1817 Jobs

  • Business Operations Associate (21-00053) – MA – Cambridge 1 d ago

    Nonclinical Study Management and Operations Specialist

    TOP 3 Skills:
    – Toxicology/DMPK in vivo research experience, direct experience managing or monitoring studies highly desirable
    – Basic understanding/familiarity with pathology phase of studies and QC procedures
    – Excellent communication, negotiation and organizational skills

     
    Description:
    We are looking for a collaborative, enthusiastic partner to provide planning, coordination and execution of nonclinical safety assessment and DMPK activities that support drug discovery and drug development programs across therapeutic areas.
     
    Primary duties include:
    • Primary responsibility for Contract Research Organization (CRO) vendor management, including CRO technical evaluation, contract development, and contract management.
    • Assist project representatives in nonclinical study start-up and maintenance activities. Specific tasks include communicating with contract research organizations (CROs) for quotes, facilitating contracts, compound management, coordinating and tracking sample shipments/receipt, verifying invoices, SEND data set coordination, monitoring studies, CRO site visits, QCing documents (protocols, reports) and maintaining file systems for accuracy and completeness.
    • Assist pathologists in maintaining the site pathology function and completing pathology studies. Specific duties include slide specimen management (receipt, inventory, return), slide scanning, QCing documents and document management.
    • Assist in Departments’ finance/contracts/SOWs processes, specific duties include drafting budgets and reforecasts, initiating and tracking master service and confidentiality agreements, generating purchase orders, tracking and processing invoices for payment, and accounting for monthly spending and accruals
    • Provide administrative assistance by arranging/executing domestic and international shipments and associated paperwork, coordinating and tracking archive requests, coordinating/planning/recording events, meetings and visitor schedules, and reviewing and processing documents.

    Requirements:
    Bachelors of Science with study in a field related to biomedical research (ex pharmacology, toxicology etc); minimum of 4 years of relevant work experience in the pharmaceutical/biotech industry or at a CRO.
    Experience in design and execution of in vivo studies is highly desirable. Basic knowledge of the drug development process, and SEND and GLP requirements for nonclinical studies a plus.
    Intermediate to advanced proficiency using Microsoft Word, PowerPoint and Excel
    Ability to travel within North America up to approximately 10% (CROs) and availability for occasional early morning and evening virtual meetings is required.
    Team player who thrives in a fast-paced environment and takes the initiative to identify, analyze and resolve issues.

    Source: Job Diva – Job Listing

  • Creator Management Operations Specialist (21-00049) – 1 d ago

     

    The Creator Management Operations Specialist will oversee the migration of our data into customer relationship management (CRM) tool and work with our product team to drive more value to our Pinners and Creators. This role will work with cross-functional teams including product, international teams, and partnerships to support various initiatives to drive Creator value. This will be a 6 month contract, based in San Francisco.

    • Work on scaling our operational rigor through a cross-functional effort to migrate all tracking tools into a unified Customer Relationship Management (CRM) Tool
    • Provide feedback on content/creator recommendations, content creation, and other product areas
    • Support the Creator Product team with content management, including content sourcing, curation, editorial
    • Provide insights on consumer trends and the creator landscape to identify opportunity areas for the creator & product teams

     

    Skills:

     

    • Prior experience with Salesforce
    • Prior experience with implementation of business process workflows and cross organizational  change management with one or more common enterprise software solutions like Salesforce.
    • A structured and detail-oriented thinker. You're as comfortable solving conceptual problems and creating frameworks to refine a team's thinking as you are getting into the weeds to understand how things work.
    • Strong communication skills. You can move seamlessly between conversing with IT

    Source: Job Diva – Job Listing

  • Clinical Development Director/Associate Clinical Development Director (21-00046) – NJ – East Hanover 1 d ago

    See the attached Job Description Document and the Skills and Experience section for details.

    See the attached Job Description Document and the Skills and Experience section for details.
    Source: Job Diva – Job Listing

  • USA-Research Associate III (Scientific) (21-00043) – MA – Framingham 1 d ago

    Duties

    The candidate will participate in drug product development of non-viral (nanoparticle based), viral vector- and cell-based gene therapies. The selected candidate will be responsible for formulation and process development (formulation screening, container closure selection, process development and scale-up of liquid, frozen, and lyophilized drug product, stability studies), and assay development to support all phases of the programs. This position offers the opportunity to contribute to a variety of projects while serving as a valuable member of a multidisciplinary team. The successful candidate would be required to:

    Develop and apply analytical methods to assess stability of non-viral, viral vectors- and cell-based therapeutics
    Assist in developing new technologies in the areas of polymer-based drug delivery technologies and drug product process development
    Troubleshoot problems and communicate solutions to project managers.
    Utilize electronic lab notebook to document and compile data.
    Present data in group and departmental meetings.
    Maintain laboratory instruments.
    Work independently as well as in a matrix environment.
    Manage multiple projects to meet aggressive deadlines.
    Train junior lab members

    Skills

    Preferred Qualifications

    Solid understanding and practical experience in drug product formulation and process development of non-viral gene therapies: formulation development of lipid nanoparticles, liposomes and polymer conjugates for nucleic acid delivery, container closure selection, stability studies, in-use studies and process development of liquid, frozen, and lyophilized drug product. Theoretical knowledge and hands-on experience in analytical techniques: Fluorescence based nucleic acid quantitation assays (e.g. Ribogreen assay), HPLC/UPLC, capillary electrophoresis, gel electrophoresis, DLS, zeta-potential, DSC, DSF, UV, CD, Cryo-TEM.
    Experience in formulation and process development of viral vector-and cell-based therapies is a plus. Experience in cell culture, flow-cytometry, qPCR, ITA, plate-based potency assay is a plus.
    Basic understanding of statistical data analysis. Good written and verbal communication skills.

    Education:

    BS in Chemical Engineering, Pharmaceutical Science, Analytical Chemistry, Biochemistry, Biology (or related discipline) with 6 plus years of relevant experience or MS in Chemical Engineering, Pharmaceutical Science, Analytical Chemistry, Biochemistry, Biology (or related discipline) with 2 plus years of relevant experience
    Source: Job Diva – Job Listing

  • USA-Process Engineer III (Engineering) (21-00041) – MA – Framingham 1 d ago

    Description:
    Support ongoing manufacturing process and technical transfer projects for protein-based biopharmaceutical as part of the team.
    Subject Matter Expert (SME) for development and validation, health authority inspections, and investigations.
    Responsible for defining and supporting continuing validation program, process improvements, support execution and documentation of development and/or validation studies and contribute to quality event investigations
    Document and interpret study results with recommendations.
    Provide technical leadership as a subject matter expert in multiple areas of responsibility.
    Participate in developing process control strategies.
    Provide technical assistance to manufacturing and quality operations for process troubleshooting, and health authority inspections to achieving site metrics (+QDCI).
     
    Experience:
    Expertise in downstream unit operation design typically used in biotech/vaccine manufacturing (harvest/clarification, UFDF, viral filtration and large-scale Chromatography).
    Knowledge of computer software common to mission (Excel, JMP, Spotfire ) is preferred.
    Strong experience in GMP environments.
    Ability to work in cross functional teams, provide strong analytical skills for troubleshooting and root cause analysis, and communicate with internal and external team members.
    Experience in equipment start-up, qualification and validation is preferred.
     
    Education:
    Bachelor's Degree/Undergraduate Degree or Advanced Degree in chemical or biochemical engineering.
    Degree in sciences with 3 years large scale process operational support, scale-up implementation & validation experience.
    Source: Job Diva – Job Listing

  • Salesforce Developer (21-00038) – CA – San Francisco 1 d ago

     Looking for a Salesforce Developer to help accelerate the use of technology on our Salesforce implementation. You will work with a fast-paced team of engineers, business system analysts, and technology partners where you will continue to develop your skills while helping ensure that client has an effective and scalable platform for our business-critical departments.
    This role will have a direct influence on the company by helping to drive productivity, efficiency and insights for the Sales organization.
    You should be able to utilize your time by reviewing system requirements, building customization on SFDC and integrated systems/applications. This is an exciting opportunity to join a collaborative, inclusive team that manages a growing Salesforce implementation.

    What you'll do:
    Provide strong analytical, problem solving, and technical skills to effectively collect requirements, identify alternatives, and design and deploy quality solutions.
    Support projects throughout the entire Sales development life cycle (including level-of-effort estimation, technical design, documentation, coding, testing, deployment, and support) Participate in the planning and analysis of business requirements for system changes and enhancements Communicate with Technical Architect and Business analysts to best understand the needs for the system.
    Design and develop solutions on the Salesforce.com platform, using Apex programming language
    Work with Salesforce.com Web Services APIs.
    Troubleshoot and fix defects for planned releases and production issues Research and find opportunities to utilize SFDC best practices, guidelines to improve system productivity, scaling and monitoring 
    Skills: Experience we're looking for: 3+ years of hands-on work as a SFDC Developer 5+ years of professional work experience You are a Salesforce Certified Developer (PDI/DEV401, PDII/DEV501) certifications. You have an excellent understanding of Apex, Visualforce, JavaScript, and CSS. You have senior experience with Apex, Lightning Components, Visualforce, REST, APIs, and SOQL. You have a strong understanding of other related technologies (SQL, SOAP, HTML, etc). You have experience with Product Development Lifecycle and DevOps Tools like GIT, Jenkins, JIRA, ANT, Force.com IDE, etc. You are able to work independently, proactive identify challenges, and be accountable You have strong written/verbal communication skills and can reconcile system behaviors with business/functional requirements You have a business-first approach to building systems and applications. You care about the business impact of your technical work Preferred, but not required: You have experience using and integrating with Data Warehouse applications (ex. Redshift, Hive, Snowflake). You have experience with building, testing, and debugging advanced SQL queries. 

    Source: Job Diva – Job Listing

  • Quality Engineer – Technical Transfer (21-00030) – CA – Irvine 1 d ago

    The Quality Engineer partners with multiple stakeholders across the organization, internally and externally to ensure the production of quality products. Responsibilities include collaborating with internal and external stakeholders when issues occur, including root cause analysis and process improvement conducted both internally and at the supplier; provide performance feedback through communication and auditing.
    Job Duties:
    Collaborates with cross functional team of Manufacturing Engineers, Quality Engineers, Buyer/Planners, Production and Procurement Develops, modifies, applies and maintains quality evaluation and control systems and protocols for processing materials into partially finished or finished materials product.
    Provides technical guidance and quality compliance for Supplier Quality engagement on products, subassemblies and parts and implementing strategies for driving product quality and continuous improvement, ensuring purchased products and components are manufactured and qualified in accordance to applicable industry standards, regulatory requirements, and *** requirements
    Collaborates with engineering laboratory and production functions to ensure quality standards are in place. Devises and implements methods and procedures for inspecting, testing and evaluating the precision and accuracy of products and production equipment.
    Designs and analyzes inspection and testing processes, mechanisms and equipment; conducts quality assurance tests; and performs statistical analysis to assess control and manage risks of product quality and determine the responsibility for products or materials that do not meet required standards and specifications.
    Audits quality systems for development acceptance criteria (parameters based on product result).
    May undertake root cause analysis of incidents requiring corrective action. Ensures that corrective measures and deviation meet acceptable reliability standards and that documentation is compliant with requirements.
    May specialize in the areas of design, incoming material, production control, product evaluation and reliability, inventory control and/or research and development as they apply to product or process quality.
    May be certified in lean and six-sigma quality methodologies and utilize quality tools to help drive continuous improvement.

    Minimum Requirements:
    Bachelors Degree
    The ability to fluently read, write, understand and communicate in English
    No prior experience required; however prior experience in an FDA regulated environment preferred.
    Experience with Quality Management System
    Familiarity with regulatory reporting requirements for medical devices (e.g. MDRs, Vigilance reports, etc);Familiarity with medical device complaint files and quality records;nowledgeable of FDA regulations, 21 CFR part 820 and Part 803 and ISO 13485 standard;
    Strong computer skills (including Excel)
    Source: Job Diva – Job Listing

  • Quality Engineer (21-00028) – CA – Irvine 1 d ago

    Duties:
    The Quality Engineer is responsible for maintaining quality and control of manufacturing processes and post-market performance of medical devices.
    Responsibilities include collaborating with internal and external stakeholders to achieve company objectives, leading technical root cause investigations, developing and executing risk-based decisions, resolving and documenting customer complaint and manufacturing investigations, and representing Quality in cross-functional projects.
    Develops and executes plans for quality and control to ensure manufacturing continuity and product conformance.
    Leads investigations into production and customer-facing quality issues to identify root cause, implement corrective and preventative actions, and monitor effectiveness
    Monitors and analyses product performance of medical devices using a statistical and risk-based approach.
    Considers any quality, compliance, customer, and business risks.
    Performs hands-on troubleshooting of customer returned devices and manufacturing nonconformities and completes associated technical documentation
    Develops tools to communicate complex technical problems and solutions to a variety of audiences within the organization
    Proficient in project management, data analysis, root cause analysis, communication, and risk determination
    Ensure compliance with the company's Quality System policies and procedures and applicable external requirements and standards, including FDA, ISO 13485, and other worldwide regulatory agencies as pertaining to medical devices.
     
    Minimum Requirements:
    Bachelor's degree in Engineering
    2 years of relevant experience in a regulated industry (FDA environment preferred)
    Knowledgeable of FDA regulations, 21 CFR part 820 and Part 803 and ISO 13485 standard
     
    Education:
    Bachelor's degree in Engineering
    Source: Job Diva – Job Listing

  • System Administrator II (21-00019) – IN – Carmel 1 d ago

     seeking a junior / mid level Systems Administrator to assist a senior admin team with day to day functions. This resource should have 2-5 years of specifically Systems Admin experience, with experience taking first pass at completing Tier I/II tickets. This resource should have a self-starter attitude, a hunger to learn, and a desire to grow in the IT space. This position is a contract to hire, with full intention to hire on permanently at the end of the contract period.
     
    Must Haves:

    • Experience patching Windows Systems / Windows Security System ADMIN not just IT
    • Strong Windows Systems capabilities
    • Experience in basic VMWare functionality
    • Ability to assist with software / hardware installation, troubleshoot software/hardware
    • Proven ability to validate and edit technical documentation

     
    Plusses:

    • Experience with Puppet, PowerShell, and Python
    • BigFix knowledge
    • Experience with ITEL

    Source: Job Diva – Job Listing

  • R & D Product Support Engineer – Electrical/ Mechanical (21-00018) – CA – Lake Forest 1 d ago

    Summary:
    Currently seeking engineering candidates with electrical / electromechanical / mechanical experience for a long-term contract assignment to provide sustaining engineering support to cross-functional teams.
    This position will provide R&D technical post market/life cycle product support to analyze and assess impact of manufacturing design and process change requests (cost improvements, obsolescence, corrective actions) of ophthalmic surgical instrumentation products (consoles and associated reusable and single-use accessories): Analyze and troubleshoot design and process changes, solve technical problems at system-level, PCB board or assembly-level and component-level, document impact on physical and functional design specifications, perform gap assessments and document product compliance to external medical device industry safety and performance standards (EN, ISO, ASTM, etc.). Provide review of complaint / adverse event data and risk assessments (in compliance to EN ISO 14971), assist in developing and reviewing technical file / design dossiers for regulatory submissions and registrations. Prepare technical product documentation including drawing revisions, Bill of materials, and engineering change orders (ECO).
    This position will also support R&D development project activities required for compliance to new European Medical Device Regulation (MDR), including managing and reporting technical product data, materials remediation (for RoHS, REACH,SVHC compliance) labeling updates and technical file updates (required to maintain European registration (CE mark) and will work to assess and maintain product compliance to existing and future regulations and product performance and safety standards and reporting (IEC, EN, ISO, etc.)
     
    Required:
    Bachelor’s Degree or Associate Degree and 8 years of directly related experience
    The successful candidate will be responsible for independently completing work requests and document change requests as assigned by engineering teams and management
    5+years of experience ideally in the medical device industry
    Experience with product Verification & Validation in developing and executing the protocols & reports at sub-system & system levels to support Optical, Electro-mechanical component End-Of-Life (EOL )projects
    Experience in Medical Device Design Control including risk assessment, management and reporting
    Experience with troubleshooting and redesign of devices to meet requirements redesign of devices to meet requirements”
    Experience in systems engineering with a background in electro-mechanical and optical systems is preferred.
    Knowledge of Wavefront technology and high definition 3-D digital visualization systems is preferred
    Familiarity with PRO-E and other Windchill product data management applications is preferred
    Familiarity with OrCAD PCB design tools for schematic capture and fabrication is preferred.
    Experience with and knowledge of EMI/ EMC testing is preferred
    Familiarity with Design Of Experiments is preferred
    Excellent written and spoken communication skills
    Demonstrate Good Documentation Practices
    Proficient in MS Office applications including basic Excel skills
    Source: Job Diva – Job Listing

  • Biostatistician (21-00014) – NJ – Woodcliff Lake 1 d ago

    SUMMARY:
    Work with the clinical study team on study design, development and/or review of clinical study protocols.
    Contribute to clinical trial design, protocol concept sheet and protocol development
    Participate study related activities and provide statistical support such as reviewing Case Report Form (CRF) and guidance, validating randomization scheme and developing Study Quality Surveillance Plan (SQS), reviewing Independent Radiology Review Committee Charter and data transfer plan, etc.
    Develop and/or review statistical documents and deliverables for clinical trials including Statistical Analysis Plan (SAP) for individual studies and integrated summaries of drug efficacy and safety, Table, Listing and Graph (TLG) shells, statistical validation plan, Data Set Specification (Rule Book), Data Monitoring Committee Charter and interim analysis plan, Clinical Study Report (CSR) and others
    Work with clinical data managers on design/review of case report form, data transfer specification, edit check specification, and participation in user acceptance testing (UAT); generate/review data tables/listings and coordinate data review meetings during the course of the study to ensure data quality.
    Oversee programming activities, perform quality assurance checks on internally or externally produced SAS tables, listings, and figures, and ensure the quality of deliverables.

    Perform post-hoc statistical analyses as needed.
    May work on submission teams as a statistician and/or a programmer.
    Generate and QC outputs for publications; review publication (abstract/manuscripts) to ensure accuracy, quality and soundness of statistical methodologies
    Will serve as lead Statistician on complex trials and across multiple studies.
    Project work including participating in the development of Clinical Development Plans (CDPs) and the protocol development process, developing and implementing Statistical Analysis Plans (SAPs), supervising CROs and interfacing with co-promoters, attending IPT meetings, consulting with clinical or regulatory affairs groups on strategic issues related to compound development, study designs, analysis, resource needs and future plans.
    Managing non-project work including infrastructure development initiatives and involvement in committees working to develop SOPs and SWPs to improve quality, efficiency and timeliness of work processes.
    Facilitate teams to identify issues related to biostatistics and propose solutions; manage day-to-day biostatistics operations and help to develop resource allocation to execute biostatistics initiatives as needed.

    QUALIFICATIONS:
    Must have a MS in Biostatistics/Statistics with at least 5 years of experience or a PhD in Biostatistics/ Statistics with at least 4 years of experience in the pharmaceutical, CRO or biotech industry.
    Strong SAS programming skills.
    Oncology experience is preferred.
    Ability to effectively work on multiple projects
    Good organization, time management and attention to detail skills needed to work in a stressful environment under tight deadlines while maintaining focus on details and quality.
    Applies good judgment and leads problem solving within the team
    Familiar with oncology clinical trial Phase I-III design and survival analysis, submission experience will be plus.
    Source: Job Diva – Job Listing

  • USA-Research Associate II (Scientific) (21-00013) – MA – Framingham 1 d ago

    The ideal candidate will join the BioProcess Analytics group and will work closely with upstream and downstream groups within the Biologics Development organization. This a laboratory position; the candidate is expected to apply a diverse array of analytical techniques to support in-process testing and develop new high throughput analytical methods
    Basic Qualifications
    BS or MS in Analytical Chemistry, Biochemistry or related field with 3-6+ years of practical experience in biopharmaceutical or biotech industry
    Hands-on experience in the analysis of monoclonal antibodies and other protein biotherapeutics
    Experience in methods development for protein and peptides using chromatography and electrophoresis separation techniques (e.g. HPLC/UPLC, SEC, CE-SDS, cIEF, and etc)
    Knowledge and experience with Microsoft including Excel, Word, and PowerPoint.
    Experience with Waters and Agilent software is highly desirable (e.g. Empower, OpenLab, and etc)
    Preferred Qualification
    Knowledge of upstream and downstream protein therapeutic development is desirable
    Designs, interprets, and executes experiments and analytical procedures. Evaluates and defines appropriate approaches. Employs in-depth technical knowledge.
    May oversee and train lower level researchers in performing established procedures.
    Collaborates in research and development efforts and makes key technical contributions affecting the direction of the project.
    Independent and self-motivated.
    Excellent written, verbal communication and presentation skills
    Exceptional organizational skills, attention to detail and ability to multitask
    Adapt and respond well to change in priorities and tight timelines
    Responsibilities
    Responsible for in-process analytical testing including released glycan assay and electrophoresis
    Execution of 20 high throughput analytical methods to support high volume testing
    Ensure data quality and reliability, documentation, accurate data interpretation and reporting in scientific, professional and expert’s manners in support of decision making.
    Prepare presentations, technical reports, SOPs etc. to support programs
    Source: Job Diva – Job Listing

  • Clinical Project Manager (21-00005) – NJ – Pennington 1 d ago

    Brief Description:
    • Monitor and report on the progress of delegated Saroglitazar USFDA clinical trials, which includes budgets and timelines Prepare, oversee, and review documents that are related to assigned clinical study Arrange or help in organizing clinical study meetings
    • Ensure the availability of necessary resources for the execution of clinical projects Review and approve invoices being presented by study vendors and external consultants
    • Answerable to questions and issues brought up by vendors and external consultants
    • Help in the training and development of clinical staff as at when due Lead the clinical project team and various study team meetings
    • Oversee the pattern and manner in which clinical research study is being conducted Fully involved in resolving issues; take part in procedure improvement initiatives
    • Attain clinical study's goals by working with other members of the study team to outline their priorities, and to also resolve conflicts that may come up in the project process
    • Work hand-in-hand with clinical trial associates and document control personnel to manage documents that are related to the clinical study.
    Requirements Abilities, Skills, and Knowledge:
    • Must possess excellent communication skills so as to be able to effectively convey messages across to both study team members and other external persons like vendors and external consultants
    • Good problem-solving, organizational, and leadership skills are highly required Ability to work with little or no supervision
    • Ability to pay keen attention to detail at all times Must be able to work within stipulated timeframes or deadlines even in the face of multiple responsibilities or projects
    • Must be able to work as part of a team or in most cases lead a team Must have a 'one of a kind' work ethic, and must exhibit a great level of self-discipline
    • Ability to organize and motivate other members of the study team
    • A Bachelor's and/or a Master's degree in any science or health related field A minimum of 5 years' experience in the field of clinical research of which 2 years must have been in a project lead role Proficient user of basic computer applications for the execution of daily project operations
    • Experience in writing clinical study procedures and other clinical document is a plus.
    • Willingness to travel

    Source: Job Diva – Job Listing

  • Injection Molding Process Engineer (21-00002) – TX – Houston 1 d ago

    Develop and sustain optimum molding process for medical manufacturing device components
    Develop injection molding process per the decouple scientific principles.
    Run Projects from start to finish.
    Inprove and troubleshoot areas in the molding department.

    Plastic experience required. Master Molder certification preferred.
    Decoupled Molding Principles
    Project Management
    Requires good communication, people skills to work well with other departments, customers.
    10+ Year in Plastic Manufacturing Industry
    Ability to write technical reports and prepare and make effective presentations
    Source: Job Diva – Job Listing

  • SAS Programmer (20-01055) – WA – Bothell 1 d ago

    • At least 8 years of hands-on experience in Stat Programming, with no employment gaps. Note, positions mostly providing oversight of outsourced projects are not considered hands-on
    • At least 4 years hands-on experience working on SDTM and ADaM data sets
    • Hands-on experience in oncology and submissions (meaning, preparing metadata for a study and/or working on an ISS or Client)
    • Strong communication skills, both written and verbal
    • Demonstrated attention to detail and focus on quality, supported by examples
    • Demonstrated proactivity, supported by examples
    • Demonstrated analytical skills, for example by creating or providing significant input into specifications as an author or while programming or conducting QC

    Source: Job Diva – Job Listing