Shire Jobs

Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Adherence to all Good Manufacturing Practices (GMP) Safety Standards

Job Description

Technical Lead Scientist

Internally known as Assoc Research Scientist, Pharma

At PPD, part of 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, 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:

The Associate Research Scientist will work within our Pharma team focusing on Oligonucleotides. The role of Associate Research Scientist is responsible for the regulatory and scientific conduct of development and stability projects in the Laboratory. They perform troubleshooting across multiple assay formats and clients and calculate and interpret data and records data in adherence with PPD SOPs and any additional requirements specific to the lab and/or client.

A day in the life:

• Independently performs analytical testing, method optimization/validation, and/or other specialist 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 completes experiments independently.

• Reviews and critiques 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 mentorship and training to staff.

• Leads analytical (procedural and instrumental) troubleshooting sessions.

• Plan, direct and implement improvements in systems and processes.

• Assists in preparation and implementation of SOPs and quality systems.

• Reviews, interprets, and analyses data for technical, quality and compliance to protocols, methods, SOPs, client criteria and Good Manufacturing Practices (GMP). Performs self and peer review of the data for accuracy and compliance with reporting requirements prior to submission to QA and issuance to customers.

Education and Experience

• Min. Degree or equivalent in Chemistry or similar

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.

• 5+ years experience that provides the knowledge and skills to perform the job

• Significant industry experience within an analytical testing laboratory and GMP environment is essential

Knowledge, Skills, Abilities

• Extensive technical expertise in HPLC/Chromatography essential

• Analysis of Oligonucleotides a distinct advantage

• Proven experience in troubleshooting methods

• Mentorship experience

• Client interaction experience is a distinct advantage

• Proven experience of method development and validation

• Ability to project management and deal with client audits

• Ideally experience in leading CMC studies including method validation

• Ability to independently perform root cause analysis for method investigations

• 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

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.

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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.