Scientist - Senior in Lexington, MA at Apex Life Sciences

Date Posted: 2/14/2018

Job Snapshot

  • Employee Type:
    Full-Time
  • Location:
    Lexington, MA
  • Job Type:
    Science
  • Experience:
    Not Specified
  • Date Posted:
    2/14/2018
  • Job ID:
    822241

Job Description


One of the Top Pharmaceutical Companies in the nation is looking for a leader/manager role. This role will have the ability to work with many departments across the company.

Description

BS in Science is required w/ a minimum of Five years in the Bio-Chem area (industry exp. Is a must).

Role is focused more on Technical PM and a QC Role – not a hands on lab position

Someone who can resolve technical issues that arise during the method validation or method transfer.

• Lead or support the execution, and data analysis of assay validation, method transfer (co-qualification) studies in the QC laboratories. Support completion of all protocols and validations in a timely and appropriate manner.
• Contribute to the evaluation of new methodologies and transfers to determine business need and applicability to the area. Perform evaluations/testing as related to improvements or project. Provide recommendations for or implement instrumentation upgrades or improvements to drive optimal performance.
• Author or support the writing of technical memos, reports, protocols, studies and other appropriate documentation to support laboratory validations, investigations and/or objectives.
• Frequent use and general knowledge of industry practices, techniques, and standards. Provide technical support to the QC Laboratories.
• Support global standards/strategies in continuous improvements.
• Comply with control of lab documentation. Review data with application of good documentation practices. Maintain data integrity and ensure compliance with company SOPs and specifications, FDA, QSR, and cGMP regulations.
• Assure compliance with company procedures, quality and regulatory requirements, and regulatory guidance documents including QSR, cGMP, USP, CFR, and compendia literature. Support and implement laboratory systems and/or guidelines to meet compliance requirements.
• Support regulatory and non-regulatory audits (e.g. Internal Quality Assessment, Corporate, FDA, etc).
• Support regulatory submissions /change control requests in a timely manner when required.
• Proactively an actively contribute to a team setting to increase efficiency, solve problems, generate cost savings, improve quality, and provide new product support.
• Support technical presentations and/or training to QC Laboratories (including management) as needed.
• Ensure personal training requirements are met and training records are current.
• Stay current in the technical and compliance field regarding lab instruments and methods.