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Job ID:  45664
Date:  Sep 11, 2021
Job function:  Manufacturing
Experience level:  Experienced Hire
Business:  DSM Nutritional Products

Technical Stability Coordinator- Belvidere NJ

DSM – Bright Science. Brighter Living.™

Royal DSM is a global, purpose-led, science-based company active in Nutrition, Health and Sustainable Living. DSM’s purpose is to create brighter lives for all. DSM addresses with its products and solutions some of the world’s biggest challenges while simultaneously creating economic, environmental and societal value for all its stakeholders – customers, employees, shareholders, and society at large. DSM delivers innovative solutions for human nutrition, animal nutrition, personal care and aroma, medical devices, green products and applications, and new mobility and connectivity. DSM and its associated companies deliver annual net sales of about €10 billion with approximately 23,000 employees. The company was founded in 1902 and is listed on Euronext Amsterdam. 

More information can be found at www.dsm.com.

 

 

The Technical Stabilty Coordinator – Quality Projects will act as a Regional Stability Operation Subject Matter Expert (SME) for commercial products with emphasis on supporting stability projects and continuous improvement initiatives for existing and new businesses within DNP while ensuring that various aspects of quality and compliance requirements are implemented in the Stability Testing Program for the Regional Stability operation for DSM Nutritional Products. 

 

Find your passion here:

 

Bring your Passion! Build your future!

 

What we look for in you:

 

  • Represent Regional Stability operation on cross-functional project teams as a SME for product stability for the transfer and/or consolidation of stability testing from existing or new internal DNP businesses into the Regional Stability Operation. Provide timely and transparent communication to cross functional teams and management
  • Designated as single point of contact for stability transfer, new product development, or changes to existing products related projects and continuous improvement initiatives.
  • Performs gap assessments and resources planning for stability transfers, assess number of studies and stability chamber conditions and capacities, lab resources, SHE considerations, ensure analytical readiness (availability of validated stability indicating methods) and author necessary stability protocols and SOP’s to achieve gap closure.
  • .
  • Performs the duties of “Creator” in Documentum for the regional stability operation.
  • Development of stability protocols and route for review and approval in Documentum (in collaboration with the Quality Coordinator - Stability) after gathering all necessary supportive internal documentations (product data sheets, specifications, C of A’s, etc).
  • Determine stability sample requirements for testing by reviewing the applicable test methods, and calculate number of samples required per study based on pack types and storage conditions for projects, develop stability protocols and ensures proper execution of approved stability protocols for all assigned projects.
  • Supports requests to provide stability data and reports to customers, regulatory (for Drug Master Files and Annual Product Review for API products) and internal and external auditors.
  • Support site QA/QC requests for supporting stability data for shelf life extension.
  • Provide technical support and perform critical and scientifically sound data analysis including statistical analysis, shelf life/retest period, data trending and trend limits, specification changes.
  • Responsible for stability data compilation, maintenance and data entry into result databases (iStability LIMS, SharePoint or Documentum).
  • Author batch specific stability studies summary reports using final approved stability data and route for management review and approval in a timely manner.
  • Ensure any stability issues or potential issues for assigned projects are appropriately and timely communicated to the Supervisor – Stability, QC.
  • Collaborate with QA functional areas in updating shelf-life specifications and testing protocols for all assigned projects.
  • Stay up-to-date and maintain an accurate schedule of stability reporting deadlines for all assigned projects.
  • Notify and coordinate with the Supervisor- Stability, QC in the event of project bottle necks or hurdles.
  • Contribute to the organization and archival of stability study documents.
  • Assist with internal and external audits; will be required to provide proper stability documentation and records during the audit process
  • Author upon request relevant stability operation SOP's under the guidance of the Supervisor- Stability, QC.
  • Recommend improvements to the stability program to achieve lean operation and efficient stability program and testing based on understanding of DNP product families and assessment of current and historical stability data.

 

What we like to see in your experience:

 

  • Minimum Bachelor’s Degree in chemistry, life sciences, or related scientific field 7 years of experience or Associate of Applied Science “A.A.S.” and with 10 years of equivalent experience.
  • Good level of conceptual and analytical thinking.
  • Strong knowledge of ICH guidelines & US Regulatory requirements and standards with emphasis on product stability for API and nutritional supplements and products.
  • Good communication skills, verbal and non-verbal required.
  • Demonstrated ability to effectively serve in cross-functional teams.
  • Prior QC stability experience is required.

 

 

 

Get the reward to match your passion

 

Working for DSM means the opportunity to really contribute to improving people’s lives and solving the challenges of today’s world. Challenging jobs, career opportunities, and an inspiring environment allow you to enhance your personal development. DSM recognizes that the on-going success of the company depends on the continued development and engagement of our employees and pursues a fair and competitive remuneration policy, recognizing individual and team competencies and performance. 

 

At DSM, we DSomething Meaningful.

 

 What we look for in you

 

What we like to see in your experience:

 

Procedure & Contact

Interested in this position? Please apply online via the career portal (https://jobs.dsm.com/)

 

Pre-employment screening procedures are part of the DSM Recruitment & Selection Process. You will be contacted when further information is required

 

 

 

DSM NA is an Equal Opportunity and Affirmative Action Employer. DSM is committed to ensuring equal employment opportunities for all job applicants and employees. Employment decisions are based upon job-related reasons regardless of an applicant's race, color, religion, sex, sexual orientation, gender identity, age, national origin, disability, marital status, genetic information, protected veteran status, or any other status protected by law.

DSM in 3 minutes

Do you know that DSM has the broadest portfolio of nutritional ingredients - that millions of people already have our biomaterials in their body - and that our innovations make materials lighter, healthier, safer, stronger, more durable and have a lower environmental footprint? This short 3 minute video shares our portfolio in Nutrition, Health and Sustainable Living