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Senior Scientific Associate

Boston, MA 02210

Posted: 03/02/2023 Employment Type: Contract Job Category: Scientific Job Number: 545424 Is job remote?: No Country: United States

Job Description


Pay Rate Range: $37-$45
POSITION SUMMARY:

The Senior Scientific Associate, Manufacturing Technical Investigations and Analytics (MTIA) will have the primary responsibility is to support deviations, CAPAs, executed batch records and to provide continuous manufacturing PAT support at the Vertex Manufacturing Center (VMC). The Senior Scientific Associate, MTIA reports directly to the Sr. Manager, MTIA.

KEY RESPONSIBILITIES:

The responsibilities of this position may include, but are not limited to, the following:

· Performs Process Analytical Technology (PAT) Operator tasks during GMP manufacture.

· Lead, write and review deviations and investigations for the VMC, including the Drug Product Facility, Facilities, Materials Management and the Kilo Lab.

· Develop corrective/preventative action plans (CAPAs) through root cause analysis of deviations.

· Author and submit revisions to controlled documents in support of GMP Operations, including Standard Operating Procedures, Work Instructions and Master Batch Records.

· Review executed batch records to ensure compliance with GDP/GMP requirements.

· Apply GMP concepts and internally aligned interpretations of regulatory guidance to ensure consistent and compliant practices across GMP Operations.

· Assist team manager with project management tasks, including data analysis, preparation of team presentations, collection and summary of meeting notes

 

MINIMUM QUALIFICATIONS:

· BS/MS in chemical, mechanical, or material science engineering or comparable degree.

· Two or more years experience working in a GMP manufacturing environment in the pharmaceuticals, biotechnology or medical device industries.

· Understanding of cGMP concepts and general practices.

· Excellent planning and organizational skills, with the ability to balance production, development and continuous improvement needs.

· Experience working in Quality Management System for regulated documents (e.g., Veeva or Trackwise) is a plus.

· Formal training in root cause investigations and technical writing a plus

The staffing industry has seen an increase in people falsely representing themselves as recruiters to gather personal information from job seekers. For your safety, do not provide sensitive data to anyone you have not spoken with thoroughly and never provide banking information during the application process. Candidate safety is a top priority at Planet Pharma.

Planet Pharma and The Planet Group of Companies are equal opportunity employers. It is our practice not to discriminate against any employee or applicant based on any criteria, condition or basis protected by laws or regulations in the locations where we do business. All qualified applicants are encouraged to apply. We celebrate diversity and are committed to providing an environment of mutual respect. We believe that diversity, equity and inclusion enable us to better meet our mission and values while serving our clients across the globe. If you have a disability or handicap and would like us to accommodate you in any reasonable way, please inform your recruiter, or contact us, so that we can discuss the appropriate alternatives available.

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Although this hasn't been an issue at The Planet Group, the staffing industry has seen an increase in people falsely representing themselves as recruiters to gather personal information from job seekers. For your safety, do not provide sensitive data to anyone you have not spoken with thoroughly and never provide banking information during the application process. Candidate safety is a top priority at The Planet Group.

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