Director, Biologics CMC & Outsourced Manufacturing

Scripps Research

Mountain House (CA)

On-site

USD 180,000 - 240,000

Full time

3 days ago

Be an early applicant

A complete application in a minute

Tailored resume and cover letter, ready to send.

Get past ATS filters

Job summary

Calibr-Skaggs Institute for Innovative Medicines, a division of Scripps Research, seeks a Director/Senior Director of Preclinical Development to lead CMC strategy for our biologics portfolio. This on-site leadership role oversees CROs/CDMOs, IND-enabling activities, and cross-functional alignment with discovery and regulatory teams.

The ideal candidate has deep CMC expertise, 10+ years in biologics, and a proven track record delivering complex antibody formats from candidate through IND filing

Qualifications

PhD in Biochemistry, Chemistry, Molecular/Cell Biology, or related field.
10+ years of biologics CMC experience with multi-specific antibodies and ADCs.
Experience leading CMC teams and IND-enabling studies.
Experience managing CROs/CDMOs and outsourced programs.
Strong GMP/ICH knowledge and regulatory experience.
On-site, full-time leadership role.

Responsibilities

Define and drive CMC development strategy for biologics programs, focusing on monoclonal antibodies and antibody-drug conjugates.
Manage external CROs/CDMOs to extend internal capacity and ensure quality, timelines, and budget.
Own CMC timelines and deliverables from lead candidate to IND submission.
Collaborate with discovery, regulatory, and program leadership to align CMC plans with milestones.

Skills

Biologics CMC

Outsourced CRO/CDMO mgmt

IND filings

Leadership

Education

PhD in Biochemistry, Chemistry, Molecular/Cell Biology, or related field

Job description

The ideal candidate has deep CMC expertise, 10+ years in biologics, and a proven track record delivering complex antibody formats from candidate through IND filing

Get your free, confidential resume review.

or drag and drop your file here.