Thermo Fisher Scientific Jobs

Job Description

Position Overview

Investigates, creates, and validates new scientific methodologies used to control raw materials, production intermediates, and final products on highly unique and complex projects. May be involved in pre-clinical, clinical, and/or post-marketing stages of drug development. Works on significant technical/scientific project activities to execute strategies and technical solutions that meet client needs and expectations through broad expertise. Participates in technical discussions with clients with a high level of technical proficiency. Engages in creation of processes and equipment design for clinical, scale up, and/or registration batches, including technology transfer of projects to and from clients. Evaluates and contributes to the design of manufacturing processes and supports problem solving as necessary with leadership and independent judgement. Typically works in a specific scientific area, such as process validation, formulations, and/or manufacturing technical support. Makes decisions that frequently require developing new options to solve complex problems.

Key Responsabilities

• Lead multiple complex validation activities associated with computers, equipment, process, and product transfer.

• Develop and implement validation plans and associated documentation in the NDA drug approval process under the FDA Pre-Approval Inspection programs.

• Coordinate validation associated audit activities; establish rationales and technical defense positions.

• Negotiate with clients the validation requirements for projects. Resolve significant validation, product and regulatory issues. Plan and establish technical communications, document flow, testing requirements, and resources vital to complete the validation of a system.

• Support systems and new product introduction by serving as a technical resource, providing technical expertise, problem solving, and strategies for problem prevention.

• Participate as the validation representative in project team activities and process design to insure CGMP compliance and interdepartmental consistency within the validation program.

• Assure compliance to all applicable regulations by proactively interpreting regulatory and compliance requirements as related to validation.

• Maintain current knowledge and serve as a technical resource for emerging trends and technologies.

• Coordinate and provide training and/or opportunities for career development of others.

• Coordinates the implementation of interdepartmental process validation programs.

• Performs validation functions to ensure accurate and timely completion with frequent decision making, coordination and communications required.

• Builds, reviews, approves, tracks and presents documents and procedures required for compliance with pharmaceutical regulations.

• Identifies areas of non-compliance, review recommendations of others and implement solutions to resolve major quality and productivity issues.

Qualifications

Bachelor’s of Science in Chemistry, Biochemistry, Biology, or related physical science. PhD preferred.

Typically requires 12 years of progressive scientific experience, including 9 years in a related life sciences field. If related Master's degree, typically requires 10 years of related experience. If related PhD, typically requires 6 experience. Experience working directly with clients.

Advanced knowledge of principles, concepts, and practices of various aspects of a specific discipline and growing knowledge of principles and concepts in other relevant disciplines. Expert knowledge of scientific methodology and development as related to the pharmaceutical industry. Thorough knowledge of Good Manufacturing Practices. Strong proficiency in Microsoft Office Suite (Word, Excel, and PowerPoint). Superior critical and logical thinking skills. Effective written, interpersonal, and presentation skills, including managing technical discussions with internal and external clients. Ability to lead multiple projects simultaneously. Ability to develop knowledge and skills in pharmaceutical processes, equipment, instrumentation, and procedures. Ability to maintain expert knowledge and to keep current with scientific literature and industry trends relating to process technologies. Ability to develop technical solutions.

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.