Scientist II or III - Bioanalytical Assay Support - FSP at Parexel

, , United States -

Full Time

Start Date

Immediate

Expiry Date

07 Feb, 26

Salary

0.0

Posted On

09 Nov, 25

Experience

2 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Bioanalytical Assays, Immunogenicity Assays, ELISA, Luminex, MSD, Serology, Pipetting Skills, GxP, GLP, LIMS, Communication Skills, Attention to Detail, Teamwork, Self-Motivation, Adaptability, Problem-Solving

Industry

Pharmaceutical Manufacturing

Description

When our values align, there's no limit to what we can achieve. At Parexel, we all share the same goal - to improve the world's health. From clinical trials to regulatory, consulting, and market access, every clinical development solution we provide is underpinned by something special - a deep conviction in what we do. Each of us, no matter what we do at Parexel, contributes to the development of a therapy that ultimately will benefit a patient. We take our work personally, we do it with empathy and we're committed to making a difference. We are looking to fill a Bioanalytical Scientist position working as a full-time employee of Parexel FSP on long-term assignment onsite at one of our clients located in Springhouse, PA. This position offers full benefits, sick time, 401K, paid holidays, and paid time off. This position does not offer any sponsorship. Responsibilities Develop and qualify cell-based or ligand-binding based bioanalytical assays to support high priority biological and vaccine programs. Analyze samples using multiple platforms such as ELISA, ELISPOT, Neutralization assays or flow cytometry Assess analytical result data on acceptability using LIMS or other computer software Maintain documentation according to guidelines similar to GxP Work according to established Standard Operating Procedures (SOPs) and regulatory guidance Maintain accurate records of ongoing projects in adherence with documentation standards Assist in generation and review of reports and contribute to trouble shooting efforts Collaborate and communicate within and across the work group Work in a structured environment under direct to moderate supervision Adhere to GLP regulations and safety requirements in BSL-2 Qualifications : Degree in Molecular Biology, Immunology, Cell Biology, Biology, Biochemistry, Biology, or related biological science discipline Scientist 2: B.S./B.A. 1-2 years of experience Scientist 3: B.S./B.A. 3-5 years of experience or MS 1-2 years of experience Required Skills and Experience Experience with immunogenicity assays such as ELISA, Luminex, or MSD Well versed in serology with excellent pipetting skills Working experience in a regulated environment (GxP, preferably GLP) Strong experience with Laboratory Information Management System (LIMS) Strong computer, scientific, and organizational skills Excellent communication (oral and written) and attention to detail Ability to work independently and as part of a team, self-motivation, adaptability, and a positive attitude Ability to learn new techniques, perform multiple tasks simultaneously, keep accurate records, follow instructions, and comply with company policies Desired Skills and Experience Experience in cell culture and cell-based assays such as nAb assays, or ELISPOT assays Ability to manage multiple projects under tight timeline and problem-solving skills High sense of responsibility, accountability, and professional integrity Experience with liquid handlers such as Hamilton About Parexel Parexel FSP includes the CMC Operations group. We provide pharmaceutical and biopharmaceutical companies with qualified and talented technical professionals to support the development and delivery of new therapies. For results-driven and caring individuals who want to make a meaningful difference in the world, Parexel is trusted by life sciences companies to meet their long-term staffing needs for scientists and engineers and related professionals in discovery and development of novel therapies, keeping patients at the center of everything we do, and where an inclusive community helps you be your best, transforming any career into a life-changing achievement. Come join us! #LI-DK1 EEO Disclaimer Parexel is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to legally protected status, which in the US includes race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status. Headquartered near Boston, Massachusetts and in Durham, North Carolina, Parexel has over 16,000 employees, with offices that support clients in over 100 countries around the world. We provide the most comprehensive drug development capabilities of any CRO worldwide. Our global regulatory expertise, Phase I-IV clinical research services, and advanced commercialization services all work together to move you through the development journey more smoothly and cost-effectively from beginning to end.

Responsibilities

Develop and qualify bioanalytical assays to support biological and vaccine programs. Analyze samples and maintain documentation according to regulatory guidelines.