Jun 22, 2022

Job Description

12,000. The number of associates worldwide working together to reimagine medicine!

The Global Drug Development (GDD) organization oversees the development of new medicines discovered by our researchers and partners. We transform the lives of people by developing innovative and life-changing medicines.

The Associate Expert, Preclinical MFG (US/DS) Drug Supply, reports to the Sr/Manager of Pre-Clinical Manufacturing and is responsible for execution of pre-clinical manufacturing operations and processes at the Technical Research and Development site.

Note: This job description is relevant to positions in either the Upstream or Downstream Preclinical teams as specified in the job posting.

What you'll be doing:

• Produce high-quality pre-clinical material at a production/pilot scale in an early research and development setting, in support of the company’s pipeline and strategic objectives.
• Safely and compliantly execute daily lab operations for large scale processes in Upstream or Downstream, depending job specific assignment.
• Conduct experiments supporting large scale development and implementation of a closed system, scale-up, recovery, and purification processes for gene therapy.
• Support tech transfer of new products, technologies, and processes to ensure smooth transition from process development into GMP manufacturing.
• Author work procedures for new equipment as it is onboarded.
• Revise or review equipment procedures, development batch records, protocols and/or sample plans to ensure accurate content and useability.
• Work cross-functionally to obtain feedback and alignment regarding projects and potential modifications to current processes.
• Capable of evaluating and summarizing data using analytical methodologies, interpreting results, drawing conclusions and recommending options for future experiments to achieve project goals.
• Adhere to Novartis Development Quality requirements, including good documentation practices (ALCOA+). Appropriately document experimental procedures and results according to established guidelines, ensure training is current, and all Quality requirements are being followed.
Support site tours or information requests for internal and external audits of manufacturing facilities/processes and support responses to any observations received per procedure.
Responsible for maintaining quality standards to meet Novartis Quality requirements related to the pre-clinical manufacturing process.
Support small scale lab experiments, as needed.
Look for opportunities to implement operational excellence and continuous improvement.
Support lab equipment upkeep in collaboration with the site Engineering team.
Partner with Development Quality to ensure a quality and compliant manufacturing environment.
Support the leadership team to meet information requirements as needed for quality, compliance, and management reporting.
Don lab gowning as required.
Adhere to all EH&S policies, procedures and guidelines.
Other related job duties as assigned.

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

What you'll bring to the role:

• Recommended 3-5 years of experience in a biopharmaceutical based manufacturing or process development setting, including experience in cell culture, recovery, and purification. Working knowledge of FDA regulations and GMP systems is preferred.
• B.S. degree in biochemistry, chemical engineering, bioengineering, related life-science field, or equivalent industry experience.
• Excellent oral and written communication skills. Strong technical writing ability required.
• Ability to motivate peers and staff, foster a culture of continuous improvement and operation excellence.
• Experience with 3rd parties (equipment vendors, and contract manufacturing insourcing/outsourcing).
• Approximately 10% travel required.
• Must be able to routinely lift over 35 lbs.

The level of this position will be based on the final candidate’s qualifications.

Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities and activities may change at any time with or without notice.

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
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.


Vaccine Policy: While Novartis does not require vaccination at this time, for certain Novartis sites in the US all associates and candidates may be required to either upload an image of their COVID-19 vaccine card demonstrating proof of full vaccination for COVID-19 (or other similar evidence of vaccination) or proof of a negative COVID-19 test taken by the associate or candidate within the past seven days to enter any of our sites and/or customer office or healthcare facility, as well as prior to participating in other work related off-site meetings. Employees working in customer-facing roles must adhere to and comply with customers’ (such as hospitals, physician offices, etc.) credentialing guidelines, which may require vaccination. As required by applicable law, Novartis will consider requests for reasonable accommodation for those unable to be vaccinated. This requirement is subject to applicable state and local laws and may not be applicable to employees working in certain jurisdictions. Please send accommodation requests to [email protected].
Global Drug Development
San Diego, CA
Research & Development
Full Time
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Expert - Preclinical Manufacturing - Drug Supply

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