Job Description

MSAT Scientist / Engineer

Location/Division
Carlsbad, CA / MMS

At Microbial Material Services (MMS), a new Business Unit within Thermo Fisher Scientifics Pharma Services Group, we deliver, from process development through commercial supply, the expertise and resources necessary to help clients deliver innovative plasmid-based therapeutics as critical raw materials, drug substances, and drug products. Placed in the forefront of our leading- and cutting-edge Cell and Gene Therapy businesses enabling clients to cure genetic, rare, and otherwise untreatable diseases as their CDMO of choice.

How will you make an impact?

The Manufacturing Sciences and Technology Scientist will be responsible for supporting all facets of Tech Transfer, Process Validation, GMP Floor Support, and Continued Process Verification in accordance with current good manufacturing practices (cGMP) for MMS clinical, commercial, and contract facilities. In this role, you will provide strong technical oversight to the business to ensure robust and reliable production processes are established.

What will you do?

* Work with process development to define common methodologies for conducting unit operations at the manufacturing scale. Typical manufacturing operations include fermentation, lysis, chromatography, ultrafiltration, and depth filtration.
* Help define and implement the procedures, systems, and practices for new product introduction, process validation, and continuous process verification in accordance with cGMP and ICH guidelines and industry best practices.
* Provide technical support to process engineers, scientists, and associates for process validation and commercial stage products including overseeing the design and execution of studies, investigation and data analysis of results, and writing/review of technical reports.
* Actively drive MSAT initiatives to improve practices and procedures
* Provide technical support and impact assessments for GMP deviations. Help create and Implement Corrective Actions.
* Manage Technology Transfer from Process Development, Process Sciences, other sites and/or Client to clinical and commercial Manufacturing ensuring effective information flow, timeline execution, issue resolution, and documentation in accordance with governing tech transfer quality system requirements while leveraging robust risk management practices.
* Review and provide technical oversight on documents created by other departments, such as Tech Transfer Protocols and SOPs
* Ensure robust strategies and approaches for facility fit and process gap analyses and risk assessments in support of process definition and improvement.
* Provide on-floor technical support for manufacturing processing, as needed.

How will you get here?

* Degree in Biochemical Engineering or Biological Sciences required; PhD or Masters degree preferred
* Proficient with computers (MS Office). Working knowledge of controlled documentation and data systems.
* In depth knowledge of cGMP regulations.
* B.S with 4+ years experience or Masters degree with 2+ years experience in Manufacturing Sciences in microbial or mammalian biologics manufacturing or other highly regulated environment
* Expertise and Knowledge of cell culture-based manufacturing, tech transfer, investigations, and process validation of commercial-scale human therapeutics.
* Experience managing internal and external customers (i.e. Clients) including demonstrated rational persuasion.
* Knowledge of plasmid / microbial manufacturing processes and equipment
* Understanding and/or knowledge of change control and performing process impact assessments.
* Experience with process for the following systems: fermenters, depth filters, mix tanks, autoclaves, chambers, chromatography, tangential flow filtration (TFF), drug product filler/isolator, etc.

Knowledge, Skills, Abilities

* Understands microbial production processes and the production environment
* Good understanding of cGMP and other regulatory requirements
* Analytical problem-solving skills
* Good business decisions using both cost and risk analysis
* Good communication and presentation skills (verbal and written in English)
* Unquestionable integrity
* Lead change
* Handle multiple tasks, issues, projects
* Work independently and as a part of a team
* Build agreement via collaboration

At Thermo Fisher Scientific, each one of our 65,000 extraordinary minds has a unique story to tell. Join us and contribute to our singular missionenabling our customers to make the world healthier, cleaner and safer.

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.