Senior Scientist - Quality Control Lab
Senior Scientist - Quality Control Lab
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Job Description
Work Schedule
First Shift (Days)Environmental Conditions
Adherence to all Good Manufacturing Practices (GMP) Safety StandardsJob Description
At Thermo Fisher Scientific youll 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 lifechanging 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 Fishers 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 fulltime benefits.
Key responsibilities:
- Perform laboratory activities to meet commitments ontime
- Perform inprocess 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 crossfunctional working teams or working with outside vendors to meet all laboratory needs
Education and Experience:
- Bachelors 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 nontraditional 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 Covid19 vaccine and you must disclose proof of your vaccination status upon employment.
Required Experience:
Senior IC
Employment Type
Full-Time
