Shire Jobs

Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Adherence to all Good Manufacturing Practices (GMP) Safety Standards

Job Description

Project Manager Labs - Pharma

At Thermo Fisher Scientific, you’ll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life - enabling our customers to make the world healthier, cleaner and safer. We provide our teams with the resources needed to achieve individual career goals while taking science a step beyond through research, development and delivery of life-changing therapies. With clinical trials conducted in 100+ countries and ongoing development of novel frameworks for clinical research through our PPD clinical research portfolio, our work spans laboratory, digital and decentralized clinical trial services. Your determination to deliver quality and accuracy will improve health outcomes that people and communities depend on – now and in the future.

Location/Division Specific Information

Our PPD® Laboratory Services team has a direct impact on improving patient health through the expertise of scientists, industry thought-leaders and therapeutic guides. As the world leader in serving science, our laboratory professionals bring their commitment to accuracy and quality to deliver groundbreaking innovations.

Discover Impactful Work:

Our site is expanding in Athlone, and we are building new lab teams. We are looking to hire a Project Manager who will have overall responsibility for the coordination and management of designated GMP analytical service projects by supervising project status, timelines and budgets. They act as the primary liaison between the client, business development, and the project team facilitating the flow of information between all parties.

A day in the Life:

• Provides oversight and coordination of client portfolio. Provides oversight to internal departments and external clients to ensure the project requirements are understood, agreed and followed at all times, this requires negotiating and real-time decision making with the client.

• Facilitates the flow of information to all partners (Client, Labs, Quality Department, Sample Management and Business Development). Consults and uses, where appropriate, the scientific input of laboratory management and technical staff to assist the client with management projects.

• Operational Project Management: Shipment inspection review, Login authorization, login verification, COA set up, QA submission. Stability Studies– review and set up of stability launches, monitor stability pull reports, organise pull check outs. Sample disposal approvals. Shipment organization. Cumulative stability reports. Maintain and Monitor metrics: TATs, Invalids, Data trending, Reference material / control trending. Deviation/Investigation metrics.

• Handle forecast of activities – new work / projects and handles contracts (FTE, fixed price, Unit cost)

• Prepare and handle client communication

• Run Internal communication – Labs, Sample Management, Quality Department.

• Prepares Documents: specifications, protocols, reports. Assures compliance with all relevant guidelines.

• Responsible for projections and accurate invoicing - coordinates with Finance for all billing and invoicing for the client’s portfolio of projects.

• Consults with BD and contract staff during initial protocol review on standard services and costs, supporting RFP feasibility assessments, advises on possible solutions if needed.

Education and Experience

• Education to Bachelors or higher level in Science (ideally chemistry or biochemistry)

• Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 5+ years’) or equivalent combination of education, training, & experience.

• You should have experience working in a GMP Laboratory environment/Analytical laboratory – coordinating projects/samples and liaising with clients on timelines and deadlines.

Knowledge, Skills, Abilities

• Ideally you will have Pharma product/testing knowledge

• Effective/Strong verbal and written communication and presentation skills.

• Outstanding time management, planning, and organisational skills

• Proficient with specific computers and enterprise applications, including office efficiency

• Confirmed analytical skills

• Confirmed compliance with procedures and policies

• Ability to perform multiple tasks efficiently in a stressful environment

• Extensive knowledge and experience in Project Management in a GMP Lab environment

• Strong client relationship leadership skills

• Ability to work successfully with multi-level teams

Physical Requirements / Work Environment

Thermo Fisher Scientific values the health and wellbeing of our employees. We support and encourage individuals to create a healthy and balanced environment where they can thrive. Below is listed the working environment/requirements for this role:

• Able to communicate, receive, and understand information and ideas with diverse groups of people in a comprehensible and reasonable manner.

• Able to work upright and stationary and/or standing for typical working hours.

• Able to lift and move objects up to 25 pounds.

• Able to work in non-traditional work environments.

• Able to use and learn standard office equipment and technology with proficiency.

• May have exposure to potentially hazardous elements, including infectious agents, typically found in healthcare or laboratory environments.

• Able to perform successfully under pressure while prioritizing and handling multiple projects or activities.

Our Mission is to enable our customers to make the world healthier, cleaner and safer. Watch as our colleagues explain 5 reasons to work with us. As one team of 100,000+ colleagues, we share a common set of values - Integrity, Intensity, Innovation and Involvement - working together to accelerate research, solve complex scientific challenges, drive technological innovation and support patients in need. #StartYourStory with PPD, part of Thermo Fisher Scientific, where diverse experiences, backgrounds and perspectives are valued.

#LI-MH1

Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.