Senior Manager / Associate Director of Analytical Research and Development

Title: Senior Manager / Associate Director of Analytical Research and Development

Location: Vacaville

Department: Research and Development

Reports to: COO / CEO

CORE VALUES

Respect ● Passion ● Teamwork ● Integrity ● Honesty ● Commitment ● Collaboration

Position Overview:

As the Head of Analytical Research and Development, you will lead our team in pioneering analytical methods that are critical to the development and commercialization of new pharmaceutical products. This role is key to our company's commitment to providing safe, effective, and innovative drug solutions to the market. Your leadership will directly influence the success of our products and uphold our reputation in the industry.

Key Responsibilities:

• Strategic Development: Design and implement strategies for the development of new analytical methods and the improvement of existing ones to enhance efficiency, accuracy, and compliance.
• Technical Leadership: Provide technical expertise in method development and validation, ensuring robust, precise, and scalable analytical processes.
• Regulatory Compliance: Ensure all analytical practices meet industry standards and regulatory requirements, including FDA, EMA, and ICH guidelines. Lead preparations for regulatory submissions and inspections.
• Cross-functional Collaboration: Work closely with other department heads to integrate analytical development with overall product development timelines and goals. Support manufacturing and quality teams by providing critical analytical data and insights.
• Team Management and Development: Lead, mentor, and develop a team of analytical chemists and research associates, promoting a culture of continuous improvement and innovation.
• Budget and Resource Management: Manage departmental budgets and resources effectively, ensuring optimal allocation for projects and strategic initiatives.
• Innovation and Research: Stay at the forefront of analytical science by engaging with academic research, attending conferences, and applying innovative techniques and technologies in the lab.
• Problem Solving: Act as the primary troubleshooter for any analytical issues during product development and post-launch, minimizing risks and delays.

Qualifications:

• PhD or MS in Chemistry, Biochemistry, or a closely related field with at least 10 years of experience in a pharmaceutical R&D setting.
• Extensive experience in leading analytical method development and validation for pharmaceutical applications.
• Proven track record of successful management and leadership in a complex, dynamic environment.
• Comprehensive knowledge of advanced analytical techniques and instrumentation, including but not limited to HPLC, GC, MS, and spectroscopy.
• Demonstrated ability to navigate and lead through regulatory audits and submissions.

Preferred Skills:

• Strategic thinker with a clear ability to set priorities, make decisions, and deliver results.
• Strong communicator capable of presenting complex data and strategies to stakeholders, including non-scientific audiences.
• Experience with international regulatory requirements and global markets.