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Stoke is seeking a Quality Control and Sample Management Specialist to join the Bioanalytical, DMPK and Biomarker Development group. The candidate will be responsible for all scientific documents quality control and sample management within the group. Specific responsibilities include but are not limited to:

• Conduct Quality Control (QC) review of Bioanalytical data (LC-MS/MS, ELISA, qPCR, etc.) generated in-house or at the CROs in support of regulated or non-regulated studies.
• QC protocols, Test methods, Bioanalytical plans, Validation protocols, Validation reports, Study reports and other study related documentation. Issue QC review observations and work closely with the PI/scientific staff to ensure proper documentation in a timely manner that meets all applicable regulatory requirements.
• Routinely conduct QC review of lab equipment and instrument logbooks, preventative maintenance and calibration documents.
• Responsible for packaging, shipping, receiving and accessioning of study samples and critical reagents in the Laboratory Information Management System (LIMS) following the laboratory’s SOPs.
• Assist in drafting or improving Bioanalytical Lab SOPs related to documentation, study samples or critical reagents shipment, receipt, accessioning and tracking.
• Assist Scientists in the lab when needed.

Skills & Experience:

• B.S. with a minimum of 5 years or M.S. with a minimum of two years of relevant experience working in pharmaceutical, CRO, Biotech or similar organizations
• Knowledge of GxP regulations and experience performing data review in a GxP environment.
• Must have excellent oral and written communication skills and demonstrated ability to work effectively in a fast-paced environment where multiple concurrent projects must be completed in a specified timeframe.
• Working knowledge of bioanalytical assays (LCMS/MS, immunoassays, etc.) is a plus.
• Proficient in standard Microsoft Office tools: Word, Excel, and PowerPoint.
• Strong attention to detail and organizations skills.
• Ability to take directions well and multi-task.
• Demonstrated proficiency with LIMS and sample management is preferred.

Compensation: Compensation will be highly competitive for the industry and directly commensurate with experience.

Primary Location:Bedford, MA

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Stoke is pioneering a new way to treat the underlying cause of severe genetic diseases by precisely upregulating protein expression. We develop antisense oligonucleotide medicines that increase gene expression to treat genetic epilepsies and other severe monogenic diseases, including genetic conditions affecting the central nervous system, eye, liver and kidney. Stoke is seeking an enthusiastic and highly motivated oligonucleotide chemist/analytical chemist to join the in-house oligonucleotide production team.

Primary Responsibilities:

• Oligonucleotide downstream processing to produce from milligram to multigram scale to support all preclinical programs
• Oligonucleotide formulation and analysis for in vitro and in vivo studies
• Operation, Maintenance and troubleshooting of oligonucleotide downstream process equipment and analytical instruments such as prep HPLC, TFF, lyophilizer, LC/MS, UV-Vis, Tm, Osmolality, pH etc.
• Independently analyze fractions, chemically modified oligonucleotides for purity determination and impurity profiling
• Conduct laboratory work in safe and efficient environment

Qualifications & Experience:

• For senior research associate, 5+ years relevant industry experience for B.Sc. or 2+ years for M.Sc. in Chemistry/Analytical Chemistry or related fields; for associate scientist, 7+ years relevant industry experience for B.Sc. or 5+ years for M.Sc. in those fields
• Previous experience in oligonucleotide downstream process including, but not limited to, purification, desalting and lyophilization
• Previous experience in analytical techniques for oligonucleotides and oligonucleotide-conjugates
• Previous experience in oligonucleotide formulation and analysis
• Previous experience with ÄKTA Oligopilot and/or MerMade oligonucleotide synthesis platforms is a plus
• Strong organizational and recordkeeping skills.
• Excellent written and verbal communication skills.
• Ability to work as a team player in a dynamic environment and complete assignments to meet timelines.

Compensation: Compensation will be highly competitive for the industry and directly commensurate with experience.

Location: Bedford, MA

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Stoke is seeking an enthusiastic and highly motivated Systems Administrator to join the Information Technology team. The Systems Administrator will be the primary contact for day to day IT operations and will be responsible for supporting workstations, servers and network, phones, and Office 365 and other cloud platforms. This position reports to the Senior Director of IT and will be based out of our Bedford and Cambridge offices.

Essential Duties and Responsibilities:

• Provide helpdesk support resolving problems relating to computers, printers, network services, and business applications. Collaborate with and manage MSP and its engineers to provide best support experience for end users.
• Participates in monitoring, investigation, and problem resolution of systems, network, and security.
• Responsible for desktop engineering discipline – develops and continuously improves installation and configuration procedures, tools, standards, and documentation for end user computer and software deployments.
• Administer and deploy cloud applications and services: Office 365, VoIP, Egnyte, Mimecast, ELN, Druva, etc.
• Manage and build servers and network services: backups, Active Directory, DNS, DHCP, and endpoint management tools.
• Support lab computers used to run lab instruments and data acquisition.
• Responsible for computer patching process, including testing and documentation.
• Owns hardware and software license management and procurement.
•  Helps with research, development, and maintenance and documentation of innovative, repeatable, and automated approaches for internal IT processes and tasks to increase overall quality of IT service including escalation guidelines, ticket categorization and IT helpdesk knowledge base.
• Create and maintain end user/IT documentation, procedures, and policies.

Qualifications:

• 5 years proven experience in an IT department of a fast paced, high growth company preferably in the Biotechnology and Pharmaceutical industry.
• Degree in MIS, Computer Science or Engineering or related studies; relevant experience may be considered in lieu of a degree.
• A positive and pleasant demeanor and clear, concise communications skills.
• Think and work methodically, independently, and prioritize to resolve problems and manage projects.
• Attention to detail and accuracy and strong analytical ability.
• Solid, hands-on experience with Windows OSes, Office 365, Intune or other MDM platforms, Active Directory, Egnyte, VMware, Veeam, Druva.
• Fluent understanding of networks (VLANs, routing, VPNs, network services (DNS, DHCP), security concepts.
•  Strong analytical ability, translating requirements into a logical architecture.
• Professional certifications and experience with Linux a plus.

Compensation: Compensation will be highly competitive for the industry and directly commensurate with experience.

Locations: Bedford, MA and Cambridge, MA

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Primary responsibilities:

Stoke is seeking to hire a Research Associate or Senior Research Associate with expertise in molecular and cell biology research, specifically in RNA metabolism. The candidate will report to a Senior Scientist in the Platform/Target Identification group and is expected to perform the following activities:

• Work in aseptic conditions and maintain cultures of various cell types
• Plan with supervisor and execute experiments involving cell-free and cell-based assays
• Troubleshoot experiments
• Perform drug screening in cell-based assays
• Process samples involving RNA and protein extraction
• Perform RT-PCR, RT-qPCR and western blot analysis
• Analyze and interpret data and write technical reports and protocols, with supervision
• Present research results at group meetings
• Keep up to date on relevant scientific literature and developments to support own research efforts.
• Maintain accurate and timely documentation of experiments.

Skills & Experience:

• Bachelor’s or Master’s degree in molecular biology
• At least 3 years’ post-graduate experience
• Expertise in RNA techniques, cell-based assays & RNA metabolism
• Knowledge in human genetic diseases and/or molecular therapeutics development is desirable
• Familiarity with RNA biology, especially RNA splicing, is a huge plus

Primary location: Bedford, MA

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Primary Responsibility

Reporting to the Head of Bioinformatics, the Bioinformatics Analyst will work collaboratively with data and experimental scientists to develop and expand internal computing capabilities within the Amazon Web Services (AWS) cloud environment, including

• Develop and maintain serverless web applications and visualization tools to deliver complex genomic results
• Develop and validate bioinformatics workflow for NGS data (bulk and single-cell RNA sequencing data) from various databases and downstream analyses
• Develop bioinformatics workflows to automate frequently used analytical procedures
• Researching, developing, and integrating new/novel technologies and computational approaches to accelerate scientific research
• Work very closely with the research team to explore and analyze NGS data in order to answer project-specific questions
• Maintain detailed documentation and well annotated scripts
• Use best practices for reproducible research

The successful candidate will have access to cutting-edge methodology and technologies, such as cloud computing, Container as a Service (CaaS), and serverless web applications, to deliver complex data analytics to end users. The candidate will work in a highly dynamic and collaborative environment to gain vast expertise in the biotech/pharmaceutical industry. More importantly, the work will have direct impact in helping to accelerate the treatment of severe genetic diseases.

Skills and Experience:

• B.S. or M.S. in bioinformatics, computational biology, computer science, software engineering, mathematics, systems biology, or any related quantitative field
• 2+ years of industry experience
• Ability to execute automated scientific workflow and analyses using Python and R
• Experience with current analytical methods for processing and mining NGS data
• Working knowledge of JavaScript, HTML5, and CSS3
• Comfortable with database related technologies (SQL, NoSQL, or BigQuery)
• Must be comfortable working in Linux/Unix environments
• Excellent problem-solving and strong communication skills

Preferred Skills/Competencies:

• Background in pharmaceutical industry or previous biotech experience
• Familiarity with RNA biology, especially RNA splicing, is a huge plus
• Proficient understanding of React, Redux, D3.js, Angular.js, JavaScript, ES6, HTML5, CSS3, Node.js, and other related build tools is highly desired
• Proficient in R programming
• Strong understanding of RESTful API use and development
• Previous experience in CaaS
• Experience with building, deploying, and maintaining software solutions in a cloud-based architecture and serverless computing

Primary Location: Bedford, MA

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This position will oversee all medicinal chemistry activities from Hit identification to clinical proof-of-concept. This position is responsible for creating and executing a chemistry strategy to support both discovery and early development activities, including the identification of key areas for investment, building appropriate internal and external capabilities, and communicating the company’s chemistry strategy both internally and to the external scientific community.

Duties & Responsibilities:

Specific duties and responsibilities include, but are not limited to:

• Create and execute overall chemistry plan to ensure robust, cost-effective support of company discovery and development portfolio
• Recruit high-quality chemistry personnel to support chemistry plan
• Oversee design and manufacture of oligonucleotides to support all stages of discovery and lead optimization for preclinical programs
• Evaluate and select CROs and CMOs to support key preclinical chemistry activities
• Oversee both internal chemistry team and external preclinical chemistry resources
• Oversee CMC activities for all preclinical programs
• Assist in authoring of CMC sections of regulatory submissions
• Regularly assess developments in the field of oligonucleotide therapeutics and identify areas for future investment
• Communicate chemistry strategy and activities to senior management and Board of Directors on regular basis
• Serve as primary liaison with corporate partners on all issues related to medicinal chemistry
• Present updates of Stoke platform and chemistry developments at key scientific conferences
• Willingness to live and work in Boston area
• Occasional travel for oversight of external CROs is expected

Required Qualifications & Experience:

• A Ph.D. in organic chemistry or medicinal chemistry or related discipline
• At least 15 years of industry experience, including at least 10 years in oligonucleotide therapeutics
• Demonstrated success in the design, medicinal chemical optimization, and formulation/delivery of oligonucleotide therapeutics
• Previous experience in the GMP manufacture of oligonucleotide therapeutics, either directly or through a contract manufacturer, is a plus
• Previous experience authoring CMC sections of regulatory submissions is a plus
• Proven experience managing multiple direct reports
• Strong presentation skills to facilitate communication with both internal and external audiences
• Strong decision-making skills to facilitate execution of timelines
• Ability to work as a team player

Location: Bedford & Cambridge

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