Celltrion Inc · 1 day ago
Sr. Principal Engineer - TS/MS Technology Modernization
Branchburg, NJ, US
Full-time
Hybrid
Senior Level, Lead/Staff
$129K/yr - $172K/yr
10+ years expCelltrion Inc is a biopharmaceutical company seeking a Sr. Principal Engineer to lead secondary loop project support and major site initiatives. This role involves managing complex technical issues, mentoring team members, and ensuring compliance with safety and regulatory expectations in the manufacturing process.
Health CarePharmaceutical
Responsibilities
Leads implementation of secondary loop projects at Celltrion Branchburg. If necessary, leads the transfer of processes from one production facility to another, anticipating and addressing complex scale-up issues
Leads implementation of major site initiatives such as MES
Provides mentorship and scientific expertise to Process Team members monitoring, trending, and analyzing production data. Applies process knowledge and data analysis skills to support the management of daily manufacturing operations. May present process data and analyses in conjunction with Process Team members at Manufacturing Process Team meetings. Drives solutions impacting results across sites or function
Authors technical reports supporting process control strategies, technology transfers, process validation, deviation/adverse event reporting, process monitoring/analyses, and technical studies
Troubleshoots issues in conjunction with Process Teams and/or manufacturing staff on the manufacturing floor. Anticipates and resolves key technical or operational problems that impact function or geography. Communicates issues in a timely manner. May lead process-related investigations and assesses technical impact. Influences complex regulatory or technical issues within the TS/MS area/function. Influences others to adopt a different point of view on difficult concepts
Writes standard operating procedures or work instructions as they relate to the activities of the TS/MS group or operations support. Reviews and approves manufacturing batch records and other manufacturing documentation
Works with Process Team members to ensure successful process knowledge transfer to the Manufacturing staff on the manufacturing floor. Assists in process-related training of Manufacturing Process Team members. As required, directly gathers additional supporting data on the manufacturing floor
As required, designs laboratory experiments in support of process troubleshooting and/or continuous improvement and executes or coordinates execution in outside laboratories. Helps to define and implement medium to large continuous improvements to manufacturing processes
Works with Manufacturing to support the start-up and validation of new facilities and the associated process equipment. Helps to define and implement control strategies for Celltrion Branchburg processes
As required, may lead, or assist in the planning and execution of process validation activities
As required, may own, or assist in the implementation of medium to large process-related change controls with greater risk, resource / financial requirements, or complexity
Makes decisions that impact a function or geography. Builds relationships with internal and external partners
Understands, and performs all job responsibilities in compliance with, safety and regulatory expectations as well as cGMP
Qualification
Required
BS degree in Chemistry, Microbiology, Biochemistry or related science, or BS in Chemical Engineering or related engineering discipline
Minimum of 10 years experience in a cGMP biopharmaceutical or pharmaceutical manufacturing and/or development environment
Experience in fermentation/cell culture and/or protein purification manufacturing
Process and equipment knowledge of cell culture or purification functions
Thorough understanding of GMP requirements for a large-scale manufacturing facility
Demonstrated leadership skills
Excellent communication skills, both oral and written
Preferred
Advanced degree preferred but not required
Process validation experience a plus
Database experience a plus
Benefits
Paid time off (holidays, vacation, and additional leave)
Medical, dental, and vision insurance
Life insurance
A company-matched retirement savings plan
Wellness programs
Short- and long-term disability coverage
Company
Celltrion Inc
Celltrion is a leading biopharmaceutical company that specializes in research, development and manufacturing of innovative therapeutics.
1001-5000 employees
Funding
Current Stage
Public CompanyTotal Funding
unknown2023-08-17Acquired
2017-07-28IPO
Recent News
2025-12-31
Company data provided by crunchbase