Director, Drug Product Development

Kardigan•Princeton, NJ

16h•$204,000 - $266,000•Onsite

About The Position

Kardigan is seeking a Director, CMC Drug Product Development, to support development of late phase projects. This role will report directly into the Head of Drug Product Development. In this role, you will be responsible for the leadership, management and oversight of outsourced formulation development, process development, scale-up, validation, technology transfer, and file launch activities required to support Kardigan’s portfolio of small molecules and oligonucleotides. This hands-on role will lead drug product development, scale-up, technology transfer, registration and validation batches, authoring of Module 3 documents and working closely with CDMOs to support inspection readiness. This is a 4-day, onsite position, based in South San Francisco or Princeton NJ.

Requirements

S. or PhD in pharmaceutical sciences, chemical engineering, or a related discipline. Advanced degree preferred.
Minimum 10 years' experience within pharmaceutical CMC development and Technical Operations. Experience with both sterile and oral products, including device development is preferred
Sound knowledge of formulation development, process engineering and plant operations
Demonstrated experience with drug product process development, scale-up, and optimization from R&D through commercialization, including an understanding of the interdependencies of functional groups and working closely with external CDMOs.
Significant experience in working with global health authorities, IND, IMPD, NDA, MAA etc.
Experience with process validation and continuous process improvement.
Extensive knowledge of regulated manufacturing, GMP, GCP and quality systems.
Creative/innovative/problem solver that actively drives progress.
Ability to manage multiple projects in a fast-paced environment.
Strong interpersonal communication skills, proven ability to build and maintain collaborative, effective internal and external relationships.
Excellent written, oral communication, and presentation skills along with the ability to communicate effectively with senior management.
Ability to effectively collaborate in a dynamic, cross-functional matrix environment.

Nice To Haves

Ideally experience with commercializing small molecule drug products

Responsibilities

Lead drug product development for both early phase and late phase assets.
A member of CMC project teams accountable for all drug product development and manufacturing activities to support both early and late phase projects.
Manage and oversee outsourced formulation development, process development, scale-up, validation, technology transfer, and clinical/commercial drug product manufacturing to support early and late Phase clinical development programs and future commercial supply.
Ensure formulation and drug products meet the target product profile necessary to enable the successful commercialization of the product.
Develop phase-appropriate pharmaceutical project plans, participate in CDMO selection, and manage successful execution of these plans consistent with corporate timelines and compliant with cGMP/regulatory requirements and expectations.
Develop, review, and approve manufacturing batch records, manage internal batch release activities.
Establish appropriate drug product specifications and stability studies in partnership with Analytical, Quality, CDMOs, Regulatory, and other subject matter experts to support intended use.
Write and review protocols, reports, and drug product sections for regulatory documents.
Contribute to product investigations and conduct root cause analysis.
Interface and coordinate activities with drug substance, analytical development, regulatory affairs, quality assurance, and product supply to ensure on time release and uninterrupted supply of drug product.
Collaborate with legal and procurement to review contract terms and execution of agreements.
Keep up with the latest regulatory and cGMP guidance and awareness of state-of-the-art manufacturing practices.
Monitor status of CDMO capacity, manage risks and make recommendations to Kardigan’s leadership team.
Manage the negotiation of contracts broadly applicable to drug product manufacturing. Ownership of the contract deliverables and obligations.