Sr. Director - BRD Analytical Development at Eli Lilly and Company

Indianapolis, Indiana, United States

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Not SpecifiedCompensation

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

Full TimeJob Type

UnknownVisa

Pharmaceuticals, BiotechnologyIndustries

Requirements

Ph.D. in Biology, Chemistry, Pharmacy, or a related life science discipline (strongly preferred); or equivalent expertise commensurate with Ph.D.-level chemist skills
Minimum of 8 years of relevant pharmaceutical industry experience
Strong communication, interpersonal, and leadership skills
Solid understanding of Good Manufacturing Practices (GMPs) and the drug development lifecycle
Ability to guide projects from early development through regulatory submission and product registration
Willingness to travel 10%

Responsibilities

Lead a team of scientists in phase-appropriate analytical development from preclinical stages through commercialization
Align integrated development plans across key functions (Drug Substance, Drug Product) and interfaces (device, discovery, manufacturing, quality)
Set and implement strategic direction for science, technology, and business operations to support pipeline delivery and organizational goals
Allocate resources and assign personnel to new projects based on scope and priority
Monitor project progress, ensure timely execution, and mobilize resources to address technical challenges
Oversee laboratory operations with a strong emphasis on safety, compliance, and inspection readiness
Ensure the team remains current with scientific advancements, emerging technologies, and evolving regulatory requirements, and integrates them appropriately
Maintain compliance with all applicable laws, regulations, and industry standards governing drug development
Provide technical consultation to manufacturing sites as needed to support product development and troubleshooting
Foster a high-performance culture through effective performance management, coaching, mentoring, and career development; contribute to talent assessment and succession planning
Uphold and promote adherence to company policies and values
Manage a team of technical experts focused on developing and executing comprehensive analytical strategies for bioproducts (antibodies, proteins, cell and gene therapies, non-viral gene delivery platforms, synthetic peptides, oligonucleotides, and conjugates)
Ensure robust systems and a well-trained workforce (internal staff, insourced personnel, external partners) to meet pipeline demands
Maintain GMP testing laboratories in a state of continuous inspection readiness and full compliance with ICH Q-series and 21 CFR Parts 11, 210, and 211

Skills

Key technologies and capabilities for this role

Analytical DevelopmentGMP ComplianceICH Guidelines21 CFRCell and Gene TherapyAntibodiesProteinsOligonucleotidesPeptidesBioprocess DevelopmentRegulatory CompliancePipeline Management

Questions & Answers

Common questions about this position

What is the employment type for this Sr. Director role?

This is a full-time position.

Is this role remote or does it require working at a specific location?

This information is not specified in the job description.

What are the key responsibilities for this leadership role?

The role involves leading a team of scientists in phase-appropriate analytical development, aligning development plans across functions, setting strategic direction, allocating resources, overseeing lab operations, ensuring compliance, and fostering a high-performance culture.

What is the company culture like at Eli Lilly?

Eli Lilly unites caring with discovery to make life better for people, puts people first, and promotes a high-performance culture through performance management, coaching, mentoring, and career development.

What makes a strong candidate for this Sr. Director position?

Strong candidates will have leadership experience managing technical experts in analytical development for bioproducts, expertise in GMP compliance and regulatory guidelines like ICH Q-series and 21 CFR Parts 11, 210, and 211, and skills in strategic planning, talent development, and cross-functional alignment.

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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