Senior Lyophilization Expert jobs in United States
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Curia · 2 hours ago

Senior Lyophilization Expert

Curia is a global contract development and manufacturing organization dedicated to providing life-saving treatments. The Senior Lyophilization Expert is responsible for operating lyophilization equipment, ensuring compliance with SOPs and cGMPs, and providing technical guidance to team members in a cleanroom environment.

BiotechnologyHealth CareManufacturing
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H1B Sponsor Likelynote

Responsibilities

Ensures lyophilizers are cleaned, sterilized and tested for leaks prior to manufacturing of a product
Operates lyophilizers according to the product specifications including temperature, pressure, time, etc
Monitors lyophilization cycles and reviews data to ensure requirements of product SOP’s have been met
Provide direction and/or technical guidance to Lyo Technicians
Assists in the development and review of SOP’s and technical reports pertaining to lyophilizer operations
Communicates with production and engineering staff pertaining to status of lyophilizer operations
Ensures site Autoclaves and terminal sterilizers are in good working order, tested for leaks
Assist Facilities group with troubleshooting refrigeration issues on HVAC units, refrigeration, and stability chambers
Assists in the development of quality reports including, but not limited to, planned deviations and non-conforming material reports
Assists other departments and shifts as needed
Understands and follows cGMP, safety practices, and SOPs
Train newly hired technicians and current technicians as needed
Serves as the subject matter expert for Lyophilizers and autoclaves for assisting maintenance and troubleshooting
Serves as the subject matter expert for assisting maintenance and troubleshooting
Maintain up to date trainings
Read/interpret SOPs to ensure compliance
Maintain up to date trainings
Other duties as assigned

Qualification

Lyophilization expertiseCGMP complianceSOP developmentHVAC experiencePharmaceutical manufacturingAnalytical reasoningTechnical communicationTeam collaborationAttention to detailProblem-solving

Required

Bachelor's degree with an emphasis in applied Science or related field of study
Minimum of eight (8) years' lyophilization experience
Minimum of five (5) years' HVAC and automation mechanical experience
Minimum of five (5) years related experience in production, manufacturing, and/or cleanroom
Minimum of five (5) year experience in a pharmaceutical manufacturing industry or relevant industry
Ability to read and interpret various documents, such as safety instructions, standard operating procedures, technical procedures, and governmental regulations
Strong written and verbal communication skills
Effective presentation skills
Proficient in executing arithmetic operations including addition, subtraction, multiplication, and division across various units of measurement
Strong grasp of algebraic and geometric principles
Ability to define problems, collect data, establish facts, and draw valid conclusions
Ability to interpret an extensive variety of technical instructions in mathematical or diagram form and deal with several abstract and concrete variables
Strong technical foundation and proven capability in effectively utilizing diverse software tools
Adeptness in manufacturing and internet software
Proficiency in Microsoft Office tools including PowerPoint, Excel, Word, and Outlook
Ability to apply analytical reasoning and root cause analysis to solve problems
Ability to work well independently or as a team
Ability to work at elevated heights
Must pass a background check
Must pass a drug screen
May be required to pass Occupational Health Screening
Must be able to obtain and maintain gowning certification
May be required to wear a respirator

Preferred

Minimum of five (5) years related experience in production, manufacturing, and/or cleanroom
Minimum of five (5) year experience in a pharmaceutical manufacturing industry or relevant industry

Benefits

Generous benefit options (eligible first day of employment)
Paid training, vacation and holidays (vacation accrual begins on first day of employment)
Career advancement opportunities
Education reimbursement
401K program with matching contributions
Learning platform
And more!

Company

Curia is a biotechnology company that offers discovery biology, synthetic, medicinal chemistry, and small-scale manufacturing services.

H1B Sponsorship

Curia has a track record of offering H1B sponsorships. Please note that this does not guarantee sponsorship for this specific role. Below presents additional info for your reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (28)
2024 (17)
2023 (8)

Funding

Current Stage
Late Stage
Total Funding
unknown
2025-03-07Debt Financing
2017-08-31Private Equity

Leadership Team

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Steve Lavezoli
Vice President, Biologics Division
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Company data provided by crunchbase