Analytical Development Support Consultant - Lexington, MA - UNQ515121
Company: Propharma Group, Inc.
Posted on: June 13, 2021
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
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
- 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
- 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
- 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
- Identify and escalate assay limitations and provide input on
- Coordinate with New Analytical methods team on activities that
are project specific, involve new assay team as needed in project
- Coordinate the extended characterization study together with
- 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
- Proficient in Microsoft Word, Excel, Power Point and
- General knowledge of quality system elements and cGMP
- 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
- Carry out duties and responsibilities with limited
- 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
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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