Discovery / Research

Systems Administrator/Analyst Direct Hire MA

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Job ID: 15767 Direct Hire MA

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Job Description:

Our client is a very well-funded biotech company at the forefront of developing the next wave of innovative live biologics to treat patients. They are looking for a Systems Administrator/Analyst with relevant industry experience to join their growing team and support their informatics-related processes! This is a full-time, permanent career opportunity and will work cross-functionally with several internal groups like R&D, quality, and clinical. Ideal candidates will leverage their industry and systems admin expertise with either LIMS, CTMS, quality systems software, and/or third-party systems integration.

Responsibilities:

• Serve as a technical project lead to liaise between the vendor and internal scientific teams and ensure Requirement Specifications and Design Detailed Specifications are in alignment

• Create and review SDLC deliverables as needed and ensure delivery of scalable, secure, and optimized solutions

• Support implementation activities and help design integrations between core systems

• Take ownership of related technical risks and issues

• Maintain infrastructure and related systems critical to GxP operations

Requirements:

• BS/MS in Life Sciences, Computer Science, or related field

• 3-5+ years of professional industry experience working with Lab Information Management Systems (LIMS), Clinical Trial Management Software (CTMS), or similar solution such as quality system or biobanking software

• Direct experience working with Microsoft SQL Server, Oracle, and/or cloud infrastructure; ideally have documented or performed Computer Systems Validations (CSV)

• Understanding of GxP and HIPAA, GDPR, etc

• Excellent communication to be able to successfully liaise between multiple internal groups and provide important updates to the project manager

Perks/Benefits:

• Medical, dental, vision, short-term, and long-term disability

• 401(k) plan with generous contribution

• 15 vacation days, flexible PTO, paid parenteral leave

• Join a truly passionate, motivated team to deliver on their mission of helping patients

• Free weekly lunches, discounted ride-sharing to the office, subsidized gym, and more!!

Candidates must be authorized to work in the US indefinitely to be considered. All resumes will be kept strictly confidential until you choose to pursue a specific opportunity with one of our clients. Formal descriptions can be supplied for interested candidates.

Sr. Toxicologist for clinical-stage biotech Direct Hire Massachusetts

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Job ID: 15758 Direct Hire Massachusetts

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Our well-funded Cambridge start-up client is seeking an experienced Toxicologist to lead pipeline projects by directing GLP & non-GLP studies with CROs and participating in Regulatory filings.  You will work closely with program leaders, clinical and regulatory teams to develop an overall toxicology development plan including lead optimization, candidate selection, IND-enabling studies, etc.

Responsibilities include but are not limited to;
•  Interact with CROs for quotes, cost estimates, and monitor study activities including protocol development and report generation.  
•  Provide strategic advice to senior leadership and relevant project teams regarding potential impact of study results on program and clinical/regulatory strategy.
•  Communicating with regulatory bodies in support of global regulatory submissions.

Formal descriptions can be supplied for interested candidates. 

Qualified candidates will have a Ph.D. in Toxicology or relevant field with a minimum of 3 - 5+ years of experience in nonclinical development and conducting regulatory toxicology studies.  More experienced candidates can also be considered.  Candidates who have DABT certification are welcome but it is not required to be considered.  Candidates must have experience in various aspects of toxicology study conduct including developmental and reproductive toxicology, carcinogenicity, toxicokinetics, and safety pharmacology as well as experience in designing, conducting, monitoring, and interpreting discovery and exploratory toxicology studies to assist lead optimization and candidate selection efforts.  Must also have experience in management of external CROs and representing Toxicology function to global regulatory agencies in support of submissions.  

All resumes will be kept strictly confidential until you choose to pursue a specific opportunity with one of our clients.

Bioinformatics Specialist Direct Hire MA

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Job ID: 15743 Direct Hire MA

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Our client is a leading cell/gene therapy company in the greater Boston area and they are seeking an experienced, highly-motivated Bioinformatics Specialist to join their cutting-edge R&D team! You will collaborate closely with multi-disciplinary scientists and help analyze NGS data for biologic insights to improve safety and efficacy! The main function of this role is to work with wetlab biologists to develop and maintain data analysis pipelines, and visualize data for cross-functional teams and stakeholders. This is a direct hire/permanent career opportunity that is immediately available!

Responsibilities:
•  Design and develop bioinformatic pipelines for next-generation sequencing (NGS) analysis and single-cell genomics to help with discovery of off-target gene editing events, and also perform genomic variant calls.
•  Work collaboratively and cross-functionally with various project teams and apply machine learning algorithms for prediction purposes.

•  Employ various bioinformatic and computational methods for analysis and data visualization mainly in Python and R, as well as additional packages such as Pandas, Matplotlib, NumPy, ggplot2, GATK, etc.

Requirements:
•  BS with minimum 5 years or MS with minimum 3 years of relevant experience.
•  Hands-on expertise with Python, R, and shell scripting, as well as data visualization in Pandas, ggplot2, etc.
•  Outstanding communication and data analysis/applied statistical knowledge (clustering, model testing, regression) to collaborate with PhD-level, multi-disciplinary, project-focused teams.
• Demonstrated track record of bioinformatics expertise, either in academia or industry.

Formal descriptions can be supplied for interested candidates. 

Must be authorized to work in the U.S. indefinitely to be considered. 

All resumes will be kept strictly confidential until you choose to pursue a specific opportunity with one of our clients.

Director, Biostatistics Direct Hire MA

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Job ID: 15720 Direct Hire MA

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Our Global Pharmaceutical client here in Cambridge, MA is seeking to add a Director, Biostatistics to their team!  This role will be responsible to act as the lead statistician on their Neuroscience projects.  Will be accountable for statistical aspects of clinical studies and submissions, including quality, relevance to regulatory perspective, and scientific validity.  Act as key statistical consultant within company.  Responsible for project staffing, resource planning and allocation within project team(s).  Responsibilities include:

  • Lead large or complex late phase project(s) / multiple indications of a large late phase project(s). Represent stat leadership in cross function working groups. Provide insights to innovative statistical application and operation strategies.
  • Mentor people working on the project.  Promote teamwork, quality, and innovation. Create productive work environment.  Ensure project team compliance with SOPs and departmental standards.
  • Direct statistical support and provide scientific leadership for one or more projects of clinical development.  Accountable for statistical aspects of clinical studies and submissions of the project(s).
  • Plan and track project activities, timelines, and resource use.  Provide justification for planned resource needs.  Seek to optimize resource utilization thru efficient and well-managed resource allocation and across projects or areas.  Capacity to respond to unscheduled increase in project workload.
  • Ensure productive collaborations with other functions in the aligned project team and with other statistics project leaders and in communicating with senior leadership.

Requirements: 

  • PhD/MS in statistics or related discipline with at least 8+ years of pharmaceutical experience
  • Demonstrated leadership, project management, and interpersonal/communication skill
  • Broad knowledge and superior understanding of advanced statistical concepts and techniques
  • Proven success, through previous submissions or interactions, in meeting regulatory guidelines and requirements for drug development
  • Experience in neuroscience clinical trials preferred but not required

Scientist/Senior Scientist, Immunology Direct Hire MA

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Job ID: 15633 Direct Hire MA

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Our client is an early-stage, VC-backed company looking to hire a highly-motivated, interactive, PhD-level Scientist or Senior Scientist (commensurate with experience) to join their cutting-edge research team! This is a direct hire/permanent opportunity in biotechnology to perform innovative translational research within immunology and gene editing, applied to transplantation and rejection. The role will leverage your in vitro and in vivo experience in innate/adaptive immunology and T cell or myeloid cell biology.

Responsibilities:
•  Design and execute diverse immunoassays to evaluate human and/or animal T-cell/myeloid cell biology, including standard immunology techniques like flow cytometry, cytokine profiling, etc.
•  Analyze experimental data, troubleshoot assays, and present internally.
•  Work collaboratively and cross-functionally to accomplish company goals.

Qualified candidates will have a PhD in Immunology, Cell/Molecular Biology, or related field and minimum 3-10 years of relevant experience. Must be well-versed with cell culture techniques and have experience sorting primary human and/or animal T cells and developing cell-based immuno-assays. Applied expertise in T cell therapeutics is a plus, either in academia or industry, especially in the context of transplantation immunology.

Formal descriptions can be supplied for interested candidates.

Must be authorized to work in the U.S. indefinitely to be considered.

All resumes will be kept strictly confidential until you choose to pursue a specific opportunity with one of our clients.

Immuno-Oncology Scientist Direct Hire MA

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Job ID: 15374 Direct Hire MA

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Our client is a highly-regarded cell/gene therapy company in the greater Boston area and they are seeking an experienced, highly-motivated Immuno-Oncology Scientist to join their research and discovery team! You will collaborate with and help other teammates troubleshoot assays, as well as identify and develop new targets and chimeric antigen and T cell receptors (CARs & TCRs). The main function of this role is to develop cell-based assays for T cell characterization, proliferation, and function, and to coordinate new research projects to overcome obstacles within the tumor microenvironment.

Responsibilities:
•  Design/execute diverse immuno-assays to evaluate T-cell biology, including cell sorting (fluorescent and/or magnetic), multi-color flow cytometry, Luminex, cytokine profiling, etc.
•  Analyze experimental data and present internally to identify promising new CAR and/or TCR candidates for subsequent development.
•  Work collaboratively and cross-functionally for preclinical development in animal models of cancer.

Requirements:
•  PhD in Immunology, Cell/Molecular Biology, or related field.
•  1-5 years of relevant experience in immunology, I/O, or autoimmunity.
•  Experience with cell culture techniques, sorting primary human and/or animal T cells, and developing cell-based immuno-assays.
•  Applied expertise in T cell therapeutics is a plus, either in academia or industry.
 

Formal descriptions can be supplied for interested candidates.

Must be authorized to work in the U.S. indefinitely to be considered.

All resumes will be kept strictly confidential until you choose to pursue a specific opportunity with one of our clients.