Job Summary:
We are seeking a highly skilled Technical Lead to join our team in a challenging and rewarding role. As a key member of our Biopharmaceutical Laboratory, you will be responsible for the regulatory and scientific conduct of development and stability projects.
About the Role:
The successful candidate will have expertise in method development, validation and troubleshooting across multiple assay formats, clients and cell lines. They will also have excellent analytical and problem-solving skills, with the ability to work independently and as part of a team.
Key Responsibilities:
• Perform analytical testing, method optimization/validation, and/or other speciality technologies studies OR method transfers for pharmaceutical and biopharmaceutical compounds in a variety of formulations and/or delivery systems
• Understand and conform to methods, and protocols applicable to assigned tasks
• Design and complete experiments independently
• Review and critique study protocols, project status reports, final study reports and other project-related technical documents
• Prepare and review study protocols, project status reports, final study reports and other project-related technical documents
• Communicate data and technical issues to clients on a weekly basis (or as needed)
• Provide technical mentorship and training to staff
• Lead analytical (procedural and instrumental) troubleshooting sessions
• Assist in preparation and implementation of SOPs and quality systems
• Review, interpret, and analyses data for technical, quality and compliance to protocols, methods, SOPs, client criteria and Good Manufacturing Practices (GMP)
Requirements:
• Degree or equivalent in Chemistry or Biochemistry
• Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 5+ years)
• Knowledge of general chemistry, biochemistry techniques (Western Blot, total protein by BCA or micro BCA assay, ELISA, HPLC/UPLC)
• Proven experience of method development of identity and purity assays by Western Blot
• Ideally experience in leading CMC studies for biopharmaceutical products including method validation
• Proficiency on technical operating systems (including Image Lab software)
• Proven problem solving and troubleshooting abilities
• Ability to independently perform root cause analysis for method investigations
• Proven ability in technical writing skills
• Time management and project management skills
• Good written and oral communication skills
• Ability to work in a collaborative work environment with a team
• Ability to train junior staff
Benefits:
We offer a comprehensive benefits package, including medical, dental, and vision insurance, as well as a generous retirement plan and paid time off.
Other Information:
This is a challenging and rewarding role that requires a high level of technical expertise and problem-solving skills. If you are a motivated and experienced professional looking for a new challenge, we encourage you to apply.