Scientist II or III - Bioanalytical Assay Support - FSP

About this role

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 ligand-binding or cell-based based bioanalytical assays to support high priority biological and vaccine programs.

• Analyze clinical samples using multiple platforms such as MSD, Luminex, or neutralization assays

• Assess analytical result data on acceptability using LIMS or other computer software

• Work according to established Standard Operating Procedures (SOPs) and regulatory guidance

• Maintain accurate records of ongoing projects in adherence with ALCOA+ principles

• Assist in generation and review of regulated documents and contribute to assay trouble shooting efforts

• Collaborate and communicate within and across the work group

• Work in a structured environment under direct to moderate supervision

• Adhere to GxP 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 or GCLP)

• 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

• Experience with Benchling LIMS

• 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 Biomek or end-to-end robotic platforms using Momentum

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!

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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.

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