1377 Jobs

  • USA-Quality Control Scientist I (Manufacturing/Quality) (20-00357) – CT – Meriden 1 d ago

    This position will be responsible for supporting therapeutic protein comparability study and analytical method development for QC testing and process development. Job responsibilities also include: Independently design and execute experiments, perform data analysis and write technical reports. Solve assay and process problems and challenges. Identify potential technical problems and proactively suggest technical solutions. Routinely coordinates completion of specific project tasks within the team and with other groups and departments. Participate in technical transfer and train new team members if needed. Work in compliance with relevant quality standards and safety regulations.This position requires working independently under general supervision and direction.. Years of Experience: 0 – 3 Years
    Source: Job Diva – Job Listing

  • USA-Quality Control Analyst I (Manufacturing/Quality) (20-00356) – CT – Meriden 1 d ago

    Perform operations necessary for quality testing and plays a role in implementing new technology within quality control. At more senior levels, provide an investigative or technological orientation in designing, executing, interpreting and validating quality procedures and test methods. Complete routine testing of raw materials, in-process and final products in accordance with SOPs for product release and validation. Aid in the development of test methods. Conduct data review and preliminary evaluation of results. Solve problems using limited predetermined options such as repeating the assay when parameters are not met to determine the cause, etc. Provide input to the technical composition of operating documentation. Work is closely supervised. Follows standard practices to obtain solutions. Contribute to the completion of routine technical tasks. Failure to achieve results can normally be overcome without serious effect on schedules and programs. Contacts are primarily with immediate supervisor and other personnel in the section or group.. Years of Experience: 0 – 3 Years
    Source: Job Diva – Job Listing

  • USA-Project Manager I (Clinical) (20-00355) – MA – Cambridge 1 d ago

    Responsible for the development, maintenance, monitoring, and tracking of ad board and company sponsored symposia project plans and key milestones. This includes:
    – Organizing and maintaining project documentation to support medical affairs initiatives
    – Communicating with project stakeholders and internal quality teams to ensure compliance to company standards and policies.
    – Managing project schedules/timelines and measuring project quality, resources, communications and risks.
    – Coordinates operational needs of project planning for KOL engagements and events. This includes tracking multiple projects within planning tools, ensuring project timelines are adhered to, escalating risks when appropriate, and maintaining organization across multiple project portfolio.
    – Supports the preparation of metrics and status reports, and present information to organizational leadership, project teams and operational support staff.
    – Coordinates periodic project meetings, develops agendas based on project plan priorities, leads and facilitates project meeting discussions, maintains and documents project meeting minutes.
    – Assists with maintaining project dashboards that help drive monitoring, quality assurance and reporting of project deliverables and present project dashboard to key organizational stakeholders and leadership.
    – Maintains the overall advisory board / medical meeting documentation as necessary in project databases (including but not limited to overall budget management, HCP engagement, and legal contracts).

    Required Experience:
    Experience 1-3 years

    Required Skills:
    Project management skills and background Strong organizational skills to manage, track, and report on multiple ongoing projects at once.
    Strong communication skills to engagement with multiple stakeholders Experience in Microsoft Office platforms, including Outlook, Word, Excel, PowerPoint, Visio, Project
    Source: Job Diva – Job Listing

  • Release Engineer (20-00364) – 1 d ago

    Collaborate with IT and the business to improve software, solution, and system quality, leading to higher quality IT overall. Support software development and delivery through CI/CD, infrastructure as code, and automation

    POSITION OVERVIEW
    Collaborate with IT and the business to improve software, solution, and system quality, leading to higher quality IT overall. Support software development and delivery through CI/CD, infrastructure as code, and automation.
    ESSENTIAL CAPABILITIES AND RESPONSIBILITIES
    •Document, design and re-design various processes to continually improve service to the organization.
    •Assist in the day to day management and administration of CI/CD tooling.
    •Accountable for the quality development of enabling automation, CI/CD tooling and release scheduling.
    •Manage CI & CD tools and pipeline as a partner to development teams.
    •Ability to make timely recommendations to effectively solve problems, using independent judgment consistent with standards, practices, policies, procedures, regulations, and/or law.
    •Professionally exercises discretion and independent judgment in day-to-day work
    •Complete all other duties as assigned

    QUALIFICATIONS AND COMPETENCIES
    EDUCATION/ EXPERIENCE
    •At least one to three years of specific experience within any of the following: software design or development, infrastructure design or development, QA automation or equivalent experience
    •Previous energy industry experience, preferred
    •Previous experience in a highly regulated industry, preferred
    Appropriate level will be determined based upon experience and knowledge
    TECHNICAL KNOWLEDGE, SKILLS, AND CAPABILITIES
    The requirements listed below are representative of the knowledge, skills, and/or abilities required to perform each essential duty satisfactorily.
    Technical Capabilities – Must also be proficient with the following:
    •Experience with PaaS technologies such as containers, container orchestration and scheduling, service registration / discovery and monitoring (Docker, Kubernetes, Open Shift, fabric8)
    •Experience with automation/configuration management using either Ansible, Puppet or an equivalent
    •Demonstrated experience installing, operating and troubleshooting a variety of open source technologies
    •Strong experience with relational and non-relational databases
    •Practical experience developing software or meeting operational needs with code and script (JavaScript, Python, Perl, Ruby, PHP, .NET or Java)
    •Experience with software quality principles and associated tools for testing and analysis
    •Knowledge of CI and CD practices and supporting tools (Jenkins, Bamboo, Team City or similar)
    •Ability to communicate technically as well as non-technically across various levels of business
    •Experience in a highly regulated environment with demonstrated success working with internal and external compliance partners
    •Experience with automation in dynamic environments such as IaaS and PaaS (on premises, hosted and hybrid)
    •Experience with programmable infrastructure and Infrastructure as Code IaC tools and principles.
    •Knowledge of platforms (Linux, UNIX or Windows).
    Time Management – Ability to work within a fast-paced, deadline oriented environment with minimal supervision. Must be well organized with a high attention to detail and accuracy
    Computer Skills – Must have intermediate skills in Microsoft Word, Outlook, Excel and PowerPoint.
    Reasoning/Analytical Ability – Ability to define problems, collect & analyzes data, establish facts, and draw valid conclusions. Ability to interpret an extensive variety of technical instructions and deal with several abstract and concrete variables.
    Industry Knowledge – Gas, Electric or Power Systems experience preferred

    GENERAL CORE COMPETENCIES
    Effective Communication – Ability to read and comprehend instructions, policies and procedures. Strong written and verbal communication skills. Ability to articulate detailed concepts in writing. Ability to collaborate with other departments to complete projects on time.
    Teamwork – Ability to collaborate in a team environment. Ability to seek regular feedback and contribute in team meetings. Provide back-up to other team members as necessary.
    Results Orientation – Be accountable for producing an accurate, timely and quality work product.
    Operational Excellence – Collaborate with others to identify efficiencies and process improvements. Embrace change and the focus on continuous improvement.

    Monument Intake Questions:
    •Years of experience?
    oJunior person; augmentation; decent amount of senior personnel, deal with someone who’s a little more junior, as long as they’ve got some good experience
    oWork doing – hard to pin down to one skillset, CIDC pipeline building, so they touch a lot of different aspects
    ?Write some code (Java, Docker, flashlight)
    ?Using lots of programing language and tool stacks
    •Linux, C++
    ?Diverse set of stuff; OS and Docker experience useful, the run time for pipeline
    ?Adaptability & ability to learn; do write a lot for java and groovy
    •Contract or Contract to Hire? 6 months – possibility for extension?
    o6 Month contract
    oOpen for a couple reasons; have some new work generated internally, want to make sure they have the capacity to handle it; try to follow the SCRUM
    oEnsure capacity
    •Location / Remote Possibility
    oLocal would be ideal. Remote if the right candidate and can accommodate EST business hours.
    oDaily standup at 9:15
    •Top 3 skillsets needed for role
    oExperience in Docker (creating applications to run in Docker) that would probably be the most helpful; one coordinating server; all goes through Docker
    oOther aspect is in a lot of different folders; GIT familiarity Linux Docker and Java
    Source: Job Diva – Job Listing

  • Release Engineer (20-00353) – IN – Carmel 1 d ago

    POSITION OVERVIEW
    Collaborate with IT and the business to improve software, solution, and system quality, leading to higher quality IT overall. Support software development and delivery through CI/CD, infrastructure as code, and automation.
    ESSENTIAL capabilities AND RESPONSIBILITIES

    • Document, design and re-design various processes to continually improve service to the organization.
    • Assist in the day to day management and administration of CI/CD tooling.
    • Accountable for the quality development of enabling automation, CI/CD tooling and release scheduling.
    • Manage CI & CD tools and pipeline as a partner to development teams.
    • Ability to make timely recommendations to effectively solve problems, using independent judgment consistent with standards, practices, policies, procedures, regulations, and/or law.
    • Professionally exercises discretion and independent judgment in day-to-day work
    • Complete all other duties as assigned

    QUALIFICATIONS AND COMPETENCIES
    EDUCATION/ EXPERIENCE

    • At least one to three years of specific experience within any of the following: software design or development, infrastructure design or development, QA automation or equivalent experience
    • Previous energy industry experience, preferred
    • Previous experience in a highly regulated industry, preferred

    Appropriate level will be determined based upon experience and knowledge
    TECHNICAL KNOWLEDGE, SKILLS, AND CAPABILITIES
    The requirements listed below are representative of the knowledge, skills, and/or abilities required to perform each essential duty satisfactorily.
    Technical Capabilities – Must also be proficient with the following:

    • Experience with PaaS technologies such as containers, container orchestration and scheduling, service registration / discovery and monitoring (Docker, Kubernetes, Open Shift, fabric8)
    • Experience with automation/configuration management using either Ansible, Puppet or an equivalent
    • Demonstrated experience installing, operating and troubleshooting a variety of open source technologies
    • Strong experience with relational and non-relational databases
    • Practical experience developing software or meeting operational needs with code and script (JavaScript, Python, Perl, Ruby, PHP, .NET or Java)
    • Experience with software quality principles and associated tools for testing and analysis
    • Knowledge of CI and CD practices and supporting tools (Jenkins, Bamboo, Team City or similar)
    • Ability to communicate technically as well as non-technically across various levels of business
    • Experience in a highly regulated environment with demonstrated success working with internal and external compliance partners
    • Experience with automation in dynamic environments such as IaaS and PaaS (on premises, hosted and hybrid)
    • Experience with programmable infrastructure and Infrastructure as Code IaC tools and principles.
    • Knowledge of platforms (Linux, UNIX or Windows).

    Time Management Ability to work within a fast-paced, deadline oriented environment with minimal supervision. Must be well organized with a high attention to detail and accuracy
    Computer Skills Must have intermediate skills in Microsoft Word, Outlook, Excel and PowerPoint.
    Reasoning/Analytical Ability Ability to define problems, collect & analyzes data, establish facts, and draw valid conclusions. Ability to interpret an extensive variety of technical instructions and deal with several abstract and concrete variables.
    Industry Knowledge Gas, Electric or Power Systems experience preferred

    GENERAL CORE COMPETENCIES
    Effective Communication Ability to read and comprehend instructions, policies and procedures. Strong written and verbal communication skills. Ability to articulate detailed concepts in writing. Ability to collaborate with other departments to complete projects on time.
    Teamwork – Ability to collaborate in a team environment. Ability to seek regular feedback and contribute in team meetings. Provide back-up to other team members as necessary.
    Results Orientation Be accountable for producing an accurate, timely and quality work product.
    Operational Excellence Collaborate with others to identify efficiencies and process improvements. Embrace change and the focus on continuous improvement.

    Source: Job Diva – Job Listing

  • Associate Director, Medical Information (20-00352) – NJ – East Hanover 1 d ago

    Duties:
    Product and disease state expert within MIC, providing strategic input and direction to internal colleagues. 
    Reviews promotional materials as a member of the product-specific Materials Approval Process (MAP) team. 
    Also reviews non-promotional tools through eMed. 
    Responds to product inquiries from external and internal customers. 
    A member of the Medical Product Team. 
    Creates, maintains, reviews, and approves Company product Medical Response Documents. 
    Participates in the development and maintenance of product dossiers. 
    Captures potential adverse events and provides disease state and product training to internal groups. 
    Takes initiative and works independently requiring minimal supervision. 
    Demonstrates superior performance in the medical information role. 
    Is a resource to other MIC colleagues, provides guidance, coaching and mentoring and acts as a role model to MIC colleagues.
    Be key contact for MIC to answer brand-specific questions and craft/review answers given to external customers
    Medical Reviewer for promotional and non-promotional materials (member of Materials Approval Process [MAP] and eMed)
    Respond to medical/scientific inquiries by searching, retrieving evaluating and summarizing the relevant information from in-house and external sources.
    Receive medical/scientific inquiries regarding marketed products and products being prepared for launch
    Review and Approve Medical Response documents for assigned products
    Based on issues identified in trials, develop product Scientific Q&A documents that can be adapted at time of launch or for business critical topics
    Collaborates closely with critical Medical Unit and brand team members
    Review analyses of customer requests for feedback and input to brand strategy
    Support internal training by providing MIM and RTMI team support
    Co-ordinate input from appropriate company personnel and global MI TA team to be incorporated into responses
    Create and update responses to maintain a current and accurate information resource for all internal customers.
    Work with clinical research teams to identify and track clinical use issues raised during trial programs that need to be addressed for launch
    Review responses with MIC Director and other Medical personnel as appropriate
    Identify and champion best practice examples in MIC
    Provide information support for commercial activities of the Brand Team (literature updates, summarized enquiry issues; competitor intelligence)
    Be a resource and provides appropriate coaching and mentoring to MIC colleagues (e.g., MRD creation, MAP interaction, MPT contributions)
    Responsible for Project management related to TA or department initiatives
    Acts as deputy to the Director
    May be granted limited supervisory responsibility within the respective team over an MIM level colleague or student/fellow/intern as part of leadership development

    Skills:
    PharmD, MD or healthcare-related PhD (Bachelor degree in pharmacy with significant industry based medical information experience also acceptable)
    Advanced degree or training in particular relevant therapeutic area desirable
    Pharmaceutical Industry Experience; minimum 2-3 years in MIM role or equivalent Medical Information experience
    Management experience
    CPO Medical Department experience
    Fluent English; Fluency in Spanish is a plus
    Excellent verbal and written communication skills
    Ability to lead cross-functional team
    Business knowledge and commercial marketing understanding
    Cross-cultural perspective
    Excellent verbal and written communication skills
    CPO Medical Department experience

    Education:
    PharmD, MD or healthcare-related PhD (Bachelor degree in pharmacy with significant industry based medical information experience also acceptable)
    Advanced degree or training in particular relevant therapeutic area desirable
    Source: Job Diva – Job Listing

  • Quality Control Technician I (20-00350) – TX – Fort Worth 1 d ago

    1st or 2nd shift ( 1st shift: 7 am – 4 pm / 2nd shift: 2pm-11pm, either Tues-Sat or Sun-Thurs)
    Provide support for QC Chemistry analytical prelim, finished product and stability testing
    Perform laboratory activities to support product testing Review laboratory data

    The ability to work independently following an approved protocol
    The ability to function in a team enviornment
    The flexibility to work overtime as required by the aggressive project schedule
    Good technical writing skills and the ability to communicate technical issues to project lead and team
    Proficient in MS Word and excel
    Source: Job Diva – Job Listing

  • Formulation Scientist (20-00349) – MA – Cambridge 1 d ago

    Work independently in supporting senior group scientists on their projects. Design, plan, and perform experiments in order to test hypotheses and advance understanding of fundamental scientific principles. Interpret and report results.
    In detail, perform basic physchem characterization of new molecular entities, such as use of analytical techniques to confirm physical form, measurement of solubility and evaluation of chemical and physical stability. Develop formulations to support in vivo studies. Carry out basic laboratory housekeeping activities such as preparation of buffers and mobile phases.

    1. Knowledge of laboratory and technical tools, such as thermal techniques, X-Ray powder diffraction and particle size analysis.
    2. Proficient in utilization of special tools and equipment, lab automation tools and specialized facilities e.g., containment and sterile labs, and analytical tools such as LC-MS, etc.
    3. Good knowledge of software and computer tools.
    4. Very good communication skills. Good presentation skills and scientific/technical writing skills.
    Source: Job Diva – Job Listing

  • Global Program Lead (20-00347) – NJ – East Hanover 1 d ago

    The Global VDO Program Lead is accountable for managing and executing programs (portfolio of projects) through expert knowledge and consultative methods, thereby enabling the organization meets its objectives. The role brings technical expertise including end-to-end project management / Lean six sigma / Agile, business transition and transformation, design thinking, solution/process design/modelling, robotic/automation/digital and consulting/facilitation support. The position also requires a leader that is able to facilitate and drive change in a heavily networked environment. Strong interpersonal, communication and networking skills are necessary, as well as an ability to make progress in an environment where there can be significant ambiguity. Key to success in this position is the ability to work within the organization at all levels, working in a "hands on and practical way.
    Major Accountabilities
    Program management leadership of cross-functional, strategic, high-business value projects for
    Global Development Operations with measureable added business value outcomes and benefits
    Drive strategic, centralized operational excellence improvement initiatives on GDD and GDO level focused on process re-engineering; producing deliverables such as the project charter, project, plan, change management plan, integrated risk register and business benefit case
    Drive business transformation in a heavily matrixed environment
    Apply disciplined, best-in-class project management methodologies (e.g. Agile, Scrum, or equivalent) to the delivery of complex and high visibility projects providing rigorous project planning, risk management, project controls and re-porting following *** Project Management framework
    Act as Scrum Master overseeing daily standups, sprint planning, demos, retrospectives
    Provide senior level, cross-unit and function (up to DCN – 1 level) stakeholder management to effectively manage change and proactively identify risks and mitigations
    Understand vision, strategic imperatives, business drivers, and changing landscape. Challenge assumptions of senior stakeholders in order uncover hidden risks and build realistic plans
    Lead cross-functional, global teams in support of initiative objectives
    Ability to multi task and manage multiple (2-3+) projects at one time
    Develop ideas for changes in process, methods, organization, location, tools and measures of success for achieving business excellence
    Utilize process improvement methodologies and best practices (e.g. IQP, Lean six sigma, etc.)
    Help develop and maintain core team processes
    Prepare roadmap reports for projects to all stakeholders, including engaging with Sr. management stakeholders
    Deputize for VDO Global Head

    Experience/Professional Requirement
    Management consulting in Pharma development organizations
    At least 3-5 years senior level experience in drug development or related experience. Familiar with both operational and scientific aspects of drug development.
    Proven track record in working across a matrix organization and demonstrates expert skills in building partnerships, negotiating agreements; excels at collaboration with diverse internal and external organizations.
    Excellent interpersonal and communication skills, able to naturally bridge scientific and business participants; Track record in enabling effective international collaboration.
    Data-driven decision making, with a strong understanding / competency of new technologies, data science and digital
    Proven ability to organize, prioritize and work effectively in a constantly changing environment and motivate the team to do the same. Strong results driven leadership style. Ability to develop bold ideas and take calculated risks
    Outstanding verbal and written communications. Ability to communicate, motivate with a persuasive, credible presentation style
    Experience with Lean/Six Sigma
    Strong delivery oriented, results driven leadership style with experience in Agile methodology
    Strong leadership and ability to manage and influence matrix organizational teams in global setting and proven ability to develop high performing teams and diverse profiles
    Significant experience, and proven ability to effectively engage & manage associates from widely varying backgrounds & functions within a dispersed and highly matrixed organization
    Strong relationship building skills, can influence, negotiate with and motivate senior leaders
    Strong tolerance for ambiguity, willingness to adapt, willing to speak-up and challenge
    Excellent presentation oral and written communication skills.
    Ability to effectively prioritize and execute tasks in a high-pressure environment.
    Must possess critical thinking, problem solving, and decision-making skills
    Strong tolerance for ambiguity, willingness to adapt to change, willing to speak-up and challenge
    5-10+ years of project management experience, delivering cross-functional technology solutions in a variety of different styles (Agile, Waterfall, etc.)
    3+ years’ experience managing teams of 10+ associates
    Further education in Change management, Facilitation /Coaching
    Source: Job Diva – Job Listing

  • Regulatory Labeling Specialist (20-00346) – CA 1 d ago

    We are looking for a Reg. Labeling specialist for MDR gap assessment & change control.

    Source: Job Diva – Job Listing

  • USA-Warehouse General I (Light Industrial) (20-00344) – PA – Taylor 1 d ago

    Warehouse duties to include picking orders (finished products). Packing and able to lift 30 lbs/14 kg to 50 lbs/23 kg on a regular basis. Shipping preparation.. Years of Experience: 0 – 3 Years
    Source: Job Diva – Job Listing

  • Laboratory Assistant (20-00343) – AZ – Tucson 1 d ago

    JOB SUMMARY
    Maintains laboratory instruments and equipment on a daily, monthly, and quarterly basis. Prepares reagents and monitors
    instruments for bulk reagent levels. Orders and stocks office and laboratory supplies and equipment. Performs onsite servicing and
    technical support of various lab equipment including Benchmark autostainers. Manages incoming/outgoing stained slide and/or
    reagent shipments. May support several different functional lab spaces and groups.
    RESPONSIBILITIES:
    Performs daily, monthly and quarterly instrument and equipment maintenance and cleaning tasks.
    Monitors and maintains usage logs for all equipment and instruments. Monitors, schedules and delivers portable equipment
    for calibration and maintains necessary paperwork.
    Troubleshoots minor equipment malfunctions by performing operational tests.
    Monitors and prepares bulk reagents daily.
    Maintains stock room and monitors and/or orders lab supplies inventory.
    Schedules internal equipment repairs and preventative maintenance as necessary.
    Prepares and schedules incoming and outgoing stained slide and/or reagent shipments.
    Other duties as assigned by management.

    QUALIFICATIONS
    Will position work with chemicals? If yes, what room(s)? -Yes, but advanced staining bulk reagents in 2075/ 2079 (non-hazardous). Position may be required to change xylene/ alcohols in coverslipping instruments, but training and PPE will be provided.

    Knowledge, Skills, and Abilities (Required):
    Able to work independently.
    Strong communications skills, verbal and written.
    Attention to detail in written instructions and documentation.
    Basic computer skills in Word, Excel and Outlook.
    Ability to lift up to 45 pounds.
    Knowledge, Skills and Abilities (Preferred):
    Ability to use hand tools such as screwdrivers, wrenches, nut-drivers and various other hand tools.
    Ability to use test equipment such as flow meters, pH meters, precision weight scales, and pressure meters.
    Knowledge of and skill in inventory management.
     
    Source: Job Diva – Job Listing

  • Senior Biostatistician (20-00335) – NJ – Woodcliff Lake 1 d ago

    Duties:
    • Work closely with clinicians, programmers, and publication managers to generate and QC outputs for publications; review publication (abstract/manuscripts) to ensure accuracy, quality and soundness of statistical methodologies; coordinate internal resource utilization for publication and generate activities metrics for management review.
    • Work with the clinical study team on study design, development and/or review of clinical study protocols.
    • Develop and/or review statistical analysis plans, including Table/listing/figure shells, and final study report for clinical studies; perform post-hoc statistical analyses as needed.
    • Work with the project statistician and 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 CRO programming activities, perform quality assurance checks on internally or externally produced SAS tables, listings, and figures, and ensure the quality of CRO deliverables.
    • May work with the Health Outcome team on the design/analysis/validation of projects.
    • May work on submission teams as a statistician and/or a programmer.
    Act as lead Statistician on complex trials and across multiple studies.
    Act as a lead representative of the of the biostatistics department on project teams.

    QUALIFICATIONS NEEDED:
    • Must have a MS in Biostatistics/Statistics with at least 8 years of experience or a PhD in Biostatistics/ Statistics with at least 5 years of experience in the pharmaceutical, CRO or biotech industry.
    • Strong SAS programming skills. – at least 3-5 years.
    • Oncology experience is highly preferred.
    • Good technical writing skills.
    • Good communication skills (verbal and written).
    • Strong teamwork ability/commitment and individual initiative.
    • Strong organizational skills with ability to effectively manage multiple projects.
    We need is an experienced statistician who can do SAS programming at the same time can clearly interpret statistical concept and results to non-statisticians and key medical opinion leaders
    Source: Job Diva – Job Listing

  • USA-Compliance Specialist III (Manufacturing/Quality) (20-00334) – PA – Swiftwater 1 d ago

     Duties
    *Authoring and resolution of deviations in order to meet production and product release requirements.
    *Identification and facilitation of interdepartmental process improvements.
    *Utilize root cause analysis techniques during deviation investigational process
    *Work cross functionally, to develop and implement continuous process improvements
    *Support production needs and continuous improvement including change control, deviation writing / review, CAPA implementation, and operational optimization.
    *Collaboration with Technical Writers to write, review, revise and prepare manufacturing documents (BPR, SOP, SWI, etc) in accordance with cGMP and regulatory guidelines.
    *Communicate across multiple groups and levels to obtain consensus in order to facilitate deviation closure
    *Manage multiple priorities either independently or part of a team in order to meet key deadlines and communicate issues and progress across all levels of organization
    *Accurately communicate (both written and verbal) progress and updates across multiple levels of the organization and regulatory agencies.
    *Will be responsible for performing administrative tasks such as gathering and preparing documentation to support investigations and or change controls/capas

    Skills
    *Working knowledge of cGMP's is required.
    *Must have knowledge of continuous improvement techniques and problem solving skills.
    *Previous experience working within a production department of a pharmaceutical company.
    *Technical Writing experience preferred
    *Candidate must be able to work extended and flexible hours (including weekends) when needed.

    Bachelor degree and minimum of 3-5 years' experience.

    Source: Job Diva – Job Listing

  • Researcher (20-00331) – MA – Cambridge 1 d ago

    Seeking a Biology Researcher with 5 years of drug discovery experience and at least a Bachelor’s degree

    Qualification and Experience:
    BS/MS in biology or related field with 5 plus years of drug discovery experience in Biotech or Pharma setting. Experience in working with anti-sense oligonucleotide/small molecule field is preferred.
    • Work in aseptic conditions and maintain cultures of various cell types related to CNS projects
    • Experience with human primary / iPSC neuronal cell cultures
    • Screening of ASO-based drug candidates in high-throughput cell-based assays
    • Experience in antisense-based target validation is a plus
    • Hands-on experience with various molecular/cell biology techniques are required; including nucleic acid isolation, qPCR methods, ELISA, IHC/ Western blot
    • Experience with tissue homogenization and RNA isolation is a plus
    • Ability to work in a cross functional environment
    Source: Job Diva – Job Listing