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Manager, Product Quality and Lot Disposition at Thermo Fisher Scientific
Plainville, MA 02762, USA - Full Time
Skills Needed
Critical Thinking, Ema, Biologics, Regulatory Requirements, Gene Therapy, Manufacturing Processes, Communication Skills, Sap, Cross Functional Relationships, Quality Operations, Trackwise, Teamwork, Pharmaceuticals, Leadership, Decision Making
Specialization
A scientific or technical subject area required advanced degree preferred
Qualification
Graduate
Experience Required
Minimum 10 year(s)
Lab Kitting Associate - Co-Op (12 months) at Thermo Fisher Scientific
Whitby, ON L1N 6J6, Canada - Full Time
Skills Needed
Pharmaceutical Industry, Dexterity, Training, Latex, Materials, Regulatory Requirements, Laboratory Equipment, Communication Skills
Specialization
High school diploma/general educational development (ged) certificate is required
Qualification
Diploma
Proposal Manager (Bioteh/Biopharma) - US, Remote at Thermo Fisher Scientific
North Carolina, North Carolina, USA - Full Time
Skills Needed
Operational Strategy, English, Writing, Regulatory Guidelines, Training, Directives, Groups, Project Management Skills, Therapeutic Areas, Thinking Skills, Communication Skills
Qualification
Graduate
Experience Required
Minimum 8 year(s)
Lead QA Technician at Thermo Fisher Scientific
2665 Bleiswijk, , Netherlands - Full Time
Skills Needed
Communication Skills, Database Systems, Regulations, Criminal Records, English
Specialization
Relevant subjects or at least 1 year of gmp experience
Qualification
Graduate
Experience Required
Minimum 1 year(s)
Quality Engineer III - QA on the Floor at Thermo Fisher Scientific
St. Louis, MO 63134, USA - Full Time
Skills Needed
Root, Interpersonal Skills, Utilities, Communication Skills, Excel, Life Sciences, Protein Purification, Cell Culture, Regulated Industry, Organization Skills
Specialization
Life sciences or related field minimum 5 years proven experience
Qualification
Graduate
Experience Required
Minimum 2 year(s)
Hardware Design Engineer (m/f/d) – Rotational Rheometers at Thermo Fisher Scientific
76227 Karlsruhe, , Germany - Full Time
Skills Needed
Good Communication Skills
Qualification
Graduate
Global Market Development Manager, Protein Expression and Viral Delivery at Thermo Fisher Scientific
Carlsbad, CA 92008, USA - Full Time
Skills Needed
Demand, Performance Metrics, Digital Marketing, Biotechnology, Reagents, Continuous Improvement, Biology, Communication Skills, Optimization, Teams, Display Advertising, Biochemistry, Cell Biology, Life Sciences, Protein Expression, Consumables
Qualification
MBA
Customer Service Representative – Production at Thermo Fisher Scientific
Georgia, Georgia, USA - Full Time
Skills Needed
Good Communication Skills
Qualification
Graduate
Sr. Finance Manager, FP&A at Thermo Fisher Scientific
West Hills, CA 91304, USA - Full Time
Skills Needed
Finance, Powerpoint, Forecasting, Sql, Reporting Tool, Budgeting, Communication Skills, Modeling, Excel
Specialization
Accounting, Finance
Qualification
MBA
Experience Required
Minimum 5 year(s)
Packaging/Labeling Technician II - 12hr Day Shift at Thermo Fisher Scientific
Greenville, NC 27834, USA - Full Time
Skills Needed
Perspectives, Sap, High Quality Standards, Communication Skills, Packaging
Qualification
Graduate
Supervisor, Formulation Manufacturing at Thermo Fisher Scientific
Pleasanton, CA 94566, USA - Full Time
Skills Needed
Root
Qualification
Graduate
Experience Required
Minimum 3 year(s)
HR Manager at Thermo Fisher Scientific
St. Louis, MO 63134, USA - Full Time
Skills Needed
Employee Relations, Management Skills, Color, Disabilities, Candor, Presentation Skills, Communication Skills, Communications, Personal Development
Specialization
Human resources business administration or a related field
Qualification
Graduate
Experience Required
Minimum 5 year(s)
Scientist I, Cell Biology (Grand Island, NY) at Thermo Fisher Scientific
Grand Island, NY 14072, USA - Full Time
Skills Needed
Biology, Biochemistry, Communication Skills, Bioengineering, Data Analysis
Specialization
Biology bioengineering biochemistry or related field or equivalent knowledge and experience
Qualification
Graduate
EHS Specialist III, Environmental Professional at Thermo Fisher Scientific
Florence, South Carolina, USA - Full Time
Skills Needed
Quality Improvement Tools, Suppliers, Color, Sc, Technical Writing, Disabilities, Outlook, Trade Associations, Contractors, Interpersonal Skills, Manufacturing Processes, Training, Iso Standards, Windows, Customer Service, Analytical Skills, Access, Excel
Specialization
Quality improvement tools and a passion for customer service
Qualification
Graduate
Experience Required
Minimum 3 year(s)
Regulatory Affairs Specialist II, Dangerous Goods Transportation at Thermo Fisher Scientific
Dallas, TX 75243, USA - Full Time
Skills Needed
Iata, Interpersonal Skills, Material Handling, Transportation, Project Management Skills, Management Software
Qualification
Graduate
Experience Required
Minimum 5 year(s)
DNA Technician at Thermo Fisher Scientific
Paisley PA4 9RE, , United Kingdom - Full Time
Skills Needed
Chemistry, Biology
Qualification
Graduate
Experience Required
Minimum 1 year(s)
Systems Administrator (Linux) at Thermo Fisher Scientific
Morrisville, NC 27560, USA - Full Time
Skills Needed
Red Hat Enterprise Linux, Troubleshooting, Backup, Technical Requirements, Active Directory, Virtualization, High Level Design, Python, Devops, Data Center Infrastructure, Operating Systems, English, Powershell, System Administration, Storage
Qualification
Graduate
Operator II, Manufacturing - 12hr Day Shift at Thermo Fisher Scientific
Greenville, NC 27834, USA - Full Time
Skills Needed
Oral Communication, Documentation Practices, Motion, Color
Qualification
Diploma
Experience Required
Minimum 1 year(s)
Proposal Manager- (Evidera) - US, Central /East Coast Region at Thermo Fisher Scientific
Washington, District of Columbia, USA - Full Time
Skills Needed
Writing, Communication Skills, Time Management, Drug Development, Life Sciences, Scientific Writing
Qualification
Graduate
Experience Required
Minimum 6 year(s)
Operator II, Manufacturing at Thermo Fisher Scientific
5048 Tilburg, , Netherlands - Full Time
Skills Needed
Gmp, Food Industry, Gloves, Writing, Stairs, Risk, Injury
Qualification
Graduate
Manager, Product Quality and Lot Disposition at Thermo Fisher Scientific
Plainville, MA 02762, USA -
Full Time


Start Date

Immediate

Expiry Date

28 Nov, 25

Salary

0.0

Posted On

29 Aug, 25

Experience

10 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

No

Skills

Critical Thinking, Ema, Biologics, Regulatory Requirements, Gene Therapy, Manufacturing Processes, Communication Skills, Sap, Cross Functional Relationships, Quality Operations, Trackwise, Teamwork, Pharmaceuticals, Leadership, Decision Making

Industry

Pharmaceuticals

Description

JOB DESCRIPTION

Thermo Fisher Scientific Inc. is the world leader in serving science, with annual revenue exceeding $40 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 efficiency in their laboratories, we are here to support them. Our team of more than 100,000 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, Patheon and PPD. For more information, please visit www.thermofisher.com.

GROUP/DIVISION SUMMARY:

Thermo Fisher Scientific - Viral Vector Services (VVS) is a dynamic gene therapy contract development and manufacturing organization (CDMO) that is seeking sharp individuals to bring the highest quality processes, products and testing to our clients. Our employees are committed to making a difference in our organization for our client partners and the patients we serve.

POSITION SUMMARY:

The Manager, Product Quality and Lot Disposition serves as the Quality representative on client core teams and is responsible for lot disposition activities for the site. This role ensures uninterrupted supply to patients by maintaining meticulous quality oversight across Clinical and Commercial Drug Substance and Drug Product operations. The manager collaborates closely with GMP and Operations to uphold compliance and product integrity.

QUALIFICATIONS:

  • Bachelor’s degree in a scientific or technical subject area required; advanced degree preferred

EXPERIENCE:

  • Minimum 10 years in Quality Assurance roles within biologics, pharmaceuticals, or cell and gene therapy sectors
  • Consistent record handling regulatory inspections (FDA, EMA, Health Canada)
  • Proven success in building and leading impactful teams
  • Hands-on experience with product disposition, deviation investigations, and batch record review in GMP environments

KNOWLEDGE, SKILLS & ABILITIES

  • Extensive knowledge of GMP regulations and global standards (FDA, EMA, Health Canada), with the ability to interpret and implement evolving regulatory requirements and industry standard methodologies.
  • Skill in biotech manufacturing processes for both bulk and finished products, including cell and gene therapies. Skilled in product disposition, deviation investigations, and batch record review.
  • Digital Proficiency: Knowledge of electronic quality systems like SAP, LIMS, and TrackWise, with the ability to bring data for trending, reporting, and decision-making.
  • Leadership & Teamwork: Established ability to lead successful teams, promote cross-functional relationships, and represent the Quality Unit in client-facing engagements and regulatory inspections.
  • Critical Thinking: Able to handle intricate disposition workflows, lead ongoing improvement efforts, and contribute to innovative quality operations.
  • Communication & Influence: Exhibits strong written and verbal communication skills, proficient in conveying technical concepts to diverse audiences and influencing outcomes with team members and collaborators.

PHYSICAL REQUIREMENTS:

  • Ability to gown aseptically and/or sterile gown
  • Capacity to write and review written documentation for extended period

How To Apply:

Incase you would like to apply to this job directly from the source, please click here

Responsibilities

Lead a team of quality professionals responsible for oversight and approval of client quality system results, supporting tech transfer and manufacturing execution through final product disposition.

  • Act as the primary Quality contact for clients, providing technical expertise and representing the Quality Unit in investigations, studies, trending evaluations, and improvement initiatives.
  • Oversee disposition activities for multiple drug substance and drug product programs
  • Manage and approve all site disposition documentation in accordance with SOPs.
  • Deliver quality metrics and status reports to support management reviews.
  • Develop working relationships with internal and external team members to efficiently address quality challenges.
  • Support product recall and stock recovery investigations and reporting
Manager, Product Quality and Lot Disposition at Thermo Fisher Scientific
Plainville, MA 02762, USA - Full Time
Skills Needed
Critical Thinking, Ema, Biologics, Regulatory Requirements, Gene Therapy, Manufacturing Processes, Communication Skills, Sap, Cross Functional Relationships, Quality Operations, Trackwise, Teamwork, Pharmaceuticals, Leadership, Decision Making
Specialization
A scientific or technical subject area required advanced degree preferred
Qualification
Graduate
Experience Required
Minimum 10 year(s)
Lab Kitting Associate - Co-Op (12 months) at Thermo Fisher Scientific
Whitby, ON L1N 6J6, Canada - Full Time
Skills Needed
Pharmaceutical Industry, Dexterity, Training, Latex, Materials, Regulatory Requirements, Laboratory Equipment, Communication Skills
Specialization
High school diploma/general educational development (ged) certificate is required
Qualification
Diploma
Proposal Manager (Bioteh/Biopharma) - US, Remote at Thermo Fisher Scientific
North Carolina, North Carolina, USA - Full Time
Skills Needed
Operational Strategy, English, Writing, Regulatory Guidelines, Training, Directives, Groups, Project Management Skills, Therapeutic Areas, Thinking Skills, Communication Skills
Qualification
Graduate
Experience Required
Minimum 8 year(s)
Lead QA Technician at Thermo Fisher Scientific
2665 Bleiswijk, , Netherlands - Full Time
Skills Needed
Communication Skills, Database Systems, Regulations, Criminal Records, English
Specialization
Relevant subjects or at least 1 year of gmp experience
Qualification
Graduate
Experience Required
Minimum 1 year(s)
Quality Engineer III - QA on the Floor at Thermo Fisher Scientific
St. Louis, MO 63134, USA - Full Time
Skills Needed
Root, Interpersonal Skills, Utilities, Communication Skills, Excel, Life Sciences, Protein Purification, Cell Culture, Regulated Industry, Organization Skills
Specialization
Life sciences or related field minimum 5 years proven experience
Qualification
Graduate
Experience Required
Minimum 2 year(s)
Hardware Design Engineer (m/f/d) – Rotational Rheometers at Thermo Fisher Scientific
76227 Karlsruhe, , Germany - Full Time
Skills Needed
Good Communication Skills
Qualification
Graduate
Global Market Development Manager, Protein Expression and Viral Delivery at Thermo Fisher Scientific
Carlsbad, CA 92008, USA - Full Time
Skills Needed
Demand, Performance Metrics, Digital Marketing, Biotechnology, Reagents, Continuous Improvement, Biology, Communication Skills, Optimization, Teams, Display Advertising, Biochemistry, Cell Biology, Life Sciences, Protein Expression, Consumables
Qualification
MBA
Customer Service Representative – Production at Thermo Fisher Scientific
Georgia, Georgia, USA - Full Time
Skills Needed
Good Communication Skills
Qualification
Graduate
Sr. Finance Manager, FP&A at Thermo Fisher Scientific
West Hills, CA 91304, USA - Full Time
Skills Needed
Finance, Powerpoint, Forecasting, Sql, Reporting Tool, Budgeting, Communication Skills, Modeling, Excel
Specialization
Accounting, Finance
Qualification
MBA
Experience Required
Minimum 5 year(s)
Packaging/Labeling Technician II - 12hr Day Shift at Thermo Fisher Scientific
Greenville, NC 27834, USA - Full Time
Skills Needed
Perspectives, Sap, High Quality Standards, Communication Skills, Packaging
Qualification
Graduate
Supervisor, Formulation Manufacturing at Thermo Fisher Scientific
Pleasanton, CA 94566, USA - Full Time
Skills Needed
Root
Qualification
Graduate
Experience Required
Minimum 3 year(s)
HR Manager at Thermo Fisher Scientific
St. Louis, MO 63134, USA - Full Time
Skills Needed
Employee Relations, Management Skills, Color, Disabilities, Candor, Presentation Skills, Communication Skills, Communications, Personal Development
Specialization
Human resources business administration or a related field
Qualification
Graduate
Experience Required
Minimum 5 year(s)
Scientist I, Cell Biology (Grand Island, NY) at Thermo Fisher Scientific
Grand Island, NY 14072, USA - Full Time
Skills Needed
Biology, Biochemistry, Communication Skills, Bioengineering, Data Analysis
Specialization
Biology bioengineering biochemistry or related field or equivalent knowledge and experience
Qualification
Graduate
EHS Specialist III, Environmental Professional at Thermo Fisher Scientific
Florence, South Carolina, USA - Full Time
Skills Needed
Quality Improvement Tools, Suppliers, Color, Sc, Technical Writing, Disabilities, Outlook, Trade Associations, Contractors, Interpersonal Skills, Manufacturing Processes, Training, Iso Standards, Windows, Customer Service, Analytical Skills, Access, Excel
Specialization
Quality improvement tools and a passion for customer service
Qualification
Graduate
Experience Required
Minimum 3 year(s)
Regulatory Affairs Specialist II, Dangerous Goods Transportation at Thermo Fisher Scientific
Dallas, TX 75243, USA - Full Time
Skills Needed
Iata, Interpersonal Skills, Material Handling, Transportation, Project Management Skills, Management Software
Qualification
Graduate
Experience Required
Minimum 5 year(s)
DNA Technician at Thermo Fisher Scientific
Paisley PA4 9RE, , United Kingdom - Full Time
Skills Needed
Chemistry, Biology
Qualification
Graduate
Experience Required
Minimum 1 year(s)
Systems Administrator (Linux) at Thermo Fisher Scientific
Morrisville, NC 27560, USA - Full Time
Skills Needed
Red Hat Enterprise Linux, Troubleshooting, Backup, Technical Requirements, Active Directory, Virtualization, High Level Design, Python, Devops, Data Center Infrastructure, Operating Systems, English, Powershell, System Administration, Storage
Qualification
Graduate
Operator II, Manufacturing - 12hr Day Shift at Thermo Fisher Scientific
Greenville, NC 27834, USA - Full Time
Skills Needed
Oral Communication, Documentation Practices, Motion, Color
Qualification
Diploma
Experience Required
Minimum 1 year(s)
Proposal Manager- (Evidera) - US, Central /East Coast Region at Thermo Fisher Scientific
Washington, District of Columbia, USA - Full Time
Skills Needed
Writing, Communication Skills, Time Management, Drug Development, Life Sciences, Scientific Writing
Qualification
Graduate
Experience Required
Minimum 6 year(s)
Operator II, Manufacturing at Thermo Fisher Scientific
5048 Tilburg, , Netherlands - Full Time
Skills Needed
Gmp, Food Industry, Gloves, Writing, Stairs, Risk, Injury
Qualification
Graduate
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