Massachusetts Jobs

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 Upstream Process Engineer II will be responsible for supporting the implementation of robust, scalable and efficient manufacturing processes through the support of technology transfer, Process Validation, late stage clinical and commercial manufacturing technical support activities. The individual will provide technical support through close communication and teamwork throughout the organization.

What will you do?

• Be a key contributor for the technology transfer, implementation and production of viral vectors.

• Collaborate with clients or other Thermofisher sites to ensure success of process transfer and scale up.

• Support effective information flow, risk assessment, timeline execution, issue resolution and documentation for multi-functional teams.

• Includes reviewing and supporting detailed process descriptions and facility fit assessment exercises.

• MST upstream support, ensuring the required process related materials, equipment, automation and documentation are in place.

• Collaborate with PS/PD/QC/QA to develop testing strategy for raw materials and process intermediates. Maintains good laboratory practices.

• Execute process establishment runs and small-scale experiments, ensuring the materials, strategies are adequately designed and aligned to achieve the desired results

• Support the review, implementation and maintenance of process control strategy documents throughout the lifecycle of a program

• Participate in the execution of risk assessment activities and associated documentation.

• Support execution of PPQ and PPQ related activities

• Support engineering teams on equipment selection, qualification, and start up activities.

• Assist in the development of sampling plans with clients and incorporate them into cGMP batch documentation.

• Support the development and ongoing monitoring/trending of process performance, including input and output parameters.

• Support investigations and root cause analysis of major deviations for cGMP manufacturing, provide product quality impact assessments and support implementation CAPA for major deviations

• Finding opportunities to improve systems and practices and support implement through existing business systems.

Keys to Success:

Education

• A degree in biochemical engineering, chemical engineering or related scientific field such as molecular biology, virology, biochemistry is the minimum education requirement. Advanced degree is preferred.

• B.S. with 2+ years, Master’s degree with 1+ years’ experience, or PhD

Experience

• Technical expertise in upstream biopharmaceutical manufacturing, technical process support and/or process development.

• Experience with adherent mammalian cells (preferably HEK).

• Knowledge of Stirred Tank Bioreactors, flat stock technology including Cellstacks, Hyperstacks and iCellis systems.

• Expertise in late stage/commercial technology transfer, process characterization and process validation of gene therapy/viral vector manufacturing processes preferred.

Knowledge, Skills, Abilities

• Familiarity with quality, compliance and regulatory aspects of biopharmaceutical manufacturing.

• Knowledge of cell and gene therapy vector production is helpful.

• Ability to work both independently and as part of a team.

• Ability to function in a fast-paced diverse team environment and balance prioritize different projects

• Project management skills desirable

• Laboratory skills and the ability to be hands-on.

• Proven troubleshooting skills and ability to tackle moderately sophisticated technical issues. Ability to compile, analyze and interpret data; Ability to write routine reports and correspondence.

• Proven interpersonal and communication skills, verbal and written. Ability to communicate in a dynamic environment.

• Ability to support off hours and weekend technical support for studies and manufacturing operations.

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 (https://jobs.thermofisher.com/global/en/5-reasons-to-work-at-thermo-fisher-scientific) . 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.

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.