Senior Scientist - Stability Testing GMP
Senior Scientist - Stability Testing GMP
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Job Description
Work Schedule
Standard (MonFri)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.
Reporting to the Associate Director CMC QC Stability will be responsible for managing routine operations of the cell banks critical intermediates Drug Substance and Drug Product for clinical GMP stability programs of cell and genetic therapies while ensuring compliance with SOPs internal policies and industry guidance. In addition this role will be responsible for supporting various GMP stability testing programs and Quality Systems including handling stability Quality Events performing stability testing delivering stability documents and coordinating with external resources (CTOs CMOs etc..
Key responsibilities:
- Draft and revises stability protocols and reports from initiation to finalization
- Creates and maintains stability schedules for GMP clinical stability studies ensuring stability samples get pulled within appropriate timeline
- Coordinate with external testing labs to retrieve stability testing data and timepoint reports
- Initiate document and address stability quality events including change controls deviations and analytical investigations as required
- Update stability related GMP documents (specifications JoS memos etc.
- Performs initiation and management of stability studies in LIMS and performs data entry and review as required.
- Support continuous improvement activities for VCGT stability program
- Provide support to applicable stability sections of regulatory submissions
- Present stability program updates to the crossfunctional group as needed
- Perform stability data trending as needed
- Periodically review and update stability SOPs
Education and Experience:
- Bachelors degree in lab sciences such as Chemistry Biochemistry Pharmaceutical Science Immunology Biology Molecular Biology or similar
- Previous experience that provides the knowledge skills and abilities to perform the job (comparable to 4 years)
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:
- Past experience with Quality Control preferably with focus on stability
- Good understanding of cGMP GDP and GLP regulations and guidelines
- Knowledge of clinical and commercial QC stability regulations (FDA EMA ICH)
- General experience in data analysis and statistical evaluation/data trending
- Ability to interact effectively within the organization and externally with CTOs and CMOs
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.
Benefits
We offer competitive remuneration annual incentive plan bonus healthcare and a range of employee benefits. Thermo Fisher Scientific offers employment with an innovative forwardthinking organization and outstanding career and development prospects. We offer an exciting company culture that stands for integrity intensity involvement and innovation!
Required Experience:
Director
Employment Type
Full-Time
