Job Summary: We are seeking a highly motivated and experienced individual to join our team as an Associate Director/Director of Analytical Development. The successful candidate will lead and manage the analytical development team, contributing to the development, validation, and implementation of analytical methods for small molecule oral solid dosage forms. This role requires a strong background in pharmaceutical analytical chemistry, regulatory compliance, and leadership skills.
Leadership and Team Management:
- Lead, mentor, and manage a team of analytical scientists, fostering a collaborative and high-performance work environment.
- Provide strategic direction and set clear objectives for the analytical development team.
Analytical Method Development:
- Develop and optimize analytical methods for the characterization and quality control of small molecule oral solid dosage forms.
- Ensure methods are robust, efficient, and compliant with regulatory requirements.
Method Validation and Transfer:
- Lead method validation activities according to ICH guidelines.
- Collaborate with cross-functional teams to ensure successful method transfer to quality control and manufacturing groups.
Instrumentation and Technology Assessment:
- Evaluate and recommend new analytical instrumentation and technologies to enhance laboratory capabilities.
- Ensure the maintenance and calibration of analytical instruments.
- Stay updated on current regulatory requirements and industry standards related to analytical development.
- Ensure all analytical activities and documentation meet regulatory standards (FDA, EMA, etc.).
- Oversee data integrity and documentation practices in compliance with Good Documentation Practices (GDP).
- Maintain accurate and organized records of analytical experiments and results.
- Collaborate with cross-functional teams to support product development and ensure project timelines are met.
- Provide analytical support for regulatory submissions.
- Ph.D. in Analytical Chemistry or related field preferred. Master's degree with substantial experience will also be considered.
- 8+ years of experience in pharmaceutical analytical development, with a focus on small molecule oral solid dosage forms.
- Proven leadership and team management skills.
- Strong knowledge of analytical techniques, including HPLC, GC, dissolution, spectroscopy, and wet chemistry.
- Experience with method validation, transfer, and regulatory submissions.
- Knowledge of cGMP regulations and quality standards.
- Excellent communication and interpersonal skills.
- Ability to work effectively in a collaborative, fast-paced environment.