Client Overview and Position Summary
Our client is working to develop novel treatments for rare diseases through their platform of gene therapy programs. They are looking for passionate individuals that are equally motivated to develop novel therapies and contribute to the advancement of AAV gene therapy.
The Engineer II, Manufacturing Sciences and Technology will be involved with the successful technical transfer, process validation, and continued technical support for our manufacturing processes at Contract Manufacturing Facilities.
- Collaborate closely with Pharmaceutical Development and Manufacturing to ensure efficient technical transfer of manufacturing processes to CMOs, technical troubleshooting, data mining of manufacturing documentation (batch records, deviations, CAPA, etc.) to assess process performance, and continuous improvement
- Involvement across GMP production in cell banking, upstream and downstream processing, and drug product activities
- Identify requirements for laboratory studies as necessary to support process fit, process transfer decisions and scale-up, process validation, identify and implement process improvements
- Review process transfer documentation, author and review gap assessments, and technical protocols and reports.
- Provide technical support for external manufacturing processes in support of critical raw material release/product release to support supply chain
- Ensure phase-appropriate manufacturing, with an appreciation of late-stage manufacturing including process characterization and process validation activities
Requirements and Qualifications
- BS/MS in a scientific field of study, preferably an Engineering degree with 2-5 years of relevant experience working in Manufacturing/Contract Manufacturing or Pharmaceutical Development
- Biologics experience required, AAV preferred
- Experience performing continuous process monitoring, providing on-floor technical support, owned and management of change control, deviations, and CAPAs in Quality systems
- In-depth technical and regulatory understanding of GMP biologics manufacturing and supply chain, as well as applicable international regulations and standards in all phases of product development, including late-stage through commercialization
- Late stage/ commercial experience required
- Proven leadership experience and people management skills with the desire and ability to work in a fast-paced, start-up environment
- Strong collaboration and team-building, communication, and organizational skills required
- Experience working with and managing third party contractors and vendors
- Excellent written and verbal communication skills
We know that a company's success starts with its employees. We also know that an individual's success starts with the right career opportunity. As a Best of Staffing® Client and Talent leader, Aerotek's people-focused approach yields competitive advantage for our clients and rewarding careers for our contract employees. Since 1983, Aerotek has grown to become a leader in recruiting and staffing services. With more than 250 non-franchised offices, Aerotek's 8,000 internal employees serve more than 300,000 contract employees and 18,000 clients every year. Aerotek is an Allegis Group company, the global leader in talent solutions. Learn more at Aerotek.com.
The company is an equal opportunity employer and will consider all applications without regards to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.
If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing process due to a disability, please call 888-237-6835 or email accommodation@aerotek .com for other accommodation options. However, if you have questions about this position, please contact the Recruiter located at the bottom of the job posting. The Recruiter is the sole point of contact for questions about this position.