Shire Jobs

Work Schedule

First Shift (Days)

Environmental Conditions

Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.)

Job Description

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.

A day in the Life:

Responsible for the regulatory and scientific conduct of development, validation, stability projects, and/or other specialty technologies such as extractable/leachable studies. Performs troubleshooting on multiple analytical instrumentation (HPLC, GC, UPLC, ICP-MS, LC/MS, GC/MS etc.) and multiple detection techniques (UV, FL, CAD, ELSD, IC etc.), calculates and interprets data, and records data in adherence with PPD SOPs and any additional requirements specific to the lab and / or client. Routinely acts as the technical project leader for multiple projects, interacts with clients on a weekly basis (or as needed) to provide updates, reviews and evaluates data, writes reports and protocols.

Essential Functions

Independently performs analytical testing, method optimization/validation, and/or other specialty technologies studies OR method transfers for pharmaceutical and biopharmaceutical compounds in a variety of formulations and/or delivery systems.

Understands and conforms to methods, and protocols applicable to assigned tasks. Designs and executes experiments independently.

Reviews and critiques study protocols, project status reports, final study reports and other project-related technical documents.

Prepares and reviews study protocols, project status reports, final study reports and other project-related technical documents.

Communicates data and technical issues to clients on a weekly basis (or as needed).

Provides technical guidance and training to staff.

Leads analytical (procedural and instrumental) troubleshooting sessions.

Assists in preparation and implementation of SOPs and quality systems.

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.

Keys to Success:

Education & Experience

• Bachelor's degree or equivalent and relevant formal academic / vocational qualificationPrevious experience that provides the knowledge, skills, and abilities to perform the job (comparable to 5+ 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

Knowledge of general chemistry and separation science

• Ability to independently perform root cause analysis for method investigations

• Proficiency on technical operating systems

• Proven problem solving and troubleshooting abilities

• Proven ability in technical writing skills

• Time management and project management skills

• Good written and oral communication skills

• Ability to work in a collaborative work environment with a team

• Ability to train junior staff

Physical Requirements / Work Environment

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

Working Conditions and Environment:

• Work is performed in a laboratory and/or a clinical environment with exposure to electrical office equipment.

• Occasional drives to site locations, occasional domestic travel.

• Exposure to biological fluids with potential exposure to infectious organisms.

• Rare exposure to skin and lung irritants, radiation, toxic materials and hazardous waste.

• Personal protective equipment required such as protective eyewear, garments and gloves.

• Exposure to fluctuating and/or extreme temperatures on rare occasions.

Physical Requirements:

• Ability to work in an upright and /or stationary position for 6-8 hours per day.

• Repetitive hand movement of both hands with the ability to make fast, simple, repeated movements of the fingers, hands, and wrists to operate lab equipment.

• Occasional mobility needed.

• Occasional crouching, stooping, with frequent bending and twisting of upper body and neck.

• Light to moderate lifting and carrying (or otherwise moves) objects including luggage and laptop computer with a maximum lift of 15-20 lbs.

• Ability to access and use a variety of computer software developed both in-house and off-the-shelf

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.

Apply today! http://jobs.thermofisher.com

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.

Accessibility/Disability Access

Job Seekers with a Disability: Thermo Fisher Scientific offers accessibility service for job seekers requiring accommodations in the job application process. For example, this may include individuals requiring assistance because of hearing, vision, mobility, or cognitive impairments. If you are a job seeker with a disability, or assisting a person with a disability, and require accessibility assistance or an accommodation to apply for one of our jobs, please submit a request by telephone at 1-855-471-2255*. Please include your contact information and specific details about your required accommodation to support you during the job application process.

*This telephone line is reserved solely for job seekers with disabilities requiring accessibility assistance or an accommodation in the job application process. Messages left for other purposes, such as not being able to get into the career website, following up on an application, or other non-disability related technical issues will not receive a response.

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.