Research Scientist Position
Our team is seeking a skilled Research Scientist to join our Biopharmaceutical Laboratory. As a key member of our team, you will be responsible for the regulatory and scientific conduct of development and stability projects.
Key Responsibilities:
* Perform analytical testing, method optimization/validation, and/or other specialty technologies studies or method transfers for pharmaceutical and biopharmaceutical compounds in various formulations and delivery systems.
* Review and critique study protocols, project status reports, final study reports, and other project-related technical documents.
* Prepare and review study protocols, project status reports, final study reports, and other project-related technical documents.
* Communicate data and technical issues to clients on a weekly basis (or as needed).
* Provide technical mentorship and training to staff.
* Lead analytical troubleshooting sessions.
* Assist in preparation and implementation of SOPs and quality systems.
* Review, interpret, and analyze data for technical, quality, and compliance to protocols, methods, SOPs, client criteria, and Good Manufacturing Practices (GMP).
Requirements:
* Master's degree or equivalent in Chemistry or Biochemistry.
* Prior experience that provides the knowledge, skills, and abilities to perform the job (comparable to 5+ years).
* Knowledge of general chemistry, biochemistry techniques (Western Blot, total protein by BCA or micro BCA assay, ELISA, HPLC/UPLC).
* Proven experience of method development of identity and purity assays by Western Blot.
* Ideal experience in leading CMC studies for biopharmaceutical products including method validation.
* Proficiency on technical operating systems (including Image Lab software).
* Proven problem-solving and troubleshooting abilities.
* Ability to independently perform root cause analysis for method investigations.
* Proven ability in technical writing skills.
* Time management and project management skills.
* Good written and oral communication skills.
* Ability to work in a collaborative work environment with a team.
* Ability to train junior staff.
Work Environment:
* 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 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.
* We support and encourage individuals to create a healthy and balanced environment where they can thrive.
* Thermo Fisher Scientific values the health and wellbeing of our employees.