Scientist : ELISA

associated scientific technical documents.

• Perform testing of study samples to support upstream and downstream manufacturing process development,

characterization, and process improvements.

• Document and evaluate experimental results and perform data verification and trending.
• Provide technical expertise and guidance to support investigations and help troubleshoot analytical operational issues.
• Identify new analytical technologies and opportunities for technical advancements.
• Support the preparation and review of regulatory submissions related to analytical procedures, method development and

validation, specifications, reference standards, extended characterization, and product stability / shelf-life.

• Support regulatory inspections, third-party audits, and customer audits through participating in inspection readiness and

addressing inspectional findings.

• Perform routine laboratory activities including sample management, instrument maintenance and calibration, inventory

and ordering of supplies, general housekeeping, and other related activities.

• Work in a diverse group environment while focusing on inclusivity and safety to produce high quality, compliant results.

Qualifications :

Specific Knowledge, Skills, Abilities, etc :

• Strong written, verbal, presentation, and interpersonal communication skills.
• Detail oriented with good organization skills.
• Ability to prioritize, independently manage and complete deliverables within given timelines.
• Ability to problem solve and apply risk-based critical thinking in a technical environment.
• Demonstrated history of continuous improvement is desired.

Education / Experience / Licenses / Certifications :

• or in Biology, Chemistry, Biotechnology, or equivalent area of related study with 2-4 years industry experience in biologic / protein analytics.
• Experience across the analytical method lifecycle in protein biotherapeutics for a variety of methodologies and

instrumentation used in the testing and characterization of raw materials, excipients, in-process, drug substance, and drug

product samples including qPCR, ELISA, CE-SDS,

iCIEF, SDS-PAGE, UV-VIS, western blotting, mass spectrometry, and cell-based assays) is preferred.

• Working knowledge and experience in the biopharmaceutical development process, GMP, PAT, CMC and regulatory

guidance, ICH guidelines, and compendial requirements is desired.

• Experience authoring, validating, and coordinating timely transfer of test methods with and to Quality Control laboratories is desired.

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.

Working Environment :

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.