Sr. Scientist – Quality Compliance Change Control

Work Schedule

Environmental Conditions

Job Description

FSP Sr. Scientist Quality Compliance / Change Control

Shift: Full-Time; Monday Friday; 8am-5pm EST

ONSITE:

This is a fully onsite role based at our customers site in (Boston MA). We welcome applicants from all locations within the US. Please note that relocation assistance is not provided for this position and any relocation costs will be the responsibility of the candidate.

Must be legally authorized to work in the United States withoutsponsorship.

Must be able to pass a comprehensive background check whichincludes a drug screening.

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.

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.

Our Laboratories Functional Service Partnership (FSP) team plays a direct role in advancing drug development by creating sustained groups of talent within our customers organizations to provide long-term support. Through this collaborative approach our professionals bring their commitment to excellence industry knowledge and operational strength directly into customer environments helping to enhance capabilities and advance the delivery of life-changing therapies.

Key responsibilities:

• Be the Analytical Development (AD) point of contact for change controls. Responsibilities include but not limited to: participate in change control review evaluate impact to AD and collaborate with SMEs for joint assessment initiate track and close change control record
• Support internal audit programs to ensure compliance and pre-approval inspection readiness
• Assist in the revision of governance SOPs for AD including but not limited to Method Validation and Method Transfer Establishing Specification
• Review analytical data. Perform data verification to ensure accuracy and completeness of information presented in analytical documents and regulatory filings (IND/BLA)
• Propose and implement ways to ensure and improve timely closure of change control investigation CAPA ELN and completion of trainings
• Support other analytical development activities as needed

Education and Experience:

• Bachelors 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:

• Relevant Analytical Development Quality Control or Quality Assurance experience is required
• Attention to detail and follow up with collaborators to ensure timely completion of assignment
• Ability to communicate to a wide variety of audiences exchanges complex and sensitive information and gain alignment around a proposed action
• Ability to prioritize objectives from multiple projects and adhere to scheduled timelines while maintaining flexibility and efficiency
• Excellent technical writing skills are essential
• Knowledge of relevant ICH and regulatory guidelines and good understanding of GMP concept
• Hands-on experience and In-depth knowledge of change control deviations CAPA and investigation
• Experience in biologics gene and cell therapy is desirable

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

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

For more information on our benefits please visit: Experience:

Senior IC