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Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Cleanroom: no hair products, jewelry, makeup, nail polish, perfume, exposed piercings, facial hair etc... allowed, Office

Job Description

MST Process Engineer/Scientist III, Downstream – PLA

JOB SUMMARY/OBJECTIVE:

The primary responsibility is to participate in Manufacturing Sciences and Technology activities in support of downstream technology transfer, late stage clinical, PPQ and commercial manufacturing of viral vectors. The individual will serve as a process expert in downstream processing. This position requires close interaction with MS&T colleagues, Project Management, Manufacturing, Quality Assurance, Quality Control, Process Development, Engineering, Supply Chain, and other departments. This role will focus on aspects of implementing manufacturing processes to produce early- and late-phase human clinical trial and commercial gene therapy products.

RESPONSIBILITIES:

+ MST process lead for Downstream technology transfer activities involved in manufacturing viral vectors following cGMP guidelines.

+ 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 multi-departmental teams (Process Development, Manufacturing, Quality, and Project Management).

+ Includes authoring detailed process definition, facility fit, and raw material risk assessments.

+ Author PPQ protocols and reports. Oversee execution of PPQ and PPQ related activities

+ Develop sampling plans with clients and incorporate them into cGMP batch documentation.

+ Monitor and trend process performance, including input and output parameters.

+ Find opportunities to improve systems and practices

KNOWLEDGE, SKILLS and QUALIFICATIONS:

+ A degree in biochemical engineering, chemical engineering or related scientific field such as molecular biology, virology, biochemistry. Advanced degree preferred.

+ B.S. with 8+ years, Master’s degree with 6+ years, or PhD with 3+ years’ professional history.

+ Technical expertise in downstream biopharmaceutical manufacturing and/or process development. Experience with automated chromatography systems (AKTA) and automated tangential flow filtration (Repligen).

+ Expertise in late stage/commercial technology transfer, process characterization and process validation biopharmaceutical/gene transfer vector manufacturing preferred.

+ Knowledge of GMP and regulatory requirements of biopharmaceutical manufacturing, specifically cell and gene therapy vector production

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

+ Proficiency in operating effectively in a fast-paced dynamic environment while juggling multiple projects

+ Project management skills desirable

+ Ability to speak effectively before groups of customers.

+ Excellent investigational skills and ability to solve technical issues. Ability to compile, analyze and interpret data; Ability to write routine reports and correspondence.

+ Strong interpersonal skills to facilitate verbal and written communication.

Excellent Benefits

+ Benefits & Total Rewards | Thermo Fisher Scientific (https://jobs.thermofisher.com/global/en/total-rewards)

+ Medical, Dental, & Vision benefits-effective Day 1

+ Paid Time Off & Designated Paid Holidays

+ Retirement Savings Plan

+ Tuition Reimbursement

OTHER

+ Relocation assistance is not provided.

+ Must be legally authorized to work in the United States now and in the future, without sponsorship.

+ Must be able to pass a comprehensive background check, which includes a drug screening

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.