What are the responsibilities and job description for the Bioanalytical Scientist II - FSP position at Parexel?
We are looking to fill a Bioanalytical Scientist II 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
The CMC Operations group is part of Parexel FSP. 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!
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 MSD, Luminex, Neutralization assays or similar platforms
- Maintain cell lines and / or reagent and lab inventories
- 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 troubleshooting 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
- Scientist 2: B.S./B.A or 1-2 yrs. of experience in Molecular Biology, Immunology, Cell Biology, Biology, Biochemistry, Biology, or related biological science discipline
- Working experience in a regulated environment (GxP, preferably GLP)
- Experience with immunogenicity assays such as ELISA, Luminex, or MSD and/or experience in cell culture or cell based assays such as nAb assays, PBMC isolation, or ELISPOT assay.
- Familiarity 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
- Ability to handle multiple projects under tight timeline and problem-solving skills
- High sense of responsibility, accountability, and professional integrity
The CMC Operations group is part of Parexel FSP. 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!
