334049BR
May 11, 2022
USA

Job Description

500 million patients were touched by Sandoz generic and biosimilar medicines in 2020 and while we’re proud of this, we know there is more we could do to continue to help pioneer access to medicines for people around the world.

Chemist III, Technical Support Services is responsible for the evaluation, development and validation of methods required for raw materials and finished products. Performs qualitative and quantitative analyses of organic and inorganic compounds to determine the identity, purity and homogeneity of drug substances and products related to each project. Conducts research to developer improve analytical techniques, methodology, procedures and investigates application of instruments in analysis. Organizes and interprets all data obtained using a wide variety of instrumental technologies. Implements QC specifications to ensure process consistency, quality and optimal performance. Ascertains relationships between molecular structure and physical properties to aid in the analysis of compounds. The associate is responsible for understanding the Change Control system and the requirements for submitting validation reports and protocols so as to fully implement method requirements and specifications. The associate must work cross-functionally to ensure the success of assigned projects. The associate has a basic understanding of project management. The chemist in this role will provide support for activities related to maintaining the overall compliance status of the site. Responsibilities include assisting in site preparedness for inspections by regulatory authorities as guided by quality leadership, execution of compliance activities such as site procedural and cGMP training, internal audits, and Novartis Quality Module knowledge.

• Demonstrates technical and theoretical understanding of all raw material and finished product methodology in support of projects.
• Develops analytical methods for full range of testing in both Raw Materials and Finished Products. Selects appropriate methodologies, technology and techniques for those methods to be validated.
• Writes and reviews validation protocols and reports.
• Works with customers in QC Supply Chain, Quality Assurance, Regulatory Affairs and Technical Services to ensure the customer’s needs are understood and met.
• Proficient in routine analytical testing for both raw material and finished products in support of AS projects.
• Shows a basic comprehension of QTS project systems and process flows.
• Thorough understanding of Change Control processes.
• Adept at instrumentation trouble shooting.
• May participate in the following functions in support of Supplier Quality Management (SQM) functions:
• Completion of QAAs, QRAs, Quality Metrics, and monitoring of schedule adherence of the supplier audit schedule for APIs, Excipients, Primary Packaging Components, Contract Laboratories, High Risk GMP Consumables, Packaging Facilities, and other suppliers/service providers as required.
• Provide maintenance of the Novartis tools for SQM oversite as needed – 3rd PAP, EMPO SharePoint, Master Chemicals List (i.e. APIs), SAP (ZC9 and AML t-codes), QRA SharePoint tool, and others as needed.
• On-time completion of APQR sections as related to SQM and Analytical Method Validation (if needed).
• Data gathering of quarterly SQM metrics for Quality Council reporting.
• Change Request and governance of supplier approval processes for new materials, services, etc...
• Updates to SOPs, implementation of global quality directives and procedures as required.
• Timely closure of assigned actions in quality systems in support of the SQM functions.
• Ensures all company policies and procedures are adhered to.
• Performs other duties as assigned.
• Adheres to all applicable procedures, cGMPs, company policies and any other quality or regulatory requirements. (For example: OSHA, DEA, FDA, EMEA, ANVISA, etc.)

Diversity & Inclusion / EEO

The Novartis Group of Companies are Equal Opportunity Employers and take pride in maintaining a diverse environment. We do not discriminate in recruitment, hiring, training, promotion or other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, marital or veteran status, disability, or any other legally protected status. We are committed to building diverse teams, representative of the patients and communities we serve, and we strive to create an inclusive workplace that cultivates bold innovation through collaboration and empowers our people to unleash their full potential.

Minimum Requirements

• B.S. or B.A. in Chemistry or related subject required.
• Minimum of 6 years of analytical chemistry experience is required.
• Ability to perform analytical techniques as required by RM and FP testing is required.
• Experience with supplier quality management responsibilities is preferred.

Why Sandoz?

How will we do this? We believe new insights, perspectives and ground-breaking solutions can be found at the intersection of medical science and digital innovation. That a diverse, equitable and inclusive environment inspires new ways of working.

We believe our potential can thrive and grow in an unbossed culture underpinned by integrity, curiosity and flexibility. And we can reinvent what's possible, when we collaborate with courage to aggressively and ambitiously tackle the world’s toughest medical challenges. Because the greatest risk in life, is the risk of never trying!

Imagine what you could do here at Sandoz!

Accessibility and reasonable accommodation

The Novartis Group of Companies are committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please send an e-mail to [email protected] call +1 (877) 395-2339 and let us know the nature of your request and your contact information. Please include the job requisition number in your message.
Novartis Technical Operations
NTO QUALITY
USA
Wilson, NC
Quality
Full Time
Regular
No
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334049BR

Chemist III, Technical Support Services

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