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Career postings for the Massachusetts Biotechnology Council

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    Org Marketing Statement
    A career at Pfizer offers opportunity, ownership and impact.

    All over the world, Pfizer colleagues work together to positively impact health for everyone, everywhere.Our colleagues have the opportunity to grow and develop a career that offers both individual and company success;be part of an ownership culture that values diversity and where all colleagues are energized and engaged;and the ability to impact the health and lives of millions of people. Pfizer, a global leader in the biopharmaceutical industry,is continuously seeking top talent who are inspired by our purpose to innovate to bring therapies to patients that significantly improve their lives.

    Role Description
    Apply and develop chemical biology techniques to advance drug discovery projects in the CardioVascular and METabolic (CVMET) disease area, through a number of methods including: design, synthesis, purification and characterization of modified proteins and/or nucleotides or complexes thereof (ribonucleoproteins); the design and application of chemical probes to biological systems; the use of chemical biology expertise to influence medicinal chemistry design strategies for drug discovery projects.

    Accountabilities of the role include producing knowledge that delivers significant impact upon CVMET projects by driving effective design and synthesis interactions to advance projects from exploratory stages to delivery of clinical candidates. Accountabilities of the role also include survival of candidates to positive clinical proof of concept (POC).

    *The role is based in Cambridge Massachusetts but will initially be located at the University of California at Berkeley as part of a research collaboration for at least 6 months.

    Responsibilities
    * Design, synthesis, purification and characterization of modified proteins and/or nucleotides or complexes thereof (ribonucleoproteins)
    * Design of single guide RNAs (sgRNA)
    * Design and apply functional chemical probes that address a specific need of the project teams in CVMET using effective partnerships with synthetic/medicinal chemistry and biophysics groups.
    * Use of proteomics for pathway interrogation and to identify opportunities for therapeutic intervention in disease where the biologic target and/or mechanism of action for active molecules is not known.
    * Use affinity/activity-based proteomics, photoaffinity probes and cellular imaging agents to assess binding sites, off-target effects, post-translational protein modifications and biological mechanisms.
    * Identify and examine modulators of enzymes, receptors, transporters, ion channels or other biological targets with unique mechanisms of action using chemical biology techniques.
    * Exploit scientific expertise of analytical chemistry, structural biology, data analytics within the Pfizer WWMC community as appropriate to ensure that appropriate technologies are applied to solving design problems.
    * Work in conjunction with computational, design and synthetic chemists, biologists, pharmacologists, structural biologists, ADME and safety scientists to advance projects within the Research Unit.
    * May be responsible for leading projects at a strategic chemistry design level.

    Qualifications
    Doctoral level degree or equivalent
    Postdoctoral experience is preferred

    Essential Training and Experience:
    * Strong track record of delivering biological insights through chemical biology experimentation.
    * Experience working on biological systems including cloning, expression and purification of proteins; quantitative gene expression and proteomic techniques; mammalian and bacterial tissue culture.
    * Experience working with Clustered Regularly Interspaced Short Palandromic Repeats (CRISPR) and CRISPR associated (Cas) protein systems type I and II.
    * Structure biology experience with Cas proteins

    Additional Training and Experience
    * Experience with peptides, proteins, cells, cell lysates, ex vivo tissues, etc.
    * Design of sgRNA
    * Comfortable applying analytical and purification techniques used in chemical biology, i.e. gel electrophoresis, Western blots, LCMS, ELISA and molecular probe design.
    * Experience in target identification and mechanism of action elucidation
    * Experience working in a majority of the following areas would be desirable:
    medicinal/organic chemistry, click chemistry, site-selective protein modification, photoaffinity
    cross-linking, genetic encoding of unnatural amino acids, affinity enrichment, cellular imaging, and/or proteomics.

    NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS
    * The role will require periodic visits to the Groton Connecticut site for face-to-face meetings and training.

    EEO & Employment Eligibility
    Pfizer is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status. Pfizer also complies with all applicable national, state and local laws governing nondiscrimination in employment as well as work authorization and employment eligibility verification requirements of the Immigration and Nationality Act and IRCA. Pfizer is an E-Verify employer.

    Application URL:http://www.aplitrak.com/?adid=amVmZnJleXN0b25lLjMyNTY0LjMxNjdAcGZpemVyLmFwbGl0cmFrLmNvbQ


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    Org Marketing Statement
    A career at Pfizer offers opportunity, ownership and impact.

    All over the world, Pfizer colleagues work together to positively impact health for everyone, everywhere.Our colleagues have the opportunity to grow and develop a career that offers both individual and company success;be part of an ownership culture that values diversity and where all colleagues are energized and engaged;and the ability to impact the health and lives of millions of people. Pfizer, a global leader in the biopharmaceutical industry,is continuously seeking top talent who are inspired by our purpose to innovate to bring therapies to patients that significantly improve their lives.

    Role Description
    Provide Engineering Tech support related to the qualification of manufacturing processes and equipment within a biopharmaceutical manufacturing facility, such as cleaning validation, cleaning monitoring, cleaning change over, chamber qualification, sterilization qualification.

    Work includes generating validation/qualification documents and execution of qualification activities

    Responsibilities
    Work with Operations, Quality, Technical groups, and other site/network groups as required to establish business and compliance requirements of the asset.
    * Plan and coordinate the validation work assigned.
    * Technical understanding of process and equipment to be qualified
    * Accountable for quality of work performed.
    * Perform the work in accordance to all of the compliance requirements and in a safe manner.
    * Role will be expected to work Monday - Friday standard shift. Weekends or off hours may be required as needed.

    Qualifications
    * HS Diploma or GED/Equivalent or prior Military experience required.
    * Hands-on experience is critical in this role of Validation Technician and selected candidates must be able to operate independently and have a minimum of five years working experience in a Biopharmaceutical or pharmaceutical manufacturing facility
    * Candidates must have a solid understanding the Biopharma manufacturing process and operation of the equipment, such as the cleaning processes, SIP processes and autoclaves.
    * Candidate should have an understanding of cGMP systems and practices.
    * Candidate must be able to work across functional areas such as operations, maintenance, quality and regulatory.
    * Good verbal and written communication skills are required.
    * Technical writing and document review skills are required.
    Understanding of cleaning / steaming processes of the equipment used in the Biopharma manufacturing is preferred.

    PHYSICAL/MENTAL REQUIREMENTS
    Minimal walking travel as required for meetings and cross functional discussions
    Normal shift: 8AM - 5PM. This may vary according to the business need.

    NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS
    * Role will be expected to work Monday - Friday standard shift. Weekends or off hours may be required as needed.

    EEO & Employment Eligibility
    Pfizer is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status. Pfizer also complies with all applicable national, state and local laws governing nondiscrimination in employment as well as work authorization and employment eligibility verification requirements of the Immigration and Nationality Act and IRCA. Pfizer is an E-Verify employer.

    Application URL:http://www.aplitrak.com/?adid=SmltLlRhdm9saWVyaS43NjcyNC4zMTY3QHBmaXplci5hcGxpdHJhay5jb20


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    What's in it for you?

    In this role, you'll have the opportunity to use your Medical Affairs experience to develop strategic communications for drugs being developed in the exciting area of microbiome therapeutics. This role will have a great impact to Seres as we develop our Medical Affairs function and as we build the platform to commercialize drugs. To be successful, you'll have a working knowledge of infectious disease and enjoy working closely with a team of highly passionate colleagues. This role reports to the VP, Medical Affairs

    How do you know if you're the right fit?

    If you have experience writing scientific/medical abstracts and manuscripts; developing strategic communications; assessing the therapeutic landscape; creating content for symposia and exhibit booths and planning of advisory boards with external experts, you're in luck.

    You will also have previous experience in creating publications plans; discussing potential research projects with external investigators; creating slide decks for external presentations for speaker trainings and experience with running meetings with patient advocacy groups.



    The other stuff

    This is typically a role best suited for an individual with either MD or PharmD background with experience writing scientific/medical communications. A working knowledge of infectious diseases, such as Clostridium difficile is advantageous, but not required. The right person will be a visionary individual who enjoys working within a cohesive, dynamic team.

     



    Apply Here

    PI92699169


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  • 01/12/16--23:53: Research Technician
  • Job ID: 27458
    Date Posted: 12/22/2015
    Location: Smith Building
    Job Family: Technician/Technologist
    Full/Part Time: Full-Time
    Regular/Temporary: Regular
    About Dana-Farber

    Located in Boston, Dana-Farber Cancer Institute brings together world renowned clinicians, innovative researchers and dedicated professionals, allies in the common mission of conquering cancer, HIV/AIDS and related diseases. Combining extremely talented people with the best technologies in a genuinely positive environment, we provide compassionate and comprehensive care to patients of all ages; we conduct research that advances treatment; we educate tomorrow’s physician/researchers; we reach out to underserved members of our community; and we work with amazing partners, including other Harvard Medical School-affiliated hospitals.


    Overview

    We are looking for a research technician to work in a research laboratory studying gene regulation in connection with cancer. Primary focus is to carry out experiments as part of a screening effort, including knock-down and knock-out experiments in multi-well formats using using high-throughput screening and deep sequencing based methods. Additional duties include general lab maintenance tasks and ordering or generating laboratory reagents.

    BA/BS in Biology or closely related field.

    Experience with cell culture and molecular biology techniques, including molecular cloning and PCR is a strong preference. Experience with screening approaches is a plus.

    Ability to learn quickly, being well-organized, punctual and able to interact well with
    others.



    Schedule

    Full-time - 40 hours per week as needed. Variable hours, some nights and weekends, may be required to complete experiments and meet deadlines.



    How to Apply

    Please apply directly online at http://www.dana-farber.org/Careers/Careers-at-Dana-Farber.aspx. Click Search Job Openings and use the Job ID number to quickly locate the appropriate job listing. Once you have located the desired job, click on the checkbox in the 'Select' column, and then click the 'Apply Now' button, located at the bottom of the screen.

    DFCI Employees please apply directly through PeopleSoft Self Service. Sign on to PeopleSoft and navigate to Main Menu > DFCI Careers.



    Equal Employment Opportunity

    Dana-Farber Cancer Institute is an equal opportunity employer and affirms the right of every qualified applicant to receive consideration for employment without regard to race, color, religion, sex, gender identity or expression, national origin, sexual orientation, genetic information, disability, age, ancestry, military service, protected veteran status, or other groups as protected by law.




    Apply Here

    PI92699505


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  • 01/12/16--23:53: QC RESEARCH ASSOCIATE
  • Quality Control Research Associate

    NO PHONE CALLS OR AGENCIES PLEASE

    Duties and Responsibilities:

     Selecta Biosciences is seeking a talented Research Associate to join its Analytical Development team to provide Quality Control testing and routine analysis support for the development of preclinical and clinical products based on the company’s proprietary Synthetic Vaccine Particle platform.

     Reporting to the head of the Analytical Development routine and QC testing group, the position’s primary responsibility is to produce timely and accurate data for analyses targeting a variety of nanoparticle components such as small molecules, peptides, proteins, oligosaccharides, oligonucleotides, and synthetic polymeric materials.

     The Research Associate will have experience in analysis of raw materials, drug substances or drug products.  Proficiency in the hands-on use and troubleshooting of a variety of HPLC techniques is desirable for this role. Experience in other analytical techniques such as SDS-PAGE, protein content methods, spectrophotometry and pH, is a plus. The candidate will also have experience with timely and high quality documentation, and familiarity with instrumentation maintenance.

     The successful candidate will independently generate analytical data, participate in the transfer of methods developed by the group’s scientists and will work closely in strengthening the routine analytical portfolio of the organization through data acquisition and method trending. As the Analytical Development group interacts closely with the Chemistry, Formulation, Process Development, and Biology groups, the candidate will contribute to transparent and reliable cross-functional collaboration to support manufacturing, regulatory filings and stability programs. 

     Education and Experience Requirements:

    A degree in Chemistry or related field, a B.S. with 3-5 years of relevant industry experience, or an M.S. with 0-2 years of industry experience, is required. Title and compensation will be commensurate to experience.  

     Additional requirements include:

    -       Experience in HPLC separations including reversed-phase, GPC and normal phase with a variety of detection modes and plate-based assays is desired

    -       Excellent critical thinking

    -       Excellent written and verbal communication

    -       Strong attention to details and organizational skills

    -       Excellent teamwork and collaborative skills

    Work Environment

    -          An employee in this position works in an environment in which safety, environmental and health concerns may demand constant attention. Strict adherence to Company policies, rules, and regulations in these as is required.

    -          While performing the duties of this job, the employee handles hazardous chemicals in the laboratory. The employee will be required to wear all appropriate safety equipment including but not limited to eye protection, gloves, shoes, and lab coat. Position may require long periods of standing

    -          The Company has active programs on developing novel immunotherapies for various food and environmental allergies.  An employee may be required to work with and/or be exposed to allergens in the laboratory. 

     Qualified candidates should send a cover letter, resume, and salary requirements to: careers@selectabio.com. Please refer to Job Code QCRA when corresponding about this position. 

    Selecta is an Equal Employment Opportunity employer of Minorities, Females, Disabled Individuals, and Veterans (M/F/D/V).

     


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    GENERAL SUMMARY OF POSITION:

    Under the supervision of the Principal Investigator or designee, the Research Laboratory Technician I, performs a variety of specimen preparatory techniques, dry lab data collection, and routine laboratory maintenance. This Research Lab Technician position will conduct and assist in the development of protocols to execute/perform complex research experiments. You will also:

    • Construct and analyze plasmids using common molecular biology techniques (e.g. restriction digest, gel purification, ligation, sequencing, etc.)
    • You will also assist in the maintenance of laboratory stock reagents, assist in carrying out experiments, maintaining lab organization, recordkeeping, artwork, keeping chemical waste records, ordering supplies and lab neatness
    • Assist with compiling standard operating procedures and maintaining inventory
    • Comply with all safety and infection control standards appropriate to this position

     

    MAJOR RESPONSIBILITIES:

    • Perform a variety of laboratory experiments using both routine and special techniques and methods
    • Assist in more complex laboratory tasks
    • Collect, analyze, and process laboratory samples
    • Record results, organize data, and perform basic computations
    • Maintain laboratory supplies and equipment
    • Comply with all safety and infection control standards
    • Perform other duties as required

    REQUIRED QUALIFICATIONS:

    • Bachelor's degree in Biological Science or equivalent experience
    • Knowledge of Microsoft Office products
    • Ability to perform duties independently
    • Judgment and action skills required to solve commonly encountered problems

    PREFERRED QUALIFICATIONS:

    • Knowledge of genetics, cell biology and molecular biology
    • Previouse mouse work experience
    • Experience with restriction digest, gel purification, ligation, sequencing
    • Proficient computer skills
    • Ability to interact with departmental and institutional offices

     



    Apply Here

    PI92700016


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  • 01/13/16--00:28: Quality Assurance Auditor I
  • BASIC SUMMARY:

    Responsible for all activities involving quality assurance and compliance with applicable regulatory requirements; conducts audits and reviews/analyzes data and documentation. Has knowledge of commonly-used concepts, practices, and procedures within a particular field. Relies on instructions and pre-established guidelines to perform the functions of the job. Works under direct immediate supervision. Typically reports to a supervisor or manager.

     ESSENTIAL DUTIES AND RESPONSIBILITIES:

    • Review/audit study (GLP) data, SOP’s, and other research data in support study reports.
    • Performs scheduled internal and vendor audits, produces Quality Assurance Inspection Reports  with supervision.
    • Reads and understands documentation for new and current compliance procedures and regulatory enforcement trends/actions.
    • Demonstrates ability to work accurately, follow instructions/schedules/timelines.
    • Knowledge of FDA, and/or OECD and cGxP regulations and guidelines.

    QUALIFICATIONS:

    Bachelor's degree in area of specialty and 0-2 years of direct experience in the field related area; or High School degree or equivalent with a minimum of 4 years experience in a GXP environment and 1-2 years direct QA experience.

    COMPETENCY STATEMENTS:

    • Accountability - Ability to accept responsibility and account for his/her actions.
    • Communication, Oral - Ability to communicate effectively with others
    • Communication, Written - Ability to communicate in writing clearly and concisely.
    • Decision Making - Ability to make critical decisions with supervision.
    • Detail Oriented - Ability to pay attention to the minute details of a project or task.
    • Organized - Possessing the trait of being organized or following a systematic method of performing a task.

    SKILLS & ABILITIES:

    Computer Skills - General computer skills including Microsoft Word, Excel and Power Point

     WORK ENVIRONMENT:

    • Animal facility and laboratories with moderate noise possible
    • Exposure to hazardous/noxious devices (e.g., needles, scalpel blades etc) and chemicals (e.g., anesthetic gases, formalin, alcohols, xylenes, etc)
    • General office working conditions, with generally quiet noise conditions

    COMMENTS:
    This position may require occasional duties on weekends and/or holidays.


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    Our exciting high growth Pharmaceutical client is seeking a meticulous QA Operations Specialist to join their talented QA team.  This is an opportunity for you to provide administrative / technical support in all department initiated improvement projects as well as aid in ensuring compliance to applicable standards and regulations as needed.  This exciting opportunity is also looking for these additional requirements:

    • A Bachelor’s Degree in a scientific discipline with 3-5 years pharmaceutical industry experience within Quality Assurance
    • Working knowledge of FDA & cGMPs
    • Strong organizational, planning, project management and communication skills and the ability to perform varied tasks in a disciplined, consistent manner.
    • Excellent interpersonal skills
    • Ability to read, analyze, and interpret technical procedures and regulations.
    • Highly proficient in using MS Excel & Word

    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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    We have an exciting newly created opportunity for an outstanding scientist in our virology group.  The ideal candidate is an expert on Respiratory Syncytial Virus (RSV), who will be mainly responsible for selecting and characterizing drug-resistance mutants, culturing clinical isolates in vitro, and performing antiviral studies. 

    Primary Responsibilities:

    • Obtain RSV clinical isolates and establish culturing and testing in house
    • Perform resistance selection with novel RSV inhibitors in vitro and characterize mechanism of resistance
    • Build reverse genetics system in house to analyze RSV mutants
    • Support in vivo efficacy studies, analyze tissue samples for viral load reduction
    • Perform time-of-addition study and investigate mechanism of action of novel inhibitors                                               

    Qualifications:

    • Interpersonal Skills– Strong interpersonal and project management skills.  
    • Communication Skills - Solid oral, written communication, and presentation skills.
    • Productivity/Organizing/Planning – Must be proactive and self-disciplined and Meets deadlines, demonstrates effective use of time, and handles multiple assignments simultaneously.
    • Collaboration & Teamwork– Advanced competence in collaboration & teamwork.

    Education and Experience Requirements:

    • Ph.D. in virology with 5+ years of relevant experience
    • Prior knowledge and experience working with RSV is highly desired.

    How to Apply:

    Please include the following attachments with your application to https://theapplicantmanager.com/jobs?pos=et136&fs=1.0em:

    • Cover Letter
    • CV

    For more information on this position, or to see other current openings, log into our website at http://www.enanta.com/careers/.

    Enanta offers employees a competitive total compensation package including a competitive base salary, bonus, stock options, and an excellent benefits package. 

    All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability, protected veteran status or any other class protected by law.

    Enanta Pharmaceuticals is an EO employer – M/F/Veteran/Disability

     

     

                                           *  *  *

     

     


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  • 01/13/16--01:01: Scientist
  • Overview

    We are seeking a highly-motivated and proactive individual to join our R&D team as consulting scientist focusing on mitochondria biology study.  The successful applicant will participate in independent and collaborative product research efforts targeted at characterization of key process elements and development of novel products using cutting-edge technology. This position involves the usage of several different cellular, molecular, and biochemical techniques.

      Responsibilities

    - Design and conduct experiments to characterize mitochondria functions including ATP production, oxidative phosphorylation, membrane potential, and other features. 
    - Evaluate mitochondria DNA mutation status using sequencing and/or qPCR. 
    - Determine mitochondria activity in oocytes and other cell types

    - Analyze experimental findings using statistical methods, database queries, and other tools 
    - Record experimental designs, results, and conclusions in both electronic and paper format 


      Qualifications

    - Ph.D in cell biology, molecular biology or related field with a minimum of three years of practical laboratory experience is required.
    -  Proficient in mitochondria biology and demonstrated hands-on experience in mitochondria functional assays including, but not limited to, mitochondria membrane potential, proton leak, ATP production, calcium signaling, and oxophos activity.

    - Previous experience on sample preparation and data analysis of electron microscopy is required.

    - Candidates should demonstrate the ability to understand, apply, and evaluate cell biology, biochemistry, and mathematical principles.
    - Experienced in primary and stem cell culture.

    - General cellular and molecular technical skills are required including immunocytochemistry, biochemistry assays, and PCR.

    - Candidate should be detail oriented and able to work collaboratively in a team-based environment.

    - Successful candidates should possess strong technical writing and presentation skills, knowledge of research laboratory and safety guidelines.
    - Candidates should have the ability to work in a multidisciplinary environment and should display excellent organizational and communication skills.


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  • 01/13/16--01:04: Scientist, Toxicology
  • We are seeking an experienced toxicologist to contribute to the success of an exciting small molecule drug pipeline. As a key team member, this role is responsible for the toxicology studies needed to bring discovery candidates forward and to support development projects.  This includes study design, dosage selection, study initiation and monitoring, data review, study reports and regulatory submissions. The successful candidate will report to the Director, Toxicology.

    Responsibilities:

    • Design toxicology studies needed to support pharmaceutical development projects
    • Initiate studies at approved contract facilities following appropriate processes for protocol development, contract implementation, test article procurement, and timeline commitments
    • Monitor studies for accuracy and timely completion, audit raw data for accuracy, and review draft reports for completion
    • Anticipate study problems and opportunities and raise issues with suggested resolutions to supervisor    
    • Ensure appropriate project management and oversight for multiple CROs
    • Prepare verbal and written summaries of study reports for internal discussions
    • Contribute to various regulatory documents and ensure regulatory compliance

    Qualifications:

    • Commitment to quality and accountability
    • Strong oral communication skills and demonstrated proficiency at technical writing are essential 
    • Excellent organizational skills and solid project management skills required to apply to extensive interactions with multiple CROs and external study monitoring responsibilities
    • Effective problem solving skills and judgment
    • Proficient at working independently as well as in team settings

    Education & Experience Requirements:

    Ph.D. or equivalent in Toxicology, Pathology, Pharmacology or related health science field strongly preferred; candidates with a M.S. degree will be considered if supported by additional years of demonstrated relevant experience. 

    Certification by the American Board of Toxicology (DABT) highly desired

    At least 3-5 years’ experience as a toxicology Study Director or as a coordinator of toxicology programs at a pharmaceutical company

    Working knowledge of GLP regulations, ICH and other regulatory guidance documents, and experience conducting and monitoring toxicology studies are critical

    Experience in supporting drug development teams and preparing IND filings is beneficial

    Other Job Requirements

    0-25% travel

    How to Apply:

    Please submit your cover letter and CV to https://theapplicantmanager.com/jobs?pos=et137&fs=1.0em.

    For more information on this position, or to see other current openings, log into our website at http://www.enanta.com/careers/.

    Enanta offers employees a competitive total compensation package including a competitive base salary, bonus, stock options, and an excellent benefits package. 

     All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability, protected veteran status or any other class protected by law.

    Enanta Pharmaceuticals is an EO employer – M/F/Veteran/Disability

                                           *  *  *

     


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  • 01/13/16--01:12: Research Associate
  • Overview

    We are seeking a highly-motivated and proactive individual to join our dynamic R&D team as a Research Associate.  The successful applicant will participate in semi-independent research efforts targeted at the development of novel, cutting-edge reproductive technology. This position involves the use of several different cellular, molecular, and biochemical techniques to support the lead scientist.

    Responsibilities

    -Support projects at the bench level using a variety of techniques and methodologies

    -Isolate specific cell types using FACS and establish and maintain primary tissue/cell culture

    -Imaging and monitoring of primary cultures using microscopy

    -Perform tissue manipulation/dissections using fine techniques

    -Analyze experimental findings using statistical methods, database queries, and other tools

    -Record experimental designs, results, and conclusions in both electronic and paper format

    Qualifications

    -BS/MS in cell biology, molecular biology or related field with requirement of at least three years of industry experience

    -Hands-on experience on cell isolation techniques from primary tissue such as FACS

    -Experienced in microscopy and working with fine dissection techniques

    -General cellular and molecular technical skills are required including cell culture and PCR

    -Confident in technical writing and presenting, knowledge of research   laboratory and safety guidelines

    -Ability to work in a multidisciplinary environment

    -Excellent organizational and communication skills

    -Detail oriented and works collaboratively in a team-based environment


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    Working primarily at the Harvard Medical School location  of the Office of Technology Development (OTD), the position will provide essential support in a fast-paced office by performing contract review and administrative duties relating to the processing, negotiation, and signing of Material Transfer Agreements (MTAs). MTAs are contracts that govern the sending and receiving of research material to and from labs at Harvard.  Responsibilities related to MTAs include, but are not limited to, handling all correspondence (email, phone or in-person) with requesting scientists, other departments at Harvard, and all correspondence with outside parties; creating and updating accurate records in a database; preparing outgoing agreements and making changes to incoming agreements as stipulated by Harvard policy; obtaining authorized signatures; administrative duties related to the agreements; participating in projects as needed.

    College graduate or equivalent, preferably with some general business training.  Minimum one to two years related work experience, plus strong customer service orientation and sills, and excellent oral and written communications.  Solid administrative office skills, including proficiency with MS Office applications, Adobe Acrobat, and databases, e-mail, and the Internet is essential.

    Familiarity with legal agreements highly preferable.  Preference given to those with the ability to manage multiple tasks simultaneously, prioritize and work well under pressure; ability to work independently with minimal supervision; attention to detail, discretion, diplomacy, flexibility, good judgment; and demonstrated ability to handle confidential information.

    Job Req # on Harvard jobs website: 38093BR

    Link: 

    https://sjobs.brassring.com/TGWebHost/jobdetails.aspx?SID=^JqSy8VQ8ZHS%2f_slp_rhc_2n_slp_rhc_AFVjq7ggNNsAS4ph_slp_rhc_yJ2TnSQWajYrUwoQXu_slp_rhc_9pA_slp_rhc_ChRlQnBW&jobId=1183321&type=search&JobReqLang=1&recordstart=1&JobSiteId=5341&JobSiteInfo=1183321_5341&GQId=0

     


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  • 01/13/16--01:58: Marketing Manager, HCP
  •  

     Overview

     The Marketing Manager, Healthcare Professionals is a customer facing position that develops clinic marketing materials across multiple platforms and manages programs for healthcare professionals to introduce OvaScience treatments. This position will be based in Waltham and will support global marketplace.

     Responsibilities

     - Ensure company and product marketing messages are creatively and professionally presented to clinics, healthcare professionals (HCPs), patients and investors about OvaScience treatments.

     - Develop thought leaders and nurture close relationships with KOLs and other stakeholder groups to support HCP programs

         - Work closely with Medical Affairs organization and HCPs to develop professional medical education content and programs.

          - Develop and introduce clinic and HCP communication materials across multiple global regions that support brand messages (e.g. brochures, presentations, web sites, training events, videos, webinars, KOL events, trade shows).

     -       Support the sales organization with targeted marketing tools that bring qualified leads through the sales    and marketing funnel.

     -        Support field sales team with all requests for the treatment portfolio information and prepare and deliver field sales training and marketing presentations.

     -       Be a reliable partner to customers, the sales team, medical affairs and brand leaders to identify unmet clinic and HCP marketing needs and then create tools or programs to meet those needs.

     -       Organize and manage professional HCP events for a life sciences company; including medical education symposia or webinars, trade shows, Sales training, Advisory Board and KOL meetings.

     -       Work closely with brand leaders, patient marketing, patient advocacy, corporate communications/PR, and   appropriate content review teams to ensure integrated and compliant deliverables.

     -         Implement systems to effectively capture and disseminate leads from trade shows and congresses.

     -       Identify new program or service growth opportunities. Prepare business case and plans or proposals to gain internal support.

     -          Manage relationships with vendors who support development of materials, events, and projects specifically related to physician marketing.

     -  Test messages and marketing tools with HCP’s to ensure appropriate brand representation and effectiveness.

     -  Assist in the development of pricing programs and treatment positioning strategies to optimize revenue, market share and profitability

     -  Help to develop a budget for physician marketing activities in support of key brands and work within agreed upon limits.

     - Interface effectively with key internal and external constituents. Be a strong cross-functional partner in the company. Provide key customer insights to   business partners to help guide strategic direction.

     Qualifications

     Education and Experience:

     -       Minimum 5 years of healthcare marketing, sales, or medical education experience

     -       Bachelor’s degree in business, life sciences or related health sciences discipline strongly preferred, MBA or similar preferred

     -       Experience in women’s health a plus 

     Knowledge, Skills and Abilities:

     -       Self-starter who is focused and results-driven with strong strategic thinking, process and business management experience, qualitative and analytical skills.

     -       Experience working effectively in a team-oriented, collaborative, and fast-growing environment

     -       Proven experience leading initiatives; managing projects from inception to completion

     -       Experience creating sales or customer-facing materials and programs

     -       Ability to quickly develop relationships and rapport with individuals at all levels

     -       Ability to manage multiple projects and to prioritize tasks in a fast-paced environment.

     -       Ability to travel up to 30%, including some weekends

     -       Must possess outstanding leadership and communication skills, including experience presenting to large groups

     -       Proven knowledge, skill, and ability to create, write, and analyze business, marketing, product plans

     Attributes:

     -       Works best in an environment with open and constructive feedback

     -       Strong written and verbal marketing communication skills

     -       Goal-oriented and well organized

     -       Ability to effectively collaborate with multiple levels and functions in a company

     

     


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    Our client, an oncology focused biotech in Waltham, MA is searching for a high caliber Associate Director of Clinical Operations to join their growing team! This is a phenomenal, not to be missed opportunity with potential for growth within an immune-oncology focused company working towards improving cancer patients lives. The selected individual will supervise clinical related activities from study start up through close out, and will interact closely with the entire team.

    The perfect fit for this role will have a thorough understanding of clinical trial mechanics and possess strong leadership qualities. Responsibilities for this role also include preparation of clinical documents & study reports, as well as management of study timelines and maintenance of tracking study metrics so organizational qualities and attention to detail are key characteristics for success in this position. 

    This amazing opportunity is looking for someone who also meets the following requirements:

    • Master’s degree in life sciences of healthcare discipline
    • At least 7 years clinical trial management experience
    • 2 years of clinical monitoring in biotech/pharmaceutical industry
    • Some oncology trial experience required
    • Leadership & supervisory qualities
    • Excellent written & verbal communication skills
    • Ability to travel an average of 25%

    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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  • 01/13/16--06:47: Head, Information Technology
  • CompanyOverview

    The mission of CRISPR Therapeutics is to develop transformative gene-based medicines for patients with serious diseases. Our therapeutic approach is to cure diseases at the molecular level using the breakthrough gene editing technology called CRISPR-Cas9.

    With our multi-disciplinary team of world-renowned academics, drug developers and clinicians, we are uniquely positioned to translate CRISPR-Cas9 technology into human therapeutics. We have licensed the foundational CRISPR-Cas9 patent estate for human therapeutic use from our scientific founder, Dr. Emmanuelle Charpentier.

    We are headquartered in Basel, Switzerland, our R&D operations are in Cambridge, Massachusetts and we have corporate offices in London, United Kingdom.

    Investors

    CRISPR Therapeutics has raised a total of $89 million in Series A and B rounds since April 2014. Our investors include SR One, Celgene Corporation, New Enterprise Associates, Abingworth and founding investor, Versant Ventures.

    Partnerships

    CRISPR Therapeutics is establishing strategic partnerships with pharmaceutical companies that are interested in using the breakthrough CRISPR-Cas9 technology to develop treatments for serious diseases.

    For more information, please visit www.crisprtx.com

    Position Summary

    We are seeking head of information technology to support our rapidly growing and evolving company. The head of information technology will be responsible for all aspects of information technology from coordinating desktop support via vendors to implementing cloud storage systems and creating FDA and Sarbanes-Oxley compliant systems.

    This is an exciting and interdisciplinary role for a highly qualified and motivated individual. The successful candidate will be a confident leader, with attention to detail and significant prior success in information technology in the biotechnology industry. The successful candidate will have experience in a wide array of information systems from desktop systems to databases and cloud storage to LIMS and lab systems. The successful candidate will have knowledge of Scientific (e.g., LIMS, ELN), G & A systems (i.e., finance, HR) and familiarity with 21CFR Part 11.  Finally, the successful candidate will be energized by solving new and different challenges and creating solutions within a growing company. We are seeking someone with a sense of urgency for helping to enable an exciting company that is developing new medicines for serious diseases and who is interested in forging new and uncharted paths to patients for the exciting CRISPR technology.

    Responsibilities

    • Responsible for all information technology activities (strategic plan/architecture and operations)

    • Work collaboratively with the management team

    • Ensure effective communication within company and across vendors to align IT with corporate strategy

    • Accountable for creation of a plan for all information technology implementation and prioritization

    • Understand and drive technology to support / enable general and administrative and research functions

    • Responsible for external IT service provider selection and management

    • Interface with, and coordinate with relevant functional groups to ensure timely execution of all IT program implementations, including risk management and mitigation

    • Foster a culture of ownership and accountability including continuous benchmarking, evaluation, recognition and improvement

    • Partner with finance and functional leaders to develop capability and capacity needs, budgets, and monitors spending; develop scenario planning for decision making

    • Responsible for ensuring adherence to any and all applicable regulations. Responsible for ensuring that all internal teams maintain compliance as required

    • Build relationships with key stakeholders both at CRISPR Therapeutics and at any Alliance Partners / vendors to ensure cross company IT needs are appropriately addressed

    Minimum Qualifications

    • BS Computer Science (or related) and 10 years experience in life sciences industry, with 5 years of demonstrated information technology leadership

    • Outstanding leadership and management skills with an integrated view of business and scientific issues, and demonstrated passion for participating in high growth, high energy companies

    • Ability to work independently and successfully in a matrix environment, prioritize and manage multiple tasks simultaneously, integrate cross-functional issues and balance competing priorities effectively

    • Proficiency in MS Office suite

    • Strong oral and written communication skills, a high degree of energy, accuracy and attention to detail, and a passion for delivering important new medicines to patients with devastating diseases

    Preferred Qualifications

    • Advanced degree

    • Experience in Sarbanes-Oxley and FDA compliant systems, experience with Linux

    • Business degree or extensive business training

    Competencies

    • Leverage Systems &Technology– Uses systems and technology in a facile way. Identifies opportunities to improve processes through systems and technology.

    • Leverage Vendor Resources– Understands vendor needs, interests and full range of offerings and maximizes benefits to the Company. Manages vendors effectively.

    • Results Oriented– Drives issues to closure and gets the job done.

    • Strategic Thinking – The ability to develop strategies and goals that recognize business issues, opportunities, and environment.

    • Problem Solving– The ability to understand a situation, task or problem by breaking it down into smaller pieces using a systematic approach and to identify patterns and connections between situations that are not obviously related.

     

    If interested and qualified, please include Requisition # 2015-115 in the subject line when emailing resume to: careers@crisprtx.com.


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    CompanyOverview

    The mission of CRISPR Therapeutics is to develop transformative gene-based medicines for patients with serious diseases. Our therapeutic approach is to cure diseases at the molecular level using the breakthrough gene editing technology called CRISPR-Cas9.

    With our multi-disciplinary team of world-renowned academics, drug developers and clinicians, we are uniquely positioned to translate CRISPR-Cas9 technology into human therapeutics. We have licensed the foundational CRISPR-Cas9 patent estate for human therapeutic use from our scientific founder, Dr. Emmanuelle Charpentier.

    We are headquartered in Basel, Switzerland, our R&D operations are in Cambridge, Massachusetts and we have corporate offices in London, United Kingdom.

    Investors

    CRISPR Therapeutics has raised a total of $89 million in Series A and B rounds since April 2014. Our investors include SR One, Celgene Corporation, New Enterprise Associates, Abingworth and founding investor, Versant Ventures.

    Partnerships

    CRISPR Therapeutics is establishing strategic partnerships with pharmaceutical companies that are interested in using the breakthrough CRISPR-Cas9 technology to develop treatments for serious diseases.

    For more information, please visit www.crisprtx.com

    Position Summary

    Reporting to the Chief Scientific Officer, the successful candidate will establish the process development and manufacturing strategy for novel gene editing-based products, both ex-vivo cell-based therapies and in vivo therapies. The successful candidate will develop the internal process development and manufacturing function in the company, and direct all process development, technology transfer and manufacturing, supply chain, quality and regulatory support as needed for all preclinical and clinical product development and commercial supply. The successful candidate will develop strong business relationships with CROs and CMOs, monitor and manage all manufacturing or technical issues and deviations as they arise. Key interactions include close collaboration with Research, Preclincal Pharmacology and Assay development, Regulatory, and Non-Clinical Toxicology, as well as with Project Management and Finance to develop and maintain detailed, robust project plans and financial management.

    Responsibilities

    • Establish (together with senior management) and manage overall process development and manufacturing strategy for novel gene editing-based products

    • Oversee all CRO and CMO activities, including providing RFPs, obtaining and selecting bids, contracting, performance management and financial control  

    • Oversee the transfer of research-based manufacturing methodologies into process development and develop industrial processes to ensure robust manufacturing at scale

    • For each product establish and execute a detailed strategic manufacturing plan

    • Ensure robust processes to ensure quality and implementation of ‘in-process controls’ for product development and regulatory requirements

    • Ensure appropriate and timely product supply and overall global supply chain management as needed for all preclinical GLP toxicology and clinical studies

    • Establish, together with Head of Regulatory Affairs, the regulatory manufacturing strategy for each product and provide content for all regulatory filings as needed

    • Manage CMC activities required to ensure successful regulatory filing – including cell line development and banking, other development & manufacturing, analytical characterization, formulation/stability or other activities as required

    • Ensure appropriate timely and transparent representation of Process Development and Manufacturing activities to Project teams and subteams as requested and required

    • Provide and ensure that all written study proposals, development reports and regulatory documents. Ensure adherence to high technical standards and compliance with applicable regulatory guidelines in the generation of process data to support development and filing

    • Develop and manage department budgets and external spend with the appropriate fiscal controls and management

    Minimum Qualifications

    • Doctorate in a relevant scientific discipline and a minimum of 15 experience in industry

    • Direct management of process development or manufacturing functions for advanced therapy medicinal products (gene or cell therapy products)

    • Prior success with process development and technology transfer to manufacturing for an advanced therapy medicinal product (gene or cell therapy product)

    • Prior success with multiple regulatory IND or CTA filings and providing drug product supply for early stage clinical trials for advanced therapy medicinal products (gene or cell therapy products)

    Preferred Qualifications

    • Direct experience overseeing or implementing Quality in the process development and manufacturing fields, experience with QBD preferred

    • Knowledge of immunology, transplantation and gene therapy a plus

    Competencies

    • Risk and Compliance Management– Demonstrates great attention to detail and assures appropriate output. Identifies situations where risk may arise and implements risk mitigation processes and strategies.

    • Adaptability / Perseverance– Adjusts to working effectively within a variety of situations; adapts enthusiastically to organizational change and to changes in job demands. Shows initiative and demonstrates learning orientation and flexibility. Pursues tasks with energy, drive and enthusiasm, even in the face of adversity.

    • Job Knowledge– Achieves and maintains technical and professional proficiency related to current job position and areas of expertise

    • Results Orientation / Productive Work Habits– Drives issues to closure and gets the job done. Skilled at analyzing scope of work, as well as planning and executing a successful outcome. Understands and assigns / utilizes resources effectively and efficiently.

    • Leverage Vendor Resources– Understands vendor needs, interests and full range of offerings and maximizes benefits to the Company. Manages vendors effectively.

    • Customer Partnering– The ability to develop and foster relationships of trust and mutual respect through assuring accessibility and responsiveness. Demonstrates knowledge of the customer’s function including key issues, processes, metrics, goals, needs and terminology. Proactively works with customer to address issues.

    If interested and qualified, please include Requisition # 2015-114 in the subject line when emailing resume to: careers@crisprtx.com.


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  • 01/13/16--06:54: Head of Regulatory Affairs
  • CompanyOverview

    The mission of CRISPR Therapeutics is to develop transformative gene-based medicines for patients with serious diseases. Our therapeutic approach is to cure diseases at the molecular level using the breakthrough gene editing technology called CRISPR-Cas9.

    With our multi-disciplinary team of world-renowned academics, drug developers and clinicians, we are uniquely positioned to translate CRISPR-Cas9 technology into human therapeutics. We have licensed the foundational CRISPR-Cas9 patent estate for human therapeutic use from our scientific founder, Dr. Emmanuelle Charpentier.

    We are headquartered in Basel, Switzerland, our R&D operations are in Cambridge, Massachusetts and we have corporate offices in London, United Kingdom.

    Investors

    CRISPR Therapeutics has raised a total of $89 million in Series A and B rounds since April 2014. Our investors include SR One, Celgene Corporation, New Enterprise Associates, Abingworth and founding investor, Versant Ventures.

    Partnerships

    CRISPR Therapeutics is establishing strategic partnerships with pharmaceutical companies that are interested in using the breakthrough CRISPR-Cas9 technology to develop treatments for serious diseases.

    For more information, please visit www.crisprtx.com

    Position Summary

    We are seeking a Regulatory leader to drive the overall success of our programs. The Regulatory strategist will build and lead the regulatory capabilities for our key programs. The individual will be responsible for all regulatory interactions and activities, including driving meetings, communications and submissions to US and EU agencies. The individual will work collaboratively with the leadership and project teams to deliver on program goals / objectives, and to support all preclinical and clinical studies.

    This is an exciting and interdisciplinary role for a highly qualified and motivated individual. The successful candidate will be a confident leader, with attention to detail and significant prior success in regulatory in the preclinical and early clinical stage programs in the biotechnology industry. The successful candidate will also have a solid scientific understanding the biology of genome technologies and multiple modes of therapeutics including cell based, viral and gene therapy, and will be ready to understand and create regulatory pathways for novel genomic therapeutics. Finally, the successful candidate will have a deep knowledge of all aspects regulations and practices in both the US and EU. We are seeking someone with a sense of urgency for developing important new medicines for devastating diseases and who is interested in forging new and uncharted paths to patients for the exciting CRISPR technology.

    Responsibilities

    • Accountable for all regulatory activities

    • Work collaboratively with the project teams to create a plan for all regulatory interactions, including driving novel thinking and pathways for gene editing products

    • Understand and drive regulatory strategy for all programs within CRISPR

    • In collaboration with the project teams and discovery scientists, establish early FDA/EMA/MHRA interactions and credibility, submitting briefing books and driving interactions

    • Ensure high quality and timely regulatory submissions

    • Coordinate with relevant functional groups to ensure timely execution of regulatory activities, including anticipating and identifying risks, mitigations and contingencies, and supporting timely action plans and issue resolution

    • Ensure effective communication within, and across the Company to align regulatory activities with corporate strategy, and ensure effective program execution

    • Foster a culture of ownership and accountability, including; continuous benchmarking, evaluation, recognition and continuous improvement

    • Partner with finance and functional leaders to develop budgets, including; capability and capacity needs, and monitors spend against budgets; develops scenario planning for decision-making

    • Ensure compliance with all applicable regulations

    • Ensure internal teams are driving compliance within their functions

    • Build relationships with key stakeholders both at CRISPR Therapeutics and at any Alliance Partners to ensure high quality decision making

    Minimum Qualifications

    • 15 years experience in life sciences industry, with 5+ years of demonstrated regulatory strategy and key submissions (IND, NDA, BLA etc)

    • Outstanding leadership and management skills with an integrated view of business and scientific issues, and demonstrated passion for creating new medicines

    • Advanced degree in the life sciences (PhD or MBA)

    • Excellent verbal and written communication skills

    • Ability to work independently and successfully in a matrix environment, prioritize and manage multiple tasks simultaneously, integrate cross-functional issues and balance competing priorities effectively

    • Proficient in MS Office suite

    • Familiar with cell and molecular biology techniques

    • High degree of energy, accuracy and attention to detail, and a passion for delivering important new medicines to patients with devastating diseases

    Preferred Qualifications

    • Experience leading gene editing or gene therapy programs

    • Business degree or extensive business training

    Competencies

    • Relationship Building– Builds and maintains productive working relationships across a diverse spectrum of people

    • Problem Solving– The ability to understand a situation, task or problem by breaking it down into smaller pieces using a systematic approach and to identify patterns and connections between situations that are not obviously related

    • Job Knowledge– Achieves and maintains technical and professional proficiency related to current job position and areas of expertise

    • Results Oriented– Drives issues to closure and gets the job done

    • Product Creation - Effective and efficient discovery strategies that will enable us to achieve ~1 IND/year

    • Strategic Thinking– The ability to develop strategies and goals that recognize business issues, opportunities, and environment

    • Integrity and Trust– Acts ethically and gains the trust and respect of others

     

    If interested and qualified, please include Requisition # 2015-2015-119 in the subject line when emailing resume to: careers@crisprtx.com.


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    Company Overview

    The mission of CRISPR Therapeutics is to develop transformative gene-based medicines for patients with serious diseases. Our therapeutic approach is to cure diseases at the molecular level using the breakthrough gene editing technology called CRISPR-Cas9.

    With our multi-disciplinary team of world-renowned academics, drug developers and clinicians, we are uniquely positioned to translate CRISPR-Cas9 technology into human therapeutics. We have licensed the foundational CRISPR-Cas9 patent estate for human therapeutic use from our scientific founder, Dr. Emmanuelle Charpentier.

    We are headquartered in Basel, Switzerland, our R&D operations are in Cambridge, Massachusetts and we have corporate offices in London, United Kingdom.

    Investors

    CRISPR Therapeutics has raised a total of $89 million in Series A and B rounds since April 2014. Our investors include SR One, Celgene Corporation, New Enterprise Associates, Abingworth and founding investor, Versant Ventures.

    Partnerships

    CRISPR Therapeutics is establishing strategic partnerships with pharmaceutical companies that are interested in using the breakthrough CRISPR-Cas9 technology to develop treatments for serious diseases.

    For more information, please visit www.crisprtx.com

    Position Summary

    We seek an accomplished Physician to develop translational and clinical plans for our lead programs in hematology and other therapeutic areas.

    The successful candidate will be responsible for strategic development and tactical implementation of the early clinical studies for our lead programs. This will include providing direct medical/physician oversight for phase 1 and proof of concept clinical trials, and clinician input into all aspects of discovery and preclinical development, from target selection to preclinical and regulatory strategy and tactics. The ideal candidate will have a thorough understanding of the principles of pharmacology, nonclinical (toxicology) and regulatory requirements for testing new therapies in humans, and experience working closely with clinical operations.

    Responsibilities

    • Understand (and eventually develop into local expert for) the underlying scientific principles of the disease indications and pipeline molecules being studied

    • Provide clinical and scientific input into Discovery Research and Early Development activities, including disease education, target identification, lead selection, preclinical pharmacology POC, nonclinical toxicology, biomarker strategy and IND enabling studies, to develop optimal translational medicine approaches to facilitate development to clinical POC

    • Contribute to the development of robust product development plans for each program, including providing content for clinical development and other sections, as needed

    • Identify and establish relationships with leading KOL’s and principal investigators, including organizing and running KOL meetings, as needed

    • Develop (and where appropriate, with clinical operations) protocol synopses and protocols

    • Oversee clinical trials as medical monitor

    • Regularly review patient eligibility / enrollment and clinical trial data

    • Oversee, review and approve clinical study reports, as needed

    • Work closely with biometrics and clinical operations to ensure clinical operations and development program success

    • Contribute to the development of regulatory strategy and act as the medical expert in meetings with regulatory authorities

    • Ensure and support effective leadership, management and governance, and seamless collaboration across all areas of Research and Development

    Minimum Qualifications:

    • A medical degree (MD or equivalent) and a minimum of 3 years experience in the pharmaceutical or biotech industry

    • Medical monitor experience in preclinical and early clinical development, or clinical translational medicine

    • Experience in the development of biologics, in particular Cell and Gene Therapy (or Advanced Therapy Medicinal Product) product development

    • Experience with regulatory activities in US and EU, as well as direct experience with IND filing required

    • Understanding of the principles of pharmacology as well as nonclinical (toxicology) requirements for testing new therapies in humans

    • Fluent English, excellent written and verbal communication skills with successful presentation capabilities

    • Ability to travel on average 20% of the time (range 0-30% each month).

    • Excellent oral and written communication skills

    • Ability to work in a team-oriented environment

    • Scientifically rigorous, highly organized, and with significant attention to detail

    Preferred Qualifications

    • Strong scientific research or clinical background in hematology, experience with hemoglobinopathies preferred

    • Experience with orphan / rare disease product development

    • Prior experience advising on NDA submissions

    Competencies

    • Scientific Rigor/Attention to detail– Maintains high scientific rigor and attention to detail in designing and testing hypotheses and analyzing data. Challenges assumptions, demonstrates highly organized thinking and documentation.

    • Product Creation - Effective and efficient discovery strategies that will enable us to achieve ~1 IND/year

    • Relationship Building– Builds and maintains productive working relationships across a diverse spectrum of people

    • Communication and Teamwork– Effectively expresses ideas in written, visual, and oral context. Able to work co-operatively with others; the genuine desire to be a part of a team and contribute to organizational and team goals.

    • Passion - Creates an exciting environment where there is a true passion for the vision of CRISPR Therapeutics to bring novel medicines to patients suffering from serious diseases.

    • Results Orientation / Productive Work Habits– Drives issues to closure and gets the job done. Skilled at analyzing scope of work, as well as planning and executing a successful outcome. Understands and assigns / utilizes resources effectively and efficiently.

     

    If interested and qualified, please include Requisition # 2015-118 in the subject line when emailing resume to: careers@crisprtx.com.


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    Org Marketing Statement
    A career at Pfizer offers opportunity, ownership and impact.

    All over the world, Pfizer colleagues work together to positively impact health for everyone, everywhere.Our colleagues have the opportunity to grow and develop a career that offers both individual and company success;be part of an ownership culture that values diversity and where all colleagues are energized and engaged;and the ability to impact the health and lives of millions of people. Pfizer, a global leader in the biopharmaceutical industry,is continuously seeking top talent who are inspired by our purpose to innovate to bring therapies to patients that significantly improve their lives.

    Role Description
    We are seeking an experienced research scientist to join the CTI-GBT group in our antibody-based therapeutic discovery efforts. The successful candidate will be responsible for lead selection and optimization to develop various immuno-oncology therapeutic modalities employing molecular biology, biochemistry, structural modeling and antibody engineering skills. The candidate is expected to contribute to more than one therapeutic program in parallel, design and execute antibody screening and engineering campaigns employing advanced biochemistry and cell biology techniques and assess therapeutic intervention employing appropriate antibody modalities. The candidate should exhibit excellent collaborative and communication skills working on cross-functional multi-disciplinary teams.

    Responsibilities
    The candidate will be responsible for:
    1. Designing of antibody generation and screening strategy and delivering therapeutic candidates on multiple projects in collaboration with CTI biology teams.
    2. Developing, optimizing and executing high throughout binding assays (ELISA, Octet) for screening antibody panels.
    3. Optimization of antibodies and alternate formats to fit the biology using antibody engineering techniques
    3. Developing cell based assays to characterize hits and leads for binding to Fc receptors and targets expressed on primary cells, assessing effector functions utilizing various sources of effector cells, re-targeting tumor cells to different immune cell types and measuring cytotoxicity.
    4. Documenting experimental data, presenting hypotheses, experimental data, conclusions and interpretations at departmental and cross-functional team meetings.
    5. Contributing to patent application examples, writing scientific publications and presenting at conferences.

    Qualifications
    MS or PhD in molecular/cellular biology, biochemistry, structural biology, immunology or a related discipline with 5-7 years for MS and 2-4 years for PhD of research experience in academia and/or Biotech/Pharmaceutical environment, a record of significant achievements in research, scientific creativity, excellent communication and leadership skills and ability to work in a multidisciplinary, team-oriented environment.

    * Experience in the design, execution, and analysis of biochemical, molecular, and/or cellular assays.
    * Hands-on work experience in the following therapeutic areas: oncology, immunology, inflammatory or autoimmune diseases.
    * Demonstrated experience in cell based assay development to aid the design & testing of therapeutics from discovery to lead-optimization
    * Self-motivated with extremely strong written and oral communication skills, organizational skills, demonstrated ability to work in a highly collaborative environment and ability to achieve high quality results

    Required:
    * Technical proficiency with cell biology pertaining to therapeutic antibody drug discovery and development. Technical skills should include extensive experience with most or all of the following: PCR, RT-PCR, TaqMan, ELISA, immunocytochemistry, advanced FACS analysis and other reliable sophisticated techniques that enable binding and functional assessment of therapeutic antibodies on cells
    * Computational tools for molecular biology and database management, Microsoft Office, GraphPad Prism
    -Experience in structure modeling of antibodies is a plus

    Preferred:
    * Prior experience with therapeutic antibody generation and engineering
    * Technical expertise in establishment and validation of cell-based assays utilizing primary cells and blood cells especially using FACS, MSD, luminex etc.
    * Experience in immunomodulation

    PHYSICAL/MENTAL REQUIREMENTS
    Ability to perform data analysis.


    Please apply at: Application URL:http://www.aplitrak.com/?adid=QWxpc29uLlR1dGx5cy4yMDA3OS4zMTY3QHBmaXplci5hcGxpdHJhay5jb20


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