Analytical Operations Senior Specialist Small Molecule

Lausanne, VD, CH, Switzerland

Job Description

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.

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Job Detail

  • Job Id
    JD1790633
  • Industry
    Not mentioned
  • Total Positions
    1
  • Job Type:
    Full Time
  • Salary:
    Not mentioned
  • Employment Status
    Permanent
  • Job Location
    Lausanne, VD, CH, Switzerland
  • Education
    Not mentioned