Director, CMC Biologics

Cambrian Biopharma is a diversified R&D platform company built on a new model for drug discovery. We partner with leading academic institutions and biotech entrepreneurs all over the world to build start-up companies, providing capital and expertise to advance a pipeline of drug development programs with a shared theme.

Cambrian is unique among biotech companies due to its focus on a specific field of scientific research: the basic biology of aging, also known as geroscience. Drugs that target the Nine Hallmarks of Aging can be exceptionally powerful medicines that could extend the healthiest years of life. Our approach is to build a pipeline of drug discovery and development portfolio companies and cultivate multiple assets, maximizing the odds that Cambrian will create multiple life-changing therapeutics that receive regulatory approvals.

Position Overview

Cambrian Biopharma is looking for an inspiring, resourceful, and collaborative Director, CMC Biologics to join our growing team. With decades of experience in the space, our diverse team possesses a deep collective understanding of age-related diseases and the future of therapeutics. You will have the unique opportunity to shape Cambrian at an early stage and play a role in potentially the most impactful new area of medicine – therapies that slow and reverse the damage of aging.

Reporting to an Executive Vice President (either Drug Discovery or Chemistry), the Director, CMC Biologics will mainly oversee the R&D and production of protein therapeutic drug candidates and other biologics modalities specifically from construct and purification strategy selection to provision of API for IND-enabling studies (toxicology and safety pharmacology) and GMP manufacturing of API for clinical human safety and efficacy evaluation in early-stage portfolio companies within Cambrian Biopharma. You will work closely with an EVP, matrixed R&D teams, and CMOs to convert strategic objectives into operational project plans and to deliver on the goals and timelines. This person will be supported by a team of highly engaged colleagues with significant scientific and entrepreneurial experience.

Responsibilities

• Coordinate manufacturing of biologics outsourced to CMOs of a number of projects in collaboration with cross-functional R&D teams and manage the planning, development, and execution of projects progressing them to value-increasing inflection points
• Provide technical leadership, management and oversight of CMOs for development of stable mammalian cell lines and establishment of cell banks for scale-up and GMP manufacturing where appropriate
• Protein design, optimization, scale-up and manufacture of biologics drug substance to support nonclinical studies and clinical evaluations
• Set clearly defined goals/objectives to ensure delivery of high-quality results
• Provide clear communication to CMC teams and functional line management regarding progress against technical objectives/milestones
• Ensure well-organized, clear and complete documentations of all activities across areas of responsibility including CMC documentation for regulatory and/or patent filings
• Create detailed project plans with timelines and budgets and track and report on progress
• Work with R&D Teams to identify risks and issues and proactively remediate issues/develop risk mitigation strategies
• Work closely with an EVP to execute CMO campaigns, and collaborate with other departments within Cambrian to start and operate companies efficiently
• Identify and own deliverables

Qualifications

• Strong scientific background with extensive experience with biologics manufacturing from discovery-stage research to early development activities/ studies
• Minimum 7 years of experience in Pharma or Biotech
• Ph.D. in Biology or Chemistry including experience with protein biochemistry
• Demonstrated success working with cross-functional and matrixed teams and CROs
• Strong analytical and technical skills, including proficiency in project management practices, project planning, and decision-making employing state-of-the art tools
• Excellent communication skills, writing and presentation skills and information management skills
• Proven ability to work collaboratively and influence others

Cambrian Offers

• Opportunities to shape new and exciting science and build teams that bring novel therapeutics to patients in need
• Exposure to the biotech company life cycle and industry
• A diverse, mission-driven, and entrepreneurial company culture
• Access to our network of international decision-makers and investors
• Competitive salary + equity
• 12 company holidays and an unlimited PTO policy
• Multiple health, vision, and dental insurance plans to choose from, supporting both individuals and families, including no-monthly-premium options
• Ancillary benefits, including pre-tax commuter benefits, access to a HealthAdvocate, a healthcare Flexible Spending Account (FSA), and others