Location
Lausanne, Vaud, Switzerland
Salary
Not specified
Type
fulltime
Posted
Today
Job Description
Have you ever dreamed of working for a company that puts people at the heart of its DNA?
Are you ready to make a difference?
Are you excited about collaborating and sharing your expertise with leaders in our industry?
YES? SO ARE WE!
GXP CONSULTING Switzerland is a Swiss company made up of a passionate team of life-science professionals. Since 2014, we have been providing our clients with cutting-edge expertise and support covering the entire product life cycle.
Join a team where your skills will have a real impact on patients’ lives.
We are looking for an Utilities \& HVAC Engineering Project Manager to lead several technical projects, mainly in the field of utilities and industrial infrastructure (renovation or construction of technical buildings).
Your Responsibilities
As a Senior Analytical Scientist, you will play a pivotal role in supporting late-stage development activities within a Gene Therapy program. Acting as the analytical reference, you will ensure the robustness, compliance, and strategic alignment of analytical methods across development, transfer, and manufacturing phases.
You will operate at the interface of
R\&D, Manufacturing, Quality, and Regulatory
, driving analytical excellence in both GMP and non-GMP environments.
Analytical Leadership \& Strategy
- Own and coordinate analytical activities across the Gene Therapy program
- Act as the
analytical subject matter expert (SME)
, guiding decision-making throughout development and manufacturing stages
- Lead analytical strategy discussions and represent analytical topics in cross-functional forums (Project Teams, SteerCo, Supply Committees)
Method Development, Validation \& Transfer
- Provide hands-on expertise in
analytical method development, validation, and transfer
- Ensure methods are robust, compliant, and fit-for-purpose across lifecycle stages
- Assess method performance and define improvement strategies where needed
Gap Analysis \& Scientific Problem Solving
- Perform detailed
gap analyses
on analytical methods and data packages
- Identify risks, constraints, and areas for improvement, and propose pragmatic solutions
- Lead troubleshooting activities and assess method impact on product quality
Documentation \& Compliance
- Review and author key analytical documentation (protocols, reports, stability studies)
- Ensure consistency and compliance of documentation with regulatory expectations
- Support CMC activities related to analytical sections for regulatory submissions
Regulatory \& Submission Support
- Contribute to regulatory documentation (e.g. briefing books, eCTD modules)
- Provide scientific justification and analytical input to support filings
- Ensure readiness of analytical packages for late-stage and submission activities
Project Support \& Stakeholder Interface
- Act as the
go-to analytical expert
for the Project Manager and cross-functional teams
- Support laboratory activities by guiding technicians and reviewing experimental approaches
- Lead or contribute to specific analytical studies (e.g. comparability, stability studies)
Your Profile
- Advanced degree (PhD or MSc) in Analytical Chemistry, Biochemistry, or related field
- Experience in
gene therapy, biologics, or advanced therapies (ATMPs)
- Proven expertise in
analytical method validation, transfer, and lifecycle management
- Solid understanding of
GMP requirements and regulatory expectations (CMC)
- Experience supporting
late-stage development and/or regulatory submissions
- Strong problem-solving mindset with the ability to operate in complex, fast-paced environments
- Excellent communication skills and ability to interact with senior stakeholders
- Fluency in english, french is a plus.
About us:
- A human-scale company where you will work alongside colleagues from diverse cultural and professional backgrounds.
- An open and transparent culture: we encourage honest communication, active listening, and continuous feedback.
- A true team spirit: every member is recognized and valued.
- Real impact on projects and clients: you are at the heart of the action, and your ideas influence strategy and outcomes in an international and multicultural environment.
- Direct access to leadership and strong internal visibility: a flat structure with no unnecessary layers — your voice truly matters.
- Continuous learning and development opportunities through internal and external training and workshops.
- A competitive salary package aligned with market standards, along with additional benefits.
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