[netherlands] Analytical Sciences

1 week geleden

Amsterdam, Nederland Santen Voltijd

**Company Description**
As a specialized company dedicated to eye health, Santen aspires to contribute to the realization of **“Happiness with Vision”** by providing valuable products and services to patients, consumers, and medical professionals around the organization.
Since its establishment in Japan in 1890, and guided by its CORE PRINCIPLE, “Tenki ni sanyo suru,” Santen has been committed to helping people maintain and improve their eye health, and is engaged in the global research and development, manufacturing, and sales and marketing of pharmaceutical products in the field of eye care, supporting the eye health of approximately 50 million people worldwide. Our duty is to create a future in which as many patients and consumers as possible can lead happy and fulfilling lives, we will continue to contribute to the realization of better eye care by providing solutions that eliminate bottlenecks in the diagnosis and treatment of eye diseases, thereby revolutionizing the treatment flow.
Each of us is deeply committed to challenging ourselves, building an organization that brings together diverse internal talents and external expertise, and to doing our utmost to realize a society in which people everywhere can feel happy through vision-related experiences. **Isn't it exactly the kind of environment you want to belong in?**
**Job Description** JOB MISSION**

Analytical Sciences & Technology Manager provides front line expert support for all analytical test methods specific issues to the assigned product manufactured and tested at CDMOs and/or testing at Third Party laboratories, to ensure the execution of on-time product release, continuously improving product quality and analytical procedures, performed in compliance to cGxP, SOPs and applicable international guidelines, regulations, and norms.

**KEY ACCOUNTABILITIES**

**Site Product Manufacturing and Release Support**
- Provide front line support to the product manufacturing process analytics, release testing and s working with the QC teams (internal sites), or in close collaboration with CDMO Analytical Expert counterparts, focusing on the testing methods for each batch, their release on time and in compliance with the batch and analytical procedures instructions and quality requirements.

**Qualification & Validation - execution and review of protocol/report**
- Support the execution of analytical methods qualifications and/or validations, re-validations, Annual Monitoring Batch (AMB) and short-term improvement projects, liaising with all the relevant parties at shop floor (internally) or CDMO manufacturing team (externally) to ensure accurate execution.
- Review and ensure that qualification / validation protocols and report are technically correct and in compliance with all applicable international guidelines and requirements.
- Ensure protocols are executed, as intended.

**Technical improvement execution**
- Execute analytical methods improvements and support methods development for additional product and/or process related characterization studies.
- Ensure that process technical batches generate sufficient analytical methods knowledge by thoroughly testing critical variables (e.g., DOE, QbD, PAT).

**Primary packaging closure assessment during changes**
- Drive the qualification and/or validation of primary packaging materials testing methods including the design of container suitability studies for the assigned product(s).
- Evaluate and ensure, in case of packaging change, that the primary packaging closure - including materials - are sufficient to ensure stability of the product and do not deteriorate quality.

**Assure consistency of Analytical Testing Procedures**
- Ensure that all critical and significant parameters are within written Instruction (e.g., Testing procedures, Validation Plan), sufficient and appropriate for the product.
- Derive in collaboration with the internal sites (QC team) / CDMO analytical team, the upper and lower control limits for each product analytical methods (where relevant), as part of the CPV program launch for all Santen products

**Deviation, Out of Expectation, Out of Specification, complaint handling**
- Lead and/or support the GPS organization with all product and process related analytical investigations and deviations including complaints, Out of Expectation, Out of Specification, in partnership with internal / external site analytical teams.
- Use scientific and statistical knowledge to analyze data to provide process understanding, and to identify root causes of product and process failures.

**Annual Product Reviews and Product Quality Reviews**
- Be highly knowledgeable of product and process trends by providing input to Annual Product Reviews and Product Quality Review for analysis and for driving process technology innovations.
- Be a resource to other departments as Subject Matter Expert for the product and process knowledge.

**Training**

Own the Training Curriculum for his/her Job Pro

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