Analytical Services Manager - Brightpath Associates LLC : Job Details

Analytical Development Manager

boca Raton, FL

Full time/onsite

Job Summary:

The Analytical Development Manager will lead and support the development and validation of analytical methods for biologics, focusing on new and improved processes. The successful candidate will bring technical expertise, management experience, and a passion for developing cutting-edge analytical solutions in a collaborative environment.

Key Responsibilities:

• Develop and improve analytical methods, processes, and protocols for biologics and other relevant applications.
• Lead and mentor a team of scientists, providing guidance in experimental design and problem-solving.
• Independently design, execute, and analyze studies in alignment with company goals and regulatory requirements.
• Stay updated on industry developments, including ICH and USP guidelines, and implement best practices.
• Collaborate with cross-functional teams (e.g., Process Development, Manufacturing, Regulatory Affairs, Quality) to ensure project alignment and successful outcomes.
• Serve as a technical expert on analytical method development, validation, and GMP compliance.
• Use statistical analysis to interpret and report data accurately.
• Interface with stakeholders to communicate project updates, address challenges, and provide innovative solutions.

Qualifications:

Education:

• PhD or Master's degree in Biochemistry, Chemical Engineering, Biophysics, Biology, or a related field.
• Alternatively, a Bachelor's degree with at least 12 years of experience in biologics or analytical development.

Experience:

10+ years of experience in developing analytical methods for biologics or related fields.

Minimum 3 years of experience working in a GMP environment.

Proven ability to manage and mentor teams, collaborate across departments, and communicate effectively.

Skills:

Strong technical expertise in analytical development and validation.

Excellent verbal and written communication skills.

Proficient in statistical analysis for data interpretation.

Ability to stay updated with industry standards and apply innovative solutions to enhance processes.