Associate VP, Head of Development

Agilent Technologies•Boulder, CO

About The Position

As a member of the executive leadership team within Agilent's Nucleic Acid Solutions Division, you will play a pivotal role in guiding the organization’s strategic direction for oligonucleotide drug substance manufacturing. This contract development and manufacturing organization is dedicated to providing clients with high-quality oligonucleotide drug substance production and related services. In this capacity, you will lead and oversee a dynamic and rapidly expanding department of scientists. Your responsibilities will include managing teams focused on developing chemical processes and analytical methods essential for the efficient manufacture and rigorous testing of oligonucleotide active pharmaceutical ingredients (APIs). By fostering collaboration and innovation within your department, you will ensure the delivery of reliable and scalable solutions that meet both client and regulatory standards. Responsible for overseeing the optimization, scale-up, and validation of manufacturing processes for oligonucleotide APIs that support investigational therapies as such therapies advance through the drug development life cycle. Provide regular interface with Agilent's clients for the purpose of technical goal alignment, project technical updates, and project status. Serve as the scientific ambassador of Agilent's Nucleic Acid Solutions Division to the world-wide BioPharma community by giving technical talks at industry trade shows and webinars, as well as authoring scientific publications including patents as applicable. Lead continuous improvement initiatives by innovating and/or collaborating on next generation manufacturing and analytical techniques for producing oligonucleotide drug substances. Support employee development, deliver feedback, evaluate performance, and ensure staff are trained in technical, scientific, regulatory, developmental, and GMP areas. Create a collaborative work culture that values teamwork, innovation, open communication, and a strong work ethic.

Requirements

Ph.D. in synthetic organic chemistry, biochemistry, or a master's degree in chemical engineering or a related discipline.
Ten years of experience in drug substance development within GMP production settings.
Five years leading teams composed of scientists, chemists, or engineers.
Advanced proficiency in pharmaceutical development, successfully transferring safe, efficient, and scalable processes and testing protocols for API preparation and analysis.
Skilled in formulating and articulating departmental objectives and strategies.
Experienced in working closely with Agilent clients to customize solutions for their specific program requirements.
Proficient at managing tight deadlines and consistently delivering projects on schedule.
Adept at applying Quality by Design and Quality Risk Management principles to the development of drug substance processes
Expertise in Design of Experiments (DOE), Process Acceptable Ranges (PAR), and statistical process control, with knowledge of PAT tools and Quality by Design practices.
Extensive hands-on experience with HPLC, GC-MS, LC-MS, MS-MS, NMR, and other analytical instruments used in chemical research.
Competent in electronic databases, and literature and patent search platforms like SciFinder.
Thorough understanding of regulatory standards including ICH Q7 and GMP compliance requirements.
Background in public speaking, technical presentations, and sharing innovative developments in process or chemical research.

Responsibilities

Lead and oversee a dynamic and rapidly expanding department of scientists.
Managing teams focused on developing chemical processes and analytical methods essential for the efficient manufacture and rigorous testing of oligonucleotide active pharmaceutical ingredients (APIs).
Ensure the delivery of reliable and scalable solutions that meet both client and regulatory standards.
Overseeing the optimization, scale-up, and validation of manufacturing processes for oligonucleotide APIs that support investigational therapies as such therapies advance through the drug development life cycle.
Provide regular interface with Agilent's clients for the purpose of technical goal alignment, project technical updates, and project status.
Serve as the scientific ambassador of Agilent's Nucleic Acid Solutions Division to the world-wide BioPharma community by giving technical talks at industry trade shows and webinars, as well as authoring scientific publications including patents as applicable.
Lead continuous improvement initiatives by innovating and/or collaborating on next generation manufacturing and analytical techniques for producing oligonucleotide drug substances.
Support employee development, deliver feedback, evaluate performance, and ensure staff are trained in technical, scientific, regulatory, developmental, and GMP areas.
Create a collaborative work culture that values teamwork, innovation, open communication, and a strong work ethic.