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[Netherlands] Analytical Sciences
2 maanden geleden
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 Profile and provide the necessary training and support to new associates joining this position.
Audit support
Maintain their work at “inspection readiness level” and to provide the necessary support in any internal or external audit.
Qualifications
- BSc. or MSc. in Pharmacy, Pharmaceutical Technology, Chemistry, Engineering, or other scientific degree.
- Fluent English language skills.
- Minimum 5 years’ experience as QC/IPC laboratory scientist of pharmaceutical /chemical GMP environment, or analytical methods development scientist.
- Basic knowledge of current CPV / OPV product and process data analysis and monitoring tools and usage.
- Fundamental understanding of international regulatory requirements across multiple health authorities (e.g., US, EU, JP, China).
- Practical knowledge of standard pharmaceutical analytical testing and methods development.
- 5S / 6S Lean Six Sigma Certification is welcome.
Deadline
Please apply no later than 24th November 2024.
Additional Information
A career at Santen is an opportunity to make a difference. Through our long-term vision outlined in Santen 2030, we are committed to be a Social Innovator - addressing the social and economic needs of people with visual impairments. We have team members around the world using their diverse talents to unlock new modalities and drive innovations for patient outcomes, education and treatment. At Santen, we believe in empowering all our team members with flexible ways of working and a highly inclusive work environment.
The Santen Group is an Equal Opportunity Employer. We are committed to building diverse teams and ensuring a safe and inclusive physical and virtual workplace for every one of our team members. All employment decisions are based on business needs, role requirements and individual qualifications regardless of race, color, ethnicity, national origin/ancestry, religion, gender, gender identity/ expression, age, disability, medical condition, marital status, veteran status, or any other characteristic protected by law.
