Associate Research Scientist, Biopharma

Job Description

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 role of Associate Research Scientist is responsible for the regulatory and scientific conduct of development and stability projects in the Biopharmaceutical Laboratory. Performs troubleshooting across multiple assay formats, clients and cell lines. Calculates and interprets 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.

• 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 mentorship and training to staff.

• Leads analytical (procedural and instrumental) troubleshooting sessions.

• 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

• Degree or equivalent in Chemistry or Biochemistry

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.

• Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 5+ years).

Knowledge, Skills, Abilities

• Knowledge of general chemistry, biochemistry techniques (SDS-PAGE, Western Blot, total protein by BCA or micro BCA assay, ELISA)

• Proven experience of method development of identity and purity assays by SDS-PAGE and Western Blot.

• Ideally experience in leading CMC studies for biopharmaceutical products including method validation

• Proficiency on technical operating systems (including Image Lab software)

• Proven problem solving and troubleshooting abilities

• 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

Benefits

We offer competitive remuneration, annual incentive plan bonus, healthcare, and a range of employee benefits. Thermo Fisher Scientific offers employment with an innovative, forward-thinking organization, and outstanding career and development prospects. We offer an exciting company culture that stands for integrity, intensity, involvement, and innovation

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.

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.