Manufacturing & Quality Scientist

6 months ago

Christchurch, New Zealand Thermo Fisher Scientific Full time

At Thermo Fisher Scientific, each one of our 100,000 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.

When you are part of the team at Thermo Fisher Scientific, you will do important work. Surrounded by collaborative colleagues, you will have the support and opportunities that only a global leader can give you. Our respected, growing organization has an outstanding strategy for the near term and beyond. Take your place on our dedicated team and help us make significant contributions to the world.

**How you will make an impact**:
You will be part of a friendly and dynamic team that supports our customers in the development of life changing drugs & vaccines, responsible for supporting both the Quality and Manufacturing departments from a technical aspect as well as performing Validation, Process Improvement and New Product Development work.

**Key Responsibilities**:

- Act as a Subject Matter Expert (SME) related to the technical aspects and scientific principles of analytical assays and manufacturing processes.
- Support the Quality department with technical expertise in Quality Control (QC) assays; conduct assay development, improvement, validation and troubleshooting as well as training staff and performing routine testing as required.
- Support the maintenance, calibration and system suitability of HPLC and other laboratory equipment.
- Work alongside the Manufacturing department with process knowledge, troubleshooting, process improvements and data evaluation. Support customer enquiries for new products and processes and conduct laboratory development work as required.
- Act as an SME on customer inquiries, complaints and audit observations.
- Complete Equipment, Assay and Process Validations.
- Perform other related duties as required to contribute to the efficient operation of the business.

**Compliance / Documentation**
- Adhere to all EHS policies, wear required PPE, report all incidents and near misses and pro-actively identify hazards in the workplace.
- Ensure that all tasks are performed safely following established processes, Standard Operating Procedures (SOPs) and align with applicable Good Manufacturing Practice (cGMP) principles.
- Participate in the writing and implementation of SOPs and Validation documents. Maintain laboratory notebooks, prepare technical reports of your work and write customer-facing technical documents as required.

**Working Conditions**:

- Work in several locations including QC Laboratories and Manufacturing areas.
- Work safely with chemicals and hazardous materials. Limited work in walk-in freezers and chillers required.
- Some overtime may be required and flexibility around hours of work preferred.

**How will you get here?**

**Experience/Qualifications**:

- Proven experience of laboratory or QC assays, especially HPLC and protein biochemistry techniques.
- Experience of independent research and/or process development in either an academic or industrial setting.
- Experience with using laboratory equipment software, Microsoft Excel, Word and PowerPoint. Experience of statistical software preferred but not required.
- Understanding of cGMP and ISO Quality Systems.

**Skills & Attributes**
- Exhibit a safety conscious, responsible and professional approach to all activities.
- Ability to work independently and make decisions regarding your work with mínimal direction.
- Contribute positively as a team member and work with other departments, including from other Thermo Fisher Scientific sites.
- Attention to detail and accuracy in all work practices.
- Strong verbal and written communication skills.
- Be proactive and display a solutions-based and right-first time focus.
- Impart knowledge, motivate and develop others with whom you are working.

**Other Job Requirements**:
All other reasonable tasks as required by the Technical Development Manager

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.

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