Apr 06, 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 Senior Manager, Pre-Clinical Manufacturing reports to the Head of Pre-Clinical Manufacturing and is responsible for organization, management, and development of pre-clinical manufacturing operations and processes at the Technical Research and Development site.

What you'll be doing:
• Directly responsible for a team of Process Science Engineers whose responsibilities include the production of pre-clinical material, large scale development work and support of small scale lab experiments, as needed.
• First line of contact to address process, equipment, or safety related issues in the lab environment.
• Oversite for one of the following: Upstream (cell culture), or Downstream (purification) activities in the large scale development team.
• Produce pre-clinical material on an annual basis that meets the site’s strategic objects and is compliant with phase appropriate requirements, the Development Quality Plan and safety regulations.
• Perform a technical review, close out and archival of development batch records.
• Author, review or contribute to run summary reports for large scale development or engineering runs.
• Partners with small scale development teams to design and conduct experiments to support the development and implementation of a cell culture scale-up, recovery, and downstream purification processes for the product pipeline.
• 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.
• Schedule daily operations (finite scheduling) for manufacturing unit operations as well as media/buffer preparation activities.
• Ensure resources are adequate to complete operations for both raw materials and personnel.
• Work with procurement to provide required bill of materials and ensure accurate material purchasing for upcoming pre-clinical batches.
• Identify process challenges based on unique consumable needs. Work with vendors to design custom solutions, as needed.
• Works cross-functionally to ensure accuracy of large scale batch sampling plans, sample pulling and sample submission to the analytical sample management team.
• Lead troubleshooting and investigations as related to process issues at scale. Partner cross-functionally with stakeholders from Early Development, Engineering, Analytical, Procurement and Quality to address these issues effectively and compliantly.
• Ensure documentation (batch records, work instructions, PLANs and SOPs) are accurate and updated as required.
• Participate in tours or information requests for all agency and internal audits of the manufacturing facilities/processes and respond to any observations received per procedure.
• Provide monthly manufacturing metrics as determined by management.
• Lead areas of tech transfer of new products and processes into the manufacturing area. Provide manufacturing feedback on engineering related projects.
• Identify and implement continuous improvement opportunities.
• Lead and mentor staff. Facilitate the professional development of each team member. Write performance reviews and annual goals, hold one-on-ones, and handle HR related matters.
• Champion for all EH&S policies, procedures and guidelines. Drives a safety first culture within the team.
• 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:
• B.S degree in biochemistry, chemical engineering, bioengineering, or related technical field, or equivalent industry experience.
• External candidates:
• Recommended 8+ years of experience in biopharmaceutical GMP or development environment including experience in Upstream Cell Culture/Bioreactors or Downstream Purifications activities.
• Internal Candidates:
• Recommended 4+ years of directly relevant internal experience. Or, a combination of internal and external experience equivalent to 8 years, where internal experience is weighted 2 times that of external experience.
• Excellent oral and written communication skills. Strong technical writing ability required.
• Excellent computer skills, proficient with Microsoft Word, Excel, PowerPoint and Visio, and working knowledge of JMP or equivalent statistical software.
• Ability to motivate and mentor peers, staff, foster a culture of continuous improvement and operational excellence. Demonstrated leadership skills.
• Project management skill set with experience in strategic/tactical planning, team building, and meeting budgets.
• Experience with gene therapy, cell therapy, AAV or Lentivirus development is a plus.

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.

Global Drug Development
San Diego, CA
Research & Development
Full Time
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Sr. Manager, Pre-clinical Manufacturing (Upstream)

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