Director, Quality Control & Stability

Establish and direct QC groups in QC support activities for GMP manufacture that will include method transfer, in-process testing, method validation, Drug Substance (DS) and Drug Product (DP) release testing, DS and DP stability studies, reference standard qualification, etc. Provides scientific leadership in the generation of, all batch release data, final substance/product disposition, certificate of analysis generation and stability report review including trend [shelf life] analysis. Develop departmental key performance indicators and analyze for opportunities to optimize department performance. Ensures stability program meeting ICH requirements for tracking trending, assessment of lot pool ability [ANCOVA] and customer expiry dating evaluation for both the core business products as well as the high potency business products. Embodies Aji Bio-Pharma’s cultural values and aligns daily actions with department goals and company culture. Develops short and long-term people and organizational strategy in alignment with company goals and direction. Leads with impact & influence. Establishes credibility, effectively persuades and develops others, and achieves important objectives collaboratively.

According to JobzMall, the average salary range for a Director, Quality Control & Stability in 11040 Roselle St, San Diego, CA 92121, USA is $121,000 to $171,000. This range is based on salaries reported by JobzMall users in the same area.

Althea is a contract development and manufacturing organization committed to process development, drug substance manufacturing and drug product manufacturing. Althea supports early-stage clinical requirements through commercial manufacturing. Althea is an expert in executing drug formulation and aseptic fill finish for vials and syringes.