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.
JOB SUMMARY:
Lead Drug Product development activities. Responsible for working with internal and external team members to meet Company timelines and objectives for CMC Drug Product. Responsibility for manufacturing, supply chain, procurement and distribution activities for drug product, as well as preparation of CMC sections for regulatory submissions. Also responsible for participating in and supporting novel drug development projects.
ESSENTIAL DUTIES AND RESPONSIBILITIES:
- Lead the formulation development, process development, manufacture, release, and stability of portfolio drug candidates with preferred expertise in drug product activities
- Take a lead in RFP writing, technical transfer, process and method development, optimization, qualification and validation of activities related to all manufacturing operations
- Evaluate third-party manufacturers by working with Quality Assurance and Regulatory Affairs, assist in negotiating effective supply/technical agreements
- Identify and manage contract analytical laboratory site(s) required to guide and support third party manufacturing relationships
- Design and oversee execution of drug product activities in preparation for Registration and Validation activities
- Participate in cross functional project teams for product development as CMC functional area representative
- Assist in the management and execution of Primary/Registration activities in preparation for regulatory filings
- Author relevant 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 CMC budget.
- Manage consultants, vendors, and CMOs to meet agreed upon program timelines/budgets.
- Manage and supervise drug product team.
- ·Other projects as deemed appropriate.
KNOWLEDGE/SKILLS/ABILITIES REQUIRED:
- Ph.D. in Pharmaceutics, Pharmaceutical Sciences or related discipline and 10+ years of hands on experience with increasing responsibility in pharmaceutical development
- Experiences in drug product development from early to late stages of small molecules.
- Must have extensive experiences with sterile injectables and liquid oral dosage forms.
- A successful track record in selection and management of CROs/CMOs including site qualification, technical transfer, clinical supply logistics and oversight of activities.
- Must have experience in writing CMC documents for regulatory submissions and a strong understanding of pharmaceutical development, quality and regulatory issues.
- In-depth knowledge and full understanding of GMP requirements and CMC regulatory requirements for small molecule drug candidates.
- Ability to multi-task/ prioritize and time management of daily activities
- Intermediate to advanced software skills (e.g., Microsoft Excel, PowerPoint, MS Project)
- High attention to detail
- Demonstrates high level of accuracy and effective oral and written communication skills.
- Flexibility within a rapidly changing environment
- Excellent ability to work in a goal and team-oriented setting.
- Well-developed organizational skills and the ability to thrive under pressure
- Management and supervisory experience preferred.
- Ability to travel up to 30%.
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