowledge of QC operations, new product introduction, and process development
Expertise in analytical lab quality and compliance requirements
Experience with regulatory submissions
Proficient in Microsoft Office and other computer systems
Strong technical writing and communication skills
Effective interpersonal skills with ability to lead leaders and influence cross-functionally
Commitment to maintaining a safe work environment
Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions

Responsibilities

Build and lead a high-performing Quality Laboratory Operations team
Ensure GMP compliance across all lab activities
Deliver the "lab of the future" vision with integrated digital, paperless processes
Collaborate with local and global quality teams to standardize lab design, processes, and systems
Participate in site and quality leadership teams
Drive strategic decisions and successful business outcomes
Coordinate lab-related planning and budget management
Promote cross-functional integration and communication
Maintain a safe, compliant work environment
Serve as a liaison for corporate communications
Ensure compliance oversight
Manage regulatory and internal inspections
Personnel Development:
Lead HR planning, performance management, and talent development
Recruit and build site capabilities for a high-functioning QC lab organization
Ensure strong administrative and technical leadership within the team

Skills

Key technologies and capabilities for this role

GMP ComplianceLaboratory OperationsQuality ControlAnalytical SciencesLeadershipStrategic PlanningBudget ManagementProcess StandardizationDigital ProcessesCommunication

Questions & Answers

Common questions about this position

What are the basic qualifications for the Sr. Director - API Manufacturing Quality Control role?

Candidates need a Bachelor’s degree in a relevant field (STEM preferred), 10+ years of supporting complex analytical testing including mass spec, bioassay, and protein characterization, and 5+ years of supervisory/leadership experience.

What salary or compensation is offered for this position?

This information is not specified in the job description.

Is this role remote or does it require on-site work?

This information is not specified in the job description.

What does the company culture look like at Eli Lilly?

Eli Lilly emphasizes uniting caring with discovery to make life better, putting people first, and building the organization, facility, and culture for a successful startup into GMP manufacturing operations.

What experience makes a candidate stand out for this role?

Preferred qualifications include knowledge of QC operations, new product introduction, and process development; expertise in analytical lab quality and compliance; experience with regulatory submissions; proficient computer skills; strong technical writing and communication; and effective interpersonal skills to lead leaders cross-functionally.

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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