338119BR
Apr 20, 2022
USA

Job Description

55! The number of reagents responsible for manufacturing to support assay development, validation, and clinical trial testing both in-house and globally with 10 new reagents in the pipeline.

This individual will work in a small group to produce and perform QC analysis on high quality in vitro diagnostic (IVD) reagents in support of QC release testing and patient testing at Navigate BioPharma.

• Works in a GMP/GCP/GLP/CLIA regulated environment and is responsible for following all applicable regulations
• Perform activities necessary to deliver high quality reagents in support of QC release testing, reagent kits used for patient testing, and specimen collection kits in support of clinical trials, including the following:
• Raw material, in-process, stability, and/or final product inspections
• Manufacture of reagents, such as material handling and inventory management
• Adherence to and meticulous maintenance of cGMP practices
• Raw material procurement, disposition and inventory maintenance
• Contribute to the creation, maintenance, review and update of manufacturing processes, documents, and records to ensure completeness, accuracy, consistency and clarity as well as compliance to cGMP and QSR requirements
• Support the maintenance and continuous improvement of GMP/QSR quality systems
• Support regulatory filings and inspections of company, as related to reagent manufacturing practices
• Communicate and coordinate directly with internal customers to ensure reagent demands are met in a timely manner in support of sample testing and QC release activities
• Trains associates on operational procedures, as needed
Other responsibilities
• Ensuring that Quality Events such as incidents and deviations are properly documented, and for supporting/owning the immediate remediation and preventative actions
• Ensuring change requests are properly initiated, completed, and approved prior to the use of the assay, system, instrument, software, etc. being changed
• Maintaining up-to-date training records and ensuring training is complete prior to performing specific job functions
• Following approved and effective procedures to perform specific job functions, and ensuring procedures accurately reflect activities being performed

PHYSICAL DEMANDS
Note: The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions

While performing the duties of this job, the employee is regularly required to sit and talk or hear. The employee is occasionally required to stand; walk; use hands to finger, handle, or feel; and reach with hands and arms. The employee must occasionally lift and/or move up to 10 pounds. Specific vision abilities required by this job include close vision, and ability to adjust focus.

WORK ENVIRONMENT
Note: The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

While performing the duties of this job, the employee is occasionally exposed to laboratory instruments.
The work environment involves moderate exposure to unusual elements including; extreme temperatures, fumes, smoke, unpleasant odors, and/or loud noises. The work environment involves exposure to potentially dangerous materials and situations that require following extensive safety precautions and includes the use of protective equipment. The noise level in the work environment is usually moderate. Interaction with laboratory equipment, samples, supplies, and laboratory personnel may be required whereby appropriate precautions are to be taken per the Company’s Safety and Injury, Illness and Prevention Plans.

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

• High School Diploma is required
• Bachelor’s Degree with scientific emphasis is preferred
• High School Diploma with 4+ years relevant experience or BS/BA with scientific emphasis with 2+ years of experience in a scientific or manufacturing setting is required
• Proficiency in the use of basic molecular biology laboratory techniques, equipment and materials required, as well as experience with Good Laboratory and Good Manufacturing Practices
• Demonstrated ability and desire to work in a dynamic, fast-paced manufacturing lab environment
• Understanding of systems and processes used in manufacturing settings, such as the use of SOP’s and LIMS
• Demonstrated strength in working within a team, as well as ability to work effectively independently
• Well organized, self-motivated and possess excellent time management skills
• Excellent interpersonal and communication skills, both verbal and written
• Ability to multitask and adapt to rapidly changing requirements
• Excellent attention to detail
• Quality minded, customer focused and driven by desire for continuous improvement
• Technical ability and demonstrated proficiency in performing and troubleshooting complex molecular biology systems
• Reagent manufacturing experience


The Novartis Group of Companies are Equal Opportunity Employers and take pride in maintaining a diverse environment. Our policies are not to discriminate in recruitment, hiring, training, promotion or other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, marital or veteran status, disability, or any other legally protected status.

Why Novartis?

769 million lives were touched by Novartis medicines in 2020, and while we’re proud of this, we know there is so much more we could do to help improve and extend people’s lives.

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 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 Novartis!

Commitment to Diversity & Inclusion:
Novartis is committed to building an outstanding, inclusive work environment and diverse team’s representative of the patients and communities we serve.

Join our Novartis Network: If this role is not suitable to your experience or career goals but you wish to stay connected to hear more about Novartis and our career opportunities, join the Novartis Network here: https://talentnetwork.novartis.com/network

Accessibility and reasonable accommodations:
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.
ONCOLOGY
NAVIGATE BIOPHARMA SERVICES
USA
Carlsbad, CA
Research & Development
Full Time
Regular
No
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338119BR

Manufacturing Scientist

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