CMCPM Radiopharmaceuticals

Chester, Maryland, United States

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Not SpecifiedCompensation

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

Full TimeJob Type

UnknownVisa

Pharmaceuticals, Biotechnology, HealthcareIndustries

Requirements

Candidates must possess 10+ years of drug development or radiopharmaceutical product experience and hold a four-year degree, preferably in a scientific or engineering field. Demonstrated expertise in PM tools and processes, including management of scope, timeline, cost, communications, risk, and procurement as defined by PMBOK, is required. The ability to identify and drive business process improvements and incorporate new PM technologies/methodologies, along with a demonstrated ability to communicate complex issues accurately and succinctly, both horizontally and vertically across the development organization, are also essential.

Responsibilities

The role involves leading the creation, development, communication, and implementation of integrated CMC plans for assets from portfolio entry through early-phase clinical development, including both therapeutics and imaging agents. Responsibilities include partnering with global program teams and therapeutic business units to translate strategy into CMC development and delivery goals, leveraging portfolio knowledge and financial acumen for investment strategies, and driving cross-functional CMC teams to maximize data value, create competitive plans, anticipate and communicate risks, and enable timely decision-making. The position also requires developing high-performing matrix teams, supporting Due Diligence efforts by leading CMC development plans, and participating in or leading continuous improvement projects within CMC development.

Skills

CMC

Project Management

Regulatory Affairs

Clinical Development

Data Analysis

Risk Management

Strategic Planning

Cross-functional Team Leadership

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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