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Job DescriptionManufacturing Associate I Drug SubstanceAt Viral Vector Services (VVS), a division of Thermo Fisher Scientific we deliver, from process development through commercial supply, the expertise and resources vital to help clients deliver innovative gene therapies. Placed in the forefront of our leading and groundbreaking Cell and Gene Therapy business enabling clients to cure genetic, rare, and otherwise untreatable diseases.This is a night shift schedule 12 Hour rotating shift (2/2/3 format) 6:45AM-7:15PM position. Flexible hours are sometimes vital to accommodate project/production demand when required.Location/Division Specific InformationLocation: Lexington, MA Shift: 12 Hour rotating shift (2/2/3 format) 6:45pm-7:15am position. Flexible hours are sometimes vital to accommodate project/production demand when required.How will you make an impact?The successful candidate will operate equipment used to manufacture drug substance in a cleanroom environment and following GMP standards. The Manufacturing Associate will autonomously run equipment, Skids, pumps, Bioreactors, and automated systems and collaborate with team members to ensure it's right the first time and on schedule, while also following SOPs and batch records and recommending opportunities for improvement.What you will do
Adhere to Safety & Environmental guidelines/policies as well as cGMP and other applicable regulatory agencies.
Perform day to day manufacturing processes for Drug Substance, including but not limited to:
Solution preparation
Adherent and suspension cell culture
Operation of Wave and disposable, single use Bio reactors
Chromatography and Tangential Flow Filtration
Viral Filtration
Complete work instructions while adhering to procedures and cGMP regulations.
Assist with manufacturing batch records reconciliation. Complete Preventative Maintenance & work notifications tasks on time.
Adhere to the Quality Management Systems by living the Quality values every day and holds peers across the site accountable as well.
Assist in the completion and identification of PPI initiatives and continuous improvements.
Maintain a culture of safety by identification of near misses, safety walkthroughsand assisting with resolution of safety observations. Ensure chemicals are properly stored and labeled.
How you will get here
Ability to function in a fast paced, dynamic environment with multiple priorities simultaneously.
Strong planning, organization, and multitasking skills.
Strong interpersonal and communication skills and the ability to work effectively with a wide range of constituencies in a diverse community.
Education/Experience
High School Diploma / minimum 0+ years of relevant experience or outstanding demonstration of skills or background
Knowledge, Skills, Abilities
Ability to apply knowledge of Good Manufacturing processes and the knowledge and skills in pharmaceutical processes, equipment, instrumentation, and procedures.
Ability to follow procedures and work in a team environment.
Understand the science behind the process with ability to interpret data and inputs.
Understand cleanroom concepts.
Specific vision abilities required by this job include close vision and ability to adjust focus with tasks.
Must be fluent in english
BenefitsWe offer competitive remuneration, annual incentive plan bonus, healthcare, and a range of employee benefits. Thermo Fisher Scientific offers employment with an innovative, forward-thinking organization, and outstanding career and development prospects. We offer an exciting company culture that stands for integrity, intensity, involvement, and innovation!Our Mission is to enable our customers to make the world healthier, cleaner and safer. Watch as our colleagues explain 5 reasons to work with us. As one global network of 100,000+ colleagues, we share a common set of values - Integrity, Intensity, Innovation and Involvement - working together to accelerate research, solve complex scientific challenges, drive technological innovation and support patients in need. #StartYourStory at Thermo Fisher Scientific, where diverse experiences, backgrounds and perspectives are valued.Apply today! http://jobs.thermofisher.comThermo 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.Accessibility/Disability AccessThermo Fisher Scientific offers accessibility service for job seekers requiring accommodations during the job application process. For example, this may include individuals requiring assistance because of hearing, vision, mobility, or cognitive impairments. If you are a job seeker with a disability, or assisting a person with a disability, and require accessibility assistance or an accommodation to apply for one of our jobs, please submit a request by telephone at 1-855-471-2255. Please include your contact information and specific details about your required accommodation to support you during the job application process.This telephone line is reserved solely for job seekers with disabilities requiring accessibility assistance or an accommodation in the job application process. Messages left for other purposes, such as not being able to get into the career website, following up on an application, or other non-disability related technical issues will not receive a response.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.
Full-time