drjobs Senior Expert Science Technology - Good Manufacturing Practices - Validation

Senior Expert Science Technology - Good Manufacturing Practices - Validation

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1 Vacancy
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Job Location drjobs

East Hanover, NJ - USA

Monthly Salary drjobs

$ 108500 - 201500

Vacancy

1 Vacancy

Job Description

Band

Level 4


Job Description Summary

#LI Onsite. Location is East Hanover New Jersey.

Title: Senior Expert Science & Technology Good Manufacturing Practices

As a key member of the Analytical Operations team this individual will support Good Manufacturing Practice (GMP) activities to aid in delivering gene therapy to patients. The successful candidate will support development projects designed to release and characterize gene therapy products through an assortment of analytical methods. This role will also contribute to crossfunctional activities including monitoring of processes and products to identify opportunities for continuous improvement. Growth mentality and passion to serve patients his/her technical team and development programs is a must.



Job Description

Major accountabilities:

  • Serves as SME (Subject Matter Experts) in several GMP assays such as AUC (Analytical Ultracentrifugation) cellbased potency ELISA (Enzyme Linked Immunosorbent Assay) PCR flow cytometry next generation sequencing and separation assays.
  • Plays an active role in establishing the site GMP lab operations to support development and commercialization of new gene therapy medicines.
  • Routine sample testing under GMP or nonGMP modes (inprocess release and stability) laboratory maintenance and participating in method qualification validation transfer and improvement. Reviews and trends results.
  • Manages theprocurement implementationuseand maintenance of equipmentinstrumentation and computer systems.
  • Writes and revises documents such as SOPs (Standard Operation Procedures) method validation/transfer protocols and technical reports.
  • Leadsinvestigations to determine root causeof deviationsand nonconforming resultsand implement appropriate corrective and preventative actions in a timely manner.
    • Identifies and implements innovative technologies to improve the compliance and efficiency of GMP operations.
    • Represents GMP to workwith other departments includingAnalytical DevelopmentQuality AssuranceandManufacturing to address compliance issues and to implement corrective actions and to improve programs.
    • Work according to appropriate GMP/GLP regulations and Novartis SOPs/Guidelines and Code of Conduct.
    • Other related job duties as assigned.

Minimum Requirements:

  • Bachelors degree in Biology Biochemistry Molecular Biology Immunology or related scientific discipline with > 4 years of prior experience in academia or industry

  • At least 4 years experience in a GMP laboratory preferred.

  • Possess strong understanding of GMP testing operations and provide expertise in several assays such as AUC cellbased potency flow cytometry ELISA PCR and separationsbased assays.

  • Ability to work independently on problem solving lab investigations and implementation of preventative and corrective actions.

  • Ability to work effectively within the group within Quality and across sites. Additional responsibilities include adherence to all GMP requirements an understanding of FDA/EMEA regulations effective interactions/communication with Quality management.

  • Demonstrated ability to work collaboratively in a fastpaced team environment and quickly acquire new technical skills and knowledge

The pay range for this position at commencement of employment is expected to be between $98700 and $183300/year; however while salary ranges are effective from 1/1/25 through 12/31/25 fluctuations in the job market may necessitate adjustments to pay ranges during this period. Further final pay determinations will depend on various factors including but not limited to geographical location experience level knowledge skills and abilities. The total compensation package for this position may also include other elements including a signon bonus restricted stock units and discretionary awards in addition to a full range of medical financial and/or other benefits (including 401(k) eligibility and various paid time off benefits such as vacation sick time and parental leave) dependent on the position offered. Details of participation in these benefit plans will be provided if an employee receives an offer of employment. If hired employee will be in an atwill position and the Company reserves the right to modify base salary (as well as any other discretionary payment or compensation program) at any time including for reasons related to individual performance Company or individual department/team performance and market factors.

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 and Rewards: Read our handbook to learn about all the ways well help you thrive personally and professionally: to Diversity & Inclusion: 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.



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 gender national origin age sexual orientation gender identity or expression marital or veteran status disability or any other legally protected status. We strive to create an inclusive workplace that cultivates bold innovation through collaboration and empowers our people to unleash their full potential.



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 email to calland let us know the nature of your request and your contact information. Please include the job requisition number in your message.

Range

$108500.00 $201500.00


Skills Desired

Continued Learning Dealing With Ambiguity Decision Making Skills Gxp Industry Standards Laboratory Equipment Laboratory Excellence Managing Resources Organizational Savvy Quality Control (Qc) Testing Quality Control Sampling SelfAwareness Smart Risk Taking Technological Expertise Total Quality Management

Required Experience:

Senior IC

Employment Type

Full-Time

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