Associate Research Scientist I - North Billerica, MA, United States - TalentBurst, Inc.

Description

Title:
Associate Research Scientist I

Duration: 6 Months


Location:
North Billerica, MA 01862

The Associate Research Scientist will develop new and improved synthesis processes including physicochemical characterizations in support of process or formulation development, radiolabeling processes, research programs and/or technology transfer to Contract Manufacturing Organizations.

These efforts support the economical, efficient, and safe manufacture of radiolabeling precursors, bulk drug substances, and/or drug products and supports the preparation of experimental drug materials used in extended process design, formulation design and clinical investigations.

Data interpretation, issue resolution as needed and final report writing is required to ensure acceptability of materials manufactured.
Position will require competency in use of automated radiolabeling synthesis modules.

Handling of positron and gamma radionuclides (F18) for small scale radiolabeling experiments of both research and commercial products is also needed.

Candidate should be familiar with Laboratory and Documentation Operations, including: InfoLinx archiving systems, Radionuclide databases, SOP systems, CMC submission document preparation within R&PD, training modules and long- term strategic goals.

Essential Functions
With minimal direction, develops procedures, and documents results in open formats.
Troubleshoots problems with a range of equipment, procedures and, or automated systems.
Accurately describes results to internal work groups. Demonstrates experience with >75% of equipment/automation systems (e.g. TRASIS ALLinONE, Neptis, Client Fastlab) and authors close-out reports.
Contributes to selection and implementation of new systems and experimental design.

Applies an ability to evaluate data, identify unusual results and design studies that address or expand the understanding of the process being studied.

Accurately documents results in established formats. Prepares written reports on all phases of laboratory and/or field experimental work with limited direction.
Demonstrates experience in writing technical documents using templates.

Understands and applies GxP principles to all aspects of experimentation and technical transfer while documenting results to current industry standards.

Actively promotes safety rules and awareness.
Demonstrates good safety practices at all times including the appropriate use of protective equipment.
Reports and takes initiative to correct safety & environmental hazards.
Actively demonstrates values of accountability, quality, efficiency, customer service, collaboration and safety.

Typical Minimum Skills and Experience and Education
BS/BA/MS in Chemistry, Pharmaceutics, Engineering or equivalent.

Usually requires a minimum of 3 4 years directly related experience with a BS degree or 1 3 years with a Master's degree.

Experience working in a GxP environment.

Other Requirements
Handling of, and/or exposure to, potentially hazardous chemical, radiological and or biological materials.
Required to follow all safety procedures, and use personal and protective equipment provided.
Expertise in the logical design and review of analytical, pharmaceutics and/or validation experiments.
Expertise with GxP documentation requirements.

Regulatory requirements:
Mastery for job function; intermediate knowledge for extended group functions; basic knowledge for development.
Routine and/or frequent lifting, up to 30 lbs.
Travel may be required as per business need.


Core Values:

The ideal candidate will embody these core values:
" Let people be their best
" Respect one another and act as one
" Learn, adapt, and win
" Know someone's health is in our hands
" Own the solution and make it happen

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