Analytical Operations Senior Specialist-Pharmaceutical Industry (Small Molecules)

For one of our clients, a growing international pharmaceutical company based near Lausanne we are looking for an Analytical Operations Senior Specialist-Pharmaceutical Industry (Small Molecules)
This global position supports analytical and quality control activities performed by manufacturing partners and contract laboratories, in close collaboration with R&D, Supply Chain, and Quality Assurance teams.
For the assigned commercial small molecule Drug Substance(s) and/or Drug Product(s), the incumbent will:

• Lead analytical routine oversight and follow-up associated with the assigned products.

• Support global analytical projects such as market/supply extensions, regulatory submissions or variations, and analytical method validation or transfer in alignment with company strategy.

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.