The PDS Analytical Development & GMP Scientist serves as a liaison between Analysts and Team Leader/Supervisor, collaborating with clients and overseeing laboratory activities.
Key Responsibilities
* Evaluate and supervise analytical laboratory activities for assigned projects in compliance with Good Manufacturing Practices (GMP) requirements, providing support to analysts on problem-solving tasks related to Active Pharmaceutical Ingredients (API)/Dosage Forms (DS) and finished products (Release and Stability).
* Develop analytical specifications, study protocols, reports, methods, and Standard Operating Procedures (SOPs) in accordance with current regulations (EU GMP and US GMP) and company quality standards.
* Coordinate customer management to maintain high customer satisfaction and meet project deadlines.
* Participate in client calls/meetings to discuss technical topics relevant to the role's area of expertise.
* Identify customer requirements for analytical technology transfer and ensure accurate and effective transfer to laboratories.
* Handle laboratory investigations (Out of Specification and Deviation Reports).
Requirements
* Degree in Chemistry, Technology, or a related field.
* Diploma in Chemical/Laboratory Technician certificate.
* Experience in pharmaceutical industries.
* Mult-year experience in Quality Control.
* Knowledge of main chemical-physical and biochemical analysis techniques and validation of analytical methods.
* Awareness of GMP and national/international regulations.
* Strong problem-solving abilities.
* Proficiency in Microsoft Office suite and analytical/statistical software (Empower, MiniTab, Sample Manager).
* Ability to work under time constraints and conflicting priorities.
About Us
Thermo Fisher Scientific is a world leader in serving science, with annual revenue exceeding $40 billion. Our mission is to enable our customers to improve global health, cleanliness, and safety. We support life sciences research, solve analytical challenges, grow efficiency in laboratories, improve patient health through diagnostics, or develop and manufacture life-changing therapies.
We are an Equal Opportunity Employer, considering all qualified applicants 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.