Manager, Biologics Drug Substance External Manufacturing

Scorpion Therapeutics

Hampton (NJ)

On-site

USD 180,000 - 240,000

Full time

14 days+

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Job summary

Scorpion Therapeutics seeks a Manager of Biologics Drug Substance External Manufacturing to oversee GMP external production for clinical and commercial biologics, ensuring quality and on-time delivery.

The role runs on-site at CDMOs with travel around 30%. You will monitor batches, review records, support validation, and drive tech transfer across cross-functional teams to enable timely batch release and investigations.

Qualifications

Bachelor’s degree in life sciences, pharmacy, chemistry or related field.
4+ years in biotech/pharma manufacturing.
2+ years experience with biologics CDMOs and late-phase biologics programs.

Responsibilities

Monitor manufacturing batches at CDMO sites.
Review batch records and reports.
Support process validation and continuous process verification.
Facilitate technology transfer of pipeline candidates.
Collaborate with analytical, quality, and regulatory teams for batch release and investigations.

Skills

Biologics manufacturing

GMP compliance

CDMO experience

Process validation

Technology transfer

Batch record review

Regulatory collaboration

Education

Bachelor's degree in Life Sciences, Pharmacy, Chemistry, or related

Job description

Role: Manager of Biologics Drug Substance External Manufacturing overseeing GMP external production for clinical and commercial biologics.

Responsibilities

monitor manufacturing batches at CDMO sites
review batch records and reports
support process validation and continuous process verification
facilitate technology transfer of pipeline candidates
and collaborate with analytical, quality, and regulatory teams for batch release and investigations

Qualifications