Suzanne Sweet has over 8 years of experience in project management for clinical trials and manufacturing of investigational medicinal products. She is currently a Project Manager at Quotient Clinical where she is responsible for managing timelines, budgets, and deliverables for various phase 1 clinical trials. Previously, she has held roles in manufacturing and production management at Quotient Clinical and Charles River Laboratories where she oversaw GMP manufacturing, equipment maintenance, and process improvement initiatives. Suzanne has a degree in Physiology from the University of Edinburgh and has developed strong skills in communication, planning, leadership, and problem solving over the course of her career.

1. Suzanne Sweet
Current location: Nottingham, UK
suesweet1982@hotmail.co.uk
D.O.B. 11th October 1982 Nationality: British
Employment History
I have been involved in the manufacturing of Investigational Medicinal Products, analysis
of biological samples and Project Management for Phase 1 clinical trials for 8.5 years.
Feb 2011 – Present Quotient Clinical
Position Held: Project Manager
Employed to manage a range of Phase 1 clinical trials including Enabled First in Human, Bio-equivalence,
RapidFaCT® and various types of radioactive studies, including ADME, IV microtracer
and gamma scintigraphy.
Outline of Major Responsibilities:
· To deliver each project on time, within budget and to the clients satisfaction
· Main point of contact for the customer and any subcontractors
· Scheduling and management of timelines for each study
· Financial control of projects including revenue forecasting and budget management
· Liaising with the Business Development group to actively seek repeat business
opportunities and support proposal generation
· Managing and developing support staff within the project management team
· Review / authoring of key study documents including protocols, informed consent forms
and regulatory submission packages
· Lead a process improvement programme for radioactive studies
· Organise and chair internal and external meetings and provide minutes
· Support numerous additional process improvement initiatives in clinical monitoring,
laboratory process and health and safety
· Writing and review of SOP’s
Nov 2009 – Jan 2011 Quotient Clinical
Position Held: Production Manager
Employed to manage all GMP manufacturing conducted in the Edinburgh facility and maintain the
clean rooms and isolator to Grade C and Grade A standards respectively.
Outline of Major Responsibilities:
· Scheduling and management of GMP manufactures
· Leading and training the manufacturing team
· Manufacturing a range of radio-labelled and non-radiolabelled products
· Client interaction
· Responsible for all audit queries and MHRA observations of GMP facility
· Authoring, reviewing and approving batch records, IMPD sections, labels and accountability
documentation
· Maintenance and monitoring scheduling of all equipment
· Continued process improvement

2. · Lead internal projects for equipment validation and implementation
· Lead a project to enable extended manufacturing capabilities across site
· Writing and review of SOP’s
April 2006 – Nov 2009: Charles River Laboratories
Position Held: Trainee Project Leader (Apr 2006 – Nov 2007)
Project Leader / Trainee Study Director (Nov 2007 – Present)
Initially employed as trainee Project Leader in the Phase 1 Clinical Research team conducting
ADME studies within pharmaceutical metabolism I was promoted to Project Leader in November
2007.
Outline of Major Responsibilities:
· Fully trained in GLP, GCP and cGMP.
· Liaising within the company, the clinic and with clients/regulatory bodies
· Production and verification of radiolabelled and non-radiolabelled IV and Oral doses,
including cytotoxics
· Handling and analysis of radiolabelled biological specimens
· Writing and Quality Control of Protocols & Reports and interpreting data
· Production and control of GMP documents (i.e. Batch Production Documents, Change
Controls, Deviations, IQ/OQ/PQ paperwork & DQ/URS paperwork)
· Presenting to clients and government bodies
· ARSAC Submissions
· Production Unit (Clean Room) maintenance and environmental monitoring
· Laboratory environmental monitoring and contamination control
· Control of GMP equipment paperwork
· Training of junior staff
Oct 2005 –April 2006: Margaret – Steele Associates Ltd
Position Held: HR Administrator
I gained temporary employment at Aegon in the Human Resources department as an administrator.
Jan 2001 – Sept 2005 Festival Inns, Edinburgh
Position Held: Bar Staff / Supervisor / Unit Deputy Manager
Initially working part time in a bar while at University, I progressed to a full time Deputy Manager of
a large hotel and bar in Edinburgh on completion of my degree. I then diversified my skills by
training and managing staff across multiple sites.
Educational History
2000 – 2004: University of Edinburgh, 2.1 Honours in Physiology
Specialist subjects included “Stress and the Brain” and “Neuroendocrinology”.
Transferable Skills
Communication Skills
· Interpersonal skills developed to a high level while dealing with staff, colleagues &
customers in all employment roles
· Able to work effectively with colleagues of all levels and all ages

3. · Presentations made throughout degree course and throughout my career to audiences of
all ages and expertise
· Delivered regular team training sessions for staff both within the hospitality industry and my
laboratory / manufacturing roles
Planning & Organisational Skills
· Effective time management, self discipline and the ability to work under pressure has
brought me academic achievement while integrating part-time work with study
· Managing and scheduling all GMP activities around staff availability and equipment
maintenance needs in order to deliver the product to the correct timelines required a high
level of organisational and planning skills
· Managing project timelines across a multi-faceted team requires high levels of
organisational and troubleshooting skills to ensure that the full project is delivered to the
clients expectations.
Team Working/ Leadership Skills
· Gained experience as a team member, team leader and manager
· Gained an award for Teamwork while working in Charles River
· I previously managed a manufacturing team and currently manage a team of project
management associates and clinical trial administrators.
IT Skills
· Experienced user of several computing packages including Microsoft Office, Focalpoint,
Alphadas, Zonal, Debra and Delphi
Problem Solving
· I gained invaluable problem solving skills when dealing with contamination control and
environmental monitoring within Charles River Laboratories
· Leadership of process improvement projects within my current position allowed me to
develop and extend my problem solving skills across various departments and sites across
the company
· Project management of clinical trials has given me numerous opportunities to develop my
problem solving skills in an assortment of situations
References:
I would be happy to provide details of references should these be required.