Description

Key Responsibilities

As 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.

In 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.