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Analytical Development Support Consultant - Lexington, MA - UNQ515121

Company: Propharma Group, Inc.
Location: Lexington
Posted on: June 13, 2021

Job Description:

ProPharma Group is an industry leading, single source provider for regulatory compliance, pharmacovigilance, and medical information services across the full development lifecycle for pharmaceutical, biotechnology, and medical device companies. Operating around the world with offices in Australia, Canada, Germany, Japan, the Netherlands, Sweden, United Kingdom, and the United States, ProPharma Group's fully integrated service offerings will provide clients with a comprehensive suite of global support services that are required to be competitive in today's dynamic markets. We build successful long-term relationships with clients by providing leading industry knowledge, experience, and proven processes.

Our client is looking for a Senior Analytical Chemist Consultant to support analytical methods transfer activities across sites. This project will be on-site 2-3 days/week, but should be considered full time, partially remote. Duties and responsibilities to include:

  • Be the first point of contact for new program implementation in existing platform assays.
  • Represent PAD in CMC meetings, and act as a link between CMC team and AD groups.
  • Lead transfer, verification, co-qualification activities with AD-AMS and QC.
  • Plan required resources to deliver platform implementation activities.
  • Escalate Timeline/Resources constrains that cannot be resolved at the team level.
  • Act as a subject matter expert for platform assays at project level or identify and involve relevant SME as needed.
  • Ensure authoring and review of analytical plan, transfer, verification, qualification, and co-qualification protocols and reports as relevant to the site.
  • Ensure specifications are set for ENG batches in collaboration with Platform AMS. Support PQM to set specifications for Clin batches.
  • Act as an IMPD/IND lead within AD when preparing up to FIM (role will be assigned per project to either AMS or LEX Platform team member). Content will be provided by relevant Team/SME in AD.
  • Identify and escalate assay limitations and provide input on improvement requirement.
  • Coordinate with New Analytical methods team on activities that are project specific, involve new assay team as needed in project specific meetings.
  • Coordinate the extended characterization study together with AMS.
  • Qualified candidates will possess a PhD in scientific or engineering discipline along with 10 plus years related industry experience, or MSc with 15 plus years relevant experience.
  • Candidate must possess possess previous experience in biologics, additional experience in Viral Vectors is preferred.
  • Proficient in Microsoft Word, Excel, Power Point and Project.
  • General knowledge of quality system elements and cGMP regulations.
  • Experience providing support to clients with quality issues such as OOS results, deviations and non-conformances arise. Also, provide advisement for the implementation of proper CAPA to resolve deviations and non-conformances.
  • Ability to write and revise Standard Operating Procedures.
  • Effective written and oral communication skills; ability to write, type, express or exchange ideas; ability to convey information/instructions accurately.
  • Carry out duties and responsibilities with limited supervision.
  • Flexibility to work occasional weekends and evenings.
  • Ability to walk, stand and move about for long periods of time; work with equipment in the field including basic hand tools, lift and manipulate reasonable weights (approximately 35 lbs.), ability to sit and type for long periods of time.
  • Ability to plan and manage own work
  • Must be willing to travel regionally and/or nationally throughout the US.

All candidates must be legally eligible to work in the United States.

We are an equal opportunity employer. M/F/D/V

  • ProPharma Group does not accept unsolicited resumes from recruiters/third parties. Please, no phone calls or emails to anyone regarding this posting.*

Keywords: Propharma Group, Inc., Boston , Analytical Development Support Consultant - Lexington, MA - UNQ515121, Other , Lexington, Massachusetts

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