1. GLAXOSMITHKLINE
JOB DESCRIPTION TEMPLATE
Name: Julian Vincent Job Title: New Product Introduction Principal Scientist
Reports to: Philip Hackett Effective Date: 05 Aug 2015
Business Level 1: Research & Development
Business Level 2: Platform Technology & Science
Business Level 3: Investigational Manufacturing Operations
JOB FACTORS
Job Purpose whyjob exists / what it must achieve
 The Principal Scientist project manages the provision of development and clinical trial materials of
appropriate quality and quantity for its intended use, in accordance with timelines agreed with key
customers (Project teams, GDS-Packaging, PharmaceuticalDevelopment Quality Assurance,Regulatory
Compliance and Clinicians).
 The Principle Scientist oversees the manufacture of supplies for Clinical Trials and other investigational
purposes, either on site, at Global Manufacturing and Supply Operations (GMS), at other R&D sites
worldwide or at a chosen contract manufacturer.
 The Principal Scientist manages all processes including availability of facilities/materials; order placement,
batch records, manufacture and in-process checking/sampling, production of relevant release documentation
and coordinates batch release in compliance with, cGMPs, SOPs,Quality and Regulatory requirements.
Key Results (Principal Accountabilities):
 Represents the department on multi-disciplinary teams, such as Project Teams,Clinical Trial Supply Teams
(CSDT's), Clinical Matrix Teams (CMTs),MPD and CMCs as necessary to ensure the maintenance of good
external communication.
 Consults and negotiates with customer base to develop a 12-24 month forecasting system for supplies of
pharmaceutical materials for projects in Phases I to IV. Plans and executes manufacturing campaigns, ensuring
quality, right first time delivery and within budget projections for all projects under their control.
 Liaises with the PharmaceuticalDevelopment Project Team,GMS factories or off-site contractors to develop
manufacture plans to ensure that agreed standards and timings are being achieved and processes are in line
with project milestones, quality definitions and timelines.
 Initiates and oversees contract manufacturing of batches and supports the transfer of technology to GMS sites.
Represents the departments on technology transfer teams. Prepares TechnicalTerms of Supply and Technical
Agreements for external manufacture
 Negotiates and identifies timings and means of procurement of comparator dugs and recommends methods of
blinding of comparator drugs.
 Develops a detailed manufacturing plan to ensure delivery of approved dosage form (active, placebo or
comparator) by the proposed commitment date. Generates metrics for assessment.
 Reviews Master Batch Records and advises on equipment choice, process and cleaning feasibility.
 Generates manufacturing or procurement requests for approval and monitors status. Reserves rooms and
equipment communicating changes,and identifies the type, grade and quantity of materials required to

2. manufacture batches.
 Reconciles product into inventory, compiles batch documentation for Team Leader review and Iiaises with QA
to ensure batch release timings are agreed.
 Ensures that training on all equipment and relevant procedures is complete and documented to ensure
compliance with SOPs and safe operating procedures (e.g. COSHH compliance).
 As required, assists with any Quality Investigation or audit action in accordance with SOPs and agreed
timelines.
 Ensures that all activities undertaken are performed in a safe and secure manner and that all relevant Company
policies and procedures are adhered to.
 Carries out audits internal and external. Evaluates new technologies and equipment, composes SOPs for new
equipment and provides training to relevant staff.
 Prepares an annualPersonal Development Plan.
 Deputises for the Team Leader as required.
 Undertakes,as requested, other tasks and responsibilities associated with the company's objectives.
Specific Activities
 Project management, budget control, people management, author’s technical agreements,batch records,
assesses contractors for suitability of supply, contributes to regulatory filings, and oversees quality control and
compliance.
Competencies
 Breadth & depth across multiple pharmaceutical disciplines, expertise in manufacturing operations,
manufacturing equipment and project management.
Managers signature: Date: 05 Aug 2015