Sr Director, Quality Large Molecule
Thermo Fisher ScientificSalary not specified
- Full Time
- Expert & Leadership (9+ years)
$60,000 – $90,000Compensation
Senior (5 to 8 years)Experience Level
Full TimeJob Type
UnknownVisa
Biopharmaceuticals, Bioprocessing, Chemical EngineeringIndustries
Requirements
Candidates should possess a Bachelor’s degree in Chemical Engineering, Bioprocessing, or a related scientific field, and hold a Master’s degree preferred. They must have at least 8 years of experience in bioprocess engineering, with a strong focus on mammalian cell culture, fermentation, and downstream processing. Demonstrated experience with scale-up and technology transfer is essential, along with a thorough understanding of GMP regulations and cGMP guidelines.
Responsibilities
The Senior/Principal Bioprocess Engineer will provide engineering subject matter expertise to support the design, construction, and preparation for the successful startup of the expanded manufacturing facilities. This includes providing support for design reviews, process safety assessments, User Requirements, C&Q support, Unit Operation Shakedown, and Facility Run Rate Readiness. They will define and own aspects of the Operational Readiness Plan, develop SOPs, support Performance Qualification strategy, lead tech transfer, and work with design and project engineers on verification activities, while also supporting initial Operations Training and alignment of lessons learned.
Skills
Mammalian Cell Culture
Fermentation
Downstream Processing
Scale-up
Technology Transfer
GMP
cGMP
Process Safety
SOPs
Operational Readiness Plan
Verification Activities
Tech Transfer
User Requirements
C&Q
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