Job Description

When youre part of the team at Thermo Fisher Scientific, youll do important work, like helping customers in finding cures for cancer, protecting the environment or making sure our food is safe. Your work will have real-world impact, and youll be supported in achieving your career goals.

Location/Division Specific Information

US - Massachusetts - Cambridge

Manufacturing Science and Technology - Drug Product

How will you make an impact?

The primary responsibility is to support Manufacturing Sciences and Technology activities such as technology transfer, data trending and analysis, risk assessments, process validations and investigations and small-scale studies in the drug product / fill-finish process of viral vector manufacturing. This position requires close interaction with the MST colleagues, manufacturing, engineering and quality departments among others. This role will focus on technical aspects of ensuring a robust, scalable and efficient manufacturing processes is established to produce late-phase clinical trial and commercial gene therapy products.

What will you do?

* Liaise with other Thermo Fisher sites or clients to generate /or finalize detailed process descriptions, and process flow diagrams to ensure successful scale up or transfer of manufacturing processes.
* Assist in preparing or review MFG documentation for technical accuracy.
* Generate technical memos, reports and risk assessments related to tech transfer of new processes.
* Identify, own and resolve technical process and facility fit issues related to tech transfer activities.
* Gather and analyze data for process parameter trending, root cause investigation of deviations or process validation support.
* Assist with assigned projects, contributing expertise and owning results for assigned tasks.
* Comfortable developing ideas/supporting systems/software platforms for use in a manufacturing environment.
* Conduct comprehensive literature searches, critically appraise and distill scientific information, and effectively communicate responses to external and internal customers inquiries.
* Identify and collect information specific to reported adverse events and document appropriately.

How will you get here?

EDUCATION AND QUALIFICATIONS

* Completion of at least two year of study from an accredited higher education institution prior to the internship commencing.
* Degree concentration(s) in Chemistry, Physical Chemistry or Biophysics, Biology, Biochemistry, Biotechnology, Pharmaceutical science or related field.
* Must completed the first of the two-semester sequence in Physical Chemistry, or Biochemistry or Organic chemistry. Comparable credential or have been trained or have equivalent course works will be considered.

POSITION REQUIREMENTS:

* Interact daily with the site MST colleagues.
* Strong interpersonal and communications skills; written and oral.
* Ability to work both independently and as part of a team, self-starting, resourceful, ability to manage multiple priorities simultaneously and meet deadlines.

PHYSICAL DEMANDS/FACTORS:

While performing the duties of this job, the employee:

* Ability to aseptically gown and/or sterile gown as needed.
* Ability to work within a biosafety cabinet and environmental clean rooms.
* Ability to navigate in a manufacturing environment with associated hazards.
* Willing accept and/or participate in additional training in operation of equipment, safe disposal of materials, safety management and accountability, hazard assessment processes, safe transportation of materials between laboratories or work areas, and emergency responses.

Note: This job description is not all-inclusive. Additional duties may be performed, as assigned.