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

TalentBurst, Inc. North Billerica, United States

2 weeks ago

Description

Title: Associate Research Scientist I

Duration: 6 Months

Location: North Billerica, MA 01862

This position requires radiolabeling synthesis.

Looking for a candidate with process chemistry experience in PET, PET operations experience.

· 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

#TB_PH

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