Careers

Careers

At Dicerna, we foster a culture of innovation through collaboration.

View our list of career opportunities.

 

We are dedicated to benefiting patients by advancing science and developing creative solutions to challenging therapeutic problems. Our core values of dedication, innovation, communication, excellence, respect, needs based and accountability drive us personally and as a team, and these are critical factors in the long-term success of our company.

We encourage open dialogue to identify and act upon novel ideas to meet the urgent needs of patients.

As innovators in the emerging area of RNAi, we seek forward-thinking talent to join our growing team, advance our robust pipeline of therapies, and provide ground-breaking medicines to those that depend on us.

Our office location in Cambridge underscores our commitment to being an employer of choice in the Massachusetts life sciences sector, and to being in close proximity to world-class research, academic and healthcare institutions as well as other life sciences leaders. We play an active role in the biotechnology community and in the Alewife business community as the area undergoes a revitalization to become a mini life sciences and technology hub. Our office is close to the MBTA subway and buses, the 120-acre Alewife Reservation, as well as many restaurants and services.

 

Dicerna is proud to be an Equal Opportunity Employer.

For interest in future employment opportunities, please submit your resume to HR@dicerna.com.

 

Career Opportunities

  • Head, Manufacturing

    Posted June 7, 2017

     

    Overview

     Dicerna is searching for a resourceful, integrative thinker for a critical operational role that is responsible for leading manufacturing strategy and product teams to support Dicerna’s non-clinical and clinical development programs.

     

    Key Responsibilities

    • Leads and oversees GalXC clinical development lead manufacturing s
    • Overall responsibility for all manufacturing activities including managing risks/capability and developing mitigation plans.
    • Oversee all risks and issues that impact quality, compliance, project timelines, resource requirements, costs and business relationships with GMP contract manufacturers.
    • Define manufacturing operations and ensure communication and coordination across internal functions and with external partners.
    • Provides strategic guidance for cross-functional planning particularly in the coordination of non-clinical and clinical API and DP supplies.
    • Responsible for managing, and executing all technical activities related to the development, manufacture and supply of drug substance and product from lead candidate declaration through clinical development
    • Responsible for GMP contract manufacturer selection and qualification and operations for both drug substance and drug product.
    • Provide technical leadership and manufacturing expertise including during discussions with Regulatory agencies.
    • Use extensive knowledge of US, EU and ICH regulatory requirements and the ability to apply knowledge both strategically and operationally to development projects in support of corporate goals.
    • Manage all submissions and interactions with global health authorities for CMC issues
    • Develop all relevant manufacturing documents necessary for regulatory filings from INDs to NDAs.
    • Build partnerships with key senior stakeholders internally (e.g., Quality, Regulatory, Preclinical, Finance, Program Development, Clinical) to ensure that strategic business goals are met

    Qualifications

    • A proven track record in manufacturing of oligonucleotide drug products for pre-clinical through late-stage clinical stage programs and up to commercialization.
    • Prior manufacturing responsibilities and team leadership functions and the management of GMP Contract Manufacturing Organizations
    • Advanced knowledge of FDA, EMA and ICH regulations, industry standards and quality principles for GMP operations.
    • Effective leader within a multi-disciplinary team in a matrix environment as well as with external partners and vendors.
    • Understanding of product development life cycle and stage gates from candidate selection to process development (and to commercial)
    • Oligonucleotide experience highly desirable

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  • Head, Quality Assurance

    Posted June 29, 2017

     

    Overview

     

    We are seeking a head of quality assurance who will develop and execute quality strategy and goals in line with the overall plan for the Company. This role requires a strategic thinker to work collaboratively across the Dicerna organization to build a quality system and processes to support all company operations. This individual will manage all aspects of quality across the GCP, GMP, GLP and quality systems functions.   This role will have significant interface with both internal teams as well as a network of external consultants/vendors.

    Key Responsibilities

     

    • Establish quality programs, policies and procedures to ensure compliance with GxP standards, FDA, ICH and other regulatory guidelines.
    • Create /revise controlled documents and ensure that the organization is trained to standards of quality excellence.
    • Represent Quality function on development project teams.
    • Review and approve documents necessary to support the program and disposition activities originating from internal departments and vendors (e.g. batch records, investigations, CAPA).
    • Responsible for the qualification program for GLP and GMP vendors. Monitor and develop metrics to review performance of vendors & CMOs.
    • Contribute to the evaluation and mitigation of program risks and escalation of potentially significant quality issues.
    • Identify procedural and process issues and oversee implementation of necessary corrective actions and continuous improvement activities.
    • Lead efforts and collaborate with internal and external partners to ensure readiness of all GCP, GLP and GMP activities associated with regulatory filings, this includes assisting in site preparations for support of regulatory inspections.
    • Work closely with both the early development and clinical groups at Dicerna. Interpret regulations and apply as appropriate to the phase of product development.
    • Assure necessary QA review of regulatory submissions of INDs, NDAs etc. as assigned.
    • Review of Quality System Metrics with Senior Management Team on a regular basis.
    • Provide quality expertise, advice and/or assistance across the organization as required

     

    Qualifications & Capabilities

     

    • Bachelor’s degree in a scientific or life science field
    • Minimum of 10+ years of quality experience in the biotechnology or pharmaceutical industry
    • Strong knowledge of cGxPs in the U.S. and internationally, with emphasis primarily on GMPs
    • Experience with all phases of product development
    • Knowledge of cGMP and ICH regulations, practices and trends pertaining to pharmaceutical product development, and manufacturing.
    • Experience auditing and building relationships with external vendors
    • Demonstrated leadership and project management skills

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  • Toxicologist

    Posted August 11, 2017

     

    We are seeking a Toxicologist to help advance the development of our growing pipeline of product candidates.  The individual in this position will participate on program development teams, and assist in the design and oversight of toxicology studies and preparation of regulatory submissions.

    Key Responsibilities

    • In conjunction with program teams, design and oversee conduct of external non-GLP investigative or GLP toxicology studies to support novel therapeutic agents through the drug development process
    • Serve as Study Monitor/Sponsor Representative for outsourced toxicology studies. Review and provide feedback on related study protocols and reports
    • Contribute to the preparation of nonclinical components for regulatory submissions.
    • Collaborate on design of internal non-GLP investigative toxicity studies in support of development compounds as needed
    • Collaborate cross functionally with Research, Regulatory, Clinical and Manufacturing
    • Communicate toxicology data to Dicerna program teams and executive leadership as required

    Qualifications

    • Ph.D in a scientific discipline, toxicology related discipline preferred, with 2-5 years of pharmaceutical industry experience as a toxicologist
    • Experience with oligonucleotides preferred
    • Knowledge of global regulatory guidances (e.g. ICH and geography-specific) and Good Laboratory Practice (GLP) standards
    • Ability to critically evaluate written toxicology documents for overall quality and acceptability of scientific interpretation
    • Experience in developing toxicology programs to support early and later stage drug development and in preparing regulatory filings such as INDs/CTAs preferable
    • Effective organization skills and ability to work in a multi-tasking, fast-paced environment
    • Ability to work well in a team setting/matrix-type organization and to build strong cross-functional relationships
    • Some travel (domestic and international) will be required depending on project needs

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  • Medical Writer

    Posted August 11, 2017

     

    Reports to:                 Chief Medical Officer

    Overview

    The medical writer will be a key member of the Project Team and will work closely with Research, Clinical Operations and Regulatory Affairs to manage all aspects of document preparation for clinical and regulatory documents according to company guidelines and international governmental regulations. S/he will provide strategic direction to cross-functional teams to ensure that key messages are consistently aligned with reporting requirements and company objectives.

    Responsibilities  

    • Plan, prepare, write, edit, format, and finalize non-clinical, clinical and regulatory documents. Documents will include, but are not limited to: IND, CTA, non-clinical summaries, clinical protocols, clinical study reports, Investigator brochures, updates to regulatory submissions, annual reports/development safety update reports (DSURs) etc.
    • Assist in developing strategy for organizing and preparing documents for regulatory health authority submissions.
    • Coordinate the internal review of documents.
    • Develop, maintain, and drive document finalization timelines.
    • Ensure final document adheres to standard operating procedures (SOP), good clinical practice (GCP), and the International Council on Harmonisation (ICH).
    • Perform quality control review of medical writing documents
    • Assist in the development of templates, style guidelines, and SOPs for clinical documentation

    Requirements

    • Minimum requirement of a bachelor’s degree with 3-5 years of medical writing experience in a pharmaceutical/biotechnology or CRO environment
    • Ability to interpret and present clinical and non-clinical data objectively in a clear, concise format.
    • Outstanding written and oral communication skills
    • Proficiency in teamwork, organization, and project management
    • Proficiency in MS Office; experience using electronic document management system

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  • Analytical Chemist

    Posted September 29, 2017

     

    Overview

     

    Dicerna is seeking an experienced Bioanalytcial/DMPK scientist specializing in metabolite identification. You will help to develop and implement our metabolite ID strategy to assist in the optimization of our DsiRNA-EX-GalNAc Conjugates.  It is highly desired that you will have extensive experience in applying high-resolution mass spectrometry to characterize metabolites and assess metabolic stability in various cellular and subcellular in vitro test systems and in vivo systems. Experience in the bioanalysis and quantitation of drug levels in biological matrices and familiarity with oligonucleotide bioanalysis would be a major advantage.

     

    Key Responsibilities

     

    • Develop and implement innovative mass spectrometry based automated metabolite profiling and identification platforms.
    • Investigate the interfacing of separation techniques (2D, on-line SPE, and micro/nano LC) with mass spectrometry for oligonucleotide bioanalysis and metabolite identification.
    • Operation and hands-on troubleshooting of multiple types of analytical instrumentation including HPLC, UPLC and LC-MS instruments.
    • Metabolic profiling and assessing the stability of oligonucleotides in cellular, sub-cellular and biological tissue extracts, and in vivo.
    • Able to review and translate complex LC-MS based metabolism data sets and articulate findings to project teams.
    • Assist in the planning and management of contract research organizations and collaborations for the outsourcing of oligonucleotide bioanalysis.

     

    Qualifications

     

    • Ph.D. in Analytical Chemistry, Chemistry or Chemical Biology with at least 1-3 years of relevant industrial experience in biotransformation and metabolite identification.
    • Demonstrated skills and proficiency in all aspects of nominal and high resolution mass spectrometry for metabolite profiling and identification.
    • Expert knowledge and fluent understanding in the operation and maintenance of                 a variety of LC-MS/MS instrumentation including Waters QTOF and Thermo Orbitrap based systems.
    • Strong computer skills and experience with software driven metabolite profiling
    • In-depth understanding of drug metabolism, enzymology, bioactivation and ADMET.
    • Experience with multiple types of analytical and chromatographic separation techniques, i.e. RP-HPLC, HILIC, SAEX and SEC.
    • The successful candidate must be a resourceful and proactive individual who is able to work as a team player in a dynamic environment with tight deadlines.
    • Specialization in biotransformation and metabolite identification of oligonucleotides is preferred.
    • Knowledge in strategies for the design of oligonucleotide therapeutics (siRNA and antisense) is desirable.

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