Scientist, Tech Ops

Role that this position reports to:

Stability Lead (Product specific)

· Positions report into this role:

None

· This position can be delegated to:

Stability Scientist

Main Responsibilities and Accountabilities

1

Conducting a variety of tasks associated with ongoing stability programs:

• Expertise in preparing protocols, compiling data, and generating detailed stability reports.

• Lead compilation, interpretation, and presentation of stability data.

• Perform advanced statistical analysis and data extrapolation to support decision-making.

• Train Stability Scientists in technical and knowledge-based aspects.

• Support lower-level regulatory requests and provide necessary documentation.

• Coordinate with QC Operations to ensure timely sample pulls, testing, and data entry into LIMS.

• Conduct risk-based assessments in collaboration with Principal Stability Scientist.

• Lead investigations into stability-related deviations and propose corrective actions.

• Ensure compliance with GMP, ICH guidelines, and internal standards.

• Skilled in using electronic systems (LIMS, Statistica) for data management.

Providing knowledge and understanding:

• High level of understanding of regulatory requirements and stability principles.

• Comprehensive knowledge of product stability profiles and key indicators.

• Ability to lead investigations and provide technical guidance.

• Good product knowledge and understanding of expected profiles

• Good knowledge of risk-based assessments and change control processes.

Working collaboratively:

• Deliver global stability activities and ensure timely execution.

• Coordinate with QC Operations to monitor progress of stability samples.

• Proactively identify and resolve issues impacting stability programs.

• Work effectively without constant supervision, demonstrating initiative and accountability

• Ability to support multiple projects and deliver objectives on time.

Education

• Science degree (e.g. Bachelor, Master, PhD) in pharmacy, pharmaceutical technology, biology, chemistry or comparable education.

Experience Required

• 3+ years’ experience in the pharmaceutical manufacturing industry with direct exposure to Stability program development and management

• Good technical understanding of product lifecycle management in a global biotech or pharmaceutical GMP environment

• Good grasp of current regulations and guidelines of stability monitoring of biopharmaceutical products

Other Essential Knowledge

• Fluency in English in both writing and oral communications

Competencies:

Knowledge/skill sharing: Provides training and technical guidance to junior scientists.

Strategic Thinking: Aligns stability activities with departmental objectives.

Analytical Skills: Applies advanced statistical methods for decision-making.

Impact and Engagement: Supports regulatory requests and cross-functional collaboration

Self-Management: Operates effectively with minimal supervision in a global environment.