BioProcess Engineer I - Fill Finish (Swing Shift)
Ready to join a team committed to developing and commercializing gene therapies for patients and families devastated by rare neurological genetic diseases? Since 2013, Novartis Gene Therapies (formerly AveXis) has had one focus: bringing change to those devastated by genetic diseases.
The Novartis Gene Therapies culture embraces this mission. As a compassionate and dedicated team, we are enthusiastic about the science behind our work and finding answers to difficult questions. We are dedicated to communities affected by rare diseases, and these patients and families are the motivation for everything we do.
We have built a team with exceptional depth of experience, unified by a common vision; to develop gene therapies with the potential to positively impact the lives of the patients and families devastated by rare and life-threatening neurological genetic diseases. Though we are proud of what we have achieved to date, we remain relentlessly focused on making that vision a reality.
The BioProcess Engineer I is responsible for assisting with organizing, running, and sustaining the manufacturing operations process at the plant/site during off hours. This individual will work on the manufacturing floor to produce product, media/buffer preparation, learn to troubleshoot equipment, participate in interviews on deviations, stocking of items in supply/ production / warehouse area, standardizing equipment and cleaning production area.
- Assist in manufacturing led investigations through partnerships with Quality and other business units at the site.
- Assist BPEs to determine root cause, implement a solution and a verification check to ensure the fix was effective.
- Assist with creation and on-going maintenance of all pertinent equipment, policies, and procedures.
- Be flexible in rotations between upstream and downstream to learn aseptic techniques, cell culture, recovery, purification, aseptic fill/finish.
- Assist in producing clinical and commercial material on an annual basis that meets the site's strategic objectives and is compliant with cGMPs.
- Support 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.
- Responsible for maintaining quality standards to meet cGMP requirements, CFR's, and internal company policies directly related to the manufacturing process.
- Partner with Quality to ensure a quality and compliant manufacturing environment.
- Assist the technical operations team to resolve any issues related to production.
- 0-2 years' experience in GMP environment with Bachelors of Science Degree in Biology, Chemistry, Biotechnology or applicable field or equivalent experience.
- Excellent oral and written communication skills.
- Entry level into the biopharmaceutical based GMP manufacturing operations, no experience necessary.
- Approximately 10% travel required.
- Must be able to routinely lift over 35 lbs. Must be able to work alternate 12 hour shifts and weekends, as needed.
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.
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.