Scientist
Job
Actalent
Sanford, NC (In Person)
$109,200 Salary, Full-Time
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Job Description
Job Title:
Scientist - Method Transfer and Development (GMP Biopharmaceuticals) Job Description This Scientist position supports a Method Transfer and Development Group within a large, flexible, multi‑product biopharmaceutical manufacturing site focused on vaccine intermediates and drug substance, as well as gene therapy drug substance and drug product. The role centers on transferring and validating analytical methods—primarily HPLC and plate-based assays—for vaccine drug products and related components being brought into the site. You will collaborate closely with a team of scientists, drive assigned projects to completion, and contribute directly to the delivery of safe and effective products to patients within a science- and risk-based quality culture. Responsibilities Transfer and validate analytical methods for various vaccine drug products and components being introduced to the manufacturing site. Perform routine and non-routine testing using HPLC/UPLC and chromatography techniques in a GMP pharmaceutical environment. Execute cell-based and plate-based assays, including ELISA and other bioanalytical plate-based methods, to support method transfer and development activities. Apply qPCR and PCR method validation expertise to support assay development and qualification for vaccine and gene therapy products. Generate, review, and interpret analytical data, ensuring accuracy, completeness, and compliance with GMP and internal quality standards. Prepare clear, detailed technical documentation and reports summarizing method transfer, validation studies, and testing outcomes. Collaborate cross-functionally with other groups and sites within the network to coordinate method transfers and resolve technical issues. Work closely with project management to drive assigned projects to completion, meeting timelines and quality expectations. Support assay development activities to improve existing methods and contribute to the implementation of new analytical approaches. Participate in troubleshooting of analytical methods and equipment, escalating issues and contributing to continuous improvement. Adhere to all laboratory procedures, GMP regulations, and safety guidelines while working with vaccine and gene therapy materials. Engage in training on additional analytical methods beyond core project scope, expanding technical breadth and supporting site innovation. Essential Skills At least 2+ years of experience in a GMP pharmaceutical environment. Hands-on HPLC/UPLC and chromatography experience, preferably 5+ years, supporting method transfer, validation, or routine testing. Demonstrated experience with plate-based assays, including ELISA, in a bioanalytical or QC setting. Practical experience with cell-based or plate-based assays for vaccine or biologics testing. qPCR experience and PCR method validation expertise applied to assay development and qualification. Bachelor's degree in a relevant scientific discipline (such as Chemistry, Biochemistry, Biology, or related field) as a minimum requirement. Proven ability to work under GMP guidelines, including documentation, data integrity, and compliance practices. Strong technical writing skills for authoring and reviewing scientific reports and method documentation. Ability to collaborate effectively with cross-functional teams and communicate technical information clearly. Additional Skills & Qualifications Advanced degree (Master's or PhD) in a relevant scientific field is a plus. Broader bioanalytical testing experience beyond core methods is considered an advantage. Experience with assay development and optimization for biologics, vaccines, or gene therapy products. Familiarity with method transfer between sites or groups within a larger networked organization. Strong problem-solving and troubleshooting skills for analytical methods and instrumentation. Comfort working in a fast-paced, high-profile project environment with evolving priorities. Motivation to learn new analytical techniques and expand technical capabilities. Commitment to a science- and risk-based quality culture that emphasizes flexibility, innovation, and customer orientation. Work Environment The role is based within a large pharmaceutical manufacturing organization that focuses on vaccine and gene therapy manufacturing, including large-scale microbial fermentation, purification, conjugation, and cell banking operations. You will work in a GMP laboratory environment equipped for HPLC/UPLC, chromatography, qPCR, and a variety of plate-based and cell-based assays. The standard schedule is first shift, Monday through Friday, typically 8:00 a.m. to 5:00 p.m., with some overtime as needed and only occasional weekend work, which is not expected to be frequent. The culture emphasizes innovation, scientific rigor, and a strong commitment to delivering high-quality, safe, and effective products to patients. Team members have the opportunity to work on high-profile, fast-track projects and to receive training on additional analytical methods beyond their core project responsibilities, contributing to professional growth and development. Job Type & Location This is a Contract position based out of Sanford, NC. Pay and Benefits The pay range for this position is $45.00 - $60.00/hr. Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to specific elections, plan, or program terms. If eligible, the benefits available for this temporary role may include the following:- Medical, dental & vision
- Critical Illness, Accident, and Hospital
- 401(k) Retirement Plan - Pre-tax and Roth post-tax contributions available
- Life Insurance (Voluntary Life & AD&D for the employee and dependents)
- Short and long-term disability
- Health Spending Account (HSA)
- Transportation benefits
- Employee Assistance Program
- Time Off/Leave (PTO, Vacation or Sick Leave) Workplace Type This is a fully onsite position in Sanford,NC.
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