Senior Manager, Global Sample Stability and Retains Program

Scorpion Therapeutics; Madison (WI); On-site; USD 140,000 - 180,000; Full time

Job summary

Scorpion Therapeutics is seeking a senior stability and retainability leader to establish and manage a global, compliant stability and retain sample program across raw materials, drug substance, drug product, and finished goods. You will design and approve protocols per Q1A(R2)/Q5C, coordinate internal labs and CMOs, and ensure data integrity for regulatory submissions.

You will mentor a growing team, oversee APQR/PQR activities, and partner with QA, regulatory affairs, and manufacturing to

Qualifications

• 8–10+ years in pharma/biotech QA/Quality Control/CMC with global stability program and retain sample management.
• 3–5+ years people management experience.
• Experience with clinical (IND-stage) and global commercial products preferred.
• Plus: RNAi/oligonucleotide/biologics/novel modality experience.
• Expert knowledge of global stability and retain regulations/guidance (FDA 21 CFR 211, EU GMP Annex 19, ICH Q1A(R2)/Q1E/Q5C, MHRA, PMDA, TGA, Health Canada).

Responsibilities

• Establish and manage a compliant global stability and retain sample program (raw materials, drug substance, drug product, finished goods) per US 21 CFR 211.170, EU GMP Annex 19, and regional regulations, including sample quantities, storage, retention periods, and inventory/chain-of-custody/disposition management.
• Develop, review, and approve stability protocols/study designs/commitments per ICH Q1A(R2), Q1E, Q5C and regional guidance; ensure studies (long-term, accelerated, intermediate, in-use, photostability, thermal cycling, transportation/excursion) are executed on schedule across internal labs and external CMOs/CTLs.
• Oversee stability data trending and statistical analysis to support shelf-life/retest date determinations and regulatory filing justifications; lead shelf-life extension activities.
• Support annual product stability reviews (APQR/PQR), stability commitment tracking, and stability chamber qualification/monitoring and excursions.
• Own end-to-end reference standard lifecycle program (selection, qualification, characterization, stability monitoring, inventory, distribution); manage requalification/replacement and bridging between lots.
• Support regulatory submissions and health authority information requests related to stability and retains.
• Directly manage, mentor, and develop a stability and retain team (hiring, performance management, training, career development).

Skills

Quality Assurance

Quality Control

CMC knowledge

Regulatory coordination

Education

Bachelor’s degree in Chemistry, Pharmaceutical Sciences, Biology, or related field

Master’s degree preferred

Tools

LIMS

Job description

Responsibilities:

• Establish and manage a compliant global stability and retain sample program (raw materials, drug substance, drug product, finished goods) per US 21 CFR 211.170, EU GMP Annex 19, and regional regulations, including sample quantities, storage, retention periods, and inventory/chain-of-custody/disposition management.
• Develop, review, and approve stability protocols/study designs/commitments per ICH Q1A(R2), Q1E, Q5C and regional guidance; ensure studies (long-term, accelerated, intermediate, in-use, photostability, thermal cycling, transportation/excursion) are executed on schedule across internal labs and external CMOs/CTLs.
• Oversee stability data trending and statistical analysis to support shelf-life/retest date determinations and regulatory filing justifications; lead shelf-life extension activities.
• Support annual product stability reviews (APQR/PQR), stability commitment tracking, and stability chamber qualification/monitoring and excursions.
• Own end-to-end reference standard lifecycle program (selection, qualification, characterization, stability monitoring, inventory, distribution); manage requalification/replacement and bridging between lots.
• Support regulatory submissions and health authority information requests related to stability and retains.
• Directly manage, mentor, and develop a stability and retain team (hiring, performance management, training, career development).

Requirements:

• Bachelor’s degree in Chemistry, Pharmaceutical Sciences, Biology, or related field (MS preferred).
• 8–10+ years in pharma/biotech Quality Assurance/Quality Control/CMC with global stability program and retain sample management.
• 3–5+ years people management experience.
• Experience with clinical (IND-stage) and global commercial products preferred.
• Plus: RNAi/oligonucleotide/biologics/novel modality experience.
• Expert knowledge of global stability and retain regulations/guidance (FDA 21 CFR 211, EU GMP Annex 19, ICH Q1A(R2)/Q1E/Q5C, MHRA, PMDA, TGA, Health Canada).

Preferred:

• LIMS experience (stability scheduling, pull-point tracking, data trending; administering stability modules).
• Strong stability study design, statistical trending, shelf-life extrapolation; regulatory inspection/audit experience.

Application:

Candidates must have current, valid authorization to work in the country where this role is located.