Research Scientist - Gmp - Assay Validation

Job Description

Research Scientist (Boston, MA)

Thermo Fisher's 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.

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.

• GMP Experience is a MUST
• Strong technical writing, strong GMP documentation, strong understanding of Assay Validation under GMP compliance with regulatory requirements, late stage/commercial stage assay development and validation, life cycle management
• Change control, deviation, out of specification / out of trend investigation, root cause analysis
• Work independently or in collaboration with internal and/or external partners in analytical lifecycle activities including method development, validation, and method transfer
• Be a key Subject Matter Expertise (SME) and represent ASAT to participate in troubleshooting and OOS investigation occurred during release and/or stability testing
• Participate in internal and external meeting
• Author and/or review technical documents, including method SOP, study protocol and technical report
• Author and/or review regulatory filing/response
• NIce to have - Next-Generation Sequencing (NGS) / Microbiology background

At PPD, part of Thermo Fisher Scientific we hire the best, develop ourselves and each other, and recognize the power of being one team. We offer continued career advancement opportunities, award winning training and benefits focused on the health and wellbeing of our employees.

To learn how PPD, part of Thermo Fisher Scientific can advance your career, apply now!

• Bachelor's degree in Microbiology or Molecular Biology, Genetics or equivalent and relevant formal academic / vocational qualification
• Previous industry experience that provides the knowledge, skills, and abilities to perform the job:
• Research Scientist: With a bachelor’s degree comparable to 8+ years, with a master’s degree comparable to 6+ years, with a PhD comparable to 4+ years.

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.

• Experience with NGS is a highly preferred skill (e.g., Illumina, nanopore, next seq, nova seq, hi seq, SMRT sequencing, Sequel, HiFi sequencing etc.).
• Experience of using JMP or similar statistical tools is plus
• Hands-on experience and In-depth knowledge of in-vitro cell-based potency assays
• Experience in Gene and Cell therapy is desirable
• Knowledge of relevant ICH and regulatory guidelines and good understanding of GMP concept.
• Experience with analytical support for late-stage or commercial biological products and cGMP manufacturing
• Ability to prioritize objectives from multiple projects and adhere to scheduled timelines while maintaining flexibility and efficiency
• Partners effectively with internal and external functions

PPD, part of Thermo Fisher Scientific values the health and well-being of our employees. We support and encourage individuals to create a healthy and balanced environment where they can thrive. 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.

Integrity – Innovation – Intensity – Involvement

If you resonate with our 4i values above, and ultimately wish to accelerate the delivery of safe and effective therapeutics for some of the world’s most urgent health needs, submit your application – we’d love to hear from you!