Sr. Manufacturing Associate (Drug Product) - 1st Shift at Thermo Fisher Scientific

Plainville, Massachusetts, United States

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Not SpecifiedCompensation

Junior (1 to 2 years), Mid-level (3 to 4 years)Experience Level

Full TimeJob Type

UnknownVisa

Biotechnology, PharmaceuticalsIndustries

Requirements

High School Diploma/GED
2+ years' proven experience in aseptic processing, fill/finish operations, visual inspection and/or other related cGMP operations
Proven track record adhering to strong ethical standards
Ability to work effectively with a wide range of individuals in a diverse community
Must be able to pass a comprehensive background check, which includes a drug screening
Able to lift 40 lbs. without assistance
Adherence to all Good Manufacturing Practices (GMP) Safety Standards
Compliance with cleanroom requirements (no hair products, jewelry, makeup, nail polish, perfume, exposed piercings, facial hair etc.)
Ability to wear PPE (safety glasses, gowning, gloves, lab coat, ear plugs etc.)
Ability to stand for full shift
Ability to gown aseptically and/or sterile gown as needed
Ability to write, read/review written documentation for extended periods of time
Specific vision requirements: close vision, distance vision, color vision, peripheral vision, depth perception, and ability to adjust focus
Ability to talk and hear
Ability to lift, stand, walk, use hands to finger, handle, or feel, reach with hands and arms, and stoop, kneel, or crouch

Responsibilities

Train on and perform Drug Product formulation, aseptic filling interventions, visual inspection, and labeling operations in a cleanroom environment
Ensure batch records and lab books are completed in line with appropriate good documentation practices (GDP)
Support timely and effective closure of compliance investigations, batch record reviews, procedural updates, and SAP transactions
Work closely with cross-functional team functions on effective planning and hand-off of operations

Skills

GMP

cGMP

aseptic processing

fill/finish operations

visual inspection

drug product formulation

GDP

cleanroom operations

batch records

SAP

Thermo Fisher Scientific

Provides life sciences products and services

About Thermo Fisher Scientific

Thermo Fisher Scientific offers a variety of products and services that support scientific research and healthcare, including laboratory equipment, reagents, and software solutions. Their products are used in applications like protein biology, real-time PCR, and sequencing, serving clients such as academic institutions and pharmaceutical companies. Unlike competitors, Thermo Fisher emphasizes customer support and education, helping clients optimize their experiments. The company's goal is to be a leading provider of life sciences solutions that contribute to a healthier and safer world.

Waltham, MassachusettsHeadquarters

1956Year Founded

$17MTotal Funding

IPOCompany Stage

Biotechnology, HealthcareIndustries

10,001+Employees

Risks

Increased competition in single-use bioprocessing may impact market share.

Sale of anatomical pathology business could create a temporary product gap.

Investment in miDiagnostics may face regulatory challenges affecting returns.

Differentiation

Thermo Fisher offers a comprehensive range of life sciences products and services.

Their well-known brands include Thermo Scientific, Applied Biosystems, and Invitrogen.

They provide strong customer support and educational resources to optimize client workflows.

Upsides

Expansion of biologics production facility enhances capacity for precision biologics monitoring.

Investment in miDiagnostics aligns with demand for rapid diagnostic solutions in BioPharma.

Collaboration with Mainz Biomed positions them in the growing cancer detection market.

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