BioProcess Engineer (All Levels) - Downstream (Manufacturing Associate)

Overview

Imagine\u2026 2 weeks after the birth of your child you realize they aren't meeting critical developmental milestones and after months of doctor's appointments you are told your baby has a rare neurological disease that would impact how they would live their lives. This is the reality of parents whose children have Spinal Muscular Atrophy (SMA) and it's the reason why we at Novartis Gene Therapies are laser focused on bringing hope and possibility to those devastated by rare genetic diseases.

The BioProcess Engineer III is responsible for organizing, running, sustaining, and continuously improving the manufacturing operations process at the plant/site. This individual will work on the manufacturing floor to produce product, troubleshoot equipment, and provide ownership for specific pieces of processing equipment.

Responsibilities

• Produce clinical and commercial material on an annual basis that meets the site's strategic objectives and is compliant with cGMPs.
• Ensure cGMP documentation is being filled out correctly, training is current and all Quality requirements are being followed.
• Participate in tours or information requests for all FDA and internal audits of the manufacturing facilities/processes and respond to any observations received per procedure.
• Responsible for maintaining quality standards to meet cGMP requirements, CFR's, and internal company policies related to the manufacturing process.
• Support tech transfer of new products and processes to ensure smooth transition from process development into GMP manufacturing.
• Provide hands on technical leadership to the manufacturing staff members.
• Look for opportunities to implement operational excellence and continuous improvement.
• Partner with Quality to ensure a quality and compliant manufacturing environment.
• Support Director of Operations to meet information requirements as needed for quality, compliance, and management reporting.
• Assist the technical operations team to resolve any issues related to production.

Qualifications

• 4+ years' experience in Biological Manufacturing environment.
• A minimum of 4-7 years of experience in biopharmaceutical based GMP manufacturing operations including experience in cell culture, recovery, purification, aseptic fill/finish with working knowledge of FDA regulations and GMP systems.
• 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).
• Project management skill set with experience in strategic/tactical planning, team building, and meeting budgets.
• 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.

Why Novartis?

769 million lives were touched by Novartis medicines in 2020, 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!

Novartis Gene Therapies Benefit Summary:

Annual bonus, long term incentive, health insurance, paid vacation/holidays, potential flexible working arrangements (based on role) and an employee recognition program are available for this position, among many other benefits provided to employees of Novartis Gene Therapies.

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.

Novartis Gene Therapies is committed to creating a diverse environment and is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity, national origin, genetics, disability, age, sexual orientation or veteran status.

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