Product Steward

WillHire; Indianapolis (IN); On-site; USD 10,000 - 60,000; Full time

Job summary

A leading global medicines company is seeking a Product Steward for a temporary 8-month contractor role in Indianapolis. The ideal candidate will manage the product lifecycle, ensure continuous validation, and support quality improvement projects. This role requires significant experience in pharmaceutical manufacturing and a relevant scientific degree.

Benefits

Health, dental, vision, 401k

Qualifications

• Minimum 8 years of process support experience, with pharmacy manufacturing or QA/QC.
• Fluent in English and proficient in local language.
• Proven understanding of GMP and regulatory aspects.

Responsibilities

• Maintain oversight and knowledge of the manufacturing process.
• Lead root cause investigations for process failures.
• Ensure ongoing verification and compliance with regulations.

Skills

Process understanding

Data handling

Applied statistics

Education

BSc in Pharmacy, Pharmaceutical Technology, or Chemistry

Job description

~~~Please note: This is a temporary contractor opportunity at Novartis ~~~
Novartis touches the lives of a tenth of the world’s population. Every role here, regardless of contract type, makes an impact on human life!

Novartis US partners with external managed service provider Magnit Global to offer engaging temporary contractor opportunities like this, to those who are looking for flexibility in their career while looking to gain new skills and experiences providing services to an inclusive global medicines company. Click here to learn more about Magnit www.magnitglobal.com

Ready to work with/through Magnit at Novartis? Please read on...
Product Steward

Responsible for educating themselves regarding process knowledge of the product(s) assigned to the site and helping assist management of the products throughout the commercial lifecycle, assists the team in maintaining the oversight on process capability, through data trending and statistical analysis of critical variables, ensuring
process(es) are robust, in continued state of validation and continuously improving.
Ensures seamless flow of knowledge and information across functions, and with other Sites when applicable, with focus on the assigned product(s). Provides second line technical/scientific process support.

Stewardship– for the product(s) assigned:
Maintain the oversight and knowledge for entire manufacturing process performed on site and throughout the
entire commercial lifecycle, since transfer from development to date, act as SPOC.
Create and maintain a product specific Quality Risk Analysis (QRAs).
Monitor all critical variables and key variables as appropriate using statistical analysis and conducting regular
product specific data trending.
Review APQR and decide on state of control.
Ensure inspection readiness for all process related aspects of assigned products.
Track and evaluate product performance, trending, detect issues, implementation of CAPAs.
Lead / support root cause investigation of process failures, initiate and lead product improvement projects,
involving cross-functional teams.
Assist initiating the product-specific monitoring of all critical In Process Controls (IPC) and release parameters in
each laboratory (transfer of the product-specific QRA).
Ensure data and trending are visible and communicated at shop floor level.
Present product performance and status of product improvement projects in site Manufacturing Robustness
Review Board (MRRB).
Assess impact of technical changes, assess their technical feasibility and determine scope / design of technical
batches, challenge technical risk and business benefit of technical changes proposed.
Ensure creation of Master Batch Record.
Contribute to registration strategy and support registration activities.

Validation – for the product(s) assigned:
Responsible for ensuring the continued state of validation (process, cleaning, ongoing verification etc.).
Ensure that the ongoing verification report (OPV) is established on time in alignment with the APQR.
Ensure an appropriate process control strategy based on CQA and where necessary on CPP, CMA is in place,
support improving the control strategy where applicable.
Review / update QRA prior to validation for technical changes.
Approve validation protocol and report related to technical changes.
Provide all necessary information to perform the validation documentation, align with stability experts and QC
labs to organize the stability samples.
Support Validation Lead and Experts to assess need and plan validations, assess revalidation need.
Launch & Transfer– for the product(s) assigned:
Provide the necessary data for the technical activities involved in transferring out a product, focusing on
existing knowledge, through the appropriate documentation and supporting at the receiving site as needed.

Manufacturing Excellence– for the product(s) assigned:
Design and manage optimization projects.
Provide SME expertise to perform process characterization of pharmaceutical processes to increase robustness
and sustainability.
Collaborate with OPEX for product / process improvements.
Training:
Own the Training Curriculum for own Job Profile.
Novartis Manufacturing Manual:
Support implementation of Novartis Manufacturing Manual principle 3.
Represent site in product stewardship network.

Key Performance Indicators
Product is maintained in constant state of validation.
Product history is documented and available and current since transfer from development to date.
Recurring Deviations.
Ppk/CpK – process capability.
OoS, OoE – Out of Specification, Out of Expectation – process-related.
Customer Complaints – process-related.
Recalls – process-related.
Success rate of Health Authorities’ inspections.
Completeness of Regulatory CMC dossier.
Effective CAPA.
Continuously improving Yield.
Technical reports executed on time and according to expectations

Education
BSc. in Pharmacy, Pharmaceutical Technology, Chemistry or equivalent
scientific degree.

Languages: Fluent in English and proficient in site local language.

Relevant Experiences:
Minimum 8 year experience in process support, e.g.
Process Expert role on the shop floor of pharmaceutical manufacturing and/or QA/QC.
Proven process understanding (Pharma, GMP, Regulatory aspects).
Sound experience of data handling and applied statistics is a must.

Location: Onsite role Indianapolis, IN
Pay Rate: $43 - $67.86/hour based on experience and qualifications (W2 Only)
Contract: 8 month
Health, dental, vision, 401k

Why Novartis:
Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you. Collaborating, supporting and inspiring each other. Combining to achieve breakthroughs that change patients’ lives. Ready to create a brighter future together?

EEO Statement:
The Novartis Group of Companies are Equal Opportunity Employers. We do not discriminate in recruitment, hiring, training, promotion or other employment practices for reasons of race, color, religion, sex, national origin, age, sexual orientation, gender identity or expression, marital or veteran status, disability, or any other legally protected status.

Accommodation:
If you require reasonable accommodation in completing this application, interviewing, completing any pre-employment testing, or otherwise participating in the employee selection process, please direct your inquiries to Magnit at [e-mail].