Job Description
Summary The Bioprocess Engineer III/IV for Cell Expansion/Upstream is responsible for assisting with organizing, running, and sustaining the manufacturing operations process at the site. Perform manufacturing tasks according to schedule, ensuring products meet quality standards and comply with cGMP, safety, and environmental regulations.
*The role level will be determined by years of relevant experience.
The role is located on-site in our Durham, NC location. Novartis is unable to offer relocation support for this role: please only apply if this location is accessible for you.
About the Role Responsibilities: - Produces clinical and commercial material on an annual basis that meets the site's strategic objectives and is compliant with cGMPs.
- Works on the manufacturing floor to produce product, troubleshoot equipment, and provide ownership for specific pieces of processing equipment.
- Mentors and provides hands-on training to newly hired Bioprocess Engineers.
- Ensures cGMP documentation is being filled out correctly, training is current and all Quality requirements are being followed.
- Participates in information requests for all FDA and internal audits of the manufacturing facilities/processes.
- Maintains quality standards to meet cGMP requirements, CFR's, and internal company policies related to the manufacturing process.
- Leads tech transfer of new products and processes to ensure smooth transition from process development into GMP manufacturing.
- Looks for opportunities to implement operational excellence and continuous improvement.
- Partners with Quality to ensure a quality and compliant manufacturing environment.
- Supports leadership to meet information requirements for quality, compliance, and management reporting.
Shift: This role is a 2-2-3 rotating shift schedule. 6am-6pm. Role Requirements: Bioprocess Engineer III: - Bachelor's of Science Degree in Biology, Chemistry, Biotechnology or applicable field with minimum 4 years' experience in cGMP experience in biologics, pharmaceutical and/or vaccine manufacturing operations, including experience in cell culture, recovery, purification, bulk formulation and/or fill finish environment.
Or
- A minimum 6 years' experience in cGMP in biologics, pharmaceutical and/or vaccine manufacturing operations, including experience in cell culture, recovery, purification, bulk formulation and/or fill finish environment in lieu of degree.
Or
- Bachelors' degree in Biology, Chemistry, Biotechnology or applicable field with 3 years' experience in the manufacturing of Novartis Gene Therapies product;
Bioprocess Engineer IV: - Bachelors of Science Degree in Biology, Chemistry, Biotechnology or applicable field with 5 years' experience in cGMP experience in biologics, pharmaceutical and/or vaccine manufacturing operations, including experience in cell culture, recovery, purification, bulk formulation and/or fill finish environment;
Or
- A minimum 7 years' experience in cGMP experience in biologics, pharmaceutical and/or vaccine manufacturing operations, including experience in cell culture, recovery, purification, bulk formulation and/or fill finish environment in lieu of degree;
Or
- Bachelors' degree in Biology, Chemistry, Biotechnology or applicable field with 3+ years' experience in the manufacturing of Novartis Gene Therapies product.
Requirements for both levels: - Excellent oral and written communication skills. Strong technical writing ability.
- Ability to motivate peers and staff, foster a culture of continuous improvement and operation excellence.
- Ability to routinely lift over 35 lbs.
The salary for this position is expected to range between: for
Bioprocess Engineer III: $32.12 and $59.62 per hour; for
Bioprocess Engineer IV: $37.02 and $68.75 per hour. 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.
Company will not sponsor visas for this position. Why Novartis: Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you. Collaborating, supporting and inspiring each other. Combining to achieve breakthroughs that change patients' lives. Ready to create a brighter future together?
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Job Tags
Hourly pay, Visa sponsorship, Relocation package, Shift work, Rotating shift,