Sr Director, Quality Large Molecule
Thermo Fisher ScientificSalary not specified
- Full Time
- Expert & Leadership (9+ years)
Not SpecifiedCompensation
Senior (5 to 8 years), Expert & Leadership (9+ years)Experience Level
Full TimeJob Type
UnknownVisa
Pharmaceuticals, Biotechnology, HealthcareIndustries
Requirements
Candidates should possess a Bachelor’s degree in Chemical Engineering or a related field, with a minimum of 10 years of experience in process engineering, preferably within the pharmaceutical or biotechnology industry. Strong understanding of pharmaceutical manufacturing processes, GMP regulations, and process validation principles is essential. Experience with API manufacturing, specifically in solid dosage forms, is highly desirable. Demonstrated ability to interpret and apply technical documentation, including batch records, SOPs, and validation protocols, is required.
Responsibilities
The Senior / Principal Process Engineer - APIEM will provide technical leadership and expertise to API EM contract manufacturer personnel, ensuring the reliable supply and commercialization of medicines. This includes on-site technical presence at the CM, overseeing manufacturing execution, supporting major investigations and troubleshooting, and developing process knowledge. The role involves collaborating with CM personnel on equipment specification, procurement, and IQ/OQ/PQ, as well as assessing HSE and PSM elements impacting Lilly products. Additionally, the engineer will coach and mentor process team members, support root cause analysis, develop process knowledge infrastructure, and provide process & equipment support to identify systemic issues and drive continuous improvement activities.
Skills
Process Engineering
Validation
Troubleshooting
Operational Control Strategy
Equipment Specification
IQ/OQ/PQ
HSE
Manufacturing Execution
Risk Assessment
Team Collaboration
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