research scientist in north billerica

posted
job type
permanent
salary
US$ 90,000 per year
apply now

job details

posted
location
north billerica, massachusetts
job category
Science & Research
job type
permanent
salary
US$ 90,000 per year
reference number
S_662779
phone
978-671-8450
apply now

job description

Designs, performs and documents research/GxP studies to support the; development of new and improved analytical methods and radiolabeling processes, installation on Positron Emitted Tomography (PET) chemical synthesis units, and technology transfer to PET Contract Manufacturing Organizations. Performs studies to support the optimization of radiolabeling, identification of impurities and degradation products formed during radio-synthesis, and scale up of radio-synthesis processes to commercial scale. Support production of clinical trial materials by CMOs including; chemical synthesis unit setup, training of CMO radiochemists on the synthesis process, qualification of production, troubleshooting of production issues related to the radio-labeling and purification processes, and support of Quality investigations resulting from production issues.

Responsibilities:
Develops and implements PET radio-synthesis processes to support the tech transfer and production of clinical trial materials at PET CMOs.
With minimal direction, designs, develops and troubleshoots processes that utilize complex equipment, experiments and systems in collaboration with other team members.
Understands and applies GxP principles to all aspects of experimentation and technical transfer while documenting results to current industry standards.
Applies an ability to evaluate data, identify unusual results and design studies that address or expand the understanding of the process being studied.
Develops and delivers technical presentations to group with minimal direction.
Acts as a technical resource to other team members on an aspect of a project.
Prepares written reports on all phases of laboratory and/or field experimental work with limited direction.
Actively promotes safety rules and awareness. Demonstrates good safety practices at all times including appropriate use of protective equipment. Reports and takes initiative to correct safety & environmental hazards.
Actively demonstrates the values of accountability, collaboration, quality, customer service, efficiency and safety.

Working hours: 8:00 AM - 5:00 PM

Skills:
BS in scientific discipline such as Chemistry/Radio-chemistry with 7-9 years of experience in PET drug product development, pharmaceutical development with experience in radio-chemistry, or other related laboratory research, or MS in relevant area with 5 plus years experience or equivalent.

Qualifications:
Handling of and/or exposure to potentially hazardous chemical and/or radiological 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.
Mastery of regulatory requirements for job functions and extended group functions, expertise with regulatory requirements for drug development.
Routine and/or frequent lifting (30lbs).
Travel up to 20% may be required.

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skills

BS in scientific discipline such as Chemistry/Radio-chemistry with 7-9 years of experience in PET drug product development, pharmaceutical development with experience in radio-chemistry, or other related laboratory research, or MS in relevant area with 5 plus years experience or equivalent.

qualification

Handling of and/or exposure to potentially hazardous chemical and/or radiological 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. Mastery of regulatory requirements for job functions and extended group functions, expertise with regulatory requirements for drug development. Routine and/or frequent lifting (30lbs). Travel up to 20% may be required.

responsibilities

Develops and implements PET radio-synthesis processes to support the tech transfer and production of clinical trial materials at PET CMOs. With minimal direction, designs, develops and troubleshoots processes that utilize complex equipment, experiments and systems in collaboration with other team members. Understands and applies GxP principles to all aspects of experimentation and technical transfer while documenting results to current industry standards. Applies an ability to evaluate data, identify unusual results and design studies that address or expand the understanding of the process being studied. Develops and delivers technical presentations to group with minimal direction. Acts as a technical resource to other team members on an aspect of a project. Prepares written reports on all phases of laboratory and/or field experimental work with limited direction. Actively promotes safety rules and awareness. Demonstrates good safety practices at all times including appropriate use of protective equipment. Reports and takes initiative to correct safety & environmental hazards. Actively demonstrates the values of accountability, collaboration, quality, customer service, efficiency and safety.

educational requirements

Bachelors