Key Responsibilities
Analytical Subject Matter Expert (SME)
* Oversee day-to-day analytical activities at partner sites and external laboratories to ensure on-time delivery of analytical results and deliverables.
* Ensure compliance of release testing, data review, specification and monograph maintenance, PQR inputs, and analytical life-cycle management.
* Ensure compliance and timely follow-up of stability studies (protocols, reports, and results review).
* Support investigations (deviations, OOS / OOT) and change controls as needed.
* Manage activity-related administrative aspects such as purchase / work orders and invoices.
* Maintain clear communication with partners and stakeholders, fostering alignment and efficiency.
* Drive simplification, harmonization, and standardization of analytical processes where possible.
Global Project Contexts
* Lead validation, transfer, and troubleshooting of analytical methods for projects related to market or supply extensions.
* Ensure project progress within agreed timelines and delivery of high-quality technical documents (validation protocols / reports, gap assessments, etc.).
* Ensure availability of reference materials, authentic substances, and documentation required by partners.
* Support overall project success and ensure “right first time” execution.
Compliance and Quality
* Perform all responsibilities in compliance with company policies, business ethics, safety standards, GMP, data integrity, and applicable regulations.
* Maintain inspection readiness for all assigned activities.
Qualifications and Experience
* Scientific degree in Chemistry, Biology, or related field.
* Minimum 3–5 years’ experience in the pharmaceutical industry, ideally in a GMP manufacturing or QC environment.
* Experience with stability study management and / or contract manufacturing oversight is a plus.
* Experience in analytical method validation and transfer beneficial.
* Proven ability to write and review technical GMP documentation.
* Excellent written and verbal communication skills in English.
* Strong interpersonal skills, proactive mindset, results-driven and pragmatic approach.
#J-18808-Ljbffr