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Work Schedule
Standard (Mon-Fri)Environmental Conditions
Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Laboratory Setting, Office, Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.)Job Description
Scientist II, Manufacturing Sciences (12 month FTC)
The Scientist II is part of the Technical Operations team within the Genetic Sciences Division (GSD), with specific focus on the Pharma Analytics portfolio supporting the BioProduction Group (BPG).
This primary responsibility of this role will be to support stability studies for ongoing validation projects within the team. The Scientist II will also contribute to technical investigations, product quality, and continuous improvement initiatives to support manufacturing performance. Working in collaboration with cross-functional teams, the role supports the resolution of escalations and delivers data-driven insights to improve quality, reliability, and productivity, while developing technical expertise and increasing ownership over time, to ensure the highest quality standards for our biopharmaceutical customers' therapeutic products.
Responsibilities:
Lead product and component stability programs in line with defined specifications.
Support technical investigations and lead validation activities across the product portfolio, ensuring alignment with quality and regulatory standards.
Contribute to the management and resolution of escalations, including non-conforming product and customer complaint investigations, using structured problem-solving and analytical tools.
Lead root cause analysis for out-of-specification (OOS) and out-of-trend (OOT) results, supporting the implementation of effective corrective actions.
Collaborate with manufacturing teams to support driving continuous improvement initiatives using PPI and other problem-solving methodologies.
Apply developing business and operational understanding to support post-market and manufacturing activities.
Analyse and trend product performance data to identify potential risks and improvement opportunities.
Build technical knowledge to support problem-solving and contribute to team decision-making.
Plan and prioritise assigned workload effectively, with guidance where needed.
Contribute to a collaborative team environment and support knowledge sharing across the group.
Support achievement of key performance indicators and continuous improvement objectives. Plan and prioritise workload effectively, including use of Agile or similar frameworks where appropriate.
Mentor, coach, and support development of team members, fostering a collaborative and high-performance team environment.
Education & Experience
Bachelor of Science (BSc) in Chemistry, Biochemistry, Molecular Biology, or a related field (or equivalent experience).
Typically 2+ years of relevant laboratory or industry experience, preferably within pharmaceutical, biotechnology, healthcare, or regulated environments.
Experience working within ISO 9001, ISO 13485, and/or GMP frameworks.
Experience within Technical Operations, Manufacturing, or Quality Control environments preferred.
Hands-on experience in DNA detection tools, workflows, and chemistries such as genetic sequencing, capillary electrophoresis (CE), qPCR or sample preparation.
Expertise in analytical techniques and laboratory instrumentation (HPLC, spectroscopy, etc.) preferred.
Good understanding of laboratory instrumentation and data quality principles.
Key Skills & Competencies
Developing analytical thinking and problem-solving skills.
Strong attention to detail and commitment to quality.
Ability to manage multiple tasks in a fast-paced, matrixed environment.
Collaborative mindset and willingness to learn from others.
Adaptable and open to organisational change.
Good written and verbal communication skills.
Proficiency in MS Office and standard data analysis tools.
At Thermo Fisher Scientific, each one of our extraordinary minds has a unique story to tell. Join us and contribute to our singular mission—enabling our customers to make the world healthier, cleaner, and safer!
