Director, CMC Project Management (Biologics)

Enigma SearchRedwood City, California

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Overview

Schedule

Full-time

Career level

Executive

Remote

On-site

Job Description

About Our Client

Our client is stealth stage biopharmaceutical company dedicated to developing next-generation antibody biotherapeutics. They are currently seeking a highly skilled and strategic Biologics CMC Project Manager to spearhead their chemistry, manufacturing, and controls (CMC) operations from Post-Candidate Selection (PCC) through IND submission.

This is a fantastic opportunity to join a lean, high-performing team where your leadership will directly impact the acceleration of life-changing therapies to clinical trials.

Responsibilities

Develop comprehensive project plans, timelines, and budgets for biologics CMC development projects from PCC nomination to IND submission.
Participate in screening, selection, and qualification of Contract Development and Manufacturing Organizations (CDMOs) for various biotherapeutic modalities including mAb, BsAb, TsAb, fusion protein, protein conjugates etc.
Support due diligence efforts associated with CMC development activities, support service contract negotiations and other CDMO related activities.
Drive multidisciplinary CMC teams, including cell line development, upstream and downstream process development, formulation development, analytical method development and qualification, drug substance and drug product manufacturing, quality control, regulatory filing, and supply chain management to maximize the value of development work and ensure effective communications and quality decisions.
Keep all the stakeholders fully apprised of project status and issues at the right level of detail. Understand escalate issues to teams and stakeholders appropriately.
Identify technical gaps in development and manufacturing and implement proactive remediations and strategies to ensure project success.
Ensure adherence to regulatory requirements for both development and manufacturing activities.

Requirements

BS/BA and above degree in biochemistry, biochemical engineering or other life science disciplines.
Minimum of 10+ years of biologic therapeutic development / commercialization experience with BS/BA degree or minimum of 6+ years biologic therapeutic development experience with an advanced degree.
Demonstrated deep understanding and experience in biologic modality drug development and manufacturing processes for mAb, BsAb, TsAb, fusion protein, protein conjugates etc.

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FAQs About Director, CMC Project Management (Biologics) Jobs at Enigma Search

What is the work location for this position at Enigma Search?

This job at Enigma Search is located in Redwood City, California, according to the details provided by the employer. Some roles may also include multiple work locations depending on the requirement.

What pay range can candidates expect for this role at Enigma Search?

Employer has not shared pay details for this role.

What employment applies to this position at Enigma Search?

Enigma Search lists this role as a Full-time position.

What experience level is required for this role at Enigma Search?

Enigma Search is looking for a candidate with "Executive" experience level.

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You can apply for this role at Enigma Search either through Sonara's automated application system, which helps you submit applications 10X faster with minimal effort, or by applying manually using the direct link on the job page.