Scientific Laboratory Leadership Position

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.

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

**Job Title: Senior QC Team Leader, Physiochemistry & Raw Materials**

**Reports to**: QC Operations Manager

**Group / Division**: PSG/DSD

**Career Band**: 05

**Job Family**: Operations

**Job Sub Family**: QC

**Job Code**: OPS.QCOP.P05

**Job Track**: Professional

**Position Location**: PSG Brisbane Australia

**Number of Direct Reports: 4**

**Position Summary**:

Our manufacturing process requires alignment with quality requirements set by regulatory agencies. To achieve compliance, we define, implement, and maintain quality systems. The Quality Control Laboratory is responsible for executing Qualification/Validation Protocols, Technical Transfer (as applicable), and performing Quality Control tests.

**Key Responsibilities:**

- Leading day-to-day management of the Quality Control Physiochemistry and Raw Materials team, including planning activities and resources, execution of analysis, reporting results, and key performance indicators
- Coaching, training, and supporting other team members.
- Ensuring compliance of facilities, raw materials, products, and systems with international quality requirements and customer-specific demands. Timely and scientifically sound output of the Quality Control Physiochemistry Laboratory, according to regulatory requirements and cGMP.

- Knowledge of equipment used for test records within the Physiochemistry laboratory (FTIR, RAMAN, TOC, pH, Osmolality, Conductivity, etc.). Coordinate Raw Material testing/release in accordance with relevant Pharmacopoeia (BP, EP, JP, USP, etc).

- Identifying, investigating, and closing non-conformances and OOS/UR on-time with high quality. Ensure compliance with cGMP and Data Integrity within the team.

- Responsible for lab equipment maintenance upgrades and improvements.

- Leading and assisting with PPI projects

- Performing any other legitimate duties as directed by the Operations Manager, QC (or delegate)

**Frequent Contacts**:

**Internal**

All Internal Departments including QC, QA, and Operations

**External**

Clients, Regulatory Agencies, Other Business units both within and external to the PSG, Equipment/Contract Laboratory/Maintenance vendors and contractors

**Required Skills and Qualifications:**

- Bachelor of Science (Biotechnology, Chemistry, or closely related degree). Background in analytical theory and technical competency with laboratory analysis. Knowledgeable with cGMP and various laboratory analyses, efficient sample workflows, in-process controls, analytical testing, and equipment maintenance/introduction.

- Ability to work on multiple projects simultaneously.

- Strong team-working and collaborative skills. Previous experience in leadership and personnel management-desirable

**Benefits:**

We strive to be a culture of engagement, accountability, and shared commitment to excellence. We deliver the best technical and scientific solutions to improve product value. Abide by all EH&S policies and procedures, operate our business in a safe, focused, responsible, and ethical fashion. Work safely and only perform tasks if currently competent and/or authorised, participate in EH&S activities such as; GEMBA walks, inspections, and risk assessments.

**Other Job Requirements:**

We are an Equal Employment Opportunity/Affirmative Action Employer and do 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.