Bioprocess Engineer I-Downstream (Days)

• Supports the product requirements to ensure that all products are produced according to plan. Learn cGMP and cGDP and ensure cGMP documentation is being filled out correctly, training is current, and all Quality requirements are being followed.
• Other related duties as assigned.
• Assists with creation and on-going maintenance of all pertinent equipment, policies, and procedures.
• Partners with Quality to ensure a quality and compliant manufacturing environment.
• Maintains quality standards to meet cGMP requirements, CFR’s, and internal company policies directly related to the manufacturing process.
• Learn aseptic techniques, cell culture, recovery, purification, aseptic fill/finish (upstream and downstream).
• Produce product, media/buffer preparation, learn to troubleshoot equipment, participate in interviews on deviations, stocking of items in supply/ production / warehouse area, and standardizing equipment and cleaning production area.
• Assists in determine root cause, implement a solution and a verification check to ensure the fix was effective.
• Assists the technical operations team to resolve any issues related to production.
• Assists in manufacturing led investigations through partnerships with Quality and other business units at the site.
• Produces product, media/buffer preparation, learn to troubleshoot equipment, participate in interviews on deviations, stocking of items in supply/ production / warehouse area, and standardizing equipment and cleaning production area.
• Assists in producing clinical and commercial material on an annual basis that meets the site’s strategic objectives and is compliant with cGMPs.

• Approximately 10% travel.
• Entry level into the biopharmaceutical based GMP manufacturing operations, no experience necessary.
• Bachelor of Science Degree in Biology, Chemistry, Biotechnology or applicable field or 2 years equivalent experience.
• Ability to work alternate 12-hour shifts and weekends.
• Excellent oral and written communication skills.
• Ability to routinely lift over 35 lbs.

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

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. Additionally, 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.

The pay range for this position at commencement of employment is expected to be between $24.90 and $37.31/hour; however, base pay offered may vary depending on multiple individualized factors, including market location, job-related knowledge, skills, and experience. The total compensation package for this position may also include other elements, including a sign-on bonus, restricted stock units, and discretionary awards in addition to a full range of medical, financial, and/or other benefits (including 401(k) eligibility and various paid time off benefits, such as vacation, sick time, and parental leave), dependent on the position offered. Details of participation in these benefit plans will be provided if an employee receives an offer of employment. If hired, employee will be in an “at-will position” and the Company reserves the right to modify base salary (as well as any other discretionary payment or compensation program) at any time, including for reasons related to individual performance, Company or individual department/team performance, and market factors.

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