Expert Science & Technology - Quality Control, Information Technology

EAST HANOVER, NJPosted 20 days ago

Job summary

• Job post source

  This job is directly from Novartis

• Job overview

  The Expert Science & Technology - Quality Control, Information Technology role at Novartis focuses on supporting and maintaining GMP analytical equipment and lab systems for cell and gene therapies to ensure regulatory compliance and data integrity.

• Responsibilities and impact

  The role involves managing GxP lab systems, ensuring compliance with regulations like 21 CFR Part 11, supporting system lifecycle management, authoring and reviewing validation documents, leading system improvement projects, and collaborating with multiple teams to maintain high-quality lab operations.

• Compensation and benefits

  The salary range is $77,000-$143,000 with potential sign-on bonus, restricted stock units, discretionary awards, and comprehensive benefits including medical, financial, 401(k), and paid time off.

• Experience and skills

  Requires a bachelor's degree in a scientific discipline, at least 3 years of pharmaceutical industry experience in automation/digitalization projects, knowledge of GxP regulations, experience with validation documentation, and skills in SQL, Java or LIMS programming; LIMS administration and cell therapy analytics experience are preferred.

• Career development

  Novartis offers opportunities for professional growth through collaborative work, innovative projects, and a supportive culture focused on breakthrough medical advancements.

• Work environment and culture

  Novartis promotes a collaborative, inclusive, and supportive work environment emphasizing innovation, diversity, and equal opportunity employment.

• Company information

  Novartis is a global pharmaceutical company focused on innovative medical solutions, particularly in cell and gene therapy, with a commitment to improving patient lives worldwide.

• Team overview

  The candidate will join a specialized team working on analytical labs for cell and gene therapies, collaborating with Analytical Development, IT, Engineering, and Validation teams.

• Job location and travel

  The position is onsite at Novartis' East Hanover, NJ facility with no remote work option and may require occasional weekend support.

• Application process

  Applicants must submit their application through Novartis' career portal; accommodations are available for disabilities upon request via email or phone.

• Unique job features

  This role is distinguished by its focus on cutting-edge cell and gene therapy technologies, involvement in GxP lab system lifecycle management, and leadership in compliance and system enhancement projects.

Company overview

Novartis is a global healthcare company based in Switzerland that specializes in the research, development, manufacturing, and marketing of pharmaceutical and biotechnology products. The company generates revenue through its innovative medicines, generics, and biosimilars, with a focus on areas such as oncology, immunology, neuroscience, and ophthalmology. Founded in 1996 through the merger of Ciba-Geigy and Sandoz, Novartis has a rich history of scientific breakthroughs and a commitment to improving patient outcomes worldwide.

How to land this job

• Tailor your resume to highlight expertise in GxP lab systems management, emphasizing experience with analytical instruments like Flow cytometer, ddPCR, UPL, and NGS, as well as compliance with 21 CFR Part 11 and Annex 11 regulations.

• Focus on showcasing your skills in lifecycle management of GxP lab systems, including validation documentation (URS, FRS, DS, IQ, OQ, PQ) and your ability to lead projects such as LIMS implementation and lab instrument qualification.

• Apply through multiple platforms including the official Novartis careers site, LinkedIn, and industry-specific job boards to maximize your chances of being noticed for this onsite East Hanover position.

• Connect with professionals in Novartis' Cell and Gene Therapy or Quality Control divisions on LinkedIn; use ice breakers like commenting on recent Novartis innovations in cell and gene therapy or asking about their experience with GxP lab systems compliance and project management.

• Optimize your resume for ATS by incorporating keywords from the job description such as 'GxP lab systems,' '21 CFR Part 11,' 'validation lifecycle,' 'LIMS,' 'analytical instruments,' and 'data integrity initiatives' to ensure your resume passes automated screenings.

• Utilize Jennie Johnson's Power Apply feature to automate application submissions across multiple channels, tailor your resume for ATS, and identify relevant Novartis contacts on LinkedIn, allowing you to focus your energy on preparing for interviews and networking.