- Lead bioanalytical testing activities, primarily focusing on ELISA techniques.
- Develop and validate analytical methods for bioanalytical testing, ensuring accuracy and reliability.
- Perform routine and non-routine analysis of raw materials, intermediates, and finished products according to established protocols and regulatory requirements.
- Lead troubleshooting efforts and investigations related to bioanalytical testing, ensuring timely resolution of issues.
- Mentor and train junior team members in bioanalytical techniques, laboratory procedures, and best practices.
- Collaborate cross-functionally with other departments, including R&D, Manufacturing, and Regulatory Affairs, to support product development and quality assurance efforts.
- Ensure compliance with relevant regulatory guidelines (e.g., FDA, EMA) and internal quality standards.
- Bachelor's or Master's degree in Chemistry, Biochemistry, or a related field.
- Minimum of 5 years of experience in bioanalytical testing, with a focus on ELISA techniques.
- Proven expertise in method development, validation, and troubleshooting in bioanalytical testing.
- Strong understanding of regulatory requirements and quality standards applicable to bioanalytical testing (e.g., cGMP, ICH guidelines).
- Excellent leadership and communication skills, with the ability to effectively mentor and guide junior team members.
- Highly organized with strong attention to detail and ability to manage multiple priorities in a fast-paced environment.
- Team player with a collaborative mindset and ability to work cross-functionally.
- Competitive salary commensurate with experience.
- Comprehensive benefits package including medical, dental, and vision coverage.
- Retirement savings plan with company match.
- Opportunities for professional development and career advancement.
- Dynamic and collaborative work environment with a focus on innovation and excellence.
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Lead Quality Control Chemist - Fort Lauderdale, United States - EPM Scientific
Description
Lead QC Chemist
Location: Fort Lauderdale, FL
Work situation: onsite
Overview: A mid-size Biotech is seeking a talented and experienced QC Chemist Lead specializing in bioanalytical testing, particularly in the utilization of ELISA techniques. The successful candidate will play a pivotal role in ensuring the quality and reliability of our products through rigorous testing protocols. This role offers the opportunity not only to lead bioanalytical testing activities but also to mentor and guide junior team members in developing their skills and knowledge.
Key Responsibilities:
Qualifications:
Benefits: