FSP - Scientist - Prod Dev - Late Stage
FSP - Scientist - Prod Dev - Late Stage
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Job 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 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.
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.
We are seeking a highly motivated analytical scientist to join our Late-Stage Product Development team. This role will support analytical testing and method development for a diverse portfolio of therapeutic modalities including AAV gene therapies antibodies peptides and small molecule pharmaceuticals. The successful candidate will perform physicochemical characterization and stability testing using state-of-the-art analytical instrumentation and techniques. This position offers exposure to multiple analytical platforms used in characterizing protein higher-order structure peptide purity and identity and small molecule pharmaceutical analysis.
Key areas of focus include:
- Preparation of solvents standards buffers and other solutions with proper weighing record-keeping and adherence of safety protocols
- Operate and maintain laboratory instrumentation and equipment and facilitate service with technicians as needed
- Collaborate and assist other lab scientists in preparing samples and performing other lab support tasks
- Maintain laboratory equipment perform calibrations/ verifications prepare mobile phases and reagents as needed.
- Create and manage documentation for study planning and organization maintain a laboratory notebook laboratory inventory and instrument maintenance schedules.
- Assemble and maintain documentation of data to allow efficient retrieval of results
- Performs other duties as assigned.
Key responsibilities:
- Preparation of solvents standards buffers and other solutions with proper weighing record-keeping and adherence of safety protocols
- Operate and maintain laboratory instrumentation and equipment and facilitate service with technicians as needed
- Collaborate and assist other lab scientists in preparing samples and performing other lab support tasks
- Maintain laboratory equipment perform calibrations/ verifications prepare mobile phases and reagents as needed.
- Create and manage documentation for study planning and organization maintain a laboratory notebook laboratory inventory and instrument maintenance schedules.
- Assemble and maintain documentation of data to allow efficient retrieval of results
- Performs other duties as assigned.
Education and Experience:
- Bachelors degree in lab sciences such as Biology Chemistry Chemical Engineering Material Science or similar
- Previous experience that provides the knowledge skills and abilities to perform the job (comparable to 2 years)
- OR Masters degree
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:
- Familiarity of physicochemical & analytical techniques as they pertain to biopharmaceutical properties for multiple modalities.
- Ability to learn quickly and think independently.
- Familiarity with the development and execution of chemical and instrumental methods (e.g. HPLC UV-Vis DLS cIEF ceSDS subvisible particulate matter osmolality pH ddPCR) of analyses for development compounds drug substances raw materials intermediates drug products and packaging materials.
- Some knowledge of a cGMP-regulated environment including familiarity of relevant US/EU regulatory and quality requirements standards and practices.
- Knowledge of pharmacopeial methods and requirements
- Familiarity with biotech/pharma product and process development
- Able to execute experiments efficiently and suggest small process improvements
- Able to recognize patterns or inconsistencies in data results
- Able to deduce meaningful results while conducting routine analyses or troubleshoot minor issues.
- Good knowledge of one scientific discipline
- Developing knowledge of scientific principles methods and techniques
- Good knowledge and some experience working with discipline specific laboratory equipment/tools
- Ability to work as part of a team
- Good computer skills
- Developing communications problem-solving analytical thinking planning and organization skills
- Detail oriented
- Understands the importance of meeting deadlines
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.
Benefits
We offer competitive remuneration annual incentive plan bonus healthcare and a range of employee benefits. Thermo Fisher Scientific offers employment with an innovative forward-thinking organization and outstanding career and development prospects. We offer an exciting company culture that stands for integrity intensity involvement and innovation!
Compensation and Benefits
The hourly pay range estimated for this position Specialist II Clinical Lab Scientist based inCalifornia is .This position may also be eligible to receive a variable annual bonus based on company team and/or individual performance results in accordance with company policy. We offer a comprehensive Total Rewards package that our U.S. colleagues and their families can count on which includes:
A choice of national medical and dental plans and a national vision plan including health incentive programs
Employee assistance and family support programs including commuter benefits and tuition reimbursement
At least 120 hours paid time off (PTO) 10 paid holidays annually paid parental leave (3 weeks for bonding and 8 weeks for caregiver leave) accident and life insurance and short- and long-term disability in accordance with company policy
Retirement and savings programs such as our competitive 401(k) U.S. retirement savings plan
Employees Stock Purchase Plan (ESPP) offers eligible colleagues the opportunity to purchase company stock at a discount
Employment Type
Full-Time
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