Senior Director, CMC Program lead, Biologic Drug Substance Process Development
Who We Are:
EvolveImmune Therapeutics is a next-generation immunotherapy platform company based in the Yale/New Haven biotechnology ecosystem with laboratories in Farmington and Branford, CT. EvolveImmune is harnessing its ‘Immunology First’ approach to create first-in-category cancer medicines, which aim to transform patients’ lives by delivering superior, long-term outcomes compared to current anti-cancer therapies. The EvolveImmune team has established a first-in-class and highly differentiated tumor-targeted T-cell co-stimulation platform designed to re-invigorate adaptive immune responses in solid tumors. In addition, building upon research that originated from the Sidi Chen Laboratory at Yale University, EvolveImmune is leveraging a novel in vivo CRISPR-based target discovery platform to develop a broad portfolio of first-in-class therapeutics for unmet needs in oncology and immune diseases.
The Role
We are looking for a candidate to lead and direct CMC development responsibilities with an emphasis on Drug Substance Process Development from preclinical stage through licensure. This role is a key leader of the CMC leadership team. This position is accountable for developing and executing phase appropriate biologic drug substance, with the goal of delivering successful clinical and commercial drug products that are safe, effective, efficient, manufactured with robust processes, and patient centric. This role interfaces with analytical and drug product leads both internal and external (CDMO).
Responsibilities
Develop and execute robust and phase-appropriate CMC and biological drug substance development strategy.
Collaborate with research to assess the developability of early-stage assets as they approach Candidate selection (manufacturability, stability, delivery) to deliver construct assessments prior to Phase 1 development work and material delivery.
Lead Process Development activities internally and in collaboration with CDMOs resulting in the progression of drugs to Phase 1 IND, including cell line development and selection, Creation of pre-MCB lines, technical oversight for creation of MCB/WCB, Upstream, and Downstream process definition and material generation to support analytical development and formulation development.
Provide technical and operational leadership to external resources (CROs and CMOs) in all aspects of analytical and drug product development.
Lead authoring and review of analytical and drug product contents of regulatory submissions; be accountable for corresponding regulatory inquiries, inspections, and audits.
Collaborate closely with internal stakeholders, including Research, Operation, Clinical Supply, Regulatory, and Quality, to align on overall product development and regulatory submission strategy, ensure Right-the-First-Time execution and deliverables.
Manage budget for analytical and drug product development in both talent acquisition and external service cost.
Qualifications
Ph.D. in Chemical engineering, Biochemistry, or Pharmaceutical Sciences
7-10 years of process development from early stage through licensure in mAbs, proteins, peptides, and synthetics
3-5 years of experience in managing both internal and CDMO/CRO development and QC laboratories
2+ years leading CMC programs
Deep knowledge of current regulatory guidelines and cGMP requirements
Extensive experience in preparing regulatory submissions from IND/IMPD through BLA/MAAs and responding to regulatory inquiries
Outstanding leadership skills and people management expertise with enterprise-level leadership vision
Other
EvolveImmune Therapeutics requires all employees to be fully vaccinated against COVID-19.
EvolveImmune Therapeutics is an equal opportunity employer.
Principals only.
Qualified applicants should apply using this link.