Sciences & Technology Manager (Including As&t +

vor 2 Wochen

PlanlesOuates, Schweiz Aptissen SA Vollzeit

As Aptissen experiences continued growth, we are actively seeking to fortify our team through the recruitment of a **Sciences & Technology Manager **responsible for overseeing Analytical and Manufacturing Sciences & Technology (AS&T + MS&T).

This newly created position involves creating and designing activities from scratch (Greenfield).

The Sciences & Technology Manager will lead and drive Aptissen’s AS&T and MS&T: Analytical and Manufacturing Sciences & Technology.

These activities include:

- Overseeing the validation and optimization of analytical methods
- Overseeing product and technical stewardship, including Qualification/Validation activities, to ensure efficient technical processes and operational integrity of the manufacturing/packaging
- Design Transfer
- Risk Management

As process and technical expert, you will participate in the development process, lead the tech transfer process, and manage the lifecycle of product in term of process. Additionnally you will co-lead capital expansions within cross-functional teams and CMOs teams.

As an Operational Excellence (OpEx) leader, you will drive continuous improvement.

**KEY TASKS & RESPONSIBILITIES**
- Managerial Responsibilities:_
- Coach the Design Transfer & Process Validation Engineer.
- Supervise the department by setting goals and objectives aligned with company objectives and providinig guidance, mentoring, and staff development for the team to meet current and future business needs.
- Represent the Sciences & Technology department for AS&T and MS&T topics during audits by regulatory agencies/Notify body.
- Analytical, Sciences and Technologies:_
- Responsible for timely execution of AS&T activities (Analytical methods, Monographs, Analysis, Stabilities, troubleshooting, OOS ), ensuring compliance with cGMP, legal and regulatory requirements, and Corporate Quality Manual and Policies.
- Oversee validation and optimization of analytical methods for cleaning and process validation of injectable products (MD / Drugs).
- Lead the stability program.
- Evaluate and implement new technologies for state-of-the-art analytical methods.
- Maintain up-to-date knowledge of health authority requirements, trends, and technologies.
- Lead and support local and global projects.
- Manufacturing, Sciences and Technologies:_
- Ensure timely execution of MS&T activities, adhering to cGMP, legal and regulatory requirements, and Corporate Quality Manual and Policies.
- Perform process monitoring, data trending, statistical analysis, process sampling plan and capability assessments.
- Lead projects such as tech transfer, remediation, and capacity increase.
- Contribute to corporate projects as a technical member (R&D projects, NPL/NPI).
- Act as a major stakeholder in all stages of technical batch release.
- Lead supportive processes like Artwork process management, KPIs implementation, and COGs optimization.
- Lead and support local and global projects.
- Qualification and Validation of equipment and processes (with the team and within our CMOs):_
- Define and implement process validation plans in accordance with subcontractors.
- Coordinate and plan process validation, equipment qualification, sterilization, cleaning validation, and computerized systems activities.
- Control the implementation of all qualification and validation activities to guarantee the maintenance of validated statuses.
- Check and approve validation protocols and reports, ensuring regulatory monitoring in terms of validation.
- Animate the validation committee.
- Transfer of the Design of New Products:_
- Act as a major stakeholder in the design control process for new products.
- Supervise stages of design transfer into production.
- Work closely with various departments and CDMOs to ensure a smooth transfer from design to production mode.
- Supervise the implementation of quality documentation for the transfer stages from design to production of new products.
- Participate in training production teams for the design-to-production transfer of new products.
- Operational Excellence:_
- Participate in strategic planning activities.
- Conduct training sessions on new technologies.
- Coordinate the implementation of cost-cutting measures.
- Deploy operational excellence: Continuous improvement, Six Sigma, Lean Manufacturing & Best practices implementation.
- Create and lead the OpEx program, including a six sigma approach (from White to Black Belt).
- Budget:_
- Responsible for team budget preparation and ensuring adherence to the approved budget.

**EDUCATION/LANGUAGES**
- Sciences/Chemical/Pharmaceutical Engineering, Pharmacist, Master’s degree in chemistry, Biology, Biochemistry, Pharmaceutical Sciences or related field
- Six Sigma certified is a plus
- French (native/fluent)
- Fluency in English
- **PROFESSIONAL SKILLS & EXPERIENCE**
- Min of 10+ years of experience in Sciences & Technology (AS&T and/or MS&T, Industrialization and validation) within Pharmaceutical industry and/or Me

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