Senior Scientist - Quality Control Lab

Work Schedule

Environmental Conditions

Job Description

At Thermo Fisher Scientific, you’ll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life - enabling our customers to make the world healthier, cleaner and safer. We provide our teams with the resources needed to achieve individual career goals while taking science a step beyond through research, development and delivery of life-changing therapies. With clinical trials conducted in 100+ countries and ongoing development of novel frameworks for clinical research through our PPD clinical research portfolio, our work spans laboratory, digital and decentralized clinical trial services. Your determination to deliver quality and accuracy will improve health outcomes that people and communities depend on – now and in the future.

Thermo Fisher's clinical research business is a leading global contract research organization and world leader in serving science. We are passionate, deliberate, and driven by our mission – to enable our customers to make the world healthier, safer, and cleaner.

Within our Analytical Services team, we have a functional service provider solution, which is a unique partnership that allows our customers to leverage the experience of our staff, while allowing you, the employee, to gain direct experience working onsite at a pharmaceutical/ biopharmaceutical company, all while maintaining full-time benefits.

Key responsibilities:

• Perform laboratory activities to meet commitments on-time
• Perform in-process, release, and stability testing following established methodology, procedures and SOPs
• Maintain accurate testing records and adhere to cGMP/GDP expectations
• Participate in planning, executing, or reviewing method validations and/or method transfers
• Troubleshoot analytical methods when necessary
• May lead OOT/OOS investigations, deviations, and identify corrective actions to prevent reoccurrence.
• Perform other laboratory duties as assigned
• Authors, reviews and approves data, SOPs, analytical methods, protocols and reports
• Participates in compliance related teams working towards the goal of continuous improvement
• Serve as CQC representative in cross-functional working teams or working with outside vendors to meet all laboratory needs

Education and Experience:

• Bachelor's degree in lab sciences such as Chemistry, Biochemistry, Material Science, Immunology, Biology, Molecular Biology or similar
• Sr. Scientist: Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 4+ years’)
• OR Masters degree and previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 2+ years’)
• OR PhD

In some cases, an equivalency, consisting of a combination of appropriate education, training and/or directly related experience, will be considered sufficient for an individual to meet the requirements of the role.

Knowledge, Skills and Abilities:

• Strong knowledge of cGMP in a pharmaceutical setting
• Strong knowledge in analytical techniques in a QC/commercial setting (e.g. HPLC, dissolution, GC, KF, etc.), including method validation/transfer
• Experience with both drug substance and drug product (oral solid dosage forms) testing
• Attention to detail
• Effective communication skills, both verbal and written

Working Environment:

Below is listed the working environment/requirements for this role:

Able to communicate, receive, and understand information and ideas with diverse groups of people in a comprehensible and reasonable manner.

Able to work upright and stationary and/or standing for typical working hours.

Able to lift and move objects up to 25 pounds

Able to work in non-traditional work environments.

Able to use and learn standard office equipment and technology with

proficiency.

May have exposure to potentially hazardous elements, including infectious agents, typically found in healthcare or laboratory environments.

Able to perform successfully under pressure while prioritizing and handling multiple projects or activities.

As a condition of employment with Thermo Fisher/PPD, in this role, you must have received your Covid-19 vaccine and you must disclose proof of your vaccination status upon employment.