Senior Analyst, Quality Control (Raw Materials)

Scorpion Therapeutics; Bedford (MA); On-site; USD 90,000 - 120,000; Full time

Job summary

Scorpion Therapeutics is seeking a Senior QC Analyst specializing in raw material testing within a GMP-regulated pharmaceutical setting, focused on ophthalmic product development using proprietary bioresorbable hydrogel technology.

You will perform and review HPLC, GC, XRPD, and Karl Fischer tests; lead investigations (OOS/OOT); author SOPs and validate methods; coordinate external testing; support raw material qualification; and mentor junior staff.

Qualifications

• Bachelor’s degree in Chemistry, Biochemistry, or related field required.
• 5+ years in GMP QC labs with analytical instrumentation experience.
• Familiarity with pharmacopeial standards (USP/EP/JP).
• Experience with LIMS and validation activities.

Responsibilities

• Perform and review complex analytical tests (HPLC, GC, XRPD, Karl Fischer).
• Lead investigations (OOS, OOT, deviations).
• Author SOPs and validate methods.
• Coordinate external testing.
• Support raw material qualification.
• Mentor junior staff.

Skills

Analytical instrumentation

Test method validation

Investigations leadership

SOP authoring

Mentoring

Education

Bachelor's in Chemistry/Biochemistry or related

Tools

LIMS

Job description

Role: Senior QC Analyst specializing in raw material testing within a GMP-regulated pharmaceutical setting, primarily for ophthalmic product development using proprietary bioresorbable hydrogel technology.

Responsibilities:

• Perform and review complex analytical tests (HPLC, GC, XRPD, Karl Fischer)
• Lead investigations (OOS, OOT, deviations)
• Author SOPs and validate methods
• Coordinate external testing
• Support raw material qualification
• Mentor junior staff

Collaborates with QA, Manufacturing, Supply Chain, and external labs; participates in audits.

Qualifications:

• Bachelor's in Chemistry, Biochemistry, or related
• 5+ years in GMP QC labs with expertise in analytical instrumentation
• Familiarity with pharmacopeial standards (USP, EP, JP)
• Experience with LIMS and validation activities

Preferred:

• Experience with regulatory submissions
• ICH/FDA guidelines
• Clean lab operations
• Continuous improvement initiatives

Work Environment:

Laboratory setting with chemical exposure, PPE use required, occasional lifting up to 25 lbs.

High-Value Details:

Focus on raw material qualification, analytical method validation, and GMP compliance; no specific therapeutic area beyond ophthalmic drug delivery.

Location and travel specifics are not provided.