Category: Scientific & Clinical
Job ID: 184471
Date Posted: 01/13/2021
Job Title: Associate Director
Global Biologics Stability (GBS) manages the stability programs for COMPANY’s commercial biologic Drug Substances and Drug Products. The global stability program supports all internal and external manufacturing sites. The contractor reports to the Associate Director of GBS and is responsible for stability product strategy and oversight of product stability programs. Activities include those associated with product stability strategy, stability program requirements, approval of stability protocols, and preparation, review and approval of stability reports and regulatory filings.
MAJOR DUTIES AND RESPONSIBILITIES:
-Provide oversight and leadership to one or more commercial stability programs.
- 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 each commercial product based on technical rationale and globally approved dossiers. Provide testing projections to the QC laboratories.
-Manage the stability book of work and ensure that stability activities are completed per site and brand timelines.
-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 or product shelf life extension.
- Provide the technical requirements in a Master stability protocol, review and approve study specific protocols or batch enrollment forms. As needed, review and activate LIMS stability studies.
-Represent GBS on laboratory and manufacturing investigation teams. Perform stability impact assessments as required.
-Support stability evaluations by reviewing OOT assessments and process robustness presentations
-Support stability data reporting by authoring or reviewing Health Authority submissions and responding to Health Authority Queries.
-Point person for global rollout of observations that may affect stability programs and develop strategies to close gaps/mitigation.
-Approve, identify, write and revise stability procedures. Assist with development of company-wide Stability directives.
-Act, escalate, identify information regarding stability program that may impact lab capacity, product studies or regulatory commitments directly and promptly to management
-Identify and devise training need for ongoing stability activities. Ensure training requirements are met.
-Works according to cGMP requirements and HA expectations.
- Represent global stability in Health Authority inspections and internal quality audits
- Participate and/or lead OpEx initiatives to streamline and standardize management of stability programs.
- Develops staff strategic capability through coaching, and counseling.
KNOWLEDGE AND SKILL
-Minimum of 4 years (PhD)/ 10 years (MS)/ 12 years (BS) relevant cGMP experience in biopharma at COMPANY or other company
- Expert knowledge and understanding of stability 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.
-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.
- Significant experience with evaluating and interpreting stability data using statistics and statistics software.
- Knowledge of Drug Substance and Drug Product manufacturing and good understanding of analytical and/ or Microbiology methods
-Exhibit strong leadership and decision making skills especially in problem solving and analytical thinking.
- Significant experience in Operational Excellence, with proven record of accomplishment in continuous improvement. Prior experience with commercial stability trouble-shooting and demonstrated expertise in Biologics or Protein Therapeutic molecule
-Significant front room FDA/Inspectional experience on stability programs
-Works independently, review data and demonstrated ability to recognize anomalous trends or results.
-Able to prioritize objectives from multiple projects, and deliver according to overall strategy.
- 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.
-Contractor works on problems of diverse scope in which analysis of situation or data requires evaluation of identifiable factors.
-Exercises judgment within generally defined practices and policies in selecting methods and techniques for obtaining solutions.
-Acts as an advisor and mentor to stability staff
-Establishes and recommends changes to policies which affect subordinate organization.
-Erroneous decisions or failure to achieve goals results in additional costs and personnel, and serious delays in overall schedules.
-Contractor receives assignments in the form of objectives and establishes goals to meet objectives.
-Provides guidance to subordinates to achieve goals in accordance with establishes policies.
-Work is reviewed and measured based on meeting established objectives and schedules.
-Identifies and reports any discrepancies from normal practices or procedures to senior management, recommending and implementing corrective actions.