Job Description

Scientist - Technical Writing (Devens, MA OR New Brunswick, NJ OR Summit, NJ)

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.

Within this role you would be on the analytical team that plays a supporting role for biopharmaceutical products’ lifecycle activities. The team focuses on support for commercialized and late-stage products with a focus on establishing the analytical CMC strategy, enabling regulatory filings, providing technical partnership for quality control laboratories around the world, managing the life cycle of specifications (methods and acceptance criteria), and authoring/reviewing responses to health authority questions on commercial products.

This role is 100% desk /office based (non-lab).

Essential Functions:

• The Associate Scientist will collaborate with different sites for analytical development, global quality product leads, technical project teams, and regulatory leads to generate and complete the pre- and commercial strategies for drug substance and drug product methods and specifications, network analytical control strategies, and support of life cycle regulatory filings. Through strong leadership, the Associate Scientist will ensure the support of analytical methods and analytical change control across the network, for third party manufacturing and our partners at outside testing labs. The Associate Scientist is responsible for data gathering, interpretation and presentation to support decision making and product analytical strategies.
• Create and maintain effective partnerships with collaborators from analytical development, manufacturing sciences and technology, Supply Chain, Regulatory, Quality, Process Sciences, Drug Product Development, Project Management, and Manufacturing to deliver analytical strategies with a high probability of technical and regulatory success, as necessary.
• Manage and coordinate analytical activities for late-stage and commercial programs.
• Effectively supports team matrix for analytical topics during all BLAs, ROW & PAS filing review and works with analytical development in supporting the responses to FUMs and PMCs.
• Participates on the implementation of effective control strategy, analytical method and specification change control as needed throughout the network, third party manufacturing and outside testing labs.
• Serves as subject matter expert for project for activities, including technical evaluations of methods and data.

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!

Education and Experience:

• Bachelor's degree in a scientific field (Biology, Biochemistry, Chemistry, etc.) or equivalent and relevant formal academic / vocational qualification
• Previous industry experience that provides the knowledge, skills, and abilities to perform the job:
  • Associate Scientist: With a bachelor’s degree comparable to 0-2+ years.
  • Scientist: With a bachelor’s degree comparable to 2+ years, with a master’s degree comparable to 0-2+ 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.

Knowledge, Skills, and Abilities:

• Proven ability in technical writing skills
• Knowledge in analytical methodologies used for the development and commercialization of biologics.
• Demonstrates a broad expertise and experiences in analytics routinely used for in-process, release and stability testing of Biologics or Protein Therapeutics drug substance and drug product.
• Working knowledge of biologics CMC regulations and cGMP requirements, as well as experience in supporting regulatory filings.
• Demonstrated skills working in cross-functional strategic teams and collaboration with internal and external partners.
• Strong decision-making skills
• Proficient in Microsoft Excel and Word
• Proven problem solving and troubleshooting abilities.
• Strong written and oral communication skills and leadership skills in a highly interactive environment
• Time management and project management skills
• Ability to work in a collaborative work environment with a team.

Working Environment:

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.
• As a condition of employment with PPD, in this role, you must have received your Covid-19 vaccine and you must disclose proof of your vaccination status upon employment.

Our 4i Values:

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!