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Career postings for the Massachusetts Biotechnology Council

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    Manufacturing Science and Technology Specialist III/IV 

    About Acceleron: 

    Acceleron is a clinical stage biopharmaceutical company focused on the discovery, development and commercialization of novel therapeutic candidates that regulate cellular growth and repair.  The company is a leader in understanding the biology of the Transforming Growth Factor-Beta (TGF-β) protein superfamily, a large and diverse group of molecules that are key regulators in the growth and repair of tissues throughout the human body, and in targeting these pathways to develop important new medicines. Acceleron has built a highly productive R&D platform that has generated innovative clinical and preclinical protein therapeutic candidates with novel mechanisms of action.  These protein therapeutic candidates have the potential to significantly improve clinical outcomes for patients with cancer and rare diseases. 

    Position Overview:  

    We are seeking an experienced and talented individual who thrives in a dynamic, fast-paced, team-oriented and collaborative environment.  The successful candidate will work in the Manufacturing Science and Technology group within the cell culture area and collaborate closely with the Process Development Cell Culture group. MSAT performs Pilot and GMP campaigns in single-use stirred tank bioreactors as well small scale experiments in the Development setting as needed. The group investigates new technology that would be useful for Acceleron, evaluates multiple options and is responsible for the implementation at Acceleron. This position will interact closely with the Development, Quality, and Materials Management groups. 

    Job Responsibilities:           

    • Support scale up studies for process transfer between bench top bioreactors to 50L, 250L, and 1000L Single Use Bioreactors (SUBs)
    • Execute seed train scale up from a vial to a 250L or 1000L bioreactor through Wave bags
    • Perform Pilot and GMP runs in SUBs at scale for multiple products for GMP campaigns
    • Examine new technology and novel products that will be useful in expanding and enhancing Acceleron’s platform process (ie perfusion Wave system to be used as part of the seeding train, virus clearance for upstream processes)
    • Assist in design and completion of flask studies to optimize processes to be used in the pilot or GMP facilities
    • Keep up with technological advances by attending workshops and industrial exhibits
    • Investigate different clarification options for multiple products (depth filtration, centrifugation) and examine their applicability and scalability in Acceleron’s platform
    • Monitor and log cell growth, nutrient and metabolite, and protein concentration data for all runs performed
    • Author SOPs, batch records, change controls, and support Engineering with PQ, IQ, and OQ activities
    • Work closely with other groups (QA, QC, Engineering, Facilities) for campaign planning and execution (schedule, raw materials orders, testing, etc)
    • Author technical reports for runs performed (Pilot and GMP campaigns)
    • Interact closely with multiple interdisciplinary groups (QA, QC, Cell Culture Process Development, Facilities, Purification Development, etc)
    • Support regulatory filings with manufacturing process descriptions and data summaries
    • Interact closely with vendors for raw material procurement and new technology implementation
    • Participate in internal and external audits
    • Support tech transfer activities to CMOs in regards to MSAT activities 

    Basic Qualifications: 

    • B.S. with 5-9 years of experience or MS with 3-7 years of experience with Pilot or GMP bioreactors
    • Industry experience (biotech or pharmaceutical) required, in GMP setting preferably
    • Excellent knowledge of cell culture techniques (aseptic processing, seed train, use of Wave bags etc) and bioreactor operation
    • Experience drafting, reviewing and submitting required documentation relevant to GMP manufacturing
    • Technical expertise and creative problem-solving ability
    • Ability to work independently, with minimal supervision, and to manage multiple projects at one time
    • Enthusiastic with a high-level of integrity and attention to detail
    • Strong interpersonal communication skills, work in team and fast pace environment, under challenging timelines and hands-on troubleshooting, great organizational and time management skills

    *Recruiters - please do not send unsolicited resumes to this posting.

    FOR IMMEDIATE CONSIDERATION PLEASE VISIT OUR WEBSITE AT:

    www.acceleronpharma.com


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    The Manager, Safety Data Collection, Clinical Trials is responsible for managing the Pharmacovigilance (PV) operations of Pre and Post-approval Clinical Studies globally. The employee supports the Senior Manager, Safety Data Collection_Clinical Trials and is responsible for setting the safety operations strategy, establishing the safety report collection standards and processes, and ensuring they are implemented and executed consistently throughout all Pre and Post-Marketing Clinical Studies globally. The AE Intake Clinical Trials Associate will provide partner / vendor oversight in relation to Clinical Trial safety report collection and will collaborate with other functions (e.g., Clinical Operations, Medical Affairs, Data Management, Medical Writing, Regulatory, Biostatistics, and others ) to ensure consistency with regulations and with departmental goals and objectives. 

    Where relevant, when partners (e.g. Global CRO) have additional safety related responsibilities, the manager ensures proper coordination between the partner and the Subject Matter Expert/function lead 


    1.Support Senior Manager, Safety Data Collection, Clinical Trials with setting the safety operation strategy and establishing the safety report collection standards and processes for Pre and Post-approval Clinical Studies globally Senior Manager, Safety Data Collection, Clinical Trials 20% 

    2.Execute the development, maintenance and implementation of: 
    a.Controlled documents (SOPs), data handling conventions and other process documents for Clinical Trials and Post-Marketing Clinical Studies 
    b.Safety operational content and processes for Clinical Trial and Post-Marketing Clinical Study tools for report collection such as protocols, CRFs, SAE forms, Pregnancy forms 
    c.Tools and processes for database requirements and configurations to enable safety-related activities during studies 
    d.Training requirements and materials for Clinical Trial safety report collection 
    e.Report metrics and KPIs for Clinical Trial safety report collection Senior Manager, Safety Data Collection, Clinical Trials 20% 

    3.Oversee and ensure study safety operational requirements are operationalized Senior Manager, Safety Data Collection, Clinical Trials 15% 

    4.Support the following Strategic Partner / vendor oversight activities, in conjunction with relevant functions (such as Global Clinical Operations) in relation to Clinical Trial safety report collection: 
    a.Provide functional support / input to set up partner and vendor relationship (e.g., business requirements, vendor selection, contract details, vendor oversight / safety management plans) 
    b.Support onboarding and ongoing maintenance of partner and vendor status to perform work (e.g., access, training, technology set-up) 
    c.Provide ongoing support of partners and vendors (e.g., questions, issues, meetings) 
    d.Conduct partner oversight and performance management on contracted work (e.g., monitoring reports, quality evaluations, annual meetings) Senior Manager, Safety Data Collection, Clinical Trials 20% 

    5.Communicates on PV legislation and regulatory commitments across the organization and externally Senior Manager, Safety Data Collection, Clinical Trials 5% 

    6.Acts as subject matter expert on Pharmacovigilance (PV) operations of Pre and Post-Marketing Clinical Studies during audits / inspections Senior Manager, Safety Data Collection, Clinical Trials 10% 

    REQUIREMENTS

    Minimum Education Requirements: 
    •Minimum of Bachelor’s level degree in nursing, pharmacy, or other health care related profession or life sciences required 
    •Master’s or Doctorate level degree in health care related profession preferred 

    Minimum Experience Requirements: 
    •4+ years in drug safety/Pharmacovigilance in pharmaceutical industry setting or the equivalent 
    •Experience interacting with clinical third parties (e.g., contract research organizations) preferred 
    •Knowledgeable in Pharmacovigilance and GCP legislation required 
    •Direct experience in GXP compliant quality systems preferred 

    Other Posting Information – Information to be included in posting (as required) 
    •Excellent written and verbal communication skills including: technical writing skills, PC skills, ability to produce clear, concise documentation and good analytical skills 
    •Must work effectively/collaboratively in a fast-paced team environment and with individuals at all levels within an organization 
    •Effective managerial skills, being a self-starter, ability to work independently, goal oriented, attention to detail and accuracy, and ability to multi-task and prioritize 
    •Ability for individual decision-making required 
    •Must demonstrate initiative to identify and communicate issues within department and across departments 

    1. Communicates study-specific requirements for AE intake 
    2. Identifies and implements corrective and preventative actions (CAPAs) resulting from non-compliances 
    3. Identifies and escalates compliance trends and risks in the AE intake space


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  • 11/22/15--23:43: QC Analyst III (Sr.)
  • Summary

    Performs GMP testing of raw materials, in-process and finished products, stability samples, and non-routine sample analyses per established procedures and methodology

     

    Responsibilities and Tasks

    • Performs release, stability, validation, analytical quality control tests and assays on raw materials, in-processing and final products 
    • Conducts, documents and follows up on assay issues, failures and complaint investigations
    • Calibrates, monitors and evaluates systems and equipment (i.e. water systems, environmental chambers, analytical instrument/equipment) 
    • Maintains data in manual or computer based logs                                                                                     
    • Develops, authors, and executes IQ/OQ and PQ protocols
    • Administers/maintains major laboratory programs (i.e. calibration program).
    • Serves as liaison to service, calibration and technical representatives
    • Washes/prepares reagents, solutions, equipment for chemical tests and assays.
    • Maintains laboratory in cGMP compliance and conduct inspections
    • Records and reviews GMP data, monitors and evaluates QC systems and equipment, recommends improvements to procedures, and revises GMP documentation as required. 
    • Serves as a leader within the QC group and a knowledge resource within the company

    Knowledge Skills and Abilities

    • Excellent oral, written and interpersonal communication skills
    • Ability to follow specific instruction (i.e. written SOPs)
    • Fundamental knowledge of chemical principles and analytical instrumentation
    • Working knowledge of cGMP/GLP
    • Proficient with wet chemical methods and tests (USP, ACS, Titration, Limit tests, etc.).
    • Proficient knowledge of basic and complex laboratory instrumentation (theory, function, basic and complex troubleshooting)
    • Able to perform standard and non-standard analytical techniques to analyze product
    • Competent computer skills including word processing, spreadsheet and instrumentation control software programs
    • Experience with qualitative and quantitative analysis using good analytical laboratory practices
    • Proficient in use of Single Wavelength Ultraviolet/Visible (UV/VIS) Spectrometer, Conductivity Meter, Dissolved Solids Meter, pH Meter, Dissolved Oxygen Analyzer, Karl Fischer Titrator, High temperature furnaces and oven, Fume hoods, Stirrer/hot plates, Propane burners, Compressed Gas Regulators and Cylinders,Infrared (IR), Gamma Ray Spectrometer, Flame Atomic Absorption (AA), Scanning Ultraviolet/Visible (UV/VIS) Spectrometer, Polarograph, Coulometer, High Pressure Liquid Chromatography (HPLC), electrophoresis

     

    Education and Experience

    • B.S. or equivalent experience
    • Minimum 5-7 years of related experience 

    Pharmalucence is an Equal Opportunity Employer

    Individuals with Disabilities and Protected Veterans are encouraged to apply.

    If you need help applying online, please contact joyce.robbins@sunpharma.com or call

    Joyce, HR Assistant at 781-275-7120


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    We are seeking a seasoned executive and Advanced Analytics visionary who will drive Ironwood’s brand management initiatives and process to the highest level possible. This individual must be a creative, hands-on executive with proven leadership skills. The successful candidate will evolve, and lead the continued implementation of innovative, science-based marketing and communication strategies. The individual will oversee all strategic and tactical analysis of the brand and related marketing programs. This individual has proven ability to be a critical thinker with full knowledge of both strategy and tactics to be able to consult with clients and tell the story, at all levels. Provides commercial insights into lifecycle management and early stage New Product Planning decisions, as well as drives target product profile. This position reports to VP, Market Research Business Analytics. 

    Responsibilities Include:

    • Establish and evolve innovative models for enhancing executive decision making by Consulting designing, developing and executing custom advanced analytics deriving insights and recommendations in support of portfolio optimization, brand performance and promotion evaluation.
    • Applies principles of advanced analytical, statistical and innovative techniques to analyze business issues for all HCP and Consumer business questions
    • Translates unstructured business problems into analytical framework. Applies framework to uncover insights and actionable recommendations.
    • Leads development of data assets that support advanced analytics
    • Applies evidenced based thinking and teaches past learnings to influence decision making
    • Designs advanced analytics strategy, derive and communicate insights that inform key decisions and help optimize the business. 
    • Must have 6-10 years with strong Advanced Analytics background and Insights; demonstrated expertise in critical thinking
    • Pharma background required and Broad Scope of industry experience including, Packaged goods, Electronics, Health care preferred
    • Experience managing multiple brands and/or franchises;
    • Proven management experience with responsibilities including experience with budgeting process, strategic and tactical planning, and project management;
    • Successful co-promote or co-marketing commercial relationships
    • Demonstrated experience influencing/leading teams in a cross-functional matrixed environment through strong collaboration skills;
    • Vendor Management
    • Excellent written and verbal communication skills, in addition to excellent interpersonal and presentation skills;
    • Proven statistical and Mathematical analytical experience. Ability to utilize multiple software systems such as SPSS or SASS as a vehicle to manipulate data to evaluate ROI and commercial effectiveness. Experience applying data sources such as: IMS, WK, claims data and various pharma sets.
    • B.A./B.S. degree required; advance degree preferred.

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    You're looking for something bigger for your career. How about creating a clinical development department for a growing, pre-IPO company?  Make an impact on a company that’s developing novel anti-cancer therapies in the area of immuno-oncology.  As a Sr. / Medical Director, you will use your talents to be a leader that is shaping my clients incredible team culture into a global leader.

    Requirements:

    • MD degree required
    • Experience with hematology, oncology and / or immune-oncology
    • Minimum of 10 years pharma experience

    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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  • 11/23/15--02:06: Administrative Assistant
  • SCOPE OF RESPONSIBILITY:

    • Provide administrative support and service to Dir, Site and approximately 6-8 staff
    • Responsible for one (1) site (Haverhill)
      PURPOSE OF THE POSITION

     

    Support Site Director and Management Team, by providing administrative assistance as outlined below

     

    ESSENTIAL JOB FUNCTIONS

     

    • Maintain the front reception area in a neat and orderly fashion, answer phone(s) and greet visitors, service persons and all others 
    • Sort and distribute mail 
    • Arrange lunch, dinner, or hotels for visits, audits and interviews as needed
    • Manage office equipment as required
    • Manage, order and maintain office supplies
    • Maintain all needs for lab coats and/or uniforms on an as needed basis
    • Schedule meetings and make travel arrangements
    • Plan, arrange all printing needs, shredding, office supply inventory, vending; including coffee, soda, etc., on an as needed basis 
    • Maintain and update supportive documentation and forms required for daily, weekly and monthly needs, such as, sign in / out forms, telephone listing updates; seating charts for offices, cubicles and work areas
    • Assist in preparation of presentations, spreadsheets and memos
    • Update postings on department bulletin boards (Internal policy notices)
    • Organize and maintain year end filing, including when records can be purged for shredding
    • Coordinate activities / team for communication and recognition of employees (i.e. anniversaries, new employees, etc…)
    • Provide other administrative duties as needed

     

     

    BASIC QUALIFICATIONS

     

    Education:

     

    High School Diploma 

     

    Experience:

     

    Minimum of three years working in various administrative positions

     

    Knowledge and Skills:

     

    • Proficient in Microsoft Office applications
    • Ability to manage time, prioritize multiple tasks and work effectively

     

     

    ADDITIONAL LOCAL NEEDS

     

    Ability to sit and operate a computer for extended periods of time

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    The Position:

    The Clinical Trial Associate (CTA) supports the Clinical Operations department in the planning, execution and management of in-house or outsourced clinical trials.  The CTA will review, track and file study specific documents as well as create and update study specific reports.  He/she must exercise discretion and judgment in handling confidential information and will follow FDA regulations, ICH guidelines and GCP in all tasks.  Strong organizational skills are required, as well as the ability to balance changing priorities.   

    Primary Responsibilities Include:

    • Collect, file and/or track clinical trial associated regulatory documents.
    • Coordinate and track the distribution and subsequent retrieval of clinical documents, including but not limited to protocols, protocol amendments, IBs, ICF’s, monitoring visits reports etc.  
    • Maintain and ensure all documentation is in a state of audit readiness.
    • Creation and maintenance the Trial Master File and electronic Trial Master File (TMF and eTMF) according to ICH-GCP, and company SOPs.
    • Assist in the preparation of study related documents, i.e. ICF, clinical trial tools & templates etc.
    • Support drug supply planning and defining supply logistics.
    • Coordinate and track or supervise drug supply.
    • Coordinate and track clinical trial equipment and supplies.
    • Review and track vendor invoices against contracts and coordinate approval.
    • Assist with site budget process.
    • Act as central point of communication for trial team as well as study sites and vendor personnel. 
    • Responsible for sending and tracking all safety letters to Investigators according to timelines provided by Clinical Trial Manager.
    • Support the trial team to produce and distribute study newsletters.
    • Assist in the coordination of Investigator Meetings.
    • Create agendas and record team meeting minutes under the direction of the Clinical Trial Manager.
    • Assist the Clinical Trial Manager with timeline maintenance.

    Education and Skills Requirement:

    • Bachelor’s degree in life sciences or healthcare related field
    • 2+ years’ experience in a clinical research related position
    • Strong computer skills including knowledge of Excel, Word, PowerPoint and Outlook   
    • Solid understanding of the responsibilities and needs of other functions in a clinical trial.
    • Proven ability to work independently and effectively handle multiple priorities in a fast-paced environment.
    • Ability to maintain confidentiality of proprietary information expected.
    • A team player that takes initiative is a must.
    • Excellent interpersonal skills, strong organizational skills, and effective communication across all levels within an organization
    • Proficient written and verbal communication skills.
    • Position may require some travel.

     


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    Excellent leadership opportunity available to oversee clinical manufacturing activities being performed at the CMOs for at a local A-list, mid-size, public company.  Based in the Kendall Square neighborhood of Cambridge, a short walk away from the Red Line.  

    Rapidly growing company with exciting and innovative therapeutic programs in preclinical and clinical development.  

    The main function of this role is to lead process and technology transfer and GMP manufacturing operations being done externally (20% travel, domestic and international).

    Responsibilities include but are not limited to;
    •  Management of the cGMP manufacturing operations 
    •  Tech transfer to CMO/CRO partners 
    •  "Person in the plant" for process engineering or training runs

    Formal descriptions can be supplied for interested candidates. 

    Qualified candidates will have a BS/MS and 10+ years of GMP biologics experience.  Must be able to demonstrate CMO/CRO management experience.  Those with experience in vaccines, monoclonal antibody production, and/or autologous cell therapy experience greatly preferred.

    Must be authorized to work in the US indefinitely to be considered.  Relocation assistance available for qualified candidates.   

    Resumes to nuno@hireminds.com to be considered.  All resumes will be kept strictly confidential until you choose to pursue a specific opportunity with one of our clients.


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    Principal Scientist, Translational Medicine and Biomarkers, at Unum Therapeutics

    Who are we?

    Recent advances in T-cell engineering and antibody therapeutics have led to phenomenal results in treating cancer patients, opening the possibility for combining these powerful therapeutic modalities. Unum Therapeutics aims to transform cancer treatment through the discovery, development, and commercialization of novel cellular immunotherapies. We’re moving forward fast, are you? Visit www.unumrx.com for our latest news!

    We are seeking an innovative and highly motivated scientist to lead the development of novel biomarker assays to support early clinical development programs.

    What will you be doing?

    • Leverage knowledge of cancer immunology to implement new platform technologies to identify both disease appropriate biomarkers as well interrogate immunological response that can be used for diagnosis and measurement of treatment response

    • Be accountable for assay development, technology transfer as well as vendor selection and oversight of assays supporting clinical trials in collaboration with the Head of Development Operations

    • Author technical documents including SOPs, qualification/validation protocols and regulatory documents

    • Mentor, train and direct PhD and non-PhD scientists

    • Work collaboratively across internal discovery and clinical groups, external collaborators and contract research organizations

    What are we seeking?

    ● PhD with 10+ years of experience, preferably in a biopharma or pharma setting
    ● Experience implementing multiple technologies, such as multi-color flow cytometry, multiplexed immunoassays, immunohistochemistry and cell-based assays in a clinical setting
    ● Prior experience developing fit-for-purpose assays for clinical application highly desirable
    ● Experience mentoring discovery scientists and working in multidisciplinary teams and collaborative environments
    ● Experienced in the preparation of technical reports and regulatory documents
    ● Demonstrated innovation to apply novel biomarker concepts in emerging therapeutic areas
    ● Strong interpersonal and communication skills and enthusiasm to work in a fast-paced startup environment

    What are we offering to you?

    This is an outstanding opportunity to be a founding member and scientific leader of an early-stage, well funded, start-up company. You will be a vital part of helping to achieve the Unum vision: to transform cancer treatment and deliver patient cures.  Unum is a place where your input matters -- you will have a direct impact on our science and will help to build our capability as a team. You will also shape the Unum culture and be a part of a passionate, transparent, and collaborative work environment.

    Where are we?

    Unum is located within walking distance of the Alewife T station in Cambridge, MA. Our space includes an open office layout designed for collaboration and state-of-the-art laboratories. Free access is provided for both on-site parking and gym facilities in the building. We are in close proximity to leading academic institutions like MIT and Harvard and to potential pharmaceutical and biotech partners. This unique location allows for a high level of energy and intellectual exchange within and among fast growing early stage companies.

    What benefits does Unum offer?

    To attract the very best talent, we are offering an extremely generous package that includes competitive pay, a performance-based bonus, stock options, health, dental, life and disability insurance coverage, trust-based time off, and commuter/parking benefits.  Relocation assistance is also available to candidates who live outside of the Boston area.

    How to Apply?

    • Please send cover letter and resume to: careers@unumrx.com
    • Unum is an equal opportunity employer.
    • We are only accepting applications from candidates with authorization to work in the United States at this time.
    • Note to agencies – we are not accepting unsolicited resumes from agencies and will not be responsible for fees associated with any such submittals.

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    Scientist/Senior Scientist, Translational Medicine and Biomarkers, at Unum Therapeutics

    Who are we?

    Recent advances in T-cell engineering and antibody therapeutics have led to phenomenal results in treating cancer patients, opening the possibility for combining these powerful therapeutic modalities. Unum Therapeutics aims to transform cancer treatment through the discovery, development, and commercialization of novel cellular immunotherapies. We’re moving forward fast, are you? Visit www.unumrx.com for our latest news!

    We are seeking an innovative and highly motivated scientist to contribute scientific and laboratory expertise to the development of novel biomarker assays to support early clinical development programs.

    What will you be doing?

    • Develop assays using both preclinical models and human-derived samples that can be used for diagnosis and measuring treatment response

    • Prepare data packages for technical reports, SOPs, and regulatory submissions

    • Manage the transfer of technical protocols to contract testing labs

    • Mentor and train other bench scientists

    • Work collaboratively across internal discovery and clinical groups, external collaborators and contract research organizations

    What are we seeking?

    ● PhD with at least 2 years of relevant industry experience or MS and at least 7 years of experience in a biopharmaceutical setting

    ● Experience with assay development across relevant diagnostic technologies with an emphasis on multi-color flow cytometry, multiplexed immunoassays, immunohistochemistry and cell-based assays

    ● Experience with developing genetic assays for oncology highly desirable

    ● Experience working with primary human cells (T cells, PBMCs) highly desirable

    ● A desire to meticulously execute bench work

    ● Strong organizational and record-keeping skills; experience with SOPs and regulatory documents a plus

    ● Strong interpersonal and communication skills and enthusiasm to work collaboratively in a fast-paced startup environment

    What are we offering to you?

    This is an outstanding opportunity to be a founding member and scientific leader of an early-stage, well funded, start-up company. You will be a vital part of helping to achieve the Unum vision: to transform cancer treatment and deliver patient cures.  Unum is a place where your input matters -- you will have a direct impact on our science and will help to build our capability as a team. You will also shape the Unum culture and be a part of a passionate, transparent, and collaborative work environment.

    Where are we?

    Unum is located within walking distance of the Alewife T station in Cambridge, MA. Our space includes an open office layout designed for collaboration and state-of-the-art laboratories. Free access is provided for both on-site parking and gym facilities in the building. We are in close proximity to leading academic institutions like MIT and Harvard and to potential pharmaceutical and biotech partners. This unique location allows for a high level of energy and intellectual exchange within and among fast growing early stage companies.

    What benefits does Unum offer?

    To attract the very best talent, we are offering an extremely generous package that includes competitive pay, a performance-based bonus, stock options, health, dental, life and disability insurance coverage, trust-based time off, and commuter/parking benefits.  Relocation assistance is also available to candidates who live outside of the Boston area.

    How to Apply?

    • Please send cover letter and resume to: careers@unumrx.com
    • Unum is an equal opportunity employer.
    • We are only accepting applications from candidates with authorization to work in the United States at this time.
    • Note to agencies – we are not accepting unsolicited resumes from agencies and will not be responsible for fees associated with any such submittals.

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    Our client is a dynamic biotechnology company in Cambridge, MA with a passion for developing new drugs in areas of high unmet need. They were nominated by Fierce Biotech in 2014 as a “Fierce 15” company “that could change how physicians approach infectious disease”

    Do you consider yourself organized, meticulous, and enthusiastic?   Then you might just be the type of Quality Assurance Specialist we're looking for to join the team. This position will assist the QA Department in quality system compliance and product quality.  You will also be maintaining systems and standards to ensure compliance with Gxp and International regulations.

    REQUIREMENTS:

    • BA/BS and 3-5 years’ experience as a QA specialist
    • GMP experience
    • Coordinate the creation, revision and distribution of controlled documents
    • Assist in creating, implementing and executing the training program

    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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    Excellent leadership opportunity available to lead QC activities a local A-list, mid-size, public company.  Based in the Kendall Square neighborhood of Cambridge, a short walk away from the Red Line, this rapidly growing company has exciting and innovative therapeutic programs in preclinical and clinical development.  

    The main function of this role is manage all activities associated with QC release testing for starting materials and Drug Product disposition, including QC testing for clinical trial material to commercialized products. 

    Responsibilities include but are not limited to;
    •  Tech transfer of testing processes to external CRO/CTO/CMO partners
    •  Release and stability testing, assay troubleshooting 
    •  Data review, analysis, and identification of trends.  Deviations, change controls, CAPAs, OOT/OOS.  Prepare and review CMC sections of regulatory filings

    Formal descriptions can be supplied for interested candidates. 

    Qualified candidates will have a BS/MS and 5+ years of GMP biologics experience.  Must be able to demostrate tech transfer and CMO/CRO management experience and strong knowledge of cGMP/ICH/FDA/EU regulations.  Those with experience supporting vaccines, monoclonal antibody production, and/or autologous cell therapy products greatly preferred.

    Must be authorized to work in the US indefinitely to be considered.  Relocation assistance available for qualified candidates.   

    All resumes will be kept strictly confidential until you choose to pursue a specific opportunity with one of our clients.


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    The Duvelisib Manager / Sr. Manager, Marketing will report into the duvelisib Marketing Director and will in collaboration with AbbVie, plan, develop, implement and measure promotional activities for HCPs; s/he will also partner with the Director, Patient Services to develop patient education materials. This individual will play an integral role in the Launch Readiness Review Process as well as developing, executing, and measuring branded and unbranded promotional strategies and tactics. 

    Responsibilities:

    • Collaborate with AbbVie to partner with Agency of record to create key pre-launch and launch deliverables/tactics for HCPs. Lead creation of the messaging and materials through close partnership with abbvie and agency. 
    • Liaise with Sales Training to develop and roll out all materials to the field teams ensuring alignment with strategic objectives
    • Be a key member of the Launch Team responsible to the JCC for timely and flawless execution of key launch deliverables – HCP promo materials, digital strategy and execution and sales training materials
    • Participate in other brand-related planning and budgeting efforts including 1-Year Tactical Plan, Launch Readiness Reviews and 3-Year Brand Plan where applicable
    • Regular domestic travel (air and car) is required

    Required Qualifications:

    • Bachelors Degree required – Marketing or Science preferably
    • 3 – 4 years or more previousexperience in product marketing, field sales, market research, advertising the pharmaceutical/biotech industry or agencies
    • Strong organizational and project management skills, along with solid decision-making skills
    • Strong analytical and interpersonal skills, proven track record of effectively and efficiently driving performance within a matrix environment,
    • Strong ability to build alignment and collaborative working relationships
    • Proven track record for consistently meeting or exceeding goals
    • Demonstrated initiative and creativity
    • Strong verbal and written  communication skills

    Preferred Qualifications:

    • MBA or other graduate-level degree
    • Experience in oncology/hematology
    • Experience working with KOLs
    • Launch experience is a big plus
    • Experience in multiple commercial areas is a big plus

    To apply, please visit our website at http://www.infi.com


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    Infinity Pharmaceuticals is seeking a qualified, highly motivated, experienced individual for the position of Quality Assurance Project Manager, within our Quality Assurance group to report into the Associate Director, Quality Assurance.  This individual will be responsible for supporting the manufacturing, testing, and release of drug products for clinical use.

    Responsibilities

    • Review and approval or rejection of drug substance, drug substance intermediates, bulk drug product and packaged/labeled products according to established standards.
    • Provide independent quality support for product development, manufacturing, testing, and release activities for drug substance, drug product intermediate, bulk drug product, and packaged/labeled product.
    • Responsible for interdepartmental and cross functional project management activities.
    • Liaison with Vendor (Contract Manufacturing Organizations, Contract Testing Laboratories, etc) Quality Assurance departments.
    • Oversee GMP product quality and compliance for assigned projects.
    • Oversee product quality investigations and resolve quality issues for assigned projects.
    • Responsible for approval or rejection of written standards, including Master Production Records, Standard Operating Procedures, Specifications, Test Methods, and Change Control Documentation.
    • Participate on project sub-teams to provide overall quality direction for product development.
    • Inform Quality management of issues and progress of assigned projects.
    • Involvement in process, compliance, and quality system improvement efforts.
    • Support submission of INDs, IMPDs and NDAs for assigned projects.
    • Cultivate a phase-appropriate quality system approach for GMP product manufacture and product development activities.
    • Support audits and inspections.
    • Represent the Quality organization to internal and external stakeholders.
    • Direct quality activities such that project timelines are met.
    • Responsible for the monitoring of compliance with the requirement of GMPs.

    Qualifications

    • BS Biology, chemistry or life sciences. 
    • Minimum of 6-10 years in Quality Assurance.
    • Minimum 2 years experience as an independent decision maker in a pharmaceutical or biotech setting. 
    • Excellent knowledge of FDA regulations and guidance documents.
    • Good knowledge of EU, ICH and other global regulatory requirements.
    • Ability to increase others’ knowledge of US and European GMP regulations and guidance.
    • Experience in implementation and administration of quality systems for drug development, manufacturing and quality control operations.
    • Experience in pharmaceutical Quality Assurance including the ability to identify and resolve compliance issues.
    • Experience participating in pharmaceutical technology transfer teams.
    • Ability to mentor junior staff. 
    • Excellence in oral and written communications
    • Works on complex problems in which analysis of situations or data requires an in-depth evaluation of various factors.
    • Exercises judgment within broadly defined practices and policies in determining actions and creating solutions.
    • Ensures that budgets, schedules, and performance requirements are met.
    • Demonstrates ability to identify critical decisions that will have a long-term effect on the company’s success.
    • Comfortable making decisions independently but demonstrates good judgment in escalating issues to management and QA colleagues.
    • Interacts internally on a regular basis with executive-level management, on matters concerning several functional areas.
    • Communicates with department colleagues to ensure harmonization between programs.
    • Has the ability to change the thinking of or gain acceptance of others in sensitive situations.
    • Recognizes individual and team contributions and aligns rewards to performance.
    • Consciously helps staff through periods of uncertainty by maintaining open communications.

    To apply, please visit our website at http://www.infi.com


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    Senior Manager, Analytics & Corporate Intelligence - Global Business Development

    Location: US-MA-Boston/Cambridge

    Category: Business Development - Business Development

     Overview

    Based out of our Cambridge (MA, USA) office, the Senior Manager, Analytics & Corporate Intelligence position, under the guidance of the Director, Operations, Global Business Development (GBD), will support analysis and execution of U.S. and global licensing, partnering and acquisition transactions as well as market/competitive intelligence across all therapeutic areas (TAs) at Teva. In addition, the Senior Manager will be involved in other GBD-related activities including strategic planning, administration and logistics for the group.

     Responsibilities

    • Supports advanced analytics (including financial, R&D, strategical, tactical and operational) for all transactions across TAs within GBD, in collaboration with other key functions within Teva
    • Interprets market and competitive intelligence to inform decision making in BD and strategy
    • Assists Director, Operations, GBD and other members of GBD to conduct, coordinate and manage appropriate due diligence for BD opportunities
    • Leverages internal and external resources for comprehensive and timely analysis and recommends solutions
    • Provides real-time customized support to GBD senior management on decision making processes on transactions, operations and strategy
    • Prepares concise/precise reports for GBD and Teva senior management on a real-time/on-demand basis across all BD-related subject matters
    • Develops collaborative and productive working partnerships within the broader Strategy & Global Business Development group as well as key functions across Teva including R&D, Commercial, Finance, Manufacturing amongst others

    Qualifications

    • Graduate degree (at least a Master degree) in life sciences required; MBA preferred
    • 6+ years of pharmaceutical/biotech industry experience in a commercial or financial setting, or 6+ years of consulting experience working with life science companies or equivalent investment banking experience required
    • Excellent skills in financial/valuation analysis, writing and other key medium of communication
    • Proficiency in Microsoft Office applications
    • Strong work ethics with focus on execution
    • Committed team player
    • Ability to multi-task, and be very organized and detail-oriented with a strong sense of urgency
    • Ability to make strong professional and credible impressions with senior-level audiences, internally and externally

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    Small Biosimilars Company here in Massachusetts, with multiple International partnerships, seeking Sr. Director, Program Management (Late-Stage Drug Development)!  This role will lead biologic programs through the strategic and tactical elements of biopharmaceutical development, drive programs to robust decision points, and advance programs through development to commercial launch in multiple global geographies. The incumbent will lead and integrate cross-functional teams including multiple external partners and vendors to advance program execution and will have responsibilities for alliance interfaces with corporate partners.

     

    • Establish an integrated program plan incorporating business drivers and intellectual property environment, technical development, manufacturing, preclinical, clinical, regulatory and commercial strategy
    • Build and lead multidisciplinary team/s to manage molecule and/or geographic development. Ensure effective integration, management and delivery of program objectives
    • Align program strategy with execution
    • Establish and maintain program goals, budget and timeline
    • Anticipate program risks. Develop and execute appropriate mitigation strategies
    • Insure program and functional goals are aligned with corporate goals
    • Build relationships with internal and external stakeholders
    • Partner with functional representatives to prioritize directives and resources, foresee caveats and design solutions to critical challenges
    • Manage project deliverables and timelines using appropriate tools. Document and communicate key project information and metrics

     

    Requirements:

    • Advanced scientific degree (strong preference for MS or PhD) with 10+ years of pharmaceutical/drug development experience (later stage; phase II and beyond a must)
    • Demonstrated development stage program management experience (pre-clinical and later stages)
    • Demonstrated experience building and leading cross functional teams
    • Exceptional writing and verbal communication, interpersonal, negotiating and influencing skills

     

     

    Please send your resumes directly to Breeana@hireminds.com for consideration.  This is a full-time/direct hire role that offers a competitive total compensation package.  Must be authorized to work for any U.S. Employer for an indefinite amount of time.    Relocation available for qualified candidates.


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  • 11/24/15--08:56: QC Analyst, Analytical
  • Title:  QC Analyst, Analytical

    Reference Number:  918

     

    RESPONSIBILITIES Analytical testing of in process, development, stability, raw materials and final product samples. Performance of testing in accordance with standard operation procedures. Perform job function in accordance with the Agenus Quality Policy and Manual, as appropriate. Work in compliance with cGMP’s

     

    REQUIRED TASKS Testing included but not limited to HPLC, SDS-PAGE, Western Blot, Bradford, ELISA and wet chemistry methods. Support the execution of approved protocols for the validation of analytical instruments and test methods. Revision and development of standard operating procedure, as needed. General laboratory support, including but not limited to, sample receipt, inventory control, reagent preparation and equipment and instrument maintenance. Monitoring of temperature controlled units using monitoring system. SPECIFIC SKILLS RELEVANT TO THE JOB Individual must be flexible, work well in a team environment and possess developed organizational skills. Prior knowledge of Empower software and other laboratory software preferred. Proficient in MS Office Prior knowledge of cGMPs.

     

    Requires B.S. in a scientific discipline or equivalent

     

    Minimum 1-3 years experience in a GMP laboratory environment


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    The Program Data Manager/Data and Analytics Lead manages the clinical data flow (data acquisition from Case Report Form (CRF) to Clinical Study Reporting (CSR)) and ensures timely project execution; recognized as an operational specialist in data flow and study execution by all functions across Development Sciences. Partners with key study team members to facilitate implementation of a robust and clear data strategy for assigned studies. Uses phase, TA and operational knowledge to establish study level operational plans and oversees CROs and other vendors to ensure timely execution. Develops study level quality plans and ensures adherence and consistent execution across the data flow. Collaborates with Program DALs to ensure alignment of study operational plans with program goals and for execution and quality.

    • Develops timeline and project manages data deliverables in collaboration with cross functional team members and vendors.
    • Oversees execution of data management deliverables. Interprets and applies data strategy, verifies consistency and usage of data, and results, Coordinates and oversees outsourced personnel, and monitors and reports on overall study/program progress. Accountable for overall quality of study data.
    • Develops risk mitigation or action plans and oversees execution when appropriate.
    • Serves as a contact representing DM within CDS and clinical study management teams (SMT and/or Clinical Development Team representatives). Liaises directly with internal customers (CDS functions, GCO, Biostatistics, Regulatory Affairs) and external customers (Full Service and Functional Service Provider Data Leads and Project Management personnel)
    • Serves as Subject Matter Expert alongside CDS counterparts for data, reporting, and analysis process definition, improvement, and innovation as needed.
    • Manages performance and quality issues with vendors and escalates to vendor managers and Management and develops appropriate risk mitigation as needed.
    • Support study-level audit and inspection readiness activities as needed.
    • Serve as project manager on special projects and initiatives; partners with Statistical Programming, VM and Quality depending on type of project.

     

    Qualifications

    • 8+ years relevant work experience with a focus on data management
    • Deep understanding of drug development and biopharmaceutical industry required
    • Strong project management skills, and ability to effectively lead and collaborate with various business functions project management certified desirable
    • High attention to detail including proven ability to manage multiple, competing priorities
    • Experience overseeing outsourced clinical trials work
    • Demonstrated ability to establish effective business relationships with external stakeholders, including implementing process change at a vendor
    • Deep knowledge of clinical data management outsourcing with full-service, global CROs and FSPs
    • Demonstrated ability to influence without authority
    • Excellent written and oral communication skills

     

    Education 

    • Bachelor’s degree, preferably in a scientific discipline such as Statistics, Mathematics, Economics, Computer Science, IT, Biology, Social Science, etc

    0 0

    The Program Data Manager/Data and Analytics Lead manages the clinical data flow (data acquisition from Case Report Form (CRF) to Clinical Study Reporting (CSR)) and ensures timely project execution; recognized as an operational specialist in data flow and study execution by all functions across Development Sciences. Partners with key study team members to facilitate implementation of a robust and clear data strategy for assigned studies. Uses phase, TA and operational knowledge to establish study level operational plans and oversees CROs and other vendors to ensure timely execution. Develops study level quality plans and ensures adherence and consistent execution across the data flow. Collaborates with Program DALs to ensure alignment of study operational plans with program goals and for execution and quality.

    • Develops timeline and project manages data deliverables in collaboration with cross functional team members and vendors.
    • Oversees execution of data management deliverables. Interprets and applies data strategy, verifies consistency and usage of data, and results, Coordinates and oversees outsourced personnel, and monitors and reports on overall study/program progress. Accountable for overall quality of study data.
    • Develops risk mitigation or action plans and oversees execution when appropriate.
    • Serves as a contact representing DM within CDS and clinical study management teams (SMT and/or Clinical Development Team representatives). Liaises directly with internal customers (CDS functions, GCO, Biostatistics, Regulatory Affairs) and external customers (Full Service and Functional Service Provider Data Leads and Project Management personnel)
    • Serves as Subject Matter Expert alongside CDS counterparts for data, reporting, and analysis process definition, improvement, and innovation as needed.
    • Manages performance and quality issues with vendors and escalates to vendor managers and Management and develops appropriate risk mitigation as needed.
    • Support study-level audit and inspection readiness activities as needed.
    • Serve as project manager on special projects and initiatives; partners with Statistical Programming, VM and Quality depending on type of project.

     

    Qualifications

    • 8+ years relevant work experience with a focus on data management
    • Deep understanding of drug development and biopharmaceutical industry required
    • Strong project management skills, and ability to effectively lead and collaborate with various business functions project management certified desirable
    • High attention to detail including proven ability to manage multiple, competing priorities
    • Experience overseeing outsourced clinical trials work
    • Demonstrated ability to establish effective business relationships with external stakeholders, including implementing process change at a vendor
    • Deep knowledge of clinical data management outsourcing with full-service, global CROs and FSPs
    • Demonstrated ability to influence without authority
    • Excellent written and oral communication skills

     

    Education 

    • Bachelor’s degree, preferably in a scientific discipline such as Statistics, Mathematics, Economics, Computer Science, IT, Biology, Social Science, etc

    0 0

    The Bioassays group within Quantitative Biology is seeking an independent and motivated scientist to join a growing research team focused on therapeutic discovery, assay development and high throughput screening (HTS). The successful candidate will be responsible for helping coordinate and track projects run externally at CROs or academic groups, perform assay data analysis, complete electronic uploading of assay results, coordinate lab supervision and operational related activities. These efforts will support programs for multiple disease areas, including immunology and neurobiology. It is required that the candidate have experience with cell based assay development and screening. Familiarity with assay work outsourcing activities is needed. The candidate must demonstrate a thorough knowledge of experimental design, underlying scientific principles, and the ability to independently assess results. The individual needs to have a demonstrated track record of coordinating support activities for multiple research projects. This position requires a Bachelor’s or Master’s degree in Biology, Cell/Molecular Biology or related field with 5-10 years of academic or industrial research experience.

    Responsibilities:

    Coordination of external collaborations including:

    • management of meetings and presentations
    • tracking of activities and action items
    • complete operational paper work
    • track, coordinate and register data generated by our collaborators
    • external sharepoint site administrator

     

    Assay data analysis and data recording for in-house and outsourced generated data will include:

    • perform curve fitting, generation of IC50s, standard and benchmark track and trend analysis, assay variability studies
    • big-data examination using Spotfire software to stablish data trending and hit determination
    • Electronic data uploading, recording and circulation

     

    Laboratory management and screening activities will include:

    • schedule of equipment maintenance and support
    • coordination of equipment purchase and installation
    • keep freezer, critical reagent, equipment and cell bank records up to date
    • coordinate lab clean up and lab organization
    • help with hands on assay optimization experiments and screening of small molecules using platforms such as: ELISA, FRET, Western Blot, and reporter cell-based assays

     

    Other skills:

    • Requires excellent communication and organizational skills and ability to present data
    • Ability to collaborate and work with others in a matrix environment
    • Ability to conduct independent research and be a team player
    • Ability to prioritize responsibilities
    • Comfortable with changing direction and taking risks

     

    Qualifications

    • This position requires a Ph.D. degree in Cell Biology, Biochemistry or a related discipline and 2-5 years of experience in industry work.
    • Previous experience working with CROs and assay transfer is needed
    • Previous experience assay developing, troubleshooting and screening is required
    • Knowledge on big-data analysis using Spotfire and High-content Profiler is favored
    • Knowledge on assay data analysis and biostatistics is preferred.
    • The successful candidate will be highly motivated with a demonstrated ability to successfully take on challenges and quickly adapt to new responsibilities.
    • Excellent oral and written communication skills are necessary

     

    Education

    • This position requires a Ph.D. degree or equivalent experience in Cell Biology or a related discipline

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