Senior Scientist – Quality Control
Thermo Fisher
Summary
Bachelor's 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.
Job description
Key Responsibilities
- Perform in-process, release, and stability testing and/or review independently following established methodology, procedures and SOPs
- Maintain accurate testing records and adhere to cGMP/GDP expectations
- May participate in executing method validations and/or method transfers
- Assist in troubleshooting of analytical methods with the assistance of manager when necessary
- May participate in author and review of data, SOPs, analytical methods, protocols and reports
- May participate in compliance related teams working towards the goal of continuous improvement
- Report OOT/OOS results and other deviations to area management
- Perform other laboratory duties as assigned
Education and Experience
Bachelor's 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
- Understands cGMP concepts and general practices - MUST HAVE
- Knowledge of various complex laboratory equipment including HPLC, GC, KF, dissolution, TOC, UV, IR, pH meter, and balance
- Knowledge and experience in chromatography, dissolution, and Karl Fisher
- Strong attention to detail
- Demonstrate good communication skills both oral and written
- A minimum of a Bachelor Degree in science or related discipline is required
- Typically requires 4 years of experience in GMP pharmaceutical/biopharmaceutical industry
Working 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
Requirements
- Bachelor's degree in lab sciences such as Chemistry, Biochemistry, Material Science, Immunology, Biology, Molecular Biology or similar
- Previous experience comparable to 4+ years OR Masters degree with 2+ years OR PhD
- Understands cGMP concepts and general practices
- Knowledge of complex laboratory equipment including HPLC, GC, KF, dissolution, TOC, UV, IR, pH meter, and balance
- Knowledge and experience in chromatography, dissolution, and Karl Fisher
- Strong attention to detail
- Good communication skills both oral and written
- Typically requires 4 years of experience in GMP pharmaceutical/biopharmaceutical industry
- Must be legally authorized to work in the United States without sponsorship
- Must be able to pass a comprehensive background check, including drug screening
Benefits
- Medical, Dental & Vision
- Health Incentive Programs
- Employee Assistance Program
- Family Support Programs
- Commuter Benefits
- Tuition Reimbursement
- Paid Time Off
- Paid Holidays
- Paid Parental Leave
- Accident Insurance
- Life Insurance
- Short & Long-Term Disability
- 401(k) Matching
- Employee Stock Purchase Plan
Company overview
Thermo Fisher Scientific is a global leader in serving science, with annual revenue of approximately $40 billion. The company provides a comprehensive portfolio of analytical instruments, equipment, reagents and consumables, software, and services for research, analysis, discovery, and diagnostics. Their mission is to enable customers to make the world healthier, cleaner, and safer by accelerating life sciences research, solving complex analytical challenges, improving patient diagnostics and therapies, and increasing laboratory productivity. Thermo Fisher serves pharmaceutical and biotech companies, hospitals and clinical diagnostic labs, universities, research institutions, and government agencies worldwide. The company operates through four business segments: Life Sciences Solutions, Analytical Instruments, Specialty Diagnostics, and Laboratory Products and Services.