Disc Medicine

Biopharmaceutical

PrincipalScientist/AssociateDirector,AnalyticalDevelopment&ClinicalQualityControl

$158–193k Massachusetts, United States Remote Friendly
The Brief

“Principal Scientist/Associate Director, Analytical Development & Clinical Quality Control at Disc Medicine. Skills: Analytical Development, Clinical Quality Control, Method Development, Regulatory Filings. Characterize biologic therapeutics. Develop analytical techniques”

Industry & Context.

Biopharmaceutical
Problems you'll solve

Troubleshooting; Method investigations

Eligibility Requirements

Ability to travel occasionally

What They're Looking For.

Must Have

Bachelors degree required, 10-12+ years related experience, 2+ years late-stage development experience, Hands-on experience with multiple analytical methods, Specification troubleshooting experience, Good knowledge of cGMP, Good knowledge of global regulatory requirements

Nice to Have

Advanced degree (M.S./Ph.D.) preferred, Experience in IND and BLA filings highly desired

What You'll Do.

Characterize biologic therapeutics

Develop analytical techniques

Measure product impurities

Measure process impurities

Strengthen relationships with external CDMO partners

Establish scopes of work

Manage external CDMO partners

Ensure activities within program expectations

Provide oversight into external testing facilities

Lead method performance investigations

Lead laboratory investigations

Author quality documentation

Review quality documentation

Provide authorship for regulatory documents

Provide review for regulatory documents

Collaborate cross-functionally

How You'll Work.

Team & Collaboration

Cross-functional teams; Multi-disciplinary teams

Communication Scope

Convey complex ideas

Free ATS check

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