Bioanalytical Scientist II - FSP

Posted 3 Days Ago
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Hiring Remotely in Pennsylvania
Remote
1-3 Years Experience
Pharmaceutical
The Role
The Bioanalytical Scientist II at Parexel is responsible for developing and qualifying bioanalytical assays, analyzing samples using various platforms, maintaining lab inventories, and adhering to GxP regulations. The role includes data assessment, documentation adherence, report generation, and collaboration within teams, all while ensuring compliance with safety and operational procedures.
Summary Generated by Built In

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 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

  • 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

Qualifications

  • 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

Desired Skills and Experience

  • 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

About Parexel FSP

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!

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.

Top Skills

Biochemistry
Cell Biology
Immunology
Molecular Biology
The Company
HQ: Durham, North Carolina
20,524 Employees
On-site Workplace

What We Do

Parexel is among the world’s largest clinical research organizations (CROs), providing the full range of Phase I to IV clinical development services to help life-saving treatments reach patients faster. Leveraging the breadth of our clinical, regulatory and therapeutic expertise, our team of more than 21,000 global professionals collaborates with biopharmaceutical leaders, emerging innovators and sites to design and deliver clinical trials with patients in mind, increasing access and participation to make clinical research a care option for anyone, anywhere. Our depth of industry knowledge and strong track record gained over the past 40 years is moving the industry forward and advancing clinical research in healthcare’s most complex areas, while our innovation ecosystem offers the best solutions to make every phase of the clinical trial process more efficient. With the people, insight and focus on operational excellence, we work With HeartTM every day to treat patients with dignity and continuously learn from their experiences, so every trial makes a difference. For more information, visit parexel.com.

Community Guidelines
Because Parexel’s social media channels are open to the general public and employees, we are not responsible for views expressed other than our own. However, we do not tolerate posts that are:

• Abusive, harassing or threatening to others.
• Defamatory, offensive, obscene, vulgar or depicting violence.
• Hateful targeting by race/ethnicity, age, color, creed, religion, gender,
sexual preference or orientation, nationality or political beliefs.
• Sexually explicit or pornographic.
• Fraudulent, deceptive, libelous, misleading or unlawful.
• Referencing criminal or illegal activity.
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We reserve the right to remove any comments that do not adhere to our guidelines as well as report users who violate the rules of our page.

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