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Jobs at RoslinCT (Now Hiring) — 9 open

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Senior Process Engineer

Hopkinton, Massachusetts, United States · On-site

$80k–$110k/yr

Senior$1M raised

WHO WE ARE We are a leading cell therapy contract development and manufacturing organization creating cutting-edge therapies that change people’s lives. Collaborative, dedicated, and talented people are the backbon…

Skills: Technology Transfer, Aseptic Manufacturing, Cell Culture, GMP Batch Records, SOP Drafting

RoslinCT logoRoslinCT

Process Engineer II

Hopkinton, Massachusetts, United States · On-site

$70k–$90k/yr

Mid level$1M raised

WHO WE ARE We are a leading cell therapy contract development and manufacturing organization creating cutting-edge therapies that change people’s lives. Collaborative, dedicated, and talented people are the backbon…

Skills: Technology Transfer, Aseptic Manufacturing, Cell Culture, Process Validation, GMP Batch Records

RoslinCT logoRoslinCT

Quality Assurance Supervisor – 15-Month Fixed Term Contract

City of Edinburgh, Scotland, United Kingdom · On-site

Senior$1M raised

Quality Assurance Supervisor – 15-Month Fixed Term Contract Location: Edinburgh BioQuarter Please submit your application by Monday 18th May at 12pm. Applications received after this date may not be considered. Who are w…

Skills: GMP, Regulatory Compliance, Accreditation Systems, Batch Release, Leadership

RoslinCT logoRoslinCT

Warehouse Operative

Livingston, Scotland, United Kingdom · On-site

Mid level$1M raised

Warehouse Operative Location: This role is primarily based in our Biostore site in Livingston however there may be a requirement to travel to our Edinburgh BioQuarter site. Who are we? We are RoslinCT, a world-leading ce…

Skills: GMP Experience, Inventory Management, Materials Handling, Temperature Sensitive Material Handling, Microsoft Office

RoslinCT logoRoslinCT

Quality Control Supervisor - Analytical

City of Edinburgh, Scotland, United Kingdom · On-site

Mid level$1M raised

Quality Control Supervisor - Analytical Location: Edinburgh BioQuarter Who are we? We are RoslinCT, a world-leading cell and gene therapy contract development and manufacturing organisation creating cutting-edge therapie…

Skills: Leadership, GMP Compliance, Analytical Laboratory Management, Root Cause Analysis, CAPA

RoslinCT logoRoslinCT

Cleaner - Part Time

City of Edinburgh, Scotland, United Kingdom · On-site

Entry level$1M raised

Cleaner – Part Time Location: Edinburgh BioQuarter, Little France Who are we? We are RoslinCT, a world-leading cell and gene therapy contract development and manufacturing organisation creating cutting-edge therapies tha…

Skills: Cleaning, Disinfection, Attention To Detail, Teamwork, Time Management

RoslinCT logoRoslinCT

Operational Support Team Lead

City of Edinburgh, Scotland, United Kingdom · On-site

Mid level$1M raised

Operational Support Team Lead Location: Edinburgh BioQuarter Who are we? We are RoslinCT, a world-leading cell and gene therapy contract development and manufacturing organisation creating cutting-edge therapies that cha…

Skills: Line Management, cGMP Cleanroom Operations, Health & Safety, Chemical Handling, Microsoft Word

RoslinCT logoRoslinCT

QA Administrator

City of Edinburgh, Scotland, United Kingdom · On-site

Mid level$1M raised

Administrator (Quality Assurance) Location: Edinburgh Bioquarter Who are we? We are RoslinCT, a world-leading cell and gene therapy contract development and manufacturing organisation creating cutting-edge therapies that…

Skills: Document Management, Quality Assurance, Q-Pulse, Microsoft Word, Record Keeping

RoslinCT logoRoslinCT

Manufacturing Technician - Commercial Manufacturing

City of Edinburgh, Scotland, United Kingdom · On-site

Entry level$1M raised

Manufacturing Technician Location: Edinburgh BioQuarter, Little France Who are we? At RoslinCT, we manufacture advanced cell therapies that help improve and save lives. We’re growing fast, and we’re looking for Manufactu…

Skills: Cleanroom Operations, Laboratory Cleaning, Waste Disposal, Documentation, Equipment Maintenance

RoslinCT logo

Senior Process Engineer

RoslinCT

Hopkinton, Massachusetts, United States • On-site

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Senior

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  • $80k–$110k/yr
  • Full-time
  • bachelor degree, postgraduate degree
  • Flexible And Empowering Work Environment, Attractive Benefits Package, Work-life Balance
  • Posted 1d ago
  • ~40 hrs/week

Responsibilities

Lead new product introductions and execute technology transfer plans for cell therapy programs. Support GMP production through troubleshooting, deviation assessments, and process optimization to ensure quality and efficiency.

Requirements

Requires a Bachelor's degree in Engineering with 5-10 years of experience in the Cell and Gene Therapy industry. Must have hands-on experience with aseptic manufacturing, cell culture instrumentation, and quality systems like CAPAs and Change Controls.

Full job description

WHO WE ARE 

We are a leading cell therapy contract development and manufacturing organization creating cutting-edge therapies that change people’s lives. Collaborative, dedicated, and talented people are the backbone of our culture. We work both autonomously and in driven teams to make life-changing products utilizing ground-breaking science.

THE ROSLINCT WAY 

Here at RoslinCT, our team contributes to the development of revolutionary treatments. We live every day by our core values: Partner Focus, One Team, Personal Growth, Integrity, Innovation, and Trust and Respect. We put our employees at the forefront by providing a flexible and empowering work environment, an attractive benefits package, and an emphasis on work-life balance. Our people are the key to our success. At RoslinCT we focus on developing our corporate culture, people’s development, growth, and the ability to impact patients.

ACCELERATING YOUR FUTURE 

The Senior Process Engineer, as a key member of the MS&T team, will develop and execute technology transfer plans for RoslinCT’s partner programs, including collaborating with key stakeholders in Manufacturing, Quality, Facilities, and Operations departments. As a technical subject matter expert, the position will also support routine production with troubleshooting, technical assessments of deviations, and product disposition evaluations. The Process Engineer will play a key role in optimizing manufacturing processes, ensuring compliance, and continuously improving quality, efficiency, and reliability while supporting products through clinical development to commercialization. 

 HOW YOU WILL MAKE AN IMPACT  

  • Lead the New Product Introduction for products entering the RoslinCT facility
  • Partner with colleagues in Operations, Quality Control, and Quality Assurance as well as external clients and suppliers to execute technology transfer, equipment setup and qualification, engineering and training runs, and process validation as applicable
  • Draft and design GMP Batch Records and SOPs to support partner programs and right-first-time execution by Manufacturing
  • Support GMP production with process or equipment troubleshooting, deviation investigations, and CAPAs, as needed
  • Execute feasibility testing of new or alternative technologies and engage with key stakeholders to ensure technology development alignment with RoslinCT and client program requirements 
  • Collaborate with partners to experimentally determine key process and product monitoring and control attributes, analyze results and draft technical reports.
  • Perform test runs and development studies as needed to support client and RoslinCT initiatives 
  • Compile comprehensive data packages, operating procedures, and technical documentation to support technology transfer and process improvement 
  • Be proactive in identifying opportunities to add value to processes and cross-functional teams 

WHAT YOU WILL BRING

  • Bachelor’s degree. in Biological, Biomedical or Chemical Engineering (or similar) with 5-10 years of relevant process and/or analytical experience within the Cell and Gene Therapy industry 
  • Hands-on experience with aseptic manufacturing processes, cell culture, and cell therapy instrumentation
  • Experience with cell therapy equipment support and troubleshooting 
  • Proficiency with Quality Systems including but not limited to Deviations, CAPAs, and Change Controls
  • Demonstrated independence in experimental design, execution, data analysis, and troubleshooting 
  • Excellent technical writing and oral communication skills 
  • Experience with Microsoft Excel and statistical programs for data analysis and visualization 

 Preferred Qualifications

  • Advanced degree or additional certifications in science, engineering, or cGMP operations 
  • Expertise in bioreactor cell culture
  • Expertise in cell selection, cell washing, lentiviral transduction, and cryopreservation 
  • Knowledge of aseptic media fills, process validation and comparability.
  • Experience performing Risk Assessments (e.g. FMEAs).
  • Experience supporting both clinical and commercial cell therapy programs.
  • Experience in hands-on training curriculum development for cell therapy manufacturing personnel.
  • Driven and works well independently and within cross-functional teams 

*May serve in an “on call” rotation to respond remotely to urgent issues (~1 week per month) 

OUR COMMITMENT

All RoslinCT employees embrace the principles of our culture and values and are deeply committed to fostering an environment where diversity and inclusion are not only valued but prioritized. We believe a diverse and inclusive community empowers us to act courageously, care deeply, and dream boldly to impact people in big ways.

RoslinCT is proud to be an equal opportunity employer, we seek to create a welcoming and diverse environment. All applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability, age, veteran status, or any other applicable legally protected characteristics.

Related keywords

Cell TherapyGene TherapyMS&TGMPcGMPAseptic ProcessingBioreactorsFMEAProcess ValidationTechnology TransferCell SelectionCell WashingLentiviral TransductionCryopreservationMicrosoft ExcelStatistical Analysis

About RoslinCT

LinkedInVisit site

Your Advanced Cell Therapy CDMO Partner

Industry
Biotechnology Research
Company size
201-500 employees
Founded
2015
Headquarters
Edinburgh
LinkedIn followers
22,926
Total funding
$1M

RoslinCT is a leading global contract development and manufacturing services organization (CDMO) focused on Advanced Cell Therapies. Established in 2005 and built upon the groundbreaking technology cloning of Dolly the Sheep at the Roslin Institute in 1997, RoslinCT has harnessed cutting-edge science to advance the development of human medicines. With a remarkable heritage in the field, the company has achieved significant milestones, including being among the first in the world to produce clinical-grade human pluripotent stem cells and advancing the first CRISPR-edited stem cell-based therapy for a major disease to marketing authorization. Equipped with 22 purpose-built cGMP cell therapy processing suites in Edinburgh, Scotland, and Hopkinton, Massachusetts, RoslinCT provides innovative process and analytical development, cGMP clinical and commercial manufacturing for a range of cell types for both autologous and allogeneic processes, and cGMP iPSC cell line development, gene editing, and differentiation. With tailored CDMO solutions, RoslinCT enables partners to efficiently progress from development to commercialization and deliver life-saving Cell and Gene Therapies worldwide. Discover more about our services at www.roslinct.com.

Offices: Nine Edinburgh BioQuarter, 9 Little France Road, Edinburgh, EH16 4UX, GB · 97 South St, Hopkinton, Massachusetts 01748, US

Gap AnalysisTissue ProcurementProcess DevelopmentOptimisation & Scale-UpGMP ManufactureCell BankingIn-Process and Final Product QC TestingQP Batch CertificationGMP Storageand Controlled Temperature Distribution to Clinical Sites Worldwide
View all jobs at RoslinCT

About RoslinCT

LinkedInVisit site

Your Advanced Cell Therapy CDMO Partner

Industry
Biotechnology Research
Company size
201-500 employees
Founded
2015
Headquarters
Edinburgh
LinkedIn followers
22,926
Total funding
$1M

RoslinCT is a leading global contract development and manufacturing services organization (CDMO) focused on Advanced Cell Therapies. Established in 2005 and built upon the groundbreaking technology cloning of Dolly the Sheep at the Roslin Institute in 1997, RoslinCT has harnessed cutting-edge science to advance the development of human medicines. With a remarkable heritage in the field, the company has achieved significant milestones, including being among the first in the world to produce clinical-grade human pluripotent stem cells and advancing the first CRISPR-edited stem cell-based therapy for a major disease to marketing authorization. Equipped with 22 purpose-built cGMP cell therapy processing suites in Edinburgh, Scotland, and Hopkinton, Massachusetts, RoslinCT provides innovative process and analytical development, cGMP clinical and commercial manufacturing for a range of cell types for both autologous and allogeneic processes, and cGMP iPSC cell line development, gene editing, and differentiation. With tailored CDMO solutions, RoslinCT enables partners to efficiently progress from development to commercialization and deliver life-saving Cell and Gene Therapies worldwide. Discover more about our services at www.roslinct.com.

Offices: Nine Edinburgh BioQuarter, 9 Little France Road, Edinburgh, EH16 4UX, GB · 97 South St, Hopkinton, Massachusetts 01748, US

Gap AnalysisTissue ProcurementProcess DevelopmentOptimisation & Scale-UpGMP ManufactureCell BankingIn-Process and Final Product QC TestingQP Batch CertificationGMP Storageand Controlled Temperature Distribution to Clinical Sites Worldwide
View all jobs at RoslinCT

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