Vacancy caducado!
Job Title: Associate I, Manufacturing Drug ProductRequisition ID: 118103BRWhen you're part of the team at Thermo Fisher Scientific, you'll do important work, like helping customers in finding cures for cancer, protecting the environment or making sure our food is safe. Your work will have real-world impact, and you'll be supported in achieving your career goals.Location/Division Specific InformationLexington, MA- Viral Vector Services (VVS)What will you do?
Performing basic to complex activities on the fill finish line for production of Drug Product.
Performing critical downstream activities in preparation for fill finish of Drug Product.
Documentation of all activities in Batch Records, Logbooks, Forms, Etc.
Follows verbal and written procedures in operating production equipment and performing processing steps; accurately completes appropriate production documentation.
Identifies, escalates and documents events and subtle variances that deviate from normal operation; participate as needed in investigations.
Monitor processes using automated production systems and controls with limited supervision.
Equipment preparation activities including, parts cleaning, autoclaving, and room clearance.
Demonstrates ability to troubleshoot basic mechanical operations.
Post-Fill tasks will include visual inspection, secondary packaging, and environmental monitoring.
Daily Aseptic processing within a controlled isolator environment and within a BSC.
Conducts training for less experienced personnel
How will you get here?Expectations:
Must be able to work in a fast-paced environment.
A strong attention to detail.
Work towards solutions to given problems and operate under cGMP requirements.
Work cross-functionally with support groups such as Facilities, Engineering, Contamination Control, Quality Control and Quality Assurance.
Qualify to work in aseptic environments to complete required production activities.
Maintain facility and room inspection readiness.
Ability to lift at least 50lbs.
Ability to aseptically gown and/or sterile gown as needed.
Work Hours:
The incumbent will onboard and support project and Manufacturing activities Monday through Friday, 7:00 AM to 4:00 PM.
May require overtime to work evenings, weekends or holidays, as required to meet project/Manufacturing timelines.
Additional Responsibilities:
Work in accordance with site and company EHS programs.
Work in accordance with regulations, detailed protocols, Batch Record's, SOP's and Work Instructions.
Prepare and process components, materials and equipment for aseptic fill finish activities, operate filling equipment and perform aseptic manipulations, able to inspect finished vials and perform labeling activities to support shipment.
Knowledge, Skill and RequirementsMinimum Qualifications:-Bachelor's Degree with 0-3 years of industry related experience in cGMP manufacturing.-High School diploma and 2-4 years' industry related experience in cGMP manufacturing.-Independently motivated and can work within a cross-functional teamPreferred Qualifications:-Bachelor's Degree with 2-4 years of Drug Product experience in cGMP manufacturing.-High School diploma with 3-5 years of Drug Product experience in cGMP manufacturing.Note: This job description is not all-inclusive. Additional duties may be performed, as assigned. It acts as a guideline and is subject to change over time.Thermo Fisher Scientific Inc. is the world leader in serving science, with annual revenue exceeding $25 billion. Our Mission is to enable our customers to make the world healthier, cleaner and safer. Whether our customers are accelerating life sciences research, solving complex analytical challenges, improving patient diagnostics and therapies or increasing productivity in their laboratories, we are here to support them. Our global team of more than 75,000 colleagues delivers an unrivaled combination of innovative technologies, purchasing convenience and pharmaceutical services through our industry-leading brands, including Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services and Patheon. For more information, please visit www.thermofisher.com .Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.Thermo Fisher Scientific is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, creed, religion, color, national or ethnic origin, citizenship, sex, sexual orientation, gender identity and expression, genetic information, veteran status, age or disability status.
Vacancy caducado!