As part of the Thermo Fisher Scientific team, you’ll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life every single day to enable our customers to make the world healthier, cleaner and safer. We provide our global teams with the resources needed to achieve individual career goals while helping to take science a step beyond by developing solutions for some of the world’s toughest challenges, like protecting the environment, making sure our food is safe or helping find cures for cancer.

Location: Lexington, MA

Thermo Fisher Scientific-Viral Vector Services (VVS) is a rapidly growing, dynamic gene therapy contract development and manufacturing organization (CDMO) that is seeking sharp individuals to bring the highest quality processes, products and testing to our clients! Placed in the forefront of our leading and groundbreaking Cell and Gene Therapy business enabling clients to cure genetic, rare, and otherwise untreatable diseases.

Our employees are committed to making a difference in our organization, for our client partners and the patients we serve. We are looking for top talent with proven proficiencies and strong character to join our team and help lead our organization into the future.

How will you make an impact?

The MST Downstream Process Engineer II will be responsible for implementation of robust, scalable and efficient manufacturing processes.

The individual will provide technical expertise and leadership and requires close collaboration with throughout the organization.

What you will do:

• Support technology transfer for cGMP manufacturing of viral vectors.
• Collaborate with other sites or clients to ensure success of process transfer and scale up.
• Ensure effective information flow, risk assessment, timeline execution, issue resolution and documentation for cross-functional teams.
• Lead MST Downstream team on process establishment runs and small-scale experiments.
• Ensure the materials, strategy and documentation are in place.
• Collaborate with PS/PD/QC/QA to develop testing strategy for raw materials and process intermediates.

Implement

• Perform scale down model of manufacturing processes. Maintains a good laboratory practice.
• Author facility fit assessments, detailed process definitions, process control strategy documents, risk assessments, PPQ protocols and reports.
• Perform PPQ and PPQ related activities
• Support engineering teams on equipment selection, qualification, and start up activities.
• Develop sampling plans with clients and incorporate them into cGMP batch documentation.
• Monitor and trend process performance, including input and output parameters.
• Investigate root causes of major deviations for cGMP manufacturing, and implement CAPA for major deviations
• Find opportunities to improve systems and practices
• Work with counterparts in Process Development, Process Sciences, Manufacturing, Quality, Project Management teams etc. to facilitate technology transfer and project success.

Education

• A degree in biochemical engineering, chemical engineering or related scientific field such as molecular biology, virology, biochemistry. Advanced degree preferred.
• B.S. with 4 years, Master’s degree with 2 years’ experience, or PhD.

Experience

• Have technical expertise in downstream biopharmaceutical manufacturing and/or process development.
• Have experience with a variety of at-scale filtration and column purification methods including TFF, Depth and viral filtration, affinity, ion exchange and size exclusion chromatography as well as applicable analytical methods for process characterization.
• Have expertise in late stage/commercial technology transfer, process characterization or process validation biopharmaceutical/gene transfer vector manufacturing.

Knowledge, Skills, Abilities

Understand GMP and regulatory requirements of biopharmaceutical manufacturing.

Have knowledge of cell and gene therapy vector production highly desirable.

Work independently and as part of a team.

Function in a fast-paced diverse team environment and prioritize multiple projects

Have project management skills

Exhibit strong interpersonal and communication skills and the ability to work effectively with a wide range of constituencies in a diverse community.

Have excellent troubleshooting skills and ability to tackle complex technical issues

Ability to compile, analyze and interpret data; Ability to write routine reports and correspondence.

Our Mission is to enable our customers to make the world healthier, cleaner and safer. Watch as our colleagues explain 5 reasons to work with us. As one team of 100,000 colleagues, we share a common set of values - Integrity, Intensity, Innovation and Involvement - working together to accelerate research, solve complex scientific challenges, drive technological innovation and support patients in need. #StartYourStory at Thermo Fisher Scientific, where diverse experiences, backgrounds and perspectives are valued.

Apply today! http://jobs.thermofisher.com

Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.

Accessibility/Disability Access

Job Seekers with a Disability: Thermo Fisher Scientific offers accessibility service for job seekers requiring accommodations in the job application process. For example, this may include individuals requiring assistance because of hearing, vision, mobility, or cognitive impairments. If you are a job seeker with a disability, or assisting a person with a disability, and require accessibility assistance or an accommodation to apply for one of our jobs, please submit a request by telephone at 1-855-471-2255*. Please include your contact information and specific details about your required accommodation to support you during the job application process.