Director, mAb CMC Development (monoclonal antibodies)
My biotech client is expanding and seeks a fully remote Director, mAB CMC Development to support their biologic candidate development through commercial.
Key
Responsibilities:
Manage relationships with CDMOs for the development, scale-up, and manufacturing of monoclonal antibodies.
Provide strategic direction for all CMC-related activities, from early development stages to commercialization.
Contribute to IND applications, including authoring the CMC sections.
Ensure strict adherence to regulatory standards and quality assurance practices.
Address regulatory queries and compliance issues related to CMC.
Provide leadership to matrix teams and foster a collaborative work environment.
Preferred
Experience:
10
years of biologics development experience, with a focus on monoclonal antibodies.
Proven track record in successful IND filings for mAB, including experience in writing CMC sections for IND applications.
Demonstrated experience in working with both US and non-US based CDMOs.
Significant experience working with small teams.
Essential
Qualifications:
Advanced degree in Biochemistry, Biotechnology, Chemical Engineering, or a related field.
Ability to lead and work effectively in small team environments.
Strong organizational, communication, and project management skills.
Additional Points:
-This is a full time, remote position and the title can be Director or Sr Director.
The ideal person will be based near the East Coast.
-Title and salary (including base, bonus, and options) are commensurate with experience.
#J-18808-Ljbffr Recommended Skills Biochemistry Biotechnology Chemical Engineering Communication Hardworking And Dedicated Leadership Estimated Salary: $20 to $28 per hour based on qualifications.
Key
Responsibilities:
Manage relationships with CDMOs for the development, scale-up, and manufacturing of monoclonal antibodies.
Provide strategic direction for all CMC-related activities, from early development stages to commercialization.
Contribute to IND applications, including authoring the CMC sections.
Ensure strict adherence to regulatory standards and quality assurance practices.
Address regulatory queries and compliance issues related to CMC.
Provide leadership to matrix teams and foster a collaborative work environment.
Preferred
Experience:
10
years of biologics development experience, with a focus on monoclonal antibodies.
Proven track record in successful IND filings for mAB, including experience in writing CMC sections for IND applications.
Demonstrated experience in working with both US and non-US based CDMOs.
Significant experience working with small teams.
Essential
Qualifications:
Advanced degree in Biochemistry, Biotechnology, Chemical Engineering, or a related field.
Ability to lead and work effectively in small team environments.
Strong organizational, communication, and project management skills.
Additional Points:
-This is a full time, remote position and the title can be Director or Sr Director.
The ideal person will be based near the East Coast.
-Title and salary (including base, bonus, and options) are commensurate with experience.
#J-18808-Ljbffr Recommended Skills Biochemistry Biotechnology Chemical Engineering Communication Hardworking And Dedicated Leadership Estimated Salary: $20 to $28 per hour based on qualifications.
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