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 Process Science 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
- Design and conduct experiments supporting the development and implementation of a closed system, scale-up, recovery, and purification processes for gene therapy.
- 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.
- Produce pre-clinical and clinical material on an annual basis that meets the site's strategic objectives and is compliant with cGMPs.
- Appropriately document experimental procedures and results according to established guidelines. For cGMP manufacturing, ensure 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.
- Adhere to all EH&S policies, procedures and guidelines.
- 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.
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.