Sr Director, Quality Large Molecule
Thermo Fisher ScientificSalary not specified
- Full Time
- Expert & Leadership (9+ years)
Eli Lilly and Company
Principal Associate Quality API External Manufacturing
Not SpecifiedCompensation
Junior (1 to 2 years)Experience Level
Full TimeJob Type
UnknownVisa
PharmaceuticalsIndustries
Requirements
Candidates must possess a Bachelor’s degree in a science-related field, such as Pharmacy, Chemistry, or Biological Sciences, with a focus on Life Sciences. Previous experience in GMP manufacturing, particularly in API or finished product manufacturing and QA, is required. Knowledge of pharmaceutical manufacturing operations and regulatory requirements is also essential.
Responsibilities
The Principal Associate Quality API External Manufacturing will serve as a liaison between CMs and Lilly, providing quality oversight of external manufacturing partners. This role involves escalating quality issues, assisting in the establishment of Quality Agreements, coordinating QA responsibilities of API shipments, participating in regulatory inspections, providing on-site support during manufacturing events, evaluating and dispositioning API batches, ensuring documented checks are completed, and maintaining awareness of regulatory findings. The position also requires participation in projects to improve productivity, involvement in Joint Process (JPT) and Post Launch Optimization (PLOT) teams, and reviewing and approving various quality-related documents such as procedures and change control proposals.
Skills
Quality Assurance
cGMP
Regulatory Compliance
API Manufacturing
Quality Oversight
Inspection Preparation
External Manufacturing
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.
Key Metrics
Indianapolis, IndianaHeadquarters
1876Year Founded
$1,180.1MTotal Funding
IPOCompany Stage
Biotechnology, HealthcareIndustries
10,001+Employees