Sr. Scientist, Pharmaceutical Development

Scorpion Therapeutics; San Diego (CA); On-site; USD 131,000 - 179,000; Full time

Benefits offered by this job

Annual bonus (30%)

Equity long-term incentive

Health benefits

Paid vacation/holidays/personal days

Job summary

Scorpion Therapeutics is seeking a senior technical leader in Pharmaceutical Development to represent CMC across the product lifecycle, guiding strategy for process development, material characterization, and analytic strategies. You will oversee CRO/CMO/CDMO partnerships and provide CMC representation on cross-functional teams.

The role demands advanced cGMP drug product manufacturing knowledge, extensive regulatory experience (IND/NDAs), and leadership in development programs from discovery to

Qualifications

• Advanced cGMP drug product manufacturing knowledge and quality/compliance mindset.
• Expertise in product development (process design/optimization/scale-up/validation/lifecycle).
• Regulatory expertise authoring/reviewing drug product sections of INDs/NDAs.
• Experience managing CROs and CMOs/CDMOs; IND/NDA experience.

Responsibilities

• Lead drug product development programs from early discovery through launch; align goals, timelines, and regulatory expectations.
• Run internal/NBI-CMO/CDMO project meetings; communicate progress, risks, resource gaps, and timelines.
• Design/develop/scale robust, phase-appropriate formulations and manufacturing processes using QbD and statistical methods.
• Lead process development (DoE, modeling, scale-up, validation, technology transfer).
• Serve as SME to resolve complex preformulation/formulation/analytical/manufacturing issues via root-cause analysis.
• Oversee external partners (CDMOs/vendors) to ensure capability, quality, compliance, and supply.
• Act as technical lead/person-in-plant during manufacturing campaigns.
• Author/review regulatory submissions and development documentation (IND, IMPD, NDA, MAA; ICH/FDA/EMA/cGMP).
• Drive CPV/CPI via CPP/CQA monitoring; mentor teammates; other duties as assigned.

Skills

CMC leadership

Process development

QbD and statistics

DoE

Regulatory strategy

CRO/CMO management

Mentoring

Education

BS/BA in Chemistry/Biochemistry/Chemical Engineering

MS/MA in Chemistry/Biochemistry/Chemical Engineering

PhD in Chemistry/Biochemistry/Chemical Engineering

Job description

About the Role

Serve as a senior technical leader within Pharmaceutical Development representing CMC project teams across the product lifecycle from early discovery through commercialization and lifecycle management. Provide strategic/scientific leadership in process development, material characterization, and analytical strategies; manage developability risks; and support IP and commercial objectives. Establish/oversee CRO/CMO/CDMO partnerships and provide CMC representation on cross-functional teams.

Your Contributions

• Lead drug product development programs from early discovery through launch; align goals, timelines, and regulatory expectations
• Run internal/NBI-CMO/CDMO project meetings; communicate progress, risks, resource gaps, and timelines
• Design/develop/scale robust, phase-appropriate formulations and manufacturing processes using QbD and statistical methods
• Lead process development (DoE, modeling, scale-up, validation, technology transfer)
• Serve as SME to resolve complex preformulation/formulation/analytical/manufacturing issues via root-cause analysis
• Oversee external partners (CDMOs/vendors) to ensure capability, quality, compliance, and supply
• Act as technical lead/person-in-plant during manufacturing campaigns
• Author/review regulatory submissions and development documentation (IND, IMPD, NDA, MAA; ICH/FDA/EMA/cGMP)
• Drive CPV/CPI via CPP/CQA monitoring; mentor teammates; other duties as assigned

Requirements

• BS/BA + 6+ years OR MS/MA + 4+ years OR PhD + 2+ years (Chemistry/Biochemistry/Chemical Engineering or related)
• Advanced cGMP drug product manufacturing knowledge and quality/compliance mindset
• Expertise in product development (process design/optimization/scale-up/validation/lifecycle)
• Analytical methods, method validation, technology transfer, stability programs
• Regulatory expertise authoring/reviewing drug product sections of INDs/NDAs
• Experience managing CROs and CMOs/CDMOs; IND/NDA experience

Benefits (as stated)

• Base salary: $130,800-$179,000; annual bonus target 30%; equity long-term incentive eligibility
• Retirement match, paid vacation/holidays/personal days, caregiver/parental and medical leave; health benefits (medical, prescription drug, dental, vision).