Band

Level 4

Job Description Summary

The Senior Engineer, Manufacturing Science and Technology – ADP, is responsible for leading process introduction and improvement activities for the drug product manufacturing processes used to fill sterile products at the Durham, NC campus.

Job Description

Location:

• This position will be located in Durham, NC and will be an onsite role.
• Novartis is unable to offer relocation support for this role: please only apply if this location is accessible for you.

Key Responsibilities:

• Collection and interpretation of continued process verification data and collaboration with other departments on manufacturing related issues to drive resolution and process improvements.
• Serves as a scientific and technical lead for process-related issues and investigations at the facility.
• Partners with manufacturing to meet the production schedule, ensure commercial supply and uphold quality standards.
• Performs trending and monitoring of critical quality attributes/critical process parameters to maintain product quality and to control process drift.
• Implements potential process improvements in conjunction with operations.
• Participates in start-up efforts of new equipment, software or processes in manufacturing.
• Assists in documenting changes/updates to manufacturing processes and working with manufacturing, engineering and validation to implement those changes.
• Provides technical/scientific support on project deliverables, i.e. remediation initiatives, plan reports.
• Partners with Technology Development and/or network sending sites to support tech transfer of new products and processes and ensure smooth transition from process development to GMP manufacturing.
• Looks for opportunities to implement operational excellence and continuous improvement.
• Partners with Quality to ensure a compliant manufacturing environment.
• Assists the technical operations team to resolve any issues related to production.
• Completion of requisite training, as well as applicable policies and procedures, related to the job function is an expectation to support ongoing manufacturing support.
• Other related duties as assigned.

Essential Requirements:

• Bachelor of Science degree in biochemistry, chemical engineering, bioengineering, or related technical field and at least 6 years of experience in support of biopharmaceutical manufacturing

OR

• Master of Science degree in biochemistry, chemical engineering, bioengineering, or related technical field and at least 4 years of experience in support of biopharmaceutical manufacturing

OR

• PhD in biochemistry, chemical engineering, bioengineering, or related technical field and at least 2 years of experience in support of biopharmaceutical manufacturing.

AND

• Excellent oral and written communication skills.
• Preferred Experience: 6 years of experience in biopharmaceutical based GMP manufacturing operations including direct experience in aseptic fill/finish and/or technology transfer.
• Familiar with global regulations on devices, drugs, validation/qualification requirements.
• Strong technical writing ability.
• Proven ability to effectively lead and participate on teams.
• May travel up to 10% - 15%.

Novartis Compensation and Benefit Summary:

The salary for this position is expected to range between $114,100 and $211,900 annually

The final salary offered is determined based on factors like, but not limited to, relevant skills and experience, and upon joining Novartis will be reviewed periodically. Novartis may change the published salary range based on company and market factors.

Your compensation will include a performance-based cash incentive and, depending on the level of the role, eligibility to be considered for annual equity awards.

US-based eligible employees will receive a comprehensive benefits package that includes health, life and disability benefits, a 401(k) with company contribution and match, and a variety of other benefits. In addition, employees are eligible for a generous time off package including vacation, personal days, holidays and other leaves.

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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 e-mail to tas.nacomms@novartis.com 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.

https://www.novartis.com/careers/careers-research/notice-all-applicants-us-job-openings

Salary Range

$114,100.00 - $211,900.00

Skills Desired

Applied Statistics, Change Control, Data Analytics and Digital, GDP Knowledge, gmp knowledge, HSE Knowledge, Manufacturing Process, Manufacturing Production, Manufacturing Technologies, Operational Excellence, Process and Cleaning Validation, Process Control, Quality Compliance, Regulatory Compliance, Resilience and Risk Management, Technical Leadership, Technology Transfer