Quality

Principal Scientist

Location: Devens, MA

Work Schedule: Mon - Fri, Business Hours

Description - External

Global Biologic Stability (GBS) has oversight of the stability programs for all commercial biologics Drug Substance and Drug Products across internal and external manufacturing sites. The Stability Scientist reports to the Senior Principal Scientist or Associate Director of GBS and is responsible for stability product strategy involving fulfilling annual enrollments and assessing impact to process changes and investigations. The Scientist may represent the stability function on Technical Product Teams and also assist with stability study generation, sample management, stability data evaluation/trending, and stability data reporting, in accordance with cGMPs and Company SOPs/requirements.

MAJOR DUTIES AND RESPONSIBILITIES:

- 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.

-Perform and document change control impact assessments. Initiate change controls for changes to stability operations, as necessary.

-Represent GBS on laboratory and manufacturing investigations and perform stability impact assessments.

- Provide the technical requirements and support generation/revision/review/approval of master stability protocols (MSP) and study specific protocols (SSP).

-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.

-Approve, identify, write and revise SOPs/WIs. Assist with development of company-wide stability directives.

-Identify, escalate, and act on 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.

Qualifications - External

KNOWLEDGE AND SKILL

-Minimum of - 2 years (PhD)/ 6-8 years (MS)/ 8-10 years (BS) relevant cGMP experience in biopharma at Client or other company.

- 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.

-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.

-Experience with evaluating and interpreting stability data using statistics and statistics software.

-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.

-Exhibit strong leadership and decision making skills especially in problem solving and analytical thinking.

-Experience in Operational Excellence, with proven record of accomplishment in continuous improvement preferred.

-Prior experience with commercial stability trouble-shooting, specifically with demonstrated expertise in small molecule analysis.

-Works independently, reviews data and demonstrates 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.

DECISION MAKING

-Scientist 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 to subordinate staff to resolve problems. Develops performance requirements and evaluates subordinates accordingly. Establishes and recommends changes to policies which affect subordinate organization.

-Recognizes erroneous decisions or failure to achieve goals, which result in additional costs and personnel, and serious delays in overall schedules.

SUPERVISION RECEIVED

-Scientist receives assignments in the form of objectives and establishes goals to meet objectives.

-Work is reviewed and measured based on meeting established objectives and schedules.

-Identifies and reports any discrepancies from normal practices or procedures to management, recommending and implementing corrective actions.

SUPERVISION EXERCISED

-Direct Supervision of exempt/non-exempt employees may be required.