Technical Project Manager

• ARS

Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Office

Location

Athlone, Ireland

About Thermo Fisher Scientific

Thermo Fisher Scientific Inc. is the world leader in serving science, with annual revenue of more than $40 billion. Our Mission is to enable our customers to make the world healthier, cleaner and safer. Whether our customers are accelerating life sciences research, solving complex analytical challenges, increasing productivity in their laboratories, improving patient health through diagnostics or the development and manufacture of life-changing therapies, we are here to support them. Our global team delivers an unrivaled combination of innovative technologies, purchasing convenience and pharmaceutical services through our industry-leading brands, including Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services, Patheon and PPD.

About the Role

This position will operate in a Technical Project Manager capacity, supporting the supervisor and Project Manager with the overall management of the programmes in the group from a PM and technical perspective. Our PPD® Laboratory Services team has a direct impact on improving patient health through the expertise of scientists, industry thought-leaders and therapeutic experts. As the world leader in serving science, our laboratory professionals bring their commitment to accuracy and quality to deliver groundbreaking innovations. This role is based at our Analytical GMP labs facility and analytical testing on drug substances and products.

Responsibilities

• Performs a variety of complex sample preparation and analysis procedures to quantitatively measure pharmaceutical and biopharmaceutical compounds in a variety of formulations and/or biological matrices for stability and analytical testing
• Possesses a thorough understanding of laboratory procedures and can reliably conduct complex analysis with increased independence
• Supporting the supervisor and Project Manager with the overall management of the programmes in the group from a PM and technical perspective
• Planning technical studies
• Supporting report approvals
• Day to day workbook approvals
• QA audit management/NC conformance and other required tasks
• Follows validated or experimental analytical procedures with periodic direct supervision
• Responsible for review and compilation of results and data comparison against SOP acceptance criteria, methodology, protocol and product specifications
• Enters data into databases and reports
• Performs self-review for own data prior to QC submission
• Works with multiple functional groups to meet business needs
• Plans and organizes work with periodic supervision
• Sets up and maintains analytical instrumentation
• Trains on routine operation, maintenance and theory of analytical instrumentation, SOPs and regulatory procedures and guidelines
• Ensures QA findings are addressed appropriately
• Aids and training to other team members
• Problem solving, either independently or with assistance pertaining to extraction and/or instrumentation problems
• Communicates project status to project leader
• Performs work assignments accurately, and in a timely and safe manner
• Reviews, interprets, and analyzes data for technical, quality and compliance to protocols, methods, SOPs, client criteria and Good Manufacturing Practices (GMP) or Good Laboratory Practices (GLP)
• Performs self and peer review of the data for accuracy and compliance with reporting requirements prior to submission to QA and issuance to customers

Qualifications

Education

• Bachelor's degree or equivalent and relevant formal academic / vocational qualification
• Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 6+ years)
• In some cases, an equivalency, consisting of a combination of appropriate education, training and/or directly related experience, will be considered sufficient for an individual to meet the requirements of the role

Knowledge, Skills, Abilities

• Technical Project Management experience
• Demonstrated knowledge of multiple applicable techniques such as: HPLC, GC, MS, Dissolution Testing, Inhalation Testing, Biopharmaceutical Testing, Karl Fischer, UV-Vis, FT-IR, TOC
• Proficient in Microsoft Excel and Word
• Proven ability to interpret data by performing trend analysis
• Proven ability in technical writing skills
• Ability to independently optimize analytical methods
• Proven problem solving and troubleshooting abilities
• Good written and oral communication skills
• Time management and project management skills
• Ability to work in a collaborative work environment with a team

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

Equal Opportunity

Thermo Fisher Scientific will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation. Thermo Fisher Scientific is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, creed, religion, color, national or ethnic origin, citizenship, sex, sexual orientation, gender identity and expression, genetic information, veteran status, age or disability status.