How will you make an impact?

The PDS Analytical Development & GMP Scientist is a joining link between Analysts and Team Leader/Supervisor, working with clients and handling the laboratory activities.

What will you do?

• Ensures both the execution and constant supervision of analytical laboratory activities for projects assigned in accordance with GMP requirements, supporting analysts in problems solving for analytical activities relating to API / DS and finished products (Release and Stability)

• Draws up analytical specifications, study protocols and reports, analytical methods and SOPs in compliance with current regulations (current EU GMP, US GMP) and company quality standards.

• Coordinates the customer's management with the aim of maintaining a high level of customer happiness and completing the required activities on schedule.

• Participates in calls/meetings with customers to support the discussion on technical topics for their area of expertise.

• Identifies the requirements for analytical technology transfer from customers, then ensuring the accurate and effective transfer to the laboratories

• Handles laboratory investigations (Out of Specification and Deviation Reports)

How will you get here?

Education

Degree in CTF, Chemistry, Biology or other similar fields

Diploma Chemical/Laboratory technician certificate

Experience

• Experience in pharmaceutical industries

• Multi-year experience in Quality Control

Knowledge, Skills, Abilities

• Knowledge of the main techniques of chemical-physical and biochemical analysis and validation of analytical methods

• Knowledge of GMP and national/international regulations

• Good problem-solving abilities

• Proficiency in Microsoft Office suite and both analytical and statistical software (Empower, MiniTab, Sample Manager)

• Be prepared to work with conflicting priorities and under time constraints.

Thermo Fisher Scientific Inc. is the world leader in serving science, with annual revenue of approximately $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 analytical challenges, growing efficiency in their laboratories, improving patient health through diagnostics or the development and manufacture of life-changing therapies, we are here to support them. Our distributed team delivers an outstanding 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.

Thermo Fisher Scientific is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, creed, religion, color, national or ethnic origin, citizenship, sex, sexual orientation, gender identity and expression, genetic information, veteran status, age or disability status.