Director/Sr. Director, Drug Product Manufacturing
Posted on Friday, January 19, 2024
Cullinan Oncology is dedicated to creating new standards of care for patients with cancer.
We innovate without borders to find the most promising clinic-ready cancer therapies, whether from our own discovery efforts or through exceptional engagement with our academic and industry partners.
Anchored in a deep understanding of immuno-oncology and translational cancer medicine, we leverage our scientific excellence in small molecules and biologics to create differentiated ideas, identify unique targets, and select the optimal modality to develop transformative therapeutics across cancer indications.
Powered by our novel research model, we push conventional boundaries from candidate selection to cancer therapeutic, applying rigorous early experimentation to fast-track only the most promising assets to the clinic and ultimately commercialization.
As a result, our diversified pipeline is strategically built with assets that activate the immune system or inhibit key oncogenic drivers across a wide range of modalities, each with the potential to be the best or first in their class.
Our people possess deep scientific expertise, seek innovation openly, and exercise creativity and urgency to deliver on our promise to bring new therapeutic solutions to patients with cancer.
The Director/Sr. Director of Formulation & Drug Product Development and Manufacturing (Clinical and Commercial) will be responsible for leading the development and characterization of formulations and drug product processes for biologics programs throughout the lifecycle of a program, from early Clinical Development to Pivotal, and Commercial stages. They will be a member of the CMC Team that is responsible for providing strategy, decisions, and oversight on the development and manufacturing processes for all aspects of process development (Cell Culture, Purification, Drug Product, Analytical Sciences). The execution of all development and manufacturing activities for Cullinan Oncology is via a network of external providers.
- Provide leadership and direction in Formulation and Drug Product Development and Manufacturing.
- Accountable for development and characterization of robust formulations that deliver to phase appropriate Target Product Profiles (TPPs) and drug product processes to support Clinical and eventual Commercial manufacturing, including Lifecycle Management.
- Support regulatory filings by guiding the review and approval of appropriate CMC sections; support associated agency interactions and product-related inspections.
- Partner with cross functional members across Cullinan Oncology, including Quality, Supply Chain, Regulatory Affairs, Research, Clinical Development, Finance, and Legal to ensure successful development of the pipeline portfolio, as well as on time delivery of clinical and commercial product.
- Manage network of external vendors for all development and manufacturing activities, as appropriate, for a broad pipeline of products.
- Demonstrate a knowledge of the cGMP practices and compliance requirements.
- Drive development and implementation of new process technologies to meet business and portfolio needs.
- Remain current on trends and new technology advancements across the biopharmaceutical industry.
- Establish goals that are consistent with the portfolio & functional priorities and ensure the right balance between near term and longer-term objectives to position the organization for sustained success.
- Ph.D. or M.S. in Chemical Engineering or relevant scientific discipline with at least 15 years of experience in formulation and drug product development and a record of roles with increasing responsibility and track record of progressing portfolio assets from INDs to MAAs.
- Strong understanding and extensive hands‐on experience in drug product process development. In-depth knowledge and deep understanding of formulation development, fill/finish process engineering, with a particular working knowledge of non-standard biologics (non-monoclonal antibodies). In-depth knowledge of industry best practices & trends.
- Proven experience in the generation of relevant regulatory sections of IND, BLA and MAA filings.
- Previous success working effectively in a multidisciplinary, highly matrixed environment.
- Excellent decision-making, written and verbal communication skills.
- Proven ability to manage external contractors, contract development and testing laboratories.
- Exceptional interaction, leadership and command skills are required.
- Motivated self-starter with excellent interpersonal and organizational skills. Strong self-awareness of the impact communication and working style has on others.
- Exceptional influencing, partnership, and collaboration skills and ability to drive results within a matrix environment.
- Leadership qualities of the successful candidate include the following: collaboration, accountability, stakeholder management, cross-functional engagement and influence, program management, strategic vision, executive presence.
- Proven track record of managing external vendors for testing, development, and manufacturing is essential.
- Experience with design and execution of in use compatibility studies (and regulatory expectations), drafting relevant sections of pharmacy manuals would be value added.
Cullinan Oncology is proud to be an Equal Opportunity Employer. We are committed to creating an inclusive and diverse environment for all employees and applicants without regard to a person’s race, color, gender, age, religion, national origin, ancestry, disability, veteran status, genetic information, sexual orientation or any characteristic protected under applicable law.