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Career postings for the Massachusetts Biotechnology Council

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  • 11/05/15--06:38: Import Manager
  • CLIENT: BIOTECH COMPANY

    COMPENSATION: $$$

    • Write/update and maintain policies and procedures related to management of US imports 
    • Prepare training materials on US import compliance. 
    • Develop and manage broker Standard Operating Procedures (SOP) 
    • Assign the Harmonized Tariff Schedule (HTS) product codes and FDA codes required for importation of products and shipments. 
    • Maintain all records related to shipments he/she is involved in. Responsible for record-keeping for import operations. 
    • Respond to internal customers and external suppliers on requests for proper classification, Country of Origin and customs valuation. 
    • Work with Compliance Manager to negotiate fees and approve payments of invoices from US Customs, government agencies, and brokers. 
    • Assist US personnel in completing applications to obtain required import/export permits, i.e. Drug Enforcement Agency (DEA), Food and Drug Administration (FDA), Center for Disease Control (CDC), etc. 
    • Provide broker clearance instructions and required documentation for imports for Biogen 
    • Responsible for maintaining current certifications/Permits: bond, FDA, F&W, USDA as well as annual renewal 
    • Ensure compliance with all applicable government agencies.
    • Participation on project teams as requested 

     

    1+ years experience in a similar role in the Bio/pharma Industry 

    Customs Broker License or Certification Customs Specialist highly desirable 

    5-7 years’ experience managing an import compliance program for a manufacturer.


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    Tempero is one of GlaxoSmithKline’s Discovery Performance Units (DPU) within the Immuno-Inflammation Therapeutic Area, and it is located in Cambridge, MA.

    We are seeking a highly motivated and experienced PhD-level medicinal chemist to join our drug discovery team and play an important role in our efforts to develop novel therapeutics for the treatment of inflammatory and autoimmune diseases. This individual will have the opportunity to become the lead chemist in a new program, contribute to and execute the medicinal chemistry strategy and get involved in the early science of this new program.

    Key responsibilities include:                                       

    • Work in partnership with cross-functional teams to design and synthesize novel small molecule ligands for high value targets in various stages of optimization.
    • Design new analogs based on biological data, analyze and interpret biological data and establish SAR hypotheses, and contribute/craft the medicinal chemistry strategy for the project.
    • Independently plan and implement efficient synthetic routes to complex molecules of interest, applying state of the art purification, and characterization techniques for lead optimization and SAR generation.
    • Develop new synthetic methods as needed, and help identify and implement innovative technologies.
    • Analyze, interpret, and report experimental results in a small group setting
    • Maintain detailed records of experiments in lab notebooks in accordance with company policy
    • Share in responsibilities to support general lab functions
    • Contribute to writing and conceptual framework of publications, presentations and patents.
    • Establish and maintain a detailed knowledge of literature related to areas of research.

    Basic qualifications:

    • Ph.D. in organic chemistry, with 5-10 years of drug discovery experience.
    • Broad and deep knowledge of practical organic chemistry and current synthetic methodology.
    • Deep understanding of medicinal chemistry principles.
    • Excellent understanding of small molecule drug discovery.
    • Excellent written and oral communication skills.
    • Ability to work effectively in a multidisciplinary matrix environment.
    • Team spirit and excellent interpersonal skills
    • Effective leadership skills
    • Self‐motivated with focus on enterprise thinking

    Preferred qualifications:

    • Experience in project leadership, ability to set the overarching medicinal chemistry strategy for a project.
    • Strong record of peer reviewed publications.
    • Learning agility and a strong desire to continuously improve and develop.

     

    Apply on the Company Website.


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    Tempero is one of GlaxoSmithKline’s Discovery Performance Units (DPU) within the Immuno-Inflammation Therapeutic Area, and it is located in Cambridge, MA.

    We are seeking a highly motivated and experience PhD-level medicinal chemist to join our drug discovery team and play an important role in our efforts to develop novel therapeutics for the treatment of inflammatory and autoimmune diseases. This individual will have the opportunity to become the lead chemist in a new program, contribute to and execute the medicinal chemistry strategy and get involved in the early science of this new program .

    Key responsibilities include:

    • Lead the chemistry efforts to design and synthesize novel small molecule ligands for high value targets in various stages of optimization.
    • Design new analogs based on biological data, analyze and interpret biological data and establish SAR hypothesis.
    • Independently plan and implement efficient synthetic routes to complex molecules of interest, applying state of the art purification, and characterization techniques for lead optimization and SAR generation.
    • Develop new synthetic methods as needed, and help identify and implement innovative technologies.
    • Analyze, interpret, and report experimental results in a small group setting
    • Maintain detailed records of experiments in lab notebooks in accordance with company policy
    • Share in responsibilities to support general lab functions
    • Contribute to writing and conceptual framework of publications, presentations and patents.
    • Participate in the initiation and management of new drug discovery programs. 
    • May manage external chemists and serve as a source of synthetic chemistry expertise.

    Basic qualifications:

    • Ph.D. in organic chemistry, with 7-10 years of drug discovery experience.
    • Broad and deep knowledge of practical organic chemistry and current synthetic methodology.
    • Deep understanding of medicinal chemistry principles, and experience in developing medicinal chemistry plans.
    • Experience in project leadership, ability to set and execute the overarching medicinal chemistry strategy for a project.
    • Excellent understanding of small molecule drug discovery.
    • Excellent written and oral communication skills.
    • Ability to work effectively in a multidisciplinary matrix environment.
    • Team spirit and excellent interpersonal skills
    • Effective leadership skills
    • Self‐motivated with focus on enterprise thinking

    Preferred qualifications:

    • Strong record of peer reviewed publications.
    • Experience in managing chemistry outsourcing would be an advantage.
    • Learning agility and a strong desire to continuously improve and develop.

     Apply on Company Website.


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    Job Description:

    The candidate will play a key hands-on role in the characterization of 121 Bio diagnostic antibody leads, with a specific focus on their validation in mouse tumor studies.

     

    Primary R&D activities and responsibilities include:

    • Expression and purification of antibodies.
    • Antibody characterization, including demonstration of antibody performance in flow cytometry.
    • Establishment and characterization of tumor mouse models, with a focus on tumor immunology assays (ex vivo analyses of immune infiltrating cells, analysis of T cell activation, preparation of specimens for histology,).
    • Sourcing, characterization and maintenance of tissue culture cell lines, including tumor cell lines and primary immune cells.
    • Collection and organization of samples for downstream analyses.
    • Managing routine laboratory operations, including ordering supplies and ensuring that equipment meets the needs of R&D staff.

     

    Typical experiments may include expression and purification of antibodies in bacterial systems, flow cytometry analyses on primary immune cells and tumor cell lines, subcutaneous or intravenous injection of tumor cell lines in mice, monitoring of tumor-bearing mice and recording of vital signs, post-mortem tumor dissection and analysis by a variety of techniques.

    The candidate will be responsible for data analysis, thorough documentation of the work, and clear communication of results in group settings.

     

    Qualifications and experience:

    • Bachelor’s or Master’s degree in biology or a related field.
    • 2-5 years of relevant laboratory experience in an academic or industrial setting.
    • Expertise in the following techniques is required:
      • Molecular biology and protein analysis, including SDS-PAGE and western blotting.
      • Cell culture.
      • Flow cytometry.
      • Mouse handling and general mouse husbandry procedures.
      • Implantation of tumor cell lines subcutaneously or intravenously.
      • Collection of serum/plasma/whole blood, tissues, primary tumor material and metastases.
      • Additional experience in isolation and manipulation of primary immune cells, immune function cell-based assays, and whole animal or ex-vivo imaging is a plus.

       

    Company profile:  121 Bio, LLC, a privately-held, early-stage life sciences company in Cambridge, MA, is positioned to become the premier company for antibody diagnostics to aid in immuno-oncology patient management.  The company was founded by James Gorman, M.D., Ph.D., a veteran biologics dealmaker, antibody R&D executive and biotech entrepreneur, and is based on groundbreaking molecular immunology research in the laboratory of scientific founder Hidde Ploegh, Ph.D., a Professor of Biology at Massachusetts Institute of Technology and a member of the Whitehead Institute for Biomedical Research.

     

    The company is looking for highly motivated, hard-working, dedicated people with an entrepreneurial spirit and flexibility, to be rewarded by the opportunity to grow with a fast-paced and dynamic new organization.


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    Tempero is one of GlaxoSmithKline’s Discovery Performance Units (DPU) within the Immuno-Inflammation Therapeutic Area, and it is located in Cambridge, MA.

    We are seeking an experienced and highly motivated BS/MS organic/medicinal chemist to join our drug discovery team and play an important role in our efforts to explore novel targets and develop therapeutics for the treatment of inflammatory and autoimmune diseases

    Key responsibilities include:                                       

    • Design and implement synthetic schemes to facilitate efficient access to a diverse range of organic compounds
    • Apply parallel synthesis as applicable, as well as purification and characterization techniques
    • Regular and clear communication of data and ideas within multidisciplinary teams
    • Maintain detailed records of experiments in lab notebooks in accordance with company policy
    • Share in responsibilities to support general lab functions
    • Contribute to writing and conceptual framework of publications, presentations and patents
    • Establish and maintain a detailed knowledge of literature related to areas of research

    Basic qualifications:

    • BS degree in Organic Chemistry with 5+ years or MS degree with 3+ years of full-time laboratory research experience in organic or medicinal chemistry
    • Ability to work effectively in a multidisciplinary matrix environment
    • Demonstrated independence in decision making
    • High level of scientific and personal integrity
    • Excellent written and oral communication skills
    • Team spirit and excellent interpersonal skills
    • Self‐motivated with focus on critical and innovative thinking

    Preferred qualifications:

    • Proficiency in identifying SAR, with an ability to contribute to the design and prioritization of synthetic targets
    • Experience with structure-based drug design is preferred
    • Learning agility and a strong desire to continuously improve and develop

    Apply on Company Website.


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  • 11/05/15--07:30: Administrative Assistant
  • Position: Administrative Assistant

    TARIS Biomedical is a unique therapeutically-focused urology company developing drug-device combination products for the treatment of genitourinary diseases. The Administrative Assistant reports to the Executive Assistant/Office Manager. This position requires strong inter-personal and organizational skills, and the ability to use Excel and Word software.

     

    Primary responsibilities include but are not limited to the following:

    • General administrative & clerical support, as needed, for all non C-level staff
    • Manage front desk, answer phones, greet and assist visitors
    • Filing, scanning, reminders, faxes, and correspondence, as requested, including Accounts Payable
    • Update employee and consultant phone contact information
    • Keep inventory of all office & kitchen supplies and replenish as needed
    • Organize and facilitate on-site company meals
    • Maintain a clean, organized office, including kitchen and conference rooms
    • Run company errands such as grocery store, post office, etc as needed
    • Manage telephone system and printer/copier services
    • Manage and plan company meetings, special events and gatherings
    • Receive, sort, and distribute daily US mail
    • Shipping express packages including completing air bills
    • Time-off tracking
    • Maintain & update company website
    • Post open positions to company website and job posting sites
    • Perform other related duties as required

     

    Skills:

    • High degree of professionalism
    • Excellent communication, interpersonal and organizational skills
    • Attention to detail
    • Strong initiative
    • Able to work independently and maintain high level of confidentiality
    • Multi-tasking, works well under pressure

     

    Qualifications and experience:

    • Proficient in Microsoft Office Products including Word, Excel & PowerPoint
    • Previous administrative experience

     

    To apply, please send your CV to careers@tarisbio.com


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    COMPANY:

    The development of CRISPR/Cas9 gene editing technology opens a new frontier in biomedical research and clinical intervention. Adapted from a natural cellular process, CRISPR/Cas9 permits the editing of any gene in any organism with unprecedented simplicity and flexibility. Intellia was founded in 2014 by Caribou Biosciences and Atlas Venture, along with a consortium of leading scientists who have helped define the space. Intellia Therapeutics holds exclusive access to a broad intellectual property portfolio covering the application of CRISPR/Cas9 technology for human therapeutic use.

    APPLY HERE: http://grnh.se/w3qeua

    SUMMARY:

    Intellia is seeking highly skilled and motivated formulation Research Associate to join our team. The primary responsibilities for this position will be to prepare and characterize formulations for the delivery of nucleic acids and proteins for both ex vivo and in vivo applications.  Experience with nanoparticle formulation and/or related analytics (HPLC, DLS, SEC, LC/MS) is desired. 

    GENERAL RESPONSIBILITIES:

    • Support formulation efforts including optimization and analytical development
    • provide high quality material for in vitro and in vivo evaluation
    • Conduct experiments, independently and in collaboration with colleagues in support of project goals.
    • Design, implement, troubleshoot and modify experiments to reach desired goals.
    • Communicate research and development findings with internal and external partners.
    • Operate and maintain multiple laboratory instruments.
    • Assist in maintaining general laboratory functionality, including lab equipment maintenance and the ordering and receiving of lab supplies.

    REQUIRED SKILLS:

    • Design, create and characterize formulations for the delivery of nucleic acid and proteins.
    • Collaborate with internal groups in pharmacology and biology for the testing of formulations in PD/PK/Tox studies.
    • Work with Production group for scale up of formulations.

    QUALIFICATIONS:

    • Bachelor’s Degree in Biochemistry or Chemistry with at least 5 years of industry experience, or M.S. in Biology or Biochemistry with at least 2 years of industry experience.
    • Experience with production of various lipid-based formulations at scales sufficient for rodent and higher species in vivo work.

     

    APPLY HERE: http://grnh.se/w3qeua

     

    COMPETENCIES:

    Attention to detail

    Exceptional time management

    Effective communication skills (both written and oral)

    Ability to work independently and collaboratively

      

    POSITION: Full-Time, Exempt

    EEOC Statement: Intellia believes in a diverse environment, and is committed to equal employment opportunity for all its employees and qualified applicants. We do not discriminate in recruitment, hiring, training, promotion or any other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, marital or veteran status, disability, or any other legally protected status. Intellia will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law.


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  • 11/05/15--09:41: Training Specialist
  •  

    Summary

    Coordinate the training program covering cGMP requirements, OSHA regulations, security and corporate policy, and other topics to a broad spectrum of professional individuals that serve company’s manufacturing plant, research and development laboratories, and general business operations.

     

    Responsibilities and Tasks

    • Evaluate training needs and participate in the development and delivery of training materials for the company including Manufacturing, Quality, and Support groups ensuring compliance with the training policy and all training procedures
    • Administer the LMS and coordinate training activities, including scheduling sessions, updating training records, generating reports, etc.
    • Responsible for maintaining a compliant record keeping (data entry and hard-copy files) system
    • Assist  in developing curricula of on-the-job training requirements including appropriate documentation, qualifying trainers, and assuring approved training content and working with area supervision, manages assignments within the learning management system
    • Support efforts to determine effective instructional procedures and/or training methods such as individual training, group instruction, self-study techniques, demonstrations, and computer based training as appropriate
    • Work with area managers to determine training frequency/re-training intervals based on roles and responsibilities.
    • Assist in developing training assessment tools, such as tests and competency evaluation worksheets
    • Interact and assist with the Health, Safety, and Environmental Department and other departments to ensure that all training components are current, accurate, well crafted, and effective
    • Update and/or modify contractor training presentations and related training materials as needed to address routine or unique training needs
    • Performs other duties as assigned

     

    Knowledge Skills and Abilities

    • Experience with Learning Management Systems
    • Experience in Manufacturing and Quality positions, preferably both
    • Experience performing work that requires decision making and the consistent exercise of independent judgment and discretion
    • Experience in developing and managing various types of training initiatives expected; background in Instructional Design, adult learning theory, and class-room style training highly preferred
    • Working knowledge of a Quality Management System (QMS) and adherence to 21 CFR Parts 210, 211; aseptic drug manufacturing experience a plus
    • Ability to present self in a professional, credible manner and communicate effectively at all levels of the organization
    • Ability to prioritize and organize own work, multi-task, meet deadlines and keep commitments
    • Excellent administrative & organization skills
    • Superior internal and external customer service/people skills
    • Ability to manage multiple responsibilities and training projects in a fast paced environment, while performing in an efficient manner
    • Public speaking, instructional presentation skills and/ or instructor-led training experience is required
    • Positive attitude; values others and works well independently and in a team environment
    • Excellent verbal, written and interpersonal communication skills
    • Works under minimal supervision following established procedures along with own judgment.
    • Must have a strong understanding of FDA and other cGMP regulatory requirements as they relate to industrial and non-industrial tasks at a biotech manufacturing facility and/or R&D facility
    • Must have excellent computer skills, including MS Word, PowerPoint and Excel.  Experience with commercially available CBT authoring tools a plus.

    Education and Experience

    • Bachelor’s Degree in related field or equivalent required; Teaching/instructional degree preferred;
    • 1 plus years of experience in developing, delivering and assessing training in both individual and classroom settings, and experience working in a regulated environment, pharmaceutical/biotech industry preferred

    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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    This position will require relocation to New York area.

    At Regeneron, we are driven by science and motivated by patients, every step of the way. We are voted #1 Biopharmaceutical Employer in Science Magazine for 3 years in a row and FORTUNE 100 Best Company to Work For. Regeneron commercializes medicines for eye diseases, high LDL-cholesterol, and a rare inflammatory condition and has a robust pipeline in development in other areas of high unmet medical need, including immuno-oncology, rheumatoid arthritis, asthma, atopic dermatitis, pain, and infectious diseases. Currently, we have over 50 R&D  job openings in Tarrytown, New York. Please visit us at http://careers.regeneron.com and apply to the jobs and connect with us!

    Research Associate IV – Oncology ( Patient-Derived Xenograft ) – 2 openings

    Job ID: 5008BR & 5009BR

    This is an ideal career opportunity for an experienced PDX model researcher to advance his/her career in management of a preclinical translational research unit focusing on hematological malignancies (Job ID: 5008BR) or solid tumors (Job ID: 5009BR).  You will be responsible for the generation, propagation and analysis of PDX models representing various patient tumor types and will be critically involved in establishing a PDX repository for Regeneron's Oncology Research teams.

    Qualifications:

    • BS/BA/MA/MS in biomedical sciences or related field
    • 3-5+ years of experience working with PDX tumors
    • In vivo mouse experience: Extensive experience in utilizing PDX tumor models (implantation of frozen and fresh patient-derived tumor tissue, monitoring tumor growth, iv, sc, ip, im injections, minor surgeries and necropsy) is a must
    • Highly proficient in FACS based analysis of in vivo hematologic cell populations (5008BR)
    • Experience with solid PDX tumor models and tissue processing, sectioning and histology / IHC (5009BR)

    Please submit your application online at:

    5008BR Research Associate IV - Hematological malignancies PDX

    https://sjobs.brassring.com/TGWEbHost/jobdetails.aspx?partnerid=25570&siteid=5080&jobId=554910&code=MassBio

    5009BR Research Associate IV - Solid tumors PDX

    https://sjobs.brassring.com/TGWEbHost/jobdetails.aspx?partnerid=25570&siteid=5080&jobId=554923&code=MassBio

    Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, sexual orientation, gender identity, disability status, protected veteran status, or any other characteristic protected by law.

     


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    ABOUT NEW ENGLAND CONTROLS:

    New England Controls, an Emerson Local Business Partner, is the leading solutions supplier of process control and information technology solutions in the New England region.
    New England Controls is looking for entrepreneurial, hard-working, fun-loving people who have a desire to work with the latest technology and the brightest minds to solve our customers' problems. Our people are differentiated by their high energy and do-what-it-takes attitude. We see ourselves as one team working together with a passion to serve the customer first. Our customers and partners include the most significant Life Sciences, Energy, Pulp and Paper, and Chemical companies.

    New England Controls provides a professional environment where you can grow, be independent and contribute to a shared spirit of creativity and innovation. As an ESOP (Employee Stock Ownership Plan) company, "we don't just work here, we own the place!""The leader in process control products, solutions and service - because we hire the best."

    POSITION SUMMARY:

    The Advanced Services Engineer is expected to be a technical resource to customer projects that require the design, development and implementation of databases, manufacturing execution systems, system interfaces and/or reporting systems based on the service lines that constitute the Advanced Services business at New England Controls.  These services may include but are not limited to the following areas:

    • Install, configure and maintain Manufacturing Execution Systems and the interfaces between an MES and other systems including control systems

    • Installation and configuration of data collection systems, databases and historians to collect and organize manufacturing data

    • Design, development and deployment of manufacturing intelligence tools (including OSI PI Process Book) to evaluate information captured by MES, process historians and other data collection systems.

    He/she shall be responsible for developing and implementing the configuration and/or the custom software components necessary to meet the project requirements for the project to which he/she is assigned.

    The Advanced Services Engineer is expected to continuously improve his/her technical skills through interaction with Senior Engineers and Managers during development and implementation of software deliverables and the peer review process.

    PRINCIPAL DUTIES AND RESPONSIBILITIES:

    • Interact with Senior and Principal Advanced Services Engineers to understand the customer requirements and subsequent system design of manufacturing execution system components / functions, manufacturing intelligence system user interfaces and database reports.

    • Provide services in several of the following services areas based on his/her specific experience:

    o   From the design provided by the project leadership, develop and implement configurations for the Syncade and/or Werum manufacturing execution systems.

    o   From the design provided by project leadership develop and implement configurations for data historian systems such as OSI PI and DeltaV as well as the associated data visualization modules such as OSI PI Process Book.

    o   Based on the design provided by project leadership, develop and implement custom developed web parts, web pages and reports to present data to customers in an easy to use and meaningful format.

    o   Based on the design provided by project leadership develop and implement custom software solutions for the management of customer information in support of manufacturing intelligence projects.

    • Execute his/her responsibilities in accordance with New England Controls policies and procedures including but not limited the quality systems Project Management Plan (QUA-901) and safety plans.

    • Perform other duties as assigned

    REQUIRED SKILLS AND EXPECTATIONS:

    • Excellent written and oral communication skills

    • Excellent interpersonal skills within and across work functions as well as with superiors

    • Ability to work independently based on the task guidance as provided by others.

    • Ability to configure Manufacturing Execution Systems, manufacturing intelligence tools, Process Control System historians and interfaces between these systems and enterprise resource planning systems

    • Computer programming and debugging skills with specific emphasis on Visual Basic or VB Script, C#, SQL, Javascript, HTML5, and XSLT Style Sheets.

    ADDITIONAL DESIRED CAPABILITY:

    • Ability to design, implement, and interrogate relational database schemas for Warehouse and Datamart infrastructures

    • Ability to design, implement, and modify SQL Server Integration Services packages (or similar ETL applications)

    • Experience with Microsoft .NET and associated tools, specifically Visual Studio 2010 or greater, C#.Net, Razor Syntax, LINQ, ASP.NET/MVC, Entity Framework, and jQuery

    • Ability to design, implement, and troubleshoot web based UI applications

    • Experience with Agile project execution processes

    HIRING SPECIFICATIONS:

    • Bachelor’s Degree in Electrical, Mechanical, Automation, Bioengineering or Chemical Engineering or equivalent.

    • Demonstrated success in development and implementation of configured and/or custom software solutions using Visual Basic or VB Script, C#, SQL, Java, and/or HTML Style Sheets or equivalent.

    • 2 to 5 years' experience in a combination of process control, automation, software product development or information systems management in pharmaceuticals, biotechnology or other life sciences industries.

    POLICY ON THIRD-PARTY UNSOLICITED RESUME SUBMISSIONS: Please note that any third-party unsolicited resume submissions will immediately become the property of New England Controls. New England Controls will not pay any fee to a submitting employment agency, person, or entity unless a signed agreement is established.


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  • 11/04/15--23:43: QC Microbiologist I
  • 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

    Record GMP data, monitors and evaluates QC systems and equipment Recommend improvements to procedures, and revise SOP’s and GMP documentation as required Interact with internal and external auditors including government agencies and contract manufacturing representatives Perform release, stability, validation and complaint follow-up assays on raw materials, in-process and final products Perform microbial identification related to product and environmental testing Perform sampling of raw materials as required for QC testing Perform routine quality control testing as required and monitors or evaluates systems, equipment (i.e. water systems, environmental chambers, sample collection and testing instruments/equipment) Maintain records in paper based or computer based systems Execute method validation protocols related to product testing Author summary reports for executed method validations Author deviation reports and microbiological assessment reports related to departmental activities and product support Provide technical input on product testing issues and instrumentation/equipment Serve as liaison to service, calibration and technical representatives Conduct and document assay failure and complaint investigations Ensure that laboratory is in cGMP compliance and conduct inspections

    Knowledge Skills and Abilities

    Experience in pharmaceutical microbiology and microbiology testing not limited to endotoxin, method validation, sterility, bioburden, microbial identification, growth promotion and environmental monitoring testing; ability to perform standard and non-standard microbiology techniques to analyze product Excellent verbal, written and interpersonal communication skills Proficient at following specific instruction (i.e. written SOPs) Working knowledge of cGMP/GLP Good computer skills including word processing and working with spreadsheets

    Education and Experience

    BS in related scientific field required

    0-2 years 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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    RaNA Therapeutics, located in Cambridge, Massachusetts, is pioneering the discovery and development of a new class of RNA-based therapeutics that selectively activate protein expression. RaNA’s novel drugs restore the expression of beneficial proteins through epigenetic mechanism. We focus on developing treatments for diseases with a significant unmet need that are difficult or impossible to address with existing technologies. Our lead programs include the upregulation of SMN2 for the treatment of Spinal Muscular Atrophy and the upregulation of Frataxin for the treatment of Friedreich’s Ataxia. Along with these lead programs, we are targeting other rare genetic diseases, musculoskeletal diseases and inflammatory diseases. We are dedicated to translating cutting-edge science in the areas of gene regulation, lncRNA and epigenetics into drugs that will have a significant impact in the treatment of life-threatening diseases. 

    We are looking for a self-motivated and detail-oriented molecular biologist to join the RaNA Discovery group. She/he is responsible for developing protocols and establishing SOPs for a variety of NGS experiments. In particular, to generate high quality NGS libraries from low-input samples. Additionally, she/he will function in a matrix environment to support in vitro screening efforts in drug discovery programs.

    General responsibilities:

    • Develop SOPs for NGS library preparation from low input samples.
    • Perform QCs for assays and reagents; troubleshoot library preparations.
    • Prepare NGS libraries and run them on a NGS instrument.
    • Work with the Bioinformatics team to track NGS samples and integrate NGS output into downstream analysis pipeline.
    • Maintain the sequencer and consumables.
    • Maintain detailed documentation of library preparations.
    • Perform in vitro screening using established cell based assays.

    Qualifications and required skills:

    • A./M.S in biology, biochemistry, molecular biology, or related field with >2 years of relevant experience.
    • Expertise in common molecular biology techniques (RNA isolation, cDNA synthesis, RT-qPCR).
    • Extensive experience in preparing NGS libraries using different kits.
    • Experience in barcoding and balancing library pools.
    • Experience in running and maintaining a sequencing instrument.
    • Bioinformatics knowledge and/or cell culture experience are pluses.
    • Excellent organizational and time management skill to meet timelines and deliverables.
    • Excellent communication skills; must be able to discuss technical points with scientists across the R&D organization.

    RaNA Therapeutics is committed to equal employment opportunity. All applicants must have authorization to work in the U.S. RaNA has a competitive employee benefits package that includes health/dental insurance, 401K retirement plan and company match, paid vacation, and much more.


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    RaNA Therapeutics, located in Cambridge, Massachusetts, is pioneering the discovery and development of a new class of RNA-based therapeutics that selectively activate protein expression. RaNA’s novel drugs restore the expression of beneficial proteins through epigenetic mechanism. We focus on developing treatments for diseases with a significant unmet need that are difficult or impossible to address with existing technologies. Our lead programs include the upregulation of SMN2 for the treatment of Spinal Muscular Atrophy and the upregulation of Frataxin for the treatment of Friedreich’s Ataxia. Along with these lead programs, we are targeting other rare genetic diseases, musculoskeletal diseases and inflammatory diseases. We are dedicated to translating cutting-edge science in the areas of gene regulation, lncRNA and epigenetics into drugs that will have a significant impact in the treatment of life-threatening diseases. 

    We are looking for a self-motivated and detail-oriented molecular biologist to join the RaNA Discovery group. She/he is responsible for developing protocols and establishing SOPs for a variety of NGS experiments. In particular, to generate high quality NGS libraries from low-input samples. Additionally, she/he will function in a matrix environment to support in vitro screening efforts in drug discovery programs.

    General responsibilities:

    • Develop SOPs for NGS library preparation from low input samples.
    • Perform QCs for assays and reagents; troubleshoot library preparations.
    • Prepare NGS libraries and run them on a NGS instrument.
    • Work with the Bioinformatics team to track NGS samples and integrate NGS output into downstream analysis pipeline.
    • Maintain the sequencer and consumables.
    • Maintain detailed documentation of library preparations.
    • Perform in vitro screening using established cell based assays.

    Qualifications and required skills:

    • A./M.S in biology, biochemistry, molecular biology, or related field with >2 years of relevant experience.
    • Expertise in common molecular biology techniques (RNA isolation, cDNA synthesis, RT-qPCR).
    • Extensive experience in preparing NGS libraries using different kits.
    • Experience in barcoding and balancing library pools.
    • Experience in running and maintaining a sequencing instrument.
    • Bioinformatics knowledge and/or cell culture experience are pluses.
    • Excellent organizational and time management skill to meet timelines and deliverables.
    • Excellent communication skills; must be able to discuss technical points with scientists across the R&D organization.

    RaNA Therapeutics is committed to equal employment opportunity. All applicants must have authorization to work in the U.S. RaNA has a competitive employee benefits package that includes health/dental insurance, 401K retirement plan and company match, paid vacation, and much more.


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  • 11/05/15--01:52: Sr. Clinical Trial Manager
  • SUPER URGENT - Sr. CTM opportunity on the SPONSOR side!

     

    JOB ORDER TITLE
    Senior Clinical Trials Manager

    Marlborough, MA

     

    1. Manages/oversees the conduct and execution of assigned clinical trials and associated activities in accordance with Good Clinical Practices (GCP) and relevant national and international requirements.


    2. Assist with the review and determination of appropriate site and vendor selection and ensuring all vendors meet the predetermined program milestones.


    3. Interacts with internal and external groups (CROs, vendors, clinical sites, etc.) to facilitate clinical trials and achieve designated timelines. Serves as primary Sponsor contact for vendors, CRO counterparts in Global study through start-up and study execution.


    4. Responsible for review, approval of monitoring trip reports and issue resolution with CRO monitoring team and site staff as needed.


    5. Oversees study timelines, clinical trial budgets, coordinates development of study plans, CRF's and other study reports and reviews and approves monitoring reports as appropriate. Reviews CRO site monitoring calendars, tracks site visits, tracks monitoring report issuance and receipt, conducts initial reviews of reports, to assure that full internal reviews are conducted on a timely basis


    6. Oversees and participates in review of clinical trial data and clinical trial files. Provides clinical review of annual reports, IB updates.


    7. Participates in periodic review and revision of departmental policies and SOPs to assure compliance with GCP and corporate policies.


    8. Participates in special projects as appropriate


    9. Maintains professional and technical knowledge by staying current on pharmaceuticals industry research and developments as appropriate; by utilizing the resources made available by the Company; and by sharing information with colleagues.


    10. Keeps management informed by escalating issues requiring intervention to the study and project teams under the supervision of the Associate Director/Director


    11. Acts on constructive feedback by using feedback from peers, Supervisors, and colleagues to improve performance and ability to provide constructive feedback to direct reports and colleagues.


    Skills:


    Knowledge and skills indicate the education level, previous experience, specific knowledge, skills and abilities necessary to meet the minimum requirements for this position.


    Knowledge and skills (general and technical):


    Extensive knowledge of clinical development principles, theories and concepts and knowledge of pharmaceutical industry practices and standards, including GCP.


    Familiarity with the lifecycle of a clinical trial: from protocol development and feasibility through study close-out and reporting.


    Ability to manage complex and global clinical trials. Pediatrics study management experience preferred


    Excellent written and oral communication skills in order to effectively communicate in English. Ability to communicate in medical and scientific terms with vendors, consultants, and peers in English.


    Ability to read, analyze and interpret professional journals, technical procedures, and/or government regulations in English. Ability to write reports, business correspondence and procedure manuals in English.


    Ability to effectively present information to and respond to questions from groups of managers, sites, etc.


    Ability to solve problems and deal with a variety of concrete variables in situations where only limited standardization exists.


    Must be tactful, mature, flexible, and have well-developed interpersonal skills. Ability to get along well with different personalities and to work well in teams.


    Must have demonstrated ability to work independently and in a team, and provide leadership in a management role.


    Must have experience interfacing and managing multiple vendors/ contractors.


    Ability to manage time, multi-task and prioritize in order to complete deliverables on schedule.


    Computer skills needed include strong knowledge of database and word processing: MS Word, MS Project, PowerPoint, and Excel


    Education level and/or relevant experience(s):


    Bachelor's degree from a four-year university or college; and 4-7 years (Mgr) or 6- 10 years (Sr. Mgr) work experience in the healthcare or clinical trial industry monitoring and managing clinical trials; or equivalent combination of education and experience.

     


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    Job ID: 26978
    Date Posted: 10/02/2015
    Date Closed: 09/24/2015
    Location: BWH 75 Francis Street
    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

    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.

    Performs professional work in support of scientific research. Under general supervision, assists in determining the most suitable methods to be used in research; independently performs scientific investigative procedures requiring application of professional judgment and technology; interprets results and determines whether they are consistent with experimental goals; reviews literature; assists in the assembly, organization and interpretation of data.

     

    PRINCIPAL DUTIES AND RESPONSIBILITIES:

    Performs technical procedures such as immunohistochemistry, fluorescent in situ hybridization, electrophoresis or other assays; prepares materials for microscopic examination.

    • Performs recombinant DNA procedures such as plasmid and prove subcloning and preparation, isolation of DNA nucleic acid hybridization, and polymerase chain reaction.
    • Prepares and processes blood and tissue specimens from human subjects.
    • Prepares and maintains tissue and bacterial cultures.
    • Operates instruments and equipment such as spectrophotometer, scintillation counters, centrifuges, fluorimeter, incubators and light microscopes.
    • Operates ancillary equipment such as photographic equipment and computer equipment.
    • Under the PI supervision, performs evaluation of immmunohistochemistry and immunofluorescence stains utilizing computer-based image analysis systems.
    • Manages and maintains database containing experimental results and reagent information and storage locations
    • Conducts literature reviews to assist in determining most suitable methods to be used in research.
    • Prepares and presents written or oral progress reports concerning studies, including assembly, organization and interpretation of data.
    • Performs statistical analysis of data.
    • Prepares laboratory reagents, chemicals, instruments and equipment.
    • Orders chemicals, reagents and other laboratory supplies.
    • Performs routine maintenance and minor repairs of laboratory apparatus and instruments.
    • Maintains a clean, orderly work area within the laboratory.
    • Undertakes standard decontamination procedures prior to disposal of certain laboratory materials.
    • Functions as the laboratory safety officer, responsible for compliance with all regulatory requirements, and the safe use of hazardous materials in the laboratory, including radioactive, biological and chemical agents.
    • May assist in supervising the work of other assigned laboratory personnel.
    • May demonstrate and explain various laboratory techniques to laboratory personnel, students and others.
    • Maintains established department policies, procedures and objectives, including the areas of quality assurance, safety, environmental and infection control.
    • Performs all other duties and responsibilities as directed.

    Desired skills but not obligatory: Immunohistochemistry, PCR and tissue processing.

    The mission of Dana-Farber Cancer Institute is to provide expert, compassionate care to children and adults with cancer while advancing the understanding, diagnosis, treatment, cure, and prevention of cancer and related diseases.

    Our Core Values are:

    Impact - Above all else, we make a difference by relieving the burden of disease now and for the future through our research, clinical care, education, outreach and advocacy.

    Excellence - We pursue excellence relentlessly and with integrity in all that we do, adhering always to the highest standards of conduct.

    Compassion and respect - For those in our care and for one another.

    Discovery - We foster the spirit of inquiry, promoting collaboration and innovation across traditional boundaries while celebrating individual creativity.



    Schedule

    Monday - Friday

    Full Time

    8:30 - 5:00



    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

    PI92240370


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    Job ID: 26498
    Date Posted: 06/30/2015
    Location: Dana
    Job Family: Bioinformatics
    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

    The mission of Dana-Farber Cancer Institute is to provide expert, compassionate care to children and adults with cancer while advancing the understanding, diagnosis, treatment, cure, and prevention of cancer and related diseases.

    Our Core Values are:

    Impact - Above all else, we make a difference by relieving the burden of disease now and for the future through our research, clinical care, education, outreach and advocacy.

    Excellence - We pursue excellence relentlessly and with integrity in all that we do, adhering always to the highest standards of conduct.

    Compassion and respect - For those in our care and for one another.

    Discovery - We foster the spirit of inquiry, promoting collaboration and innovation across traditional boundaries while celebrating individual creativity.

    Provide bioinformatics consultation to biomedical researchers in the collection, management, interpretation, and analysis on high-throughput biological/clinical data with emphasis on next-generation sequence analysis. Require good knowledge on a wide range of existing bioinformatics databases and tools as well as proficiency in programming languages such as Perl, Python, Java and R. Familiarity with biostatistics, molecular biology, human genetics, the principles of experimental design, and laboratory experiences are highly desirable. Excellent interpersonal and communication skills are essential, as are the abilities to work both independently and collaboratively and to meet deadlines.

    PRIMARY DUTIES AND RESPONSIBILITIES:

    The Bioinformatics Analyst within the Gastrointestinal Cancer Center (GCC) will:

    1. Interpret complex biological information and meet with research scientists to provide bioinformatics consultation in the analysis of experimental data
    2. Communicate with research scientists to understand and obtain data analysis specifications
    3. Design data analysis project plans and estimate time to completion
    4. Work independently and as a team member to analyze data, developing software tools where necessary
    5. Work collaboratively with other staff to develop the resources in the GCC

    _____________________________________________________________________________

    KNOWLEDGE, SKILLS, AND ABILITIES REQUIRED:

    1. Familiarity with genomic technologies and their applications, including experimental design considerations.
    2. Familiarity with a wide range of biological databases and resources, including, but not limited to GenBank, EnsEMBL, the UCSC genome browser, Reactome, and other similar resources.
    3. Familiarity with meta-analysis methods, including functional class enrichment and pathway analysis.
    4. Proficiency in programming using perl/python/java/C++/R, statistical programming using R or related tools, web-development, and database query through SQL and ability to prototype software solutions for data analysis.
    5. Excellent communication skills are essential.

    _____________________________________________________________________________

    MINIMUM JOB QUALIFICATIONS:

    Bachelors degree required, MS preferred or PhD in bioinformatics, computer science and/or the life sciences and 0-2 years relevant experience.



    Schedule

    Monday-Friday, 40 hours



    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

    PI92257413


    0 0
  • 11/06/15--08:53: Lab Head Upstream
  • The position is part of the Global Manufacturing Science & Technology organization and is based at the biologics hub in Boston. The successful candidate will lead a group responsible for establishing a thorough process understanding, identifying and implementing process improvements and establishing next generation process development opportunities for upstream manufacturing of antibodies and antibody-like molecules expressed from mammalian systems. The position reports to the Director, Upstream Development.  The newly established lab will cover the upstream aspects of the drug substance manufacturing process and focus on improving the understanding, robustness and economics of commercial manufacturing processes.  The successful candidate will be part of the Process Sciences leadership team and is responsible for providing technical and managerial leadership of the upstream laboratory and laboratory activities.   Specific responsibilities include:

    • Establish, lead and manage a laboratory focused on mammalian cell culture technology
    • Lead a team of scientists, engineers and technical staff focused on upstream process development activities
    • Establish state-of-the-art scale small-scale upstream models and capabilities at the biologics hub in Boston
    • Work collaboratively with downstream, analytical, CMC project management, CMC regulatory and manufacturing to develop an increased depth of knowledge for the drug substance process for a given product and identify improvement opportunities
    • Establish and maintain familiarity with contemporary industrial standards, practices and technology focused on mammalian cell culture
    • Establish and maintain awareness of current process and product control strategies, critical parameter identification and assessment and in-process control strategies as applied to upstream operations
    • Establish and implement platform approaches for activities and technologies applicable to upstream operations
    • Represent Process Sciences as a technical expert in mammalian cell culture technology
    • Participate in global technology projects focused on upstream activities and operations
    • Support upstream technology transfers and other change control processes  when needed with downscale model data and subject matter expertise
    • Implement QbD principles and design-of-experiment approaches to upstream development activities
    • Support end-to-end development set up with a focus on the transition from late-stage-development to launch as well as post-approval lifecycle management
    • Collaborate with other scientists/engineers across the biologics network of sites
    • Responsible for internal documentation and preparation of reports required for regulatory documents
    • Support regulatory filings and interaction with authorities as subject matter experts
    • Present data and results within department and project teams

    Leadership Qualifications

    • Strives for results – sets ambitious tangible results for the team, takes personal responsibility for achieving goals
    • Cooperates transversally – Shares information and seeks input from outside direct team. Develops strong cross functional relationships and partnerships with science and commercial organizations
    • Makes decisions  – Makes decisions when needed even if outcomes are difficult, accepts accountability for results and makes choices using sound judgment
    • Leads Teams – Sets clear priorities for the organization and empowers the team to meet challenges and take action. Encourages collaboration with and beyond the team.
    • Act for Change – Drives a continuous improvement mindset & develops high levels of employee engagement
    • Develop people – Takes responsibility for developing people. Learns from experience and helps other to do likewise. Provides feedback on a regular basis

    Basic Qualifications:

    • BS/MS in science or engineering with 7+ years or Ph.D. in science/engineering with 5+ years of experience
    • Experience in managing technical teams

    Preferred Qualifications:

    • Excellent scientific background and presentations skills
    • Strong understanding of development and commercial manufacturing operations
    • Leadership skills with a proven track record of leading a team
    • Project management skills with a proven track record
    • Experience in introducing process changes post launch
    • Highly motivated individual with the ability to work independently as well as on a cross-functional global team
    • Knowledge of worldwide biologics-focused CMC regulatory requirements
    • Experience with upstream approaches for process validation
    • Knowledge of control strategies for mammalian-expressed proteins
    • Knowledge of cell biology and cell physiological as applied to large-scale cell culture
    • Knowledge of cell culture media and media development approaches 

    #LI-GZ


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    Reporting to the Director, Clinical Operations, the successful candidate will manage clinical project activities ensuring the timely completion of deliverables through development and management of the project timeline and budget. Must be comfortable managing a clinical project through the use of vendors, and be able to manage interactions with and between monitoring, data management, biostatistics, medical writing, safety, regulatory affairs and QA. Externally manage CROs, field clinical monitors, and investigator site staff.

    Essential Functions and Duties

    • Responsible and accountable for one or more concurrent clinical studies
    • Leverages resources, expertise and knowledge across projects
    • Develops and manages trial budget & MS Project timeline
    • Trains team members, including vendors, as needed
    • Participates in contracts and budgets negotiations with clinical sites and vendors
    • Participates in protocol development
    • Develops critical study documents including informed consent forms, study conduct documents such as study manuals, study tools etc.
    • Prepares investigational site lists, participates in reviewing and approving investigational sites based on complete site assessment
    • Oversees preparation of Study Operations Manual(s)
    • Participates in the coordination of investigator meetings and all other study management meetings
    • Provides oversight of individual clinical trials to ensure that safety concerns and/or adverse events are identified and appropriate responses to such concerns are developed and executed
    • Participates in the dissemination of clinical information to the clinical team members
    • Reviews and approves corrective action plans at individual site and across study, may participate in internal/external study related audits
    • Must be able to monitor as needed

    Skills and Experience

    • BS Degree in science or a health related field is required
    • Minimum 3-5 years relevant industrial Clinical Project Management and 7-10 years of Clinical Development experience
    • Must be able to travel up to 20%, domestically and internationally
    • Good verbal and written communication skills
    • Excellent interpersonal and organizational skills
    • Detail oriented and good problem solving ability
    • Ability to work on teams and with multiple projects, and works well under general direction
    • Working knowledge of medical terminology
    • Excellent computer skills
    • Excellent knowledge of GCP, ICH and FDA regulations
    • Ability to provide appropriate leadership to clinical sites
    • Independently motivated

    0 0
  • 11/06/15--08:55: Vice President, R&D
  • CutisPharma, located in Wilmington, MA, is a specialty pharmaceutical company focused on bringing innovation to the pharmaceutical compounding market.  CutisPharma’s FIRST Unit-of-Use compounding kit franchise has provided significant benefits to pharmacists and patients by replacing traditional compounding with standardized kits that are easy to use, saves time, and provides consistent quality.  The Company is searching for an experienced and enthusiastic, hands-on Vice President, R&D.

    The successful individual will work cross-functionally, effectively collaborating across various areas including sales and marketing, research and development, quality, manufacturing and the executive team.

    Dutis and Responsibilities:

    • Lead, direct and plan overall strategy for developing and obtaining FDA approval of company’s 505(b)(2) clinical development programs
    • Lead and oversee R&D activities of all other Company pharmaceutical products and projects
    • Oversee the selection and management of CROs and bioanalytical laboratories supporting the Company’s development programs
    • Lead the Company’s R&D team including external consultants supporting Company R&D activities
    • Lead and oversee Company processes for creating and securing IP for technology generated by development activity
    • Provide strategic input for the R&D pipeline to support existing and future products
    • Establish and maintain relations with outside scientific and clinical experts in relevant disciplines to support the Company’s current and future planned R&D activities

    Required Skills and Qualifications:

    • MD or PhD in relevant disciplines pertaining to clinical development
    • Minimum 10 years of experience in pharmaceutical development of clinical-stage programs, with at least 5 of those years in a senior supervisory role, including bioequivalence studies; prior experience in gastroenterology or infectious disease therapeutic areas preferred
    • Robust clinical development experience with successful track record of programs leading to FDA approval; prior experience leading 505(b)(2) programs preferred
    • Solid knowledge of FDA and cGMP regulations
    • Solid knowledge and proven experience in creating and securing IP
    • Strong leadership and management skills
    • Excellent oral and written communication

    We recognize hard work and dedication with benefit offerings that address individual needs.  Our comprehensive package of benefits for eligible employees includes:

     Competitive compensation package as well as bonus incentives for excellent performance

    • Competitive medical and dental insurance
    • Paid time-off and holidays
    • Flexible Spending Accounts
    • Tax-advantaged savings plans [401(k) with competitive company match and deferred savings plans]
    • Company-paid life and disability insurance
    • Free parking

     

    Qualified candidates should submit their resume, statement of interest and salary requirements to careers@cutispharma.com

     

    NO PHONE CALLS PLEASE

     

    CutisPharma, Inc. is an Equal Opportunity Employer

     

    NOTE: This job description is not intended to be all-inclusive. Employee may perform other related duties to meet the ongoing needs of the organization.

     

     


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    Merrimack is a fully integrated biopharmaceutical company that views cancer as a complex engineering challenge. Through systems biology, which brings together the fields of biology, computing and engineering, Merrimack aims to decrease uncertainty in drug development and clinical validation, and move discovery efforts beyond trial and error. Such an approach has the potential to make individualized treatment of patients a reality. Merrimack's first commercial product, ONIVYDE™ (irinotecan liposome injection), was approved by the U.S. FDA on October 22, 2015. With four additional candidates in clinical studies, several in preclinical development and multiple biomarkers designed to support patient selection, Merrimack is building one of the most robust oncology pipelines in the industry. For more information, please visit Merrimack's website at www.merrimack.com or connect on Twitter at @MerrimackPharma.

      Responsibilities:
    • Develop strategies for clinical pharmacology and pharmacometrics and execute analyses to advance drug candidates in an efficient and scientifically rigorous manner
    • Develop design and preparation of clinical pharmacology activities in clinical study protocols
    • Contribute to the clinical pharmacology sections of regulatory documents, including Investigator Brochures, EOP2 meetings, NDA/BLA/MAA.  Develop, write and review clinical pharmacology regulatory submissions, and respond to queries from regulatory agencies.
    • Perform modeling and simulation analyses related to pharmacokinetics and pharmacodynamics  (PK/PD), and quantitative systems pharmacology, including non-compartmental analyses, nonlinear mixed-effect modeling
    • Collaborate with nonclinical and pharmaceutical development team members to define and generate in vitro and in vivo data to support clinical pharmacology studies
    • PhD or MD/PhD in an area relevant to clinical pharmacology and pharmacometrics with at least 5+ years of proven record in drug development from IND through regulatory submission and commercialization.  Backgrounds in engineering and quantitative approaches are preferred. The position (from senior scientist to director level) will be commensurate to experience.
    • Demonstrated accomplishments in modeling analysis, experimental design, regulatory considerations and execution of clinical PK/PD studies
    • Experience with applications of population PK/PD, modeling and simulation and model-based drug development into clinical development plans
    • Strong data analytic skills and an in-depth knowledge of pharmacokinetic and pharmacodynamics principles, including their applications in clinical research and drug development
    • Strong knowledge and experience in nonlinear mixed-effect modeling methodology
    • Comprehensive understanding of clinical regulatory requirements and knowledgeable in ICH and GCP guidelines
    • Excellent verbal and written communication and presentation skills
    • Demonstrated ability to work effectively in a matrix, team environment, manage multiple priorities and exercise sound judgment
    • Passion for fighting cancer
    Requirements:

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