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Scientist, Manufacturing Science & Technology

Company

Novartis

Address , Morris Plains, Nj
Employment type FULL_TIME
Salary $97,600 - $146,400 a year
Expires 2023-06-10
Posted at 1 year ago
Job Description

365 days a year, we aspire to be the best manufacturer of Cell & Gene therapies to ensure our patients have the treatments they need to live longer, healthier lives.
The Scientist, Manufacturing Science and Technology will design, plan, perform, interpret and report scientific experiments under the lead of the lab head to contribute to overall MS&T strategies and objectives of process transfer, improvement and process characterization in the field of cell therapy manufacturing. The role will also be responsible for the transfer of new technologies knowledge and product manufacturing processes to the Value Stream, and support/own Procedure and MBR development. Due to the nature of the new technologies potentially being employed, this role requires advanced level of proficiency and understanding of cell therapy manufacturing. Technical Transfer activities will require the associate to perform operations in cleanroom or cleanroom-like environments. These and other efforts will help realize our collective goal of delivering robust and efficient cell therapies for patients in need.
Your responsibilities include, but are not limited to:
  • Contribute to the evaluation of new equipment and associated gap assessments
  • Train peers as appropriate in process/analytical techniques
  • Author and maintain lab instructions, batch records, SOPs, Forms
  • Maintains an audit ready lab/module
  • Ability to work with & maintain laboratory and processing equipment (including routine cleaning & maintenance)
  • Participate in process characterization activities on behalf of Technical Development (as applicable).
  • Escalate issues/conflicts/opportunities within a timely manner to department leadership
  • Support IOPQ strategies where required
  • Perform Aseptic GMP activities within Laboratory or Module (Testing, Manufacturing Processing, SPQ/APV/DPQ) in support of project milestones
  • Execute and document experiments (process / analytical) for products assigned in the context of technical transfer, process improvement, process characterization, SPQ/DPQ, APV, and process validation with an end-to-end ownership mindset.
  • Draft/Own/Review/Assist Deviation Investigations, Change Controls, Safety Inspections, CAPAs
  • Actively support the transfer of analytical or manufacturing procedures to/from external sites
  • Own and support report authorship and data/trend analysis
  • Maintain up-to-date documentation of laboratory work carried out including documentation storage and archiving.
  • Comply with applicable GxP regulations, SOPs, HSE, ISEC & other Novartis Guidelines in the laboratory.
  • Contribute to new method development and reproduce published methods.
  • Identify improvement options for current processes
  • Ensure proper laboratory cleaning, housekeeping and waste disposal.
  • Represents their area of responsibility in health authority inspections.
  • Support execution and maintenance of QRAs
  • Contribute to the evaluation of new materials and associated gap assessments
  • Contribute to evaluation and implementation of state-of-the-art technologies (laboratory methods, process techniques)

**Multiple positions available.
Other Qualifications:
  • Ability to work with magnetic field equipment.
  • Alternate shifts, weekends and overtime may be required.
  • Ability to work in cleanroom environment
  • Requires handling of chemicals such as corrosives, solvents & bio-hazardous materials.
  • Ability to lift 50 lbs unassisted.

EEO Statement

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

  • Experience of working within a cleanroom environment
  • Advanced use of production related IT systems such as SAP, LIMS and MES
  • A minimum of 2 years of experience in a pharmaceutical environment (e.g. laboratory, production, cell therapy manufacturing)
  • Fluent in speaking / writing in English
  • Sound knowledge of laboratory and technical tools
  • Bachelor’s degree in chemistry, biologics, pharma or any other appropriate natural sciences
  • Awareness of safe handling of chemicals, potentially dangerous materials and equipment
Desirables:
  • Background in immunology and T cell biology experience desired
  • Knowledge in Tech Transfer and project study design is desired
  • Experience in writing/assessing/performing; deviations, OOS investigation, CAPAs, Root Cause Analysis is desired
  • Experience in Quality Risk Assessments, Gap assessments, technical writing (writing/reviewing) is desired
  • Basic presentation skills, excellent collaboration and communication skills
  • Experience with and understanding of cell therapy, virology, cell biology, development, and manufacturing; process development and characterization, strongly desired
Why Novartis?
766 million lives were touched by Novartis medicines in 2021, 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 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 Novartis!
Commitment to Diversity & Inclusion: Novartis is committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve.
Accessibility and Reasonable Accommodations: Individuals in need of a reasonable accommodation due to a medical condition or disability for any part of the application process, or to perform the essential functions of a position, please send an e-mail to [email protected] or 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.
The pay range for this position at commencement of employment is expected to be between $97,600 and $146,400/ year; however, base pay offered may vary depending on multiple individualized factors, including market location, job-related knowledge, skills, and experience. The total compensation package for this position may also include other elements, including a sign-on 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 “at-will 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.
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
Customer-facing roles only:
While Novartis does not require vaccination for Covid-

Division

Operations

Business Unit

CELL & GENE THERAPY

Country

USA

Work Location

Morris Plains, NJ

Company/Legal Entity

Novartis Pharmaceuticals

Functional Area

Technical Operations

Job Type

Full Time

Employment Type

Regular

Shift Work

No

Early Talent

No