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Career postings for the Massachusetts Biotechnology Council

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    Research Associate/Senior Research Associate Immunology

    SQZ Biotechnologies is a company spun out of MIT based on work done in the labs of Professors Klavs Jensen and Robert Langer. Our technology platform (“CellSqueeze”) enables the delivery of all types of biomolecules directly to the cell cytoplasm and has demonstrated much potential in clinical and research applications. The pioneering work of our founders has been highlighted in numerous publications, including PNAS, Nature, and Nature Methods. Scientific American also recognized our technology as one of the “Top 10 World Changing Ideas of 2014”.

    We are seeking to expand our team by recruiting a Research Associate/Senior Research Associate. The successful candidate will be working on the immunology team on high-impact projects focused on the development of novel immune-therapeutics. The successful candidate will contribute to the Immunology group utilizing cellular assays, immune cell phenotyping and in vivo pharmacology models. You will be involved in the design of and perform experiments for internally and externally-focused research programs.

    The candidate will effectively and routinely collaborate with colleagues on different projects.

    Primary responsibilities:

    • Expansion and maintenance of dendritic cell, B cell and T cell cultures
    • Characterize immune cells using standard immunological assays that include ELISA and flow cytometry
    • Maintain a lab notebook and contribute to supportive documentation when necessary
    • Contribute to experimental design and project direction
    • Provide critical lab support while working in a collaborative team environment

    Required Skills:

    • Expertise in immune cell culture
    • Experience with standard immunological assays
    • Excellent computer skills including experience with Microsoft Excel and Graphpad Prism
    • Experience acquiring and analyzing flow cytometry data
    • Experience with cell sorting
    • Proven ability to effectively plan and organize work activities to meet schedules and deadlines
    • Effectively work independently
    • Understanding of safe lab practices and BSL requirements
    • Excellent organizational skills and “do-what-it-takes” attitude
    • Capable of critical thinking and problem solving
    • Excellent oral and written communication skills

    Candidate must:

    • Work independently and manage multiple projects simultaneously
    • Demonstrate the ability to design experiments assessing complex biological systems
    • Demonstrate the ability to critically analyze and present data
    • Keep up-to-date with the literature related to his/her field
    • Demonstrate clear and professional verbal and written communication skills

    The minimum requirements for interested candidates are a BS/MS degree with 2-7 years of relevant work experience. Potential applicants should send their resume to tanesha.bland@sqzbiotech.com 


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    SQZ Biotechnologies is a company spun out of MIT based on work done in the labs of Professors Klavs Jensen and Robert Langer. Our technology platform (“CellSqueeze”) enables the delivery of all types of biomolecules directly to the cell cytoplasm and has demonstrated much potential in clinical and research applications. The pioneering work of our founders has been highlighted in numerous publications, including PNAS, Nature, and Nature Methods. Scientific American also recognized our technology as one of the “Top 10 World Changing Ideas of 2014”.

    We are seeking to expand our team by recruiting a Scientist/Senior Scientist. The successful candidate will be working on the immunology team to drive high-impact projects focused on the development of novel immune-therapeutics. You will be responsible for designing, producing and testing engineered immune cell function using both in vitro and in vivo models. You will design and perform experiments for internally and externally-focused research programs. The candidate will effectively and routinely collaborate with colleagues on different projects as well as present scientific results to multidisciplinary teams and the leadership team at SQZ Biotechnologies. The Scientist/Senior Scientist will contribute to the external scientific visibility of the company through publications and presentations at key scientific meetings and serve as a subject matter expert in immunology.

    Primary responsibilities:

    • Design, characterize and test novel cell based immunotherapies that are created with the CellSqueeze
    • platform
    • Design and establish analytical methods for the characterization of engineered immune cells
    • Design in vitro and in vivo experimental studies of complex biological systems including data analysis
    • Manage and support external R&D collaborations as a technical expert
    • Drafting of manuscripts for publication in peer-reviewed journals

    Required Skills:

    • Expertise in Dendritic cell, B cell and T cell isolation and culture and flow cytometric methods
    • Experience with molecular biology techniques including RNA, DNA and protein analysis is a plus
    • Experience with culture of tumor-infiltrating lymphocytes, TCR sequencing, and processing and characterizing of human tumors is a plus

    Candidate must:

    • Work independently and manage multiple projects simultaneously
    • Set project strategy
    • Demonstrate the ability to critically analyze and present data
    • Keep up-to-date with the literature related to his/her field
    • Demonstrate clear and professional verbal and written communication skills
    • Have strong work ethic and a team orientation
    • Attention to detail and a passion for winning

    The minimum requirements for interested candidates are a PhD in Immunology, Biochemistry, Molecular

    Biology, or related fields with 2-7years of industrial experience. Potential applicants should send their resume to tanesha.bland@sqzbiotech.com 


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    Are you looking for a fast-paced, interesting, and challenging job? If so keep reading! Our client is a biopharmaceutical company with a strong history of successful drug discovery and commercialization. They are looking for a detail-oriented, experienced, and responsible individual to join their Statistical Programming team.

    You will have the opportunity to develop, manage, and maintain analysis data; collaborate with internal cross-functional partners to ensure thorough representation and alignment of cross-functional programming, data, and reporting needs and objectives; and provide expert support and direction regarding statistical programming design.

    Requirements

    • B.S. with at least 10 years of relevant industry experience or CRO or M.S. With at least 8 years of relevant industry experience or CRO
    • Knowledge of statistical concepts, FDA/ICH guidelines, the software development lifecycle and 21 CRF Part 11 and other FDA regulations.
    • Proven SAS statistical programming experience in a pharmaceutical or CRO setting
    • Experience with pharmaceutical industry data standards, such as CDISC/SDTM and ADaM data models
    • Solid understanding of data collection and database concepts including data collection processes in clinical trials

    If this sounds like you, apply today!

    About StratAcuity
    Whether you are seeking a career change or simply interested to become part of our network, you will appreciate the ethics guiding each StratAcuity team member. We build lasting relationships with exceptional scientists and take great care to protect your personal information. Upon receiving your inquiry, you may be directly contacted by a StratAcuity team member to discuss your career goals. We will not share your information with anyone without your direct prior consent.

    CHEMISTRY IS EVERYTHING™

     


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  • 12/02/15--23:04: Senior Manager, Validation
  • Lonza Portsmouth, has significant expertise in the field of mammalian cell culture and cGMP custom manufacturing and is active in the large-scale production of biopharmaceuticals. Concretely, Portsmouth is a custom manufacturer of therapeutic monoclonal antibodies and recombinant proteins using mammalian cell culture for mammalian biopharmaceutical. The facility has been in cGMP manufacture since 1996 and is dedicated to meeting the needs of our customers. The setup and performance of projects teams with experts from Lonza and our customers working together is unmatched in the industry.  We currently have a position open in our Validation Department.

    • Responsible for executing and enhancing equipment and utility qualification/validation, cleaning validation, and computer system validation (except for QC laboratory equipment) programs at a large scale, multi-product, GMP biotech contract manufacturing facility.
    • Ensures that systems and controls for the above activities meet Global Quality standards and applicable regulatory requirements.
    • Managing and planning the work of the entire department.  Assessing workload and managing resource deployment to achieve validation goals.  Responsible for managing and tracking execution of validation activities versus project timelines.
    • Develop validation master plans, validation protocols, and project plans.  Review completed protocols/reports for completeness, cGMP compliance and acceptability of data.
    • Liaise with clients to ensure that scope, execution and reporting of validation meets their expectations.
    • Participate as required in Regulatory Inspections and client audits.
    • Selects, trains, and supervises staff to perform functions consistent with procedural and business requirements.  Develops, mentors, and coaches direct reports.
    • Determines and manages resource requirements to support operations in areas of responsibility.  Develops annual budget for group and manages expenses to budget.

    BS Science or Engineering related field

    Validation in a cGMP environment (obligatory) 10 years

    Management of validation teams (obligatory) 5 years

    Wide range of equipment qualification/validation, especially biotechnology (obligatory) 5 years

    Cleaning validation (obligatory) 5 years

    Sanitization Sterilization experience (obligatory) 5 years

    Process Validation (advantageous)

    Computerized Systems Validation/Part 11 Compliance (obligatory) 1 year

    Large scale pharmaceutical/biotech facility commissioning/validation (advantageous)

     

    KNOWLEDGE: 
    • Thorough understanding of cGMPs and life cycle approach to qualification/validation.  Understanding and experience with facility design, startup, commissioning and qualification/validation.  Experience in the practical and theoretical requirements of validation projects, including facilities, process equipment, utilities, equipment cleaning and computerized systems. 

    SKILLS: 

    • Demonstrated strong ability in problem solving, strong understanding of cGMPs, excellent interpersonal skills and the ability to prioritize multiple tasks. Must be able to act decisively.
    • Uses a team-oriented approach to project management and problem resolution.
    • Excellent understanding of validation/qualification principles, industry practices, and standards with demonstrated ability to apply these to GMP operations.
    • Ability to work both independently and collaboratively in a team structure.  Holds self and others accountable ion achieving collective goals.
    • Excellent verbal and written communication skills, including the ability to influence others and lead complex projects.  Successful interactions with regulatory agency staff and customers desirable.
    • Working knowledge of manufacturing processes, validation, and change control concepts for pharmaceutical manufacturing.
    • Strong attention to detail with strong documentation and coordination practices.
    • Demonstrated ability to multi-task and manage competing priorities.
    • Demonstrated ability to lead GMP operations, make sound decisions regarding evaluation of GMP compliance, and leadership abilities in the management of QA oversight.
    • Demonstrated strength as a manager including mentoring and coaching of staff, establishing priorities, and delivering on projects within budget and on time.
    An Equal Opportunity Employer      M/F/Disability/Veterans  http://lonzavirtualtours.com/

                                                                                                                              


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    Lonza Portsmouth, has significant expertise in the field of mammalian cell culture and cGMP custom manufacturing and is active in the large-scale production of biopharmaceuticals. Concretely, Portsmouth is a custom manufacturer of therapeutic monoclonal antibodies and recombinant proteins using mammalian cell culture for mammalian biopharmaceutical. The facility has been in cGMP manufacture since 1996 and is dedicated to meeting the needs of our customers. The setup and performance of projects teams with experts from Lonza and our customers working together is unmatched in the industry.  We currently have a position open in our QC Department.

     

    QC Analyst, Level 2-Electrophoresis-Portsmouth, NH

     

    Job Responsibilities: 

    Duties and Responsibilities include but are not limited to:

    • Analysis of in-process and final bulk product samples according to Standard Operating Procedures and Test Methods
    • Documentation of results in accordance with current Good Manufacturing Practices (cGMP)
    • General lab support including housekeeping, equipment maintenance, inventory of supplies, etc.
    • Problem solving of analytical methods as well as troubleshooting of equipment
    • Experience with Electrophoresis methods including but not limited to: SDS-PAGE, qPCR, IEF, iCE, Appearance and UVIS.
     

    Level II will accomplish the following with minimal supervision:

    • Performs routine and product release testing
    • Author or update existing SOPs and TMs as needed
    • Troubleshoot equipment/methods
    • Train other analysts on methods
    • Prioritize workload
    • Review routine data with supervisory audit

    Qualifications:

    • BS/BA or MS in related Science field 
    • 2-5 Years of lab experience in biotech or medically related field
    • Experience with the following methods is preferred: SDS-PAGE, IEF, UVIS, pH, Conductivity, QPCR.
    • Candidate must have excellent written and verbal communcation skills.
    • Good work ethic and attention to detail. 
    • Efficient time management and ability to prioritize work load.
     An Equal Opportunity Employer

          M/F/Disability/Veterans

     

    Please take virtual tour of the Portsmouth, NH site. Click here http://lonzavirtualtours.com/

       

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    Lonza Portsmouth, has significant expertise in the field of mammalian cell culture and cGMP custom manufacturing and is active in the large-scale production of biopharmaceuticals. Concretely, Portsmouth is a custom manufacturer of therapeutic monoclonal antibodies and recombinant proteins using mammalian cell culture for mammalian biopharmaceutical. The facility has been in cGMP manufacture since 1996 and is dedicated to meeting the needs of our customers. The setup and performance of projects teams with experts from Lonza and our customers working together is unmatched in the industry.  We currently have a position open in our QC Department.

     

    QC Raw Materials Specialist-Portsmouth, NH

     

    Job Responsibilities:
    • Creation, revision and review of GMP documentation as it applies to raw materials, including Specifications, Test Methods, SOPs.
    • Ensure vendor and QC requirements listed in the raw material specifications comply with process requirements; customer expectations; compendia monographs (e.g., USP, EP, JP), if applicable; and any regulatory expectations for each material.
    • Responsible for evaluating new vendors and materials as part of second sourcing initiative.  This may include review of vendor specifications, review of development and laboratory testing data, and/or vendor audits.
    • Communication with vendors to obtain certificates of analysis, specifications, certificate of analysis and technical data relating to material manufacture and/or testing.
    • Monitor vendor certificates and compendia changes. Initiate necessary process and/or document change controls.
    • Representing QCRM in customer project team meetings when necessary and communicate information, requests and requirements to management.  
    • Maintain QC related modules in SAP.
    • Based on Manufacturing schedules, coordinate efforts between Materials Management, Procurement and Raw Materials assuring that Materials are prioritized and released on time.
    • Ensure raw material data packets storage is maintained.  Filed and archived information can be readily retrieved.
    • Ensure inventory of raw material retains is accurate and maintained.
    • Shipment of samples to contract lab.

     

    Qualifications: 
    • Ability to handle multiple tasks while working within schedule timelines. 
    • Must be a mature, self-motivated team player with good organization, time management, and people skills. 
    • Familiarity with monograph/wet chemistry testing, TLC, FTIR, Karl Fischer, HPLC, GC, Atomic Absorption. 
    • Ability to work in Microsoft Word, Excel and PowerPoint required. 
    • Experience with LIMS and SAP preferred. 
    • In-depth knowledge of cGMP regulations. 
    • 3-5 years of Quality Control related raw material experience in the biotechnology or pharmaceutical field is preferred
    An Equal Opportunity Employer

          M/F/Disability/Veterans

     

    Please take virtual tour of the Portsmouth, NH site. Click here http://lonzavirtualtours.com/

     

     


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    Lonza Portsmouth, has significant expertise in the field of mammalian cell culture and cGMP custom manufacturing and is active in the large-scale production of biopharmaceuticals. Concretely, Portsmouth is a custom manufacturer of therapeutic monoclonal antibodies and recombinant proteins using mammalian cell culture for mammalian biopharmaceutical. The facility has been in cGMP manufacture since 1996 and is dedicated to meeting the needs of our customers. The setup and performance of projects teams with experts from Lonza and our customers working together is unmatched in the industry.  We currently have a position open in our Deviation Department.

     

    Temporary Deviation Investigator-Portsmouth, NH

     

    Independently responsible for the efficient and thorough investigation of process deviations (that occur in manufacturing; cell culture and purification, engineering, controls, metrology, and QC), determination of root cause, and initiation of corrective/preventative actions designed to adequately address and correct the Quality related deficiencies identified during the investigation process. Responsible to provide proactive corrections based on noted trends to minimize the potential for repeat incidents. The position requires working with minimal supervision to manage assigned investigations from initiation to completion.

       Responsibilities:

    • As part of each investigation, gathers information from all necessary internal and external sources in order to evaluate the impact of the deviation on manufactured product, as well as the risk to future operations.
    • Prepares and analyzes manufacturing and laboratory analytical historical data, and uses methodical root-cause analysis tools to determine root causes and effectively documents the root cause.
    • Properly assess the manufacturing or analytical environment and independently conceives and documents appropriate corrective/preventative actions designed to mitigate Quality deficiencies identified in the investigative process using analytical tools.
    • The individual in the position provides technical expertise to the site on thorough and complete deviation investigations.
    • Works independently to comply with procedure driven guidelines relating to Deviation investigations. 
    • Demonstrates strong technical skills; and solves complex problems.
    • Ensures that deadlines are maintained and monitors the need for extensions in order to maintain compliance in this area.

     

    Qualifications:

    • BA/BS Degree in science field, e.g., Biology, Microbiology, Chemistry, Pharmacy, etc. or equivalent combination of education and experience 3-5 years of pharmaceutical or related work experience with emphasis on current Good Manufacturing Practices including: QA, QC, Validation, Manufacturing, or process engineering.
    • Good deductive and inductive critical thinking skills required.
    • Advanced writing skills required.
    • Candidate must possess strong interpersonal, written, and verbal communication skills.
    • Incumbent must be able to interface positively with Regulatory Agencies, customers, and company departments.
    • Able to lead cross functional teams and ensure alignment and agreement on documented findings.
    • Strong time management skills and an ability to multitask in a face paced environment. 
    • Good knowledge of MS Office programs, including Word and Excel, and TrackWise

    Skills

      Demonstrated ability to deliver results  in project mgmt role in cross functional team environment Demonstrated ability in facilitating group discussions to finalize path forward Responsibilities Present investigation outline to customers and facilitate deviation approval process   An Equal Opportunity Employer

          M/F/Disability/Veterans

     

    Please take virtual tour of the Portsmouth, NH site. Click here http://lonzavirtualtours.com/ 


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    Lonza Portsmouth, has significant expertise in the field of mammalian cell culture and cGMP custom manufacturing and is active in the large-scale production of biopharmaceuticals. Concretely, Portsmouth is a custom manufacturer of therapeutic monoclonal antibodies and recombinant proteins using mammalian cell culture for mammalian biopharmaceutical. The facility has been in cGMP manufacture since 1996 and is dedicated to meeting the needs of our customers. The setup and performance of projects teams with experts from Lonza and our customers working together is unmatched in the industry.  We currently have a position open in our Capital Projects Department.

     

    Senior Project Engineer - Capital Projects (Automation) (SF)-Portsmouth, NH

     

    Job Responsibilities: 

    Lonza is recruiting for a Senior Project Engineer-Automation supporting the Portsmouth, NH facility. This position will focus on automation and instrumentation. They will be responsible for overall project management and coordination of the process automation effort associated with large capital projects.  Emphasis is on management of scope, schedule, cost, and deliverables associated with the project. 

    Candidate to have demonstrated experience with design and operation of:

    • cGMP Process Control Systems including Emerson DeltaV DCS, PI, and Allen-Bradley SLC/PLC systems
    • cGMP Building Automation System (BAS)associated instrumentation design and application
    • Candidate must be fully committed to Lonza’s adherence to Safety Regulations and Guidelines
    • Design and construction in accordance with Local, State and Federal laws and practice. All construction to meet Lonza and local standards (whichever is higher).
    • Responsible for providing technical leadership and direct support in the execution and delivery of large Capital projects within Lonza.
    • Assure adherence to schedule and budgets.  Properly maintain record keeping of all budgetary project expenses.
    • Engineering design of new facility (Basis of Design, Conceptual, and Detailed Design)
    • Leadership and coordination of cross functional teams consisting of Internal Lonza customers such as Manufacturing, MSAT, and Quality Assurance to properly identify design needs
    • Direct and manage activities of technical staff on URS/FRS generation, software configuration and coding, DCS hardware specification as well as specification and selection of instrumentation.
    • Control panel design
    • Preparation of QA related documentation such as cGMP Process Change Controls
    • Responsible to assure adherence to cGMP requirements throughout all phases of Capital Project execution
    • Responsible for all controlled engineering documentation throughout the project lifecycle
    • Provide technical input in support of equipment procurement
    • Bid package preparation, bid evaluation, vendor selection
    • Construction, commissioning, startup activities
    • Supervision and management of external engineering contractors and software/hardware vendors
    • Coordinate and manage project activities to meet scope, schedule, budget, safety, and quality requirements
    • General management and oversight to the software documentation effort
    •  Assist with development of project schedule and then assuring software development, hardware purchase and install, and validation efforts adhere to plan
    • Liaise where necessary with DCS platform provider, engineering contractor, and equipment vendors on the lifecycle of document preparation, approval, coding, and delivery
    • Participate in FATs and SATs to provide automation support
    • Review control panel layouts and designs including power distribution, grounding requirements and I/O assignments
    • Ensuring consistency and software revision control
    • Candidate must have strong troubleshooting skills in support of startup activities
    •  Responsible for assuring Engineering Turnover Packages are accurate, complete, and adhere to Quality Assurance requirements
    • Validation execution and management
    • Protocol management and execution of validation activities
    • Provide routine project management updates in accordance with Lonza procedures
    • Project Close-out activities involving completion of technical close-out reports and summary of assets in accordance with Lonza financial recognition requirements

    Qualifications:

    • Candidate should have BS EE, ChemE, MechE or BioE

     

    • 10 years of experience in the design and operation of  Biopharmaceutical facilities, both manufacturing and support systems (cGMP manufacturing, pilot plant & laboratories).

     

    • 4 years of experience with control systems (PLC, DCS, Loop controllers) desirable.

     

    • 6 years of experience in project management and coordination associated with the execution of capital projects in an industrial environment

     

    • 6 years of practical experience in the management and coordination of engineering & construction management consultants, equipment vendors and contractors.

     

    • Candidate must have capacity to deliver strong and effective project engineering skills on capital projects greater than $5 Million or on a case by case basis as agreed with various Lonza sites.

     

    • Candidate will have a strong understanding of the latest ASME Bioprocess Equipment standard including sanitary design of equipment/piping systems and design for Cleaning in place (CIP) and Sterilization in place (SIP) design and operation.

     

    • Candidate must have strong communication and project management skills to coordinate and manage the activities of internal Lonza staff, consultants, vendors and contractors to meet scope, schedule, budget, safety and quality requirements of assigned Capital projects.

     

    • Team oriented individual who functions well in a Team environment and fully supports the objectives of the Project Team.

     

    • Ability to quickly adjust to a dynamic and fast paced environment

     

    • This position does not require day to day supervision.  Expected to work independently to achieve specified goals. Understands business impact of decisions and applies risk assessment skills.

     

    Excellent Communication Skills

    Ability to effectively communicate via writing and oral communication at all levels. Express ideas effectively in individual and group situations (including non-verbal communication). Ability to communicate to internal and external personnel and to communicate technical information to both technical and non-technical people. Ability and willingness to express opinions and argue their basis

    Project Management Skills

    Ability to handle multiple projects (5-10) simultaneously, keeping track of costs and schedule and ensuring compliance with quality and safety standards. Use organizational skills to prioritize and resolve project issues.

    Technical Knowledge

    A solid understanding of design principles and standards within Biopharmaceutical facilities. Ability to look at plant problems and come up with options for solutions. Ability to understand and challenge design and execution concepts from outside vendors/engineers.

    Judging/Problem Solving

    Ability to develop alternative courses of action that are based on logical assumptions, factual data and sound engineering principles. The alternate actions take into consideration resources (financial and manpower), constraints and organizational priorities. Provides solutions to a wide range of difficult problems; solutions are imaginative, thorough and practicable. Gain approval for recommended solution and implement through proper channels.

    Quality/Attention to Details

    Ability to accomplish tasks through concern for all areas involved. Demonstrating the proper level of detail for all aspects of the job; accurately checking processes, data and tasks; and maintaining watchfulness over a period of time.

    Teamwork/Collaboration

    Ability to work effectively with internal and external teams or those outside formal line of authority (e.g. peers, Senior Managers, Directors) to accomplish project goals. Take actions that respects the needs and contributions of others; contributing to and accepting the consensus; subordinating own objectives to the objectives of the project team. Represents the organization in providing solutions to difficult technical problems; frequent inter-organizational, customer and outside contacts.

    Planning/Work Management

    Ability to establish a project execution plan that outlines the course of action for self and/or others to accomplish a specific goal.  Monitor the activities of consultants, vendors and contractors to insure that resources are allocated properly in order to achieve project goals. An understanding of how to work through company systems to establish goals.

    Initiative

    Ability to make active attempts to influence events to meet the goals of the project or organization. Given very general direction; independently determines and develops an approach to problem solving or project execution. Reviews work in terms of meeting project and organizational objectives. 

    Travel Requirements

    Travel to vendors during construction and similar within the USA and International. Occasional travel outside the US approximately 2x per year for Global Engineering Team meetings.

    Working Conditions

    Office environment and construction site
     

     An Equal Opportunity Employer

          M/F/Disability/Veterans

     

    Please take virtual tour of the Portsmouth, NH site. Click here http://lonzavirtualtours.com/

     

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    We seek an experienced Associate Director/Director, Regulatory Affairs who will be responsible for developing regulatory strategies for our innovative gene therapy oncology programs.  This position will be responsible for the preparation, submission and approval of INDs and CTAs, pediatric investigation plans, orphan drug designations, and managing corresponding interactions with regulatory authorities.Join bluebird bio’s enthusiastic and collaborative team by contributing to the overall success of our novel gene therapy approach.

    About the role:

    • Proactively participate in design of regulatory strategies for the development of gene therapy products for oncology in the US and the EU. 
    • Manage preparation and submission of high-quality regulatory dossiers in the US and the EU according to set timelines; this will require cross-functional interactions, excellent project management and writing skills, as well as a good understanding of the underlying science.
    • Manage transparent and proactive regulatory agencies interactions for oncology projects
    • Collaborate with regulatory-CMC function to ensure seamless integration of CMC components to all submissions
    • Drive adherence to regulatory guidelines for development of gene therapy products.
    • Participate in regulatory intelligence activities; monitor regulatory guidelines and trends.

    About you:

    • BA/BS degree in life sciences, MS/PhD preferred
    • At least 5-10 years of pharmaceutical product development, preferably oncology biologics
    • Well-versed in regulatory strategy, and regulatory science writing
    • Experience as primary regulatory author for IND and CTA documents
    • Knowledgeable in ICH, FDA and EMA guidelines
    • Understanding of advanced therapy products development
    • Ability to work independently and thrive in a fast-paced environment.
    • Excellent people leadership skills
    • Excellent communication skills and ability to influence across multiple functions
    • Experience in the development of biomarker in oncology and immuno-oncology, and translation of these biomarkers into use in clinical trials, including development of laboratory developed tests (LDTs) and in vitro diagnostics (IVDs)
    • Experience in the field of gene or cell therapy and orphan diseases
    • BLA/MAA experience

     

     

    • Ability to execute and follow-through to completion and documentation.
    • Ability to work effectively in a collaborative team environment where results are achieved through influence and the incorporation of multiple points of view.
    • Independently motivated, detail oriented and good problem solving ability.
    • Excellent communication skills and ability to influence across multiple functions.
    • Be ready to embrace the principles of the bluebird bio culture:  b colorful, b cooperative, and b yourself

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    Lonza Portsmouth, has significant expertise in the field of mammalian cell culture and cGMP custom manufacturing and is active in the large-scale production of biopharmaceuticals. Portsmouth is a custom manufacturer of therapeutic monoclonal antibodies and recombinant proteins using mammalian cell culture for mammalian biopharmaceutical. The facility has been in cGMP manufacture since 1996 and is dedicated to meeting the needs of our customers. The setup and performance of projects teams with experts from Lonza and our customers working together is unmatched in the industry.  We currently have a position open on our QA team.

     

    QA Manager-Portsmouth, NH Responsibilities: 

    The QA Manager position is part of the Quality organization at Lonza Portsmouth, and report directly to the QA Associate Director. Variable work schedule may be required to maintain project timelines and support continued manufacturing operations. The ideal candidate will be expected to independently make decisions for QA, and demonstrate the ability to defend those decisions within Lonza and externally through customer meetings or audits / inspections.  Strong decision making skills are required for this position. 

     

    The QA Manager position will supervise a team of individuals that are committed to providing real-time guidance to manufacturing operations, and a team of specialists that perform the technical QA review on deviations. 

     

    The ideal candidate for the QA Manager position will demonstrate initiative, dependability, and a team-oriented attitude.  A QA Manager candidate should demonstrate solid supervisory skills, including development of staff and ability to effectively prioritize workload.  This position may require supervision of up to six direct reports. 

            Qualifications:

    • The Quality Assurance (QA) Manager position requires approximately eight or more years of industry experience. 
    • A four-year college degree is required, preferably in a science or technical discipline. 
    • Strong technical expertise when reviewing and approving deviations, investigations, CA/PA, and effectiveness checks. 
    • Ability for independently determining approaches to aid in manufacturing and QC deviation investigations, and effectively communicates the requirements to the respective individuals.
    • Proven leadership qualities, including team building skills, to facilitate scheduling of tasks for direct reports (if applicable). 
    • Ability to relay technical information to customers and regulatory bodies during Audits or Inspections. 
    • Capacity for leading effective meetings, and making independent decisions.
    • Provides a consistent quality voice for the organization, able to clearly communicate needs or expectations.
    • Motivated to implement improvements to existing policies and procedures.   
    • Experience resolving deviations and performing root cause analysis.

     

    A desirable candidate will begin to develop the following skill sets within the six months of employment:

     

    • Demonstrated ability to supervise QA specialists.  Provide training when necessary, review the work as needed, schedule tasks and determine deadlines.  Yearly goals and career objectives should be determined, and evaluated for progress each month. 
    • Aptitude for participating in large investigations, and providing QA guidance with clear expectations.   
    • Successful implementation of Operational Excellence projects that result in significant cost savings or time savings. 
    • Strong technical writing skills. 
    • Ability to prioritize workload of others, and effectively schedule tasks that are aligned with the deadlines.
    • Represent technical QA in customer audits and regulatory inspections.
    • Demonstrate ability to prioritize tasks as needed to support the changing business demands.

     

    An Equal Opportunity Employer

          M/F/Disability/Veterans 

    Please take virtual tour of the Portsmouth, NH site. Click here http://lonzavirtualtours.com/

     


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    Lonza Portsmouth, has significant expertise in the field of mammalian cell culture and cGMP custom manufacturing and is active in the large-scale production of biopharmaceuticals. Concretely, Portsmouth is a custom manufacturer of therapeutic monoclonal antibodies and recombinant proteins using mammalian cell culture for mammalian biopharmaceutical. The facility has been in cGMP manufacture since 1996 and is dedicated to meeting the needs of our customers. The setup and performance of projects teams with experts from Lonza and our customers working together is unmatched in the industry.  We currently have a position open in our Capital Projects Department.

     

    Project Engineer - Upstream (SF)-Portsmouth, NH

     

    Job Responsibilities:
    • Support Lonza Project Team/Lead Project Engineer for upstream processing design, construction, installation and commissioning.
    • Focus is on Upstream Processing Unit Operations.  Candidate must have demonstrated experience in including Media Preparation, Fermentation and Primary Recovery operations.
    • Candidate must be fully committed to Lonza’s adherence to Safety Regulations and Guidelines
    • Must support the Senior Project Engineering in design and construction in accordance with Local, State and Federal laws and practice. All construction to meet Lonza and local standards (whichever is higher).
    • Responsible for providing technical support in the execution and delivery of large Capital projects within Lonza as directed by Senior Project Engineer.  
    • Support adherence to schedule and budgets
    • Engineering design of new facility (Basis of Design, Conceptual, and Detailed Design)
    • Facilitating cross functional teams consisting of Internal Lonza customers such as Manufacturing, MSAT, and Quality Assurance to properly identify design needs
    • Preparation of QA related documentation such as cGMP Process Change Controls
    • Responsible to assure adherence to cGMP requirements throughout all phases of Capital Project execution
    • Provide technical input in support of equipment procurement
    • Bid package preparation, bid evaluation, vendor selection
    • Construction, commissioning, startup activities
    • Including supervision and management of external engineering contractors and equipment vendors
    • Candidate must have strong troubleshooting skills in support of startup activities
    • Responsible for assuring Engineering Turnover Packages are accurate, complete, and adhere to Quality Assurance requirements
    • Validation execution and management
    • Protocol management and execution of validation activities as directed by Senior Project Engineer
    • Provide routine project management updates in accordance with Lonza procedures
    • Project Close-out activities involving completion of technical close-out reports and summary of assets in accordance with Lonza financial recognition requirements
    • Candidate must have capacity to work in a technical contributor capacity and provide effective project engineering skills with appropriate direction on capital projects greater than $5 Million or on a case by case basis as agreed with various Lonza sites.
    • Candidate will have a solid understanding of the fundamentals of Cell Culture Operations including, large scale fermentation operation, Centrifugation, and depth filtration. Experience with single use bioreactors preferred but not mandatory. 
    • Candidate will have a solid understanding of the latest ASME Bioprocess Equipment standard including sanitary design of equipment/piping systems and design for Cleaning in place (CIP) and Sterilization in place (SIP) design and operation.
    • Candidate should have experience with design and operation of large scale distributed control systems, preferably the Emerson DeltaV platform.
    • Candidate must have strong communication and project management skills to support coordination of internal Lonza staff,consultants, vendors and contractors to meet scope, schedule, budget, safety and quality requirements of assigned Capital projects.
    • Team oriented individual who functions well in a Team environment and fully supports the objectives of the Project Team.
    • Ability to quickly adjust to a dynamic and fast paced environment
    • This position does not require day to day supervision. Expected to work independently to achieve specified goals. Understands business impact of decisions and applies risk assessment skills.
    Qualifications:
    • BS ChemE or BioE preferred 
    • 4+ Years of experience in the design and operation of Biopharmaceutical facilities, both manufacturing and support systems (manufacturing, pilot plant & laboratories).
    • 2+ Years of design experience control systems (PLC, DCS, Loop controllers)desirable.
    • 2+ Years of experience with project management and coordination experience associated with the execution of capital projects in an industrial environment.
    • 2+ Years of practical experience in the management and coordination of engineering & construction management consultants, equipment vendors and contractors.
      Excellent Communication Skills

    Ability to effectively communicate via writing and oral communication at all levels. Express ideas effectively in individual and group situations (including non verbal communication). Ability to communicate to internal and external personnel and to communicate technical information to both technical and non-technical people. Ability and willingness to express opinions and argue their basis.

      Project Management Skills

    Ability to handle multiple projects (5-10) simultaneously, keeping track of costs and schedule and ensuring compliance with quality and safety standards. Use organizational skills to prioritize and resolve project issues.

      Technical Knowledge

    A good understanding of design principles and standards within biopharm facilities. Ability to look at plant problems and come up with options for solutions. Ability to understand and challenge design and execution concepts from outside vendors/engineers.

      Judging/Problem Solving

    Ability to develop alternative courses of action that are based on logical assumptions, factual data and engineering principles. The alternate actions take into consideration resources (financial and manpower), constraints and organizational priorities. Provides solutions to a wide range of difficult problems; solutions are imaginative, thorough and practicable. Gain approval for recommended solution and implement through proper channels.

      Quality/Attention to Details

    Ability to accomplish tasks through concern for all areas involved. Demonstrating the proper level of detail for all aspects of the job; accurately checking processes, data and tasks; and maintaining watchfulness over a period of time.

      Teamwork/Collaboration

    Ability to work effectively with internal and external teams or those outside formal line of authority (e.g. peers, senior mangers) to accomplish project goals. Take actions that respect the needs and contributions of others; contributing to and accepting the consensus; subordinating own objectives to the objectives of the project team. Represents the organization in providing solutions to difficult technical problems; frequent inter-organizational and outside contacts.

      Planning/Work Management

    Ability to establish a project execution plan that outlines the course of action for self and/or others to accomplish a specific goal. Monitor the activities of consultants, vendors and contractors to insure that resources are allocated properly in order to achieve project goals. An understanding of how to work through company systems to establish goals.

      Initiative

    Ability to make active attempts to influence events to meet the goals of the project or organization. Given very general direction; independently determines and

    develops an approach to problem solving or project execution. Reviews work in terms of meeting project and organizational objectives.

     An Equal Opportunity Employer

          M/F/Disability/Veterans

     

    Please take virtual tour of the Portsmouth, NH site. Click here http://lonzavirtualtours.com/

     

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    Lonza Portsmouth, has significant expertise in the field of mammalian cell culture and cGMP custom manufacturing and is active in the large-scale production of biopharmaceuticals. Portsmouth is a custom manufacturer of therapeutic monoclonal antibodies and recombinant proteins using mammalian cell culture for mammalian biopharmaceutical. The facility has been in cGMP manufacture since 1996 and is dedicated to meeting the needs of our customers. The setup and performance of projects teams with experts from Lonza and our customers working together is unmatched in the industry.  We currently have a position open on our Engineering team.   Instrumentation and Controls Engineer-Portsmouth, NH Responsibilities:

    • Responsible for providing instrumentation and controls support for the design, construction, start-up, operation, and maintenance of, spares for, and possible upgrades to, Instrumentation and Process Automation Systems in a cGMP biotech large scale production facility.
    • Primary responsibility for accuracy of project, and in-future site, Panel Drawings, Instrument and I/O Lists.
    • Lead the consistent implementation of panel, conduit, power, grounding and instrumentation designs.
    • Ensure projects are executed with a practical minimum number of unique instrumentation/automation spares.
    • Ensure projects are executed with a practical minimum impact on Operations—preserving SOPs, Trainings, etc., already present where practical.
    • Participates in FATs, Commissioning and Validation efforts.  Multi-week travel may be required on limited cases to oversee instrumentation implementations on larger modules—i.e. large scale Bioreactors.
    • Assist Manufacturing Sciences and Technology (MSAT) and Operations in selection of instrumentation based on process and user requirements, and related interfacing to Process Controls System.
    • Review and approve vendor instrument submissions.
    • May assist in Process Controls support.
    • Create, review and/or approve change controls as necessary for instrumentation and controls related changes.
    • Must be able to support large engineering projects with little direction.  Interaction with outside consultants, contractors and support resources is required.
    • Must be able to document all work as required by cGMP and local/global procedures.   
    ALL LONZA BIOLOGICS EMPLOYEES HAVE THE FOLLOWING RESPONSIBILITIES: 
    • Quality should be the responsibility of allpersons involved in Manufacturing.  Adherence to cGMPs is required at all times during the manufacture of APIs.
    • All personnel are responsible fornotifying responsible management in a timely manner of regulatory inspections, serious GMP deficiencies, product defects and related actions (e.g. quality related complaints, recalls, regulatory actions, etc).
    • All personnel should practice good sanitation and health habits.
    • Personnel suffering from an infectious disease or having open lesions on the exposed surface of the body should not engage in activities that could result in compromising the quality of APIs.  

     

    Qualifications:
    • Experience in the design /operation of Biopharmaceutical facilities, both manufacturing and support systems (cGMP manufacturing, pilot plant & laboratories). 4 years
    • Experience with specifying instrumentation to meet user needs; 4 years
    • Experience with calibration and instrumentation repair; 6 years
    • Experience with control systems (PLC, DCS, Loop controllers) desirable; 3 years
    • Experience with Siemons COMOS, AutoCAD, Excel, SQL databases, Trackwise desirable; 3 years
    • Construction and coordination experience associated with theexecution of capital projects in an industrial environment
    • Practical experience in themanagement and coordination of engineering & construction management consultants, equipment vendors and contractors; 3 years
     An Equal Opportunity Employer      M/F/Disability/Veterans Please take virtual tour of the Portsmouth, NH site. Click here http://lonzavirtualtours.com/

    0 0

    Lonza Portsmouth, has significant expertise in the field of mammalian cell culture and cGMP custom manufacturing and is active in the large-scale production of biopharmaceuticals. Concretely, Portsmouth is a custom manufacturer of therapeutic monoclonal antibodies and recombinant proteins using mammalian cell culture for mammalian biopharmaceutical. The facility has been in cGMP manufacture since 1996 and is dedicated to meeting the needs of our customers. The setup and performance of projects teams with experts from Lonza and our customers working together is unmatched in the industry.  We currently have a position open in our QC Department.

     

    QC Scientist, Electrophoresis-Portsmouth, NH

     

    Job Responsibilities: 
    • Perform and oversee laboratory experiments to support laboratory investigations, studies, qualifications and validations related to the Electrophoresis team.
    • Technical lead for deviation investigation, out-of-specification or aberrant results and process changes.
    • Troubleshoot assay and instrumentation issues.  This will involve data mining, trending and analysis to identify problems or determine process control.  Determination and/or execution of corrective and preventative actions (CA/PA)
    • Technical expertise in: SDS-PAGE, IEF, isoelectric capillary electrophoresis (iCE), UVIS spectrophotometry.
    • Review and approval of GMP documentation including test methods, protocols, reports and raw data.
    • Provide hands-on and theoretical training as appropriate for QC and other operational groups.
    • Performance of QC testing to maintain skills, identify process/assay improvements and support QC deliverables.
    • Implementation of new laboratory technology (justification, procurement, setup, validation, training, documentation)
    • Proactively shares knowledge with others and encourages analyst development.
    • Self directed, resourceful and capable of effectively collaborating with others.  Identifies and resolves obstacles within projects, testing.
    • Manages laboratory projects and/or is technical lead on projects
    • Thorough understanding of cGMP regulations
    • Works on problems of diverse scope in which analysis or data requires evaluation of identifiable factors
    • Exercises judgment within generally defined practices and within defined procedures in obtaining solutions.
    • Demonstrated success in technical proficiency, scientific creativity, collaboration with others and independent thought.
    • Expert knowledge of scientific principles and concepts.
    • Reputation as emerging leader in field with sustained performance and accomplishment.
    • Normally receives no instructions on routine work and general instruction on new assignments.
    • Education: BS/BA, MS or PhD in related field.
    • 5+ Years of Relevant Laboratory experience in biotech or related field
    • 3+ Years of Experience of Working knowledge of cGMP
    • Working knowledge of Electrophoresis based and capillary methods.
    • Strong technical skills required.  Must be able to effectively communicate with customers, analysts, and management; organize projects; design experiments; write reports; analyze data and troubleshoot laboratory problems.

     

    An Equal Opportunity Employer

          M/F/Disability/Veterans

     

    Please take virtual tour of the Portsmouth, NH site. Click here http://lonzavirtualtours.com/


    0 0

    Lonza Portsmouth, has significant expertise in the field of mammalian cell culture and cGMP custom manufacturing and is active in the large-scale production of biopharmaceuticals. Concretely, Portsmouth is a custom manufacturer of therapeutic monoclonal antibodies and recombinant proteins using mammalian cell culture for mammalian biopharmaceutical. The facility has been in cGMP manufacture since 1996 and is dedicated to meeting the needs of our customers. The setup and performance of projects teams with experts from Lonza and our customers working together is unmatched in the industry.  We currently have a position open in our QC Department.

     

    QC Supervisor-Electrophoresis-Portsmouth, NH

     

    Job Responsibilities:
    • Supervision of techniques including but not limited to: SDS-PAGE, qPCR, IEF, iCE, Appearance and UVIS spectrophotometry
    • Schedules applicable testing and work activities and coordinates with internal and external customers as necessary.
    • Ensures that the testing is released in a timely manner by supervising the review of laboratory data and the closeout of quality records.
    • Oversees cGMP/technical training for staff. Ensures documentation for training files is up to date.
    • Understands regulatory requirements and Lonza policies pertaining to area of responsibility.
    • Perform annual reviews of direct reports.
    • Provides motivational and team oriented atmosphere
    • Supports QC projects and activities by authoring, reviewing, and approving records such as change controls, investigations, deviations, SOPs, and reports.
    • Supports customer and regulatory agency interaction as required
    • Works interdepartmentally to ensure that any issues are resolved and to provide communication on lab related activities
    • Communicate effectively with Manager and other members of QC Management.

    Qualifications:

     
    • BS/BA, MS or PhD in scientific field or related
    • 5+ Years experience in Supervisory role in biotech field
    • 2+ Years in cGMP practices
    • Excellent communication skills
    • Ability to prioritize tasks according to business needs
    • Ability to troubleshoot laboratory results and review data packets
    • Good technical writing skills
    An Equal Opportunity Employer

          M/F/Disability/Veterans

     

    Please take virtual tour of the Portsmouth, NH site. Click here http://lonzavirtualtours.com/


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    Lab Support, a scientific staffing firm, is currently recruiting for a Research Associate specializing in cell culture and animal handling/dosing. The company specializes in addressing unmet medical needs and focuses on oncology. The location is in the north shore area of Massachusetts.

    - Daily work involves regular passaging of cells, thawing and freezing cell lines, and processing samples.
    - Other responsibilities include preparation of cell culture media, sampling, cleaning, and autoclaving bioreactors, and maintaining laboratory equipment.
    - Cage washing and disinfection, along with monitoring animal health

    The candidate will work in a team environment, collaborating with process and analytical scientists to participate in the clone selection process, evaluate cellular responses to process operations, assess their effects on product quality, and determine process scalability.

    Basic Qualifications:
    Bachelor’s degree and 2 years of Bench experience, particularly in the area of mammalian cell culture.


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    Lab Support, a scientific staffing firm, is currently recruiting for a Research Associate specializing in cell culture, flow cytometry, and gel electrophoresis. The company specializes in addressing unmet medical needs and focuses on oncology. The location is in the north shore area of Massachusetts.

    - Daily work involves regular passaging of cells, thawing and freezing cell lines, and processing samples.
    - Other responsibilities include preparation of cell culture media, sampling, cleaning, and autoclaving bioreactors, and maintaining laboratory equipment.

    The candidate will work in a team environment, collaborating with process and analytical scientists to participate in the clone selection process, evaluate cellular responses to process operations, assess their effects on product quality, and determine process scalability.

    Basic Qualifications:
    Bachelor’s degree and 2 years of Bench experience, particularly in the area of mammalian cell culture.


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  • 12/03/15--01:46: Medical Director
  • Phase III trials looking for a leader in the Bay Area

    Our client, a clinical development focused biopharmaceutical company in the Bay area is looking for an experienced Medical Director to join their team. This is an extremely progressive & innovative company working on a very exciting science that will create an exponential increase in the quality of life for patients. For this high profile position, the selected individual will join a dynamic team in a cohesive, collaborative environment and have the opportunity to lead Phase III trials with their eyes on a quick path to NDA. This individual should be comfortable facilitating recruitment efforts for the clinical operations group, engaging & relationship building with foundations and partners, and making sure protocols are followed as written.

    REQUIREMENTS:

    • MD degree
    • Industry experience
    • Gastroenterology experience or Generalist
    • Willingness to collaborate and share innovative ideas throughout the company
    • Exhibit strong leadership qualities & handle day to day medical functions
    • Possess ability to build positive collaborative relationships and handle outreach to relevant foundations & partners

    About StratAcuity
    Whether you are seeking a career change or simply interested to become part of our network, you will appreciate the ethics guiding each StratAcuity team member. We build lasting relationships with exceptional scientists and take great care to protect your personal information. Upon receiving your inquiry, you may be directly contacted by a StratAcuity team member to discuss your career goals. We will not share your information with anyone without your direct prior consent.

    CHEMISTRY IS EVERYTHING™

     


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    Support the Global Business Development Oncology organization in the analysis and execution of business development opportunities including product licenses, research collaborations, acquisitions, asset divestitures and strategic investments.  This position is primarily responsible for independently leading the financial modeling and evaluation of transactions, with additional participation on deal teams through the transaction process, including negotiations support and due diligence.

    ACCOUNTABILITIES:

    • Provide support to the global business development group through the construction and analysis of valuation models and associated presentations.
      • Work with functional areas to test and refine their inputs to the valuation model, including both commercial and R&D assumptions.
      • Support transaction leaders in the development of deal terms & structures.
      • Work with internal and external accounting and tax advisors to understand implications of deal structures.
    • Lead the finance portion of the due diligence process by providing specialist knowledge on the finance side of the transaction, being the conduit to getting other areas of finance involved in diligence and involving external experts, where appropriate.
    • Prepare quick, “first-pass” analyses with respect to potential deals (M&A, licensing, etc.), as well as more complex, fully developed models.
    • Keep apprised of the oncology sector in general, with special attention to current business development trends and implied valuations.
    • Provide thought leadership in the ongoing review of current practices by identifying opportunities to improve the function and operation of the global business development group with respect to financial analysis, deal structuring and business case preparation/evaluation.
    • Keep current on developments in accounting policy and finance methods applicable to business development transactions.
    • Develop and maintain relationships across functional areas providing key valuation inputs.
    • Serve additional role(s) as needed on transaction teams, including negotiation support and overall project management.

    Education and Experience - Required:

    • Bachelor’s degree
    • 8 years of relevant business experience including demonstrated business investment analysis modeling skills (NPV, ROI, etc.)
    • 4 years of healthcare industry experience
    • Knowledge of applicable accounting standards (GAAP/IFRS) and familiarity with SEC filings (10-K, 10-Q, etc.).
    • Strong computer software skills (Microsoft Office Suite – Word, Excel, PowerPoint). 
    Education & Experience – Desired:
    • MBA or CPA.
    • Previous experience in investment banking/consulting (or similar experience where valuation-type services are provided).
    Skills:
    • Ability to work independently with limited oversight.
    • Ability to communicate ideas and data both verbally and written, in a persuasive, organized and appropriate manner, including preparing presentations.
    • Ability to analyze financial results and know how to use this information to drive projects that will impact the business.  Must be able to conduct market, industry, and company research with limited available information under time constraints.
    • Capability to set priorities and meet specific deadlines in an unpredictable environment, while maintaining flexibility to deal with change effectively.
    • Ability to gain trust of high-level management and the business development team and leverage relationships to provide best possible financial plans and drive impactful analytical projects.
    • Propensity to successfully work with others at all levels within a complex, team oriented, global organization, with the skills and acumen to assume roles of greater responsibility over time within the organization.
    • Ability and desire to take ownership over activities and projects, desire to shape the organization, consistent demonstration of “out of the box” thinking.
    PHYSICAL DEMANDS: The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job.  Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
    • Ability to drive to or fly to various meetings/client sites – limited overnight.
    • Manual dexterity required to operate office equipment (i.e. computers, phones, etc.).
    • Ability to sit for long periods of time.
    • Carrying, handling, and reaching for objects.

    TRAVEL REQUIREMENTS:

    • Periodic overnight travel may be required including some international.

     


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    Job Summary

    The Senior Director, Discovery Research will formulate the strategy to identify appropriate targets for Juno’s CAR and TCR platforms and develop technologies to asses activity and safety of JUNO immunotherapy products.  He/she will provide leadership to accelerate drug discovery and development, and will operate in a matrixed environment that spans across multiple functions, including Translational Medicine, Molecular Biology, Regulatory, and Research Informatics.  Responsibilities include: (1) formulating a strategy for identifying potential tumor targets of interest, (2) assessment of tumor targets from internal and external sources, (3) development of assays or models to assess structure/function relationships in the context of CAR and TCR molecular design, and (4) manage the development and performance of assigned personnel to ensure high productivity, growth and continuity of technical and managerial talent to achieve current and future goals.  Candidate will interface and partner with project teams, internal departments, collaborators, and scientific co-founders on topics related to tumor biology and our CAR and TCR platforms.  

    Qualifications and Education Requirements

    • PhD or MD with 10+ years of experience in drug discovery and pre-clinical/clinical development
    • Expertise leading multiple oncology focused research programs and proven track record of driving discovery of novel therapeutic targets 
    • 5+ years of building, leading, and directly managing a team of therapeutic discovery scientists
    • Deep expertise in T cell biology, protein and cell sciences, and oncology
    • Expertise in cancer immunotherapy
    • Experience leading teams in a fast-paced, high growth company
    •  Ability to work in a high paced team environment, meet deadlines, & prioritize work on multiple projects
    •  Strong verbal and written skills

    Preferred Skills

    •  Familiarity with current molecular and cellular immunology tools
    •  Experience designing and implementing pre-clinical activity assessments in murine tumor models
    •  Understanding of viral vector technology
    •  Prior experience contributing to FDA filings
    •  Expertise in structural biology
    • Expertise in T cell signal transduction



    Our headquarters, situated in the bustling South Lake Union district of Seattle, sits among some of the most visible organizations in the world. Seattle offers award-winning restaurants, a vibrant, hip music scene and spectacular views of water and mountains. Within an hour’s drive of Seattle, you can be fishing, skiing, hiking or tasting world-class Washington wines. 

    THINK BIG. BE BRAVE. DELIVER.


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