Biotechnology company is hiring a Scientist to join the Analytical Development team to support method development, qualification, and execution for the characterization of complex biologics. This position requires hands-on laboratory experience working with analytical techniques for testing of drug substance and drug product to provide phase appropriate analytical development in support of clinical programs to commercial registration and post approval improvements.

This is a 9-month contract.

Responsibilities

• Execute technical analytical methodologies to support development and validation of test methods.
• Author and review analytical methods, protocols, reports, and other technical documents, including instrument qualification and change control.
• Operate and maintain (as well as overseeing the installation of) sophisticated analytical instrumentation and associated computer control systems.
• Be part of a team that establishes, maintains, and improves technical operations and project outcomes in the Analytical Development area.
• Provide support for laboratory operations – inventory tracking, reagent preparation, sample management, and documentation review.
• Execute analytical and biological methods ensuring compliance with applicable ICH guidelines and global regulations.
• Ensure adherence to GMPs, GLPs, GCPs and GDPs where required.

Qualifications

• Master's in biological sciences and 5+ years of experience or PhD with 2+ years of experience in the biotechnology or pharmaceuticals industry.
• Experience performing basic analytical assay techniques such as absorbance assays, chromatography, CE-SDS, ELISA/AlphaLISA, and western blot.
• Ability to work on multiple projects simultaneously, demonstrating organizational and problem-solving skills
• Self-motivated, proactive and driven individual with an interest in experimental design and development.
• Strong GxP knowledge.
• Preferred qualifications:
• Expert level understanding in drafting protocols, methods, and/or procedures.
• Expert level understanding in method qualification and validation.
• Experience or working knowledge in neurotoxin as therapeutics.
• Experience in performing change control, deviation, laboratory investigation, and/or other quality records.

Pay

• $48.41-$60.52/hr

Why Choose R&D Partners?

As an employee, you have access to a comprehensive benefits package including:

• Medical insurance – PPO, HMO & HSA
• Dental & Vision insurance
• 401k plan
• Employee Assistance Program
• Long-term disability
• Weekly payroll
• Expense reimbursement
• Online timecard approval

R&D Partners is a global functional service provider and strategic staffing resource specializing in scientific, clinical research & engineering. We provide job opportunities within major pharmaceutical, biopharmaceutical, biotechnology, and medical device companies.

R&D Partners is an equal-opportunity employer.