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AD or Director, Drug Substance (biologics)

Company: HCPro, Inc.
Location: Waltham
Posted on: September 12, 2020

Job Description:

AD or Director, Drug Substance (biologics)

SP AD or Director, Drug Substance (biologics) Key Responsibilities

• Define and manage drug substance CMO activities. Build strong relationships with all CMO/CROs involved in the program.

• Review Master and Executed Batch Records, release testing data and stability data.

• Provide direct oversight and represent Syndax CMC as person-in-plant during certain critical manufacturing activities at participating CMO/CRO sites.

• Participate in designing comparability and characterization studies and review reports.

• Perform risk assessment for upstream and downstream activities; create and implement any remediation plans necessary.

• Apply a science and risk-based approach for addressing deviations, investigations, and process issues.

• Provide clear communication to functional group and project teams.

Requirements

• Ph.D. and 10 years of biopharmaceutical manufacturing experience or MS with more than 10 years of relevant experience.

• Experienced in all aspects of antibody drug substance manufacturing and development including expression, upstream cell culture operations, downstream purification operations, process and analytical characterization, and process validation.

• Experienced in advancing processes through clinical development to commercialization.

• Demonstrated ability to work outside of the box and influence novel CMC and regulatory pathways to accelerate development.

• Knowledgeable and practiced with Single Use Bioreactors for GMP manufacturing.

• Excellent written and verbal communication.

• Demonstrated ability to work well in a fast-paced environment.

• Must be able to effectively manage multiple activities and problem-solve to achieve business needs.

• Strong communication skills, able to work independently and collaborate with key internal and external stakeholders.

• Excellent planning and project management skills.

• Dynamic and energetic, hands on approach to challenges.

• Business travel to various CMO/CRO sites, company offices, suppliers, and partners as required.

To apply for this position, please send your resume to careers@syndax.com

Job Information

Job ID: 54627248

Location:

Waltham, Massachusetts, United States

Position Title: AD or Director, Drug Substance (biologics)

Company Name: Syndax Pharmaceuticals

Job Function: Manufacturing

Job Type: Full-Time

Job Duration: Indefinite

Min Education: Master's Degree

Required Travel: 10-25%

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Keywords: HCPro, Inc., Waltham , AD or Director, Drug Substance (biologics), Other , Waltham, Massachusetts

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