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Job DescriptionWhen you’re part of the team at Thermo Fisher Scientific, you’ll do important work, like helping customers in finding cures for cancer, protecting the environment, or making sure our food is safe. Your work will have real-world impact, and you’ll be supported in achieving your career goals.At Viral Vector Services (VVS) a division of Thermo Fisher Scientific we deliver, from process development through commercial supply, we offer the expertise and resources vital to help clients deliver innovative gene therapies. Placed in the forefront of our leading and groundbreaking Cell and Gene Therapy business enabling clients to cure genetic, rare, and otherwise untreatable diseases.Location/Division Specific InformationUS - Massachusetts - CambridgeResponsible for the support of clinical and commercial drug manufacturing at the viral vector manufacturing facility located in Cambridge, MA. Scope includes supporting the at-scale manufacture of late-stage and commercial gene therapy drugs from both a process and equipment standpoint with a focus on the upstream process and technology. Individual will join an experienced team of process engineers working closely with groups such as manufacturing, quality assurance, quality control, and validation.What will you do?
Supports cross functional technology transfer teams for GMP manufacturing of viral vectors. Collaborate with other sites or clients to ensure success of scale up/process transfer. Ensure effective information flow, risk assessment, timeline execution, issue resolution and documentation for cross-functional teams.
Author or provide technical review of batch records and related cGMP documentation ( e.g ., raw material specifications, equipment specifications, validation, supportive development protocols / reports, applicable sections of CMC regulatory filings, etc.) and associated PDPRs.
Author or assist in preparing PPQ protocols and reports. Assist in providing ‘person in plant’ oversight to development and qualification related activities ( e.g. , oversee execution of development, GMP and PPQ related activities).
Support continued process verification (CPV) efforts through statistical process control charting and report authoring.
Maintain critical quality attribute, in-process and release data tracking and trending, analysis, as well as in-process equipment parameter tracking and trending analyses.
Lead equipment selection, qualification, and start up activities as needed.
Investigate root causes of major deviations for cGMP manufacturing and implement CAPA for major deviations.
Provide on-the-floor support for manufacturing operations as needed.
Execute preventative maintenance plans as well as on-demand corrective work for process equipment.
How will you get here?Education
Bachelor’s degree (required) in biochemical or chemical engineering, pharmaceutical science or a related scientific discipline such as chemistry or biology with 0-2 years of experience.
Knowledge, Skills, AbilitiesStrong interpersonal and communications skills; written and oral.
Ability to function in a fast-paced dynamic team environment and balance prioritize multiple projects.
Knowledge of cell and gene therapy vector production highly desirable.
Ability to be hands-on.
Ability to function in a rapidly changing environment & handle multiple priorities.
Work Hours: Monday through Friday, 8:00 AM to 5:00 PM. Requires overtime to work evenings, weekends, or holidays, as required to meet project timelines.
Ability to support on-call rotation supporting off-hours calls for process and equipment troubleshooting.
Ability to lift up to 25 lbs.
We offer competitive salary, an annual incentive bonus plan, 401K with company match up to 6%, tuition reimbursement and a range of other employee benefits! We foster an exciting company culture that encourages innovation, forward-thinking, and an outstanding career and development prospects. Come be a part of the team!Our Mission is to enable our customers to make the world healthier, cleaner and safer. As one global 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.Apply today! http://jobs.thermofisher.comThermo 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 : We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.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.
