Zentalis Pharmaceuticals is a San Diego based pharmaceutical company dedicated to the discovery and development of small molecule therapeutics targeting fundamental biological pathways of cancer. In the six years since our inception, we have successfully cleared four INDs with the FDA. We believe our deep pipeline of oncology therapeutics has the potential to significantly improve the lives of patients with various types of cancer.
SUMMARY:
Lead process development activities for all drug candidates from early-stage development thru commercialization for small molecule and biologic programs in support of Zentalis’ Integrated Discovery Engine. Provide strategic leadership to our team for the management of CDMOs to develop and optimize API, manufacture clinical supply and commercial supply. Responsible for building and motivating a collaborative team with exceptional subject matter expertise. In cooperation with Quality and Regulatory functions, ensure all development and manufacturing operations are compliant with applicable laws, regulations and guidelines to ensure patient safety and to support regulatory filings worldwide.
RESPONSIBILITIES:
- Manage the Process Chemistry group and supervise the process development and manufacture of starting materials, intermediates, and portfolio drug candidates
- Participate in cross functional project teams for product development and as CMC functional area representative
- Responsible for the design, development and optimization of synthetic processes that are suitable for drug substance manufacturing on production scale
- Assist in RFP writing, technical transfer, route optimization, qualification and validation of activities related to all manufacturing operations
- Alongside Quality Assurance and Regulatory Affairs, evaluate third-party manufacturers and assist in negotiating effective supply/technical agreements
- Design and oversee execution of process development activities in preparation for Registration and Validation activities
- Assist in the management and execution of Primary/Registration activities in preparation for regulatory filings
- Assist with the writing of drug substance sections of regulatory documents, including Investigator’s Brochure, Pharmacy Manual, Study Protocols, IND filings, IMPD, and DMFs
- Track proposals and invoices to insure alignment with approved budget
- Manage consultants, and CROs/CMOs to develop robust, scalable manufacturing processes while meeting aggressive program timelines/budgets
- Supervises: Process Chemistry / CMC Team
- Other duties and projects as assigned
REQUIREMENTS:
- PhD in organic chemistry or equivalent with a minimum 15+ years of experience in process development and CMC within the biotech or pharma industry
- 5 years in significant leadership role(s) which involved management and leadership of multi-functional teams and delivering results within aggressive project timelines
- Leadership experience with CMC scientists and experience managing within a virtual manufacturing environment or a smaller biotech organization is preferred
- Demonstrated expert level knowledge of process chemistry through the development and implementation of robust drug substance manufacturing processes
- Expertise in worldwide regulatory and compliance practices, including cGMP, ICH guidelines and QbD
- Working knowledge of preparation and submission activities for global regulatory filings, specifically in relation to CMC
- Demonstrated hands on working experience with all stages of drug development, as well as in-depth knowledge and understanding of cGMP requirements and CMC regulatory requirements for small and large molecule drug candidates
- A successful track record in selection and management of CROs/CMOs including site qualification, technical transfer, clinical and commercial supply activities
- Outstanding interpersonal verbal, written, and presentation skills in communication with internal and external colleagues and partners
- Ability to facilitate and lead within a highly collaborative environment with the generosity to provide critical input at all levels and the humility to consider and integrate ideas of others
- Well-developed organizational skills with the ability to handle multiple projects and thrive under pressure
- Has demonstrated ability to manage internal and external development teams, set performance goals and ensure that objectives are met
- Has demonstrated ability to oversee contract drug substance process development and manufacturing operations at third-party service providers
- Has demonstrated ability to establish and manage budgets and schedules
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