Job Details

  • Title: Manufacturing - Stability Scientist
  • Code: RCI-30457-1
  • Location: Devens Massachusetts (MA) 01434
  • Posted Date: 02/14/2020
  • Duration: 6 Months
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  Job Description

MAJOR DUTIES AND RESPONSIBILITIES:

  • Identify and devise training need for ongoing stability activities. Ensure training requirements are met.
  • Approve, identify, write and revise SOPs. Assist with development of company-wide stability directives.
  • Provide the technical requirements and support generation/revision of master stability protocols, as well as review and approve study specific protocols.
  • Perform change control impact assessments and document the stability assessment in change controls. Review and endorse change controls as an expanded reviewer. Initiate change controls related to stability operations as necessary.
  • Work in collaboration with Technical Product Teams, Global Regulatory Sciences, and manufacturing sites to develop stability product requirements for annual enrollments, process changes and investigations. Determine the stability requirements for commercial products, based on technical rationale and globally approved dossiers. Maintain a list of required yearly stability enrollments.
  • Represent GPS on laboratory and manufacturing investigation teams by performing stability impact assessments.
  • Support stability data reporting as needed, which may include supporting or reviewing Health Authority submissions and responses to Health Authority queries. Support global rollout of observations that may affect stability programs and develop strategies to close gaps/mitigation.
  • Identify, escalate, and act on information regarding stability program that may impact lab capacity, product studies or regulatory commitments directly and promptly to management
  • Works according to cGMP requirements and HA expectations.

Qualifications - External

KNOWLEDGE AND SKILL
  • Able to prioritize objectives from multiple projects, and deliver according to overall strategy.
  • Prior experience with commercial stability trouble-shooting, specifically with demonstrated expertise in small molecule analysis.
  • Exhibit strong leadership and decision making skills especially in problem solving and analytical thinking.
  • Experience with evaluating and interpreting stability data using statistics and statistics software.
  • Knowledge and understanding of ICH Guidelines (Q1A, Q5C) and associated policies, directives and guidance documents.
  • A thorough knowledge of cGMP regulations as referenced in The Code of Federal Regulations (21CFR) and their specific application to stability programs in a biologics manufacturing facility.
  • Minimum of - 2 years (PhD)/ 6-8 years (MS)/ 8-10 years (BS) relevant cGMP experience in biopharma at Client or other company.
  • Excellent written and verbal communication skills in communicating stability strategy to technical teams and in change control and investigations management system.
  • Ability to work collaboratively in a team matrix environment is required.
  • Applied knowledge and good understanding of analytical and/ or microbiology testing techniques, as well as other technical areas related to pharmaceutical manufacturing, packaging, distribution, statistical methods, and quality control and assurance practices.
  • Experience in Operational Excellence, with proven record of accomplishment in continuous improvement preferred.
  • Works independently, reviews data and demonstrates ability to recognize anomalous trends or results.
  • Knowledge of US/EU/ROW Requirements, Corporate Directives and industry best practices; develops strategies for solving complex problems/issues; recommending and driving implementation of solutions.
  • Use computer software/programs: Microsoft Office applications, SAP, LIMS, Trackwise, JMP, etc.