Work Schedule
Standard (Mon-Fri)
Environmental Conditions
Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Office, Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.), Strong Odors (chemical, lubricants, biological products etc.), Will work with hazardous/toxic materials
Job Description
Uncover an outstanding opportunity as an Associate Research Scientist (Technical Lead) in Biopharma with Thermo Fisher Scientific Inc. This role offers the chance to be part of an exceptionally innovative team dedicated to making a world-class impact on global health. Your ambition and proven expertise will flourish in our collaborative and inclusive environment, empowering you to successfully implement groundbreaking solutions.
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Job Responsibilities
- Independently perform analytical testing, method optimization/validation, and other specialist technology studies or method transfers for pharmaceutical and biopharmaceutical compounds across various formulations and delivery systems.
- Review and critique study protocols, project status reports, final study reports, and other 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, both procedural and instrumental.
- Assist in the preparation and implementation of SOPs and quality systems.
- Review, interpret, and analyze data for technical quality and compliance with protocols, methods, SOPs, client criteria, and Good Manufacturing Practices (GMP). Perform self and peer reviews of data for accuracy and compliance before submission to QA and issuance to customers.
Education and Experience
- Degree or equivalent in Chemistry or Biochemistry. In some cases, a combination of appropriate education, training, and directly related experience will be considered sufficient.
- Previous experience, comparable to 5+ years, that provides the knowledge, skills, and abilities to perform the job.
Knowledge, Skills, Abilities
- Knowledge of general chemistry and biochemistry techniques, including SDS-PAGE, Western Blot, total protein by BCA or micro BCA assay, and ELISA.
- Proven experience in method development of identity and purity assays.
- Ideally, experience in leading CMC studies for biopharmaceutical products, including method validation.
- Proficiency in technical operating systems, including Image Lab software.
- Proven problem-solving and troubleshooting abilities, with the ability to perform root cause analysis for method investigations.
- Strong technical writing skills.
- Effective time management and project management skills.
- Good written and oral communication skills.
- Ability to work in a collaborative environment and train junior staff.
Work Environment
Thermo Fisher Scientific values the health and wellbeing of our employees. We support and encourage individuals to build a healthy and balanced environment where they can thrive. The working environment for this role includes:
- Effective communication and understanding of diverse groups.
- Ability to work upright and stationary for typical working hours.
- Capability to lift and move objects up to 25 pounds.
- Adaptability to work in non-traditional environments.
- Proficiency with standard office equipment and technology.
- Potential exposure to hazardous elements, including infectious agents, typically found in healthcare or laboratory settings.
- Ability to successfully prioritize and manage multiple projects under pressure.