Strategic Director, Biologics CMC Development

Dechra; United States; On-site; USD 180,000 - 250,000; Full time

Job summary

Dechra is seeking a Director, Biologics CMC Development to provide strategic and technical leadership across biologic drug substance development. You will lead cell line selection, upstream and downstream process development, and analytical method development, coordinating with CDMOs/CROs and internal partners to advance programs from discovery through commercialization.

The role requires strong CMC strategy, regulatory experience with FDA/EMA expectations, and the ability to build external

Qualifications

• Minimum 9+ years of biotech/pharma experience with biologics development.
• Ph.D. in Pharmaceutical Sciences or related field required.
• Experience with CDMOs/CROs and regulatory interactions is essential.

Responsibilities

• Lead biologics DS development and cell line selection.
• Oversee upstream/downstream development and scale-up readiness.
• Collaborate with regulatory, QA, and Manufacturing to support IND and commercialization.
• Develop strategies aligned with portfolio objectives and timelines.
• Manage external partners and governance meetings.

Skills

Biologics development

Cell line development

Upstream/downstream process

Quality by Design (QbD)

Regulatory strategy

Cross-functional leadership

CDMO/CRO management

Process characterization

Education

Ph.D. in Pharmaceutical Sciences or related

Tools

Regulatory submissions

Job description

Dechra is seeking a Director, Biologics CMC Development to provide strategic and technical leadership across biologic drug substance development. You will lead cell line selection, upstream and downstream process development, and analytical method development, coordinating with CDMOs/CROs and internal partners to advance programs from discovery through commercialization.

The role requires strong CMC strategy, regulatory experience with FDA/EMA expectations, and the ability to build external