Apex Systems Technical Writer, Chemistry in Andover, Massachusetts

Technical Writer, Chemistry in Andover, MA at APEX Systems

Date Posted: 1/5/2019

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Job Snapshot

  • Employee Type:

Contractor

  • Location:

Andover, MA

  • Job Type:

Project Management Office (PMO)

  • Experience:

Not Specified

  • Date Posted:

1/5/2019

Job Description Job #: 925010

Responsibilities:

  • Provide non-testing support to the cGMP QC Analytical department for technology transfer activities.

  • Coordination of method transfer activity, generating transfer documents to support monoclonal antibody product transfer between internal sites.

  • Utilize understanding of the scientific principles of test methods, data analysis and cGMP requirement.

  • Responsible for facilitating tech transfer through collaboration with laboratory subject matter experts (SMEs) and internal analysts.

  • Author method transfer documents using internal document workflow, through collaboration with SMEs

  • Support lab testing by reviewing data and documents for accuracy and compliance.

  • Support assay remediation activities and generating supporting documents.

  • Participate in across site tech transfer meeting and tracking the project timeline

  • Support sample/resource request and coordinating sample shipment and documentation

  • Communicate with receiving laboratory and supporting gap assessment, sample request and queries

Requirements:

  • MS or PhD degree in Science, preferably in Biochemistry, Analytical Chemistry or related technical discipline

  • Past experience supporting GMP writing in the biopharmaceutical field is highly preferred

  • Strong technical writing skills including validation and transfer support documents

  • Knowledge of the method transfer regulatory guidelines including ICHQ2 and USP.

  • Scientific background in analytical methods, including iCE, CGE, HCP, ProA ELISA and bioassay.

  • Working knowledge of QC analytical support and technical writing

  • Strong interpersonal, oral and written communication skills.

  • A detail-oriented approach to deliverables as the main job responsibility is data review and generation of GMP documentation.

*For immediate consideration, please email your updated resume to Ljohnson@apexlifesciences.com with 'Technical Writer MA' in the subject line.

EEO Employer

Apex is an Equal Employment Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, age, sexual orientation, gender identity, national origin, disability, protected veteran status, or any other characteristic protected by law. Apex will consider qualified applicants with criminal histories in a manner consistent with the requirements of applicable law. If you have visited our website in search of information on employment opportunities or to apply for a position, and you require an accommodation in using our website for a search or application, please contact our Employee Services Department at 844-463-6178