Lead Analytical Development Scientist, Small Molecules – Remote

OpenKrill; United States; Remote; USD 170,000 - 190,000; Full time

Benefits offered by this job

Discretionary quarterly bonus

401(k) matching

Long‑term stock incentives and ESPP

Flexible wellness benefit

Generous PTO and paid holidays

Job summary

Praxis Precision Medicines seeks a Principal Scientist, Analytical Development to steer analytical strategies for small molecule drug substances and products. You will lead method development, qualification, validation, transfer, and GMP testing with internal teams and external partners.

The role requires deep analytical chemistry expertise, with phase-appropriate strategies spanning early development to approval.

Qualifications

• PhD (preferred) in Analytical Chemistry or related field with 8+ years in industry.
• Strong analytical development experience for small molecules and drug products.
• Knowledge of US/EU cGMP requirements and analytical strategies.

Responsibilities

• Lead analytical development, qualification, validation, transfer, and GMP testing across teams and CROs/CMOs.
• Develop phase-appropriate control strategies, specifications, and stability programs for small molecules.
• Review and approve analytical docs including validation reports, stability reports, and COAs.
• Drive external partner management to ensure quality, on-time delivery, and continuous improvement.
• Support regulatory submissions and lifecycle management with cross-functional collaboration.

Skills

Analytical Chemistry

Small Molecule Development

Analytical Method Development

GMP/CMC Knowledge

Regulatory Submissions

External CRO/CMO Management

Education

PhD in Analytical Chemistry

Master’s with significant industry experience

Tools

HPLC/LC-MS

Impurity Characterization

Stability Programs

Quality Systems

Job description

Praxis Precision Medicines seeks a Principal Scientist, Analytical Development to steer analytical strategies for small molecule drug substances and products. You will lead method development, qualification, validation, transfer, and GMP testing with internal teams and external partners.

The role requires deep analytical chemistry expertise, with phase-appropriate strategies spanning early development to approval.