Investigator Initiated Research Associate

Makro Scientific; Andover (MA); On-site; USD 60,000 - 80,000; Full time

Job summary

Makro Scientific in Andover, MA is seeking an Investigator Initiated Research Associate to oversee GMP manufacturing investigations. The ideal candidate will have 3-5 years of experience in a quality and compliance setting, with a strong understanding of bio pharmaceutical processes.

This role requires candidates to perform detailed investigations and report generation while adhering to strict quality standards. Relevant educational background in science or engineering is essential.

Qualifications

• 3-5 years of experience in a relevant role.
• Experience in quality and compliance in pharmaceutical manufacturing.
• Prior experience with investigations and continuous improvement methodology.

Responsibilities

• Oversee investigations for GMP manufacturing suites.
• Perform and generate high quality investigation reports.
• Assist in defining and improving investigation philosophies.

Skills

Understanding of the investigation process

Detailed understanding of bio pharmaceutical manufacturing

Adherence to quality and compliance standards

Education

BS or MS in a scientific or engineering discipline

Job description

Investigator Initiated Research Associate

Full-time

Growing Pharmaceutical, Biotechnology and Medical Device companies always need TOP Talent. Since 1996, MakroScientific’s proven staffing solutions have helped many Life Sciences companies succeed and visualize their goals by increasing innovation and decreasing costs while maintaining the complex service level expectations.

Our global presence with offices in USA (NJ, PA, IL, CA) and offices in UK, Europe and Asia enables us to be a powerful contributor and connector of right Talent.

• Job ID : 43012
• Location : Andover, MA
• Duration : 12 Months
• Job Title : Investigator Initiated Research (IIR) Associate

• The Andover Site Investigation group is responsible for overseeing investigations for all GMP manufacturing suites in Andover, including both mammalian and bacterial based processes in support of commercial and clinical Drug Substance manufacture.
• The candidate will be responsible for performing thorough, detailed and timely investigations and generation of high quality and timely investigation reports.
• This position will report to the Manager of Investigations within the Site Operations Management Function.
• Prior experience with investigations including conducting and writing investigations and in use of continuous improve methodology preferred.
• The incumbent must be a collaborative team player with strong coordination, facilitation and writing skills.
• The incumbent will be expected to have experience in the area of quality and compliance and a working knowledge of the appropriate regulations.
• Experience with and in depth understanding of cell culture and chromatography is highly desirable.
• The incumbent will be expected to assist in continually defining and improving the philosophy and justifications involved in investigations and to continually evolve to meet changing business needs.

Skills

• Have a fundamental understanding of the investigation process as it applies to manufacturing issues
• Have detailed understanding of the processes and systems involved in the manufacture of bio pharmaceutical.
• Ensure their investigations are conducted with a strict adherence to appropriate quality and compliance standards

Experience Required

• 3-5 Years

Education

• BS or MS, preferably in a scientific or engineering discipline preferable.
• A minimum qualifications to BS + 4-6 yrs experience or MS + 2-4 yrs experience in a pharmaceutical and/or biological manufacturing operation with a strong technical background in a cGMP and Quality environment is required.

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