Scientist, Analytical Development

Actalent • Louisville, CO

359d • $53 - $66

About The Position

We are seeking a driven Scientist to join our Process Analytics team and deliver four UPLC analytical methods in Analytical Development and Quality Control. The individual contributor will develop separation methods to quantify residual process reagents in lentiviral vector Drug Product and in-process samples. Additionally, early phase validation and transfer of these methods to Quality Control is critical to enable release testing of GMP lots. The ideal candidate has experience in chromatography systems and multiple detection methods (e.g., UV/Vis, Fluorescence, CAD). The successful candidate will work independently, meet timelines, and maintain detailed documentation of experiments in an Electronic Laboratory Notebook (ELN). This role is 100% lab-based and involves close collaboration with other functions to ensure the successful transfer of qualified methods.

Requirements

• Expertise with UPLC systems, Thermo (Chromeleon) preferred.
• Experience with UV/VIS, Fluorescence detection, and CAD.
• Self-motivated and organized.
• Ability to work in a fast-paced environment, meet deadlines, and prioritize work on multiple projects.
• Excellent communication skills with the ability to build collaborative relationships and work successfully as part of a multidisciplinary team.
• PhD/MS/BS in Biology, Biochemistry, or a related discipline with 2/7/10 years of relevant experience, respectively. Equivalent combinations of education and experience will be considered.

Nice To Haves

• Experience in validating UPLC and HPLC methods.
• Industry experience with Quality Control.
• Experience in method development for polymers, lipids, and quantifying impurity methods.

Responsibilities

• Develop UPLC methods to quantify new process reagents and demonstrate effective clearance.
• Collaborate with Analytical Development and Quality Control team members on various stages of the analytical method lifecycle (development/qualification/transfer).
• Work with systems engineers to create sample submission and result reporting workflows to support ongoing testing.
• Execute experiments flawlessly and maintain compliant records in an electronic notebook system.
• Manage and prioritize sample submissions for respective methods and report data in a timely manner.
• Prepare technical data reports and presentations.
• Perform physical tasks required for the role, including standing, walking, bending, kneeling, sitting, working with hands in a biosafety cabinet, and occasionally moving materials up to 50 pounds.
• Complete project-oriented work requiring regular on-site presence.

Benefits

• 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)

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level
• Industry: Administrative and Support Services
• Education Level: Master's degree
• Number of Employees: 1,001-5,000 employees