Aduro is a dynamic, fast-paced company on the cutting edge of immunotherapy. We are seeking talented, devoted and team-oriented employees. Aduro is an equal-opportunity employer and offers a competitive benefits package.
Please view the current opportunities below. To apply, please send a pdf of your resume to: firstname.lastname@example.org
Thank you for your interest in Aduro.
Summary and Scope of Position:
Support and facilitate the Regulatory Affairs (RA) activities within a highly regulated industry to ensure that Company products comply and meet regulatory requirements. Support Quality Assurance (QA) programs for compliance with applicable national and international regulations, standards, internal procedures and best practices. This is a split-function position which broadly covers both RA/QA support at Aduro.
Primary Responsibilities – Regulatory Affairs:
- Write, review and edit regulatory documentation (including routine correspondence, INDs, BLAs, NDAs, annual reports, amendments, orphan drug applications, supplements, etc)
- Support timely submission of regulatory documentation, including working with CROs to ensure this
- Support the Director, Regulatory Affairs in the preparation for publication and submission of a variety of regulatory documents
- Develop, coordinate, and document communications with regulatory agencies; may serve as secondary contact for regulatory agency interactions
- Perform other related duties as required
Primary Responsibilities – Quality Assurance:
- Manages internal document control system, including development of document templates and forms and GMP supporting documents; coordinates report generation from preclinical/research/product development studies
- Perform internal quality audits and facilitate corrective actions with the possibility of some external auditing support
- Prepare detailed Quality reports and supporting memos
- Review and/or approve manufacturing- and Quality Control-related documentation (internal and external), including batch record review, lot release and stability testing data
- Identify and perform other related duties as required (includes projects in the areas of compliance and quality systems)
- As necessary, provide QA guidance to other development and/or scientific staff
- Develop SOPs to cover RA/QA procedures
- Work with Director, Quality to accomplish internal goals
- Bachelor’s degree in a scientific discipline or equivalent with a minimum combination of 5 years relevant Regulatory Affairs and Quality Assurance experience in pharmaceutical, medical device and/or biotechnology companies
- Broad-based regulation/standards background and current understanding of RA/QA trends and guidances
- Strong communication (verbal, written, listening) and interpersonal skills; ability to communicate across multiple disciplines successfully and accurately (internally and externally, e.g., FDA, international regulatory authorities, contract research organizations (CROs) and contract manufacturing organizations (CMOs))
- Proficient in pharmaceutical technical writing such as SOPs, reports, quality documentation and regulatory submissions
- Experience reviewing technical documentation and reports
- Proficient in Microsoft Word, Visio, Excel and Adobe Acrobat
- Time management (timelines, schedules, task prioritization) and the ability to work independently
- Attention to detail and accuracy
- Ability to integrate the needs of QA/RA with organizational objectives
- Flexible; ability to adapt to changing priorities
- Able to understand scientific, medical and manufacturing disciplines
Summary & Scope of Position:
We are seeking a dedicated, energetic and creative individual who will provide general laboratory support to Aduro BioTech’s CDN Program & the Molecular Biology group. In addition, they will provide some Animal Technician support to the Aduro vivarium.
Successful candidates will conduct a variety of in vitro/in vivo/ex vivo experiments that measure vaccine efficacy and safety, including the characterization of vaccine immunogenicity and disease prevention in various model systems.
- BS/BA in Immunology, Biology, Biotechnology, Microbiology, Virology, or related field with a minimum of 1-2 years relevant laboratory experience.
- Substantial experience is desired with in vivo experimental procedures related to mouse cellular immunology (e.g. immunizations via multiple routes, bleeds, organ harvests, etc.).
- Demonstrated knowledge of a wide range of in vitro and ex vivo immunoassays (e.g. qRT-PCR, Flow cytometry, multiplex cytokine assays, ELISPOT, ADCC, neutralization assays, cell proliferation, in vivo/ex vivo cytoxicity assays, ELISA, etc.).
- Proficiency in mammalian cell culture and sterile technique is required.
- Experience with mouse infectious disease models, tumor models, and/or toxicology is preferred.
- Previous experience working with dendritic cells, T cells and human and/or non-human primate PBMC cultures is also preferred.
- Capable of working independently with minimal supervision, including the ability to analyze data and understand, interpret, and present the final results.
- Must be well-organized and detail-oriented, with meticulous record keeping.
- Ability to work productively in a team environment and to adapt to changing project priorities and timelines.
- Proficiency in standard software (e.g. MS office and graphing programs), and excellent written and verbal communication skills.
Summary & Scope of the Position:
This is a full-time, permanent position for a Sr. CRA that provides comprehensive oversight of early phase clinical studies in a small biotechnology company. This position requires an individual with strong clinical trial management experience who has excellent professional written and verbal communication skills, good organization and attention to detail, and the ability to consistently provide high quality work while prioritizing tasks and meeting timelines. This person must be interested in working in a fast-paced, team-oriented environment and be adaptable to rapidly changing priorities.
- Leads operational activities pertaining to the execution of clinical studies, including day-to-day interactions with contract research organizations (CROs), vendors, consultants, and clinical sites as necessary
- In conjunction with CTM, contributes to development of study timelines and budgets
- Assists with tracking and monitoring study progress to ensure adherence to timelines and compliance to SOPs and applicable regulations
- Works effectively with team members (including CROs and vendors) to effectively accomplish study objectives
- Works with CTM to develop study documents including Study Reference Manuals, Pharmacy Binders, and Case Report Forms (CRFs)
- Prepares, collects and tracks required regulatory documentation from clinical sites
- Supports implementation of study monitoring plans; may include some site monitoring and/or co-monitoring
- Assists with review of monitoring reports, tracking study invoices (sites and vendors), and maintaining study files
- Participates in the evaluation and selection of new investigators and vendors such as central laboratory services and CROs
- Coordinates the planning of site initiation visits, Investigator Meetings and other study meetings (e.g., data monitoring committees)
- Works with Medical Monitor to manage critical safety issues
- Participates in development of database specifications, edit specifications and CRFs for web-based electronic data capture (EDC) system (or paper-based databases, as necessary)
- Work with biostatisticians and programmers to develop data listings and tables to meet needs for analyses and internal data review
- Assists with development and implementation of data review plans to ensure quality study data
- Projects, orders, and tracks clinical investigational drug and non-drug study supplies
- Contributes to development and maintenance of Clinical department operations, including reviewing SOPs
- Bachelor’s degree with a minimum of 4 years’ industry experience, with at least 2 years in direct clinical trial monitoring and/or management (or equivalent combination of education and experience)
- Knowledgeable in current Good Clinical Practice requirements and their application to the conduct of clinical studies in the United States
- Experience with early phase, oncology, cancer immunotherapy, and/or ex-US clinical studies a plus
- Strong communication (verbal, written, listening) and interpersonal skills with ability to communicate effectively across different levels of the organization
- Proficient in Microsoft Word, Excel and PowerPoint; MS Project also preferred
- Ability to work independently and manage time appropriately (timelines, schedules, task prioritization)
- Well-organized with attention to detail and accuracy
- Travel may be required up to 30% in both the U.S. and abroad
Summary & Scope of Position:
We are seeking a talented, dedicated, energetic and creative scientist who will contribute to the development of First-in-Human (FIH) clinical candidates utilizing proprietary small molecules (cyclic dinucleotides, or CDNs) that activate or repress the STING signaling pathway.
The ideal candidate will have a broad background in biochemistry and molecular biology and have excellent laboratory skills in protein biochemistry, cell biology and biophysical techniques. An understanding of organic chemistry, particularly how it relates to the interactions between small molecules and macromolecules is desirable. The primary focus of this position will be to work with the pre-clinical STING project team to conduct critical path activities necessary to advance a CDN-based FIH investigational agent to human trials. Additional activities will be to collaborate internally and externally to develop new CDN-based pipeline candidates.
- Contribute to the research and development of FIH product candidates utilizing proprietary CDN-based STING-activating small molecules. Develop appropriate biochemical and biophysical methods as well as in vitro cell based assays to evaluate the potency and mechanism of action of novel CDNs and formulations. Design, clone and express proteins in E.coli or other eukaryotic protein expression systems.
- Purify proteins using affinity tag and conventional chromatography.
- Characterize protein-ligand interactions using analytical methods such as ITC to measure dissociation constants.
- Evaluate, interpret and report scientific results and present work internally and at scientific meetings.
- Contribute to writing of competitive grant proposals, regulatory documents, patent applications and scientific publications.
- Manage relationships with contract research laboratories and academic collaborators.
- Ph.D. in Biochemistry, Molecular Biology or a related discipline with 2-5 years post-doctoral or relevant industrial experience in pre-clinical research and development
- Proficiency in protein purification using a variety of chromatographic methods
- Experience with molecular biology including PCR, cloning and site-directed mutagenesis
- Working knowledge of multiple of protein expression systems
- Experience with analytical characterization of purified proteins
- Understanding of and experience with the drug development process, particularly for vaccines and/or other protein drugs a plus
- Good organization and excellent problem solving skills with the ability to multi-task and adhere to tight timelines
- Excellent interpersonal and communication skills (oral and written)
- Willingness to adapt to changing priorities
- Ability to work independently as well as contribute actively to an integrated team
- The successful candidate must possess a significant publication record