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Career postings for the Massachusetts Biotechnology Council

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    Job Responsibilities/Department Description:

    The candidate will join Process Analytics (PA) department, Late Stage Process Development (LSPD).  The candidate will provide in-process sample testing using a variety of analytical assays to support cell culture, purification development and fill finish development groups.

    Responsibilities: 

    ·Provide analytical sample testing to support upstream and downstream process development activities within LSPD departments. Provide assay results in a timely manner. Follow Standard Operating Procedures (SOP) rigorously and trend assay controls and instrument performances

    ·Support assay investigation associated with analytical testing activities.

    ·Transfer and implement assay in Process Analytics; perform comparability studies and document assay transfers

    ·Participate in high throughput assay development under manager’s supervision. Write experimental protocols; consult with supervisor for guidance and approval.

    ·Document experiments, results and findings in laboratory notebook; presents work at the group and department meetings; participates in the writing of technical reports, SOPs, and analytical method protocols, etc.

    Basic Qualifications:

    ·Bachelor’s Degree and 5-8 yrs. or Master’s 3-6 yrs. experience.

    ·Technical expertise and knowledge through experience and application; hands-on with the following techniques: HPLC/UPLC (R. Phase. SEC, affinity etc.), electrophoresis (CGE, cIEF, native and denaturing SDS-PAGE gel systems); antibody based assays (Western blotting  and ELISA) and protein quantitation assays

    Preferred Qualifications:

    ·Skilled in protein sample handling, storage, and preparation ·Participates in general lab activities to maintain lab infrastructure (e.g. lab organization, assay control inventory, chemical inventory, instrument log  maintenance etc.).

    ·Maintain accurate and up to date notebook records.

    ·Analyze and present data in a clear fashion. Summarize assay results in technical presentations/reports.

    ·Ability to learn new technologies fast with good problem-solving skills.

    ·Good fundamental understanding of protein biochemical assays and process analytics.

    ·Advanced knowledge of Microsoft Excel; Proficient in Microsoft Word, Power Point


    Excellent communication and interpersonal skills; high attention to detail. Must be able to work in a team-oriented environment


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    Job Responsibilities/Department description: The Clinical Laboratory Sciences department is responsible for patient immune surveillance, pharmacokinetic, and biomarker support for clinical trials and post-marketing programs. The group develops assays and monitors treatment efficacy and immune responses to investigational and commercial therapeutic products.   The lead technologist will work on a team that is responsible for performing neutralizing antibody testing as well as T and B cell immunophenotyping for clinical trials and for supporting adverse event management in a GCLP laboratory. The primary responsibilities for the lead technologist include mastering and taking the lead in training other staff on existing and new procedures to detect neutralizing antibody and T cell and B cell subsets as well as operating and maintaining 3 BD FACS CantoII flow cytometers.  The candidate will be responsible for performing cell culture using aseptic technique that will ensure a continuous supply of adherent and non-adherent cell lines. Data collection and quality control checks are tracked using a Laboratory Information Management System as well as other software applications; the candidate will complete data entry and tabulation of patient and assay controls to meet established data submission timelines. Adherence to established laboratory compliance policies that follow Good Clinical Laboratory Practices is important for this lead position.

    Basic Qualifications: Bachelor of Science degree and 5-7 years relevant experience or a Master of Science degree and 2-4 years relevant experience in Clinical Immunology. Experience with maintenance of adherent cells using aseptic cell culture techniques, operation and maintenance of flow cytometer instruments and data analysis using a flow cytometer software such as FlowJo.

    Preferred Qualifications: Experience working with a Clinical LIMS system. Knowledge and experience with ELISA and ELISpot methodologies.  Proficient in FlowJo and Diva software. Experience working in a clinical laboratory or GCLP/GLP environment. #LI-GZ 


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    Job Responsibilities/Department description: The Clinical Laboratory Sciences department is responsible for patient immune surveillance, pharmacokinetic, and biomarker support for clinical trials and post-marketing programs. The group develops assays and monitors treatment efficacy and immune responses to investigational and commercial therapeutic products.   The lead technologist will work on a team that is responsible for performing neutralizing antibody testing as well as T and B cell immunophenotyping for clinical trials and for supporting adverse event management in a GCLP laboratory. The primary responsibilities for the lead technologist include mastering and taking the lead in training other staff on existing and new procedures to detect neutralizing antibody and T cell and B cell subsets as well as operating and maintaining 3 BD FACS CantoII flow cytometers.  The candidate will be responsible for performing cell culture using aseptic technique that will ensure a continuous supply of adherent and non-adherent cell lines. Data collection and quality control checks are tracked using a Laboratory Information Management System as well as other software applications; the candidate will complete data entry and tabulation of patient and assay controls to meet established data submission timelines. Adherence to established laboratory compliance policies that follow Good Clinical Laboratory Practices is important for this lead position.

    Basic Qualifications: Bachelor of Science degree and 5-7 years relevant experience or a Master of Science degree and 2-4 years relevant experience in Clinical Immunology. Experience with maintenance of adherent cells using aseptic cell culture techniques, operation and maintenance of flow cytometer instruments and data analysis using a flow cytometer software such as FlowJo.

    Preferred Qualifications: Experience working with a Clinical LIMS system. Knowledge and experience with ELISA and ELISpot methodologies.  Proficient in FlowJo and Diva software. Experience working in a clinical laboratory or GCLP/GLP environment. #LI-GZ 


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    Position Summary
    Moderna is seeking a Senior Associate, RNA operations for a position based at their Cambridge, MA site. The individual in this role will be responsible for producing mRNA up to the one gram scale for preclinical constructs using custom automation and chromatographic separations on HPLC/UPLC. The successful candidate must have training in HPLC/UPLC and will report to the large scale synthesis, RNA operations team lead.

    Responsibilities
    * Conduct upstream synthesis for up to one gram of RNA
    * Conduct downstream chromatography of mRNA for preclinical targets
    * Conduct mRNA purification using HPLC-based chromatography solutions
    * Assist in troubleshooting of difficult to produce constructs
    * Conduct in-process quality control assays to ensure mRNA are within specifications
    * Troubleshoot process issues and identify potential changes
    * Identify process bottlenecks and work closely with Production Science and Technology on improvements
    * Identify automation opportunities and help co-develop solutions with the automation group

    Minimum Qualifications
    * Associates or bachelor degree in related field
    * Experience with HPLC/UPLC
    * 5-7 years of experience
    * Ability to work in team settings
    * Strong analytical skills
    * Exceptional written and oral communication

    Preferred Qualifications
    * 8-10 years of experience
    * Ability to develop methods for HPLC

    Competencies
    * Flexibility/Adaptability to Change
    * Accountability
    * Decision making
    * Contributing to Team Success
    * Planning and Organizing
    * Tenacity
    * Work Standards

    Why Join Moderna
    Moderna is pioneering messenger RNA Therapeutics*, an entirely new in vivo drug modality that produces human proteins or antibodies inside patient cells, which are in turn secreted or active intracellularly. This breakthrough platform addresses currently undruggable targets and offers a superior alternative to existing drug modalities for a wide range of disease conditions. Moderna has developed a broad intellectual property estate, including more than 250 patent applications covering novel nucleotide chemistries and drug compositions. The company plans to develop and commercialize its innovative mRNA drugs through a combination of strategic relationships as well as newly formed ventures.

    Founded in late 2010 by Flagship VentureLabs, Cambridge-based Moderna is privately held and currently has strategic agreements with AstraZeneca and Alexion Pharmaceuticals.

    Moderna recently signed a collaboration agreement with Astra Zeneca that provided a $240MM upfront payment (plus milestone payments).

    Moderna is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, gender, age, religion, national origin, ancestry, disability, veteran status, genetic information, sexual orientation or any characteristic protected under applicable law. Moderna will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law.

    Please apply at: Application URL:http://www.aplitrak.com/?adid=YWxsaXNvbi5tYXllci4yNjk2NS4zMTY3QG1vZGVybmF0aGVyYXBldXRpY3NpbmMuYXBsaXRyYWsuY29t


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    Primary Duties:
    The Director, Epidemiology is a high-level, strategic and scientific role that involves developing, coordinating, and executing cutting-edge, effective, and impactful epidemiology research for product support at a global level, from early development through life cycle management. The Director, Epidemiology provides essential specialist guidance and direction to project teams, senior leaders, and other colleagues to ensure optimal management of high-impact cross-functional project opportunities and risks, to ensure scientific quality and timely, cost-effective project delivery while adhering to ethical requirements and responding to business needs. The incumbent must be highly innovative, proactive and collaborative with mature team-working behaviors. As a member of the Global Health Economics & Outcomes Research and Epidemiology department, an epidemiologist at Shire must have a broad view of the role of epidemiology and pharmacoepidemiology in product support, contributing across target identification, through drug development, value demonstration, market access, and post approval effectiveness and safety. Epidemiologists interact with a wide range of internal and external customers to ensure appropriate communication of epidemiological issues and study results to stakeholders, including providing epidemiological support for interactions with regulatory authorities.

    Responsibilities:
    *15% Develop product epidemiology strategy for drug development, pharmacovigilance, and commercial purposes across the product Iifecycle.
    * 35% Propose, design, initiate, conduct, manage, report, and present epidemiologic studies, following through on all review, stakeholder management, and compliance processes.
    * 15% Critical appraisal and synthesis of relevant epidemiological literature, including to support exploration of new disease areas.
    * 10% Contribute to the development of Target Product Profiles, Clinical Development Plans, Value Dossiers, and commercial strategies.
    * 15% Pharmacovigilance support, including risk management; PASS development and delivery; contributions to RMPs, PSURs, and regulatory responses; understanding inherent risks associated with a given product's indication; providing population-level context for safety; understanding and responding to potential safety issues.
    * 10% Maintain awareness of regulatory requirements, payer trends, external pharmacoepidemiologic initiatives, and advances in pharmacoepidemiologic methodology; support strategic development of the Epidemiology function within Shire; remain current on the capabilities of key external research partners.

    Education and Experience Requirements:
    * Ph.D. in epidemiology or a related field, or an MD with a Masters degree in epidemiology, and at least 5 years experience as an epidemiologist in the biotech/pharmaceutical industry. Alternatively, a Masters degree or equivalent and at least 10 years experience as an epidemiologist in the biotech/pharmaceutical industry.
    * Deep technical knowledge, extensive industry experience, and an established professional network in the pharmacoepidemiology community.
    * Sustained productivity in epidemiological research as manifest by successful deSign, execution, and publication of epidemiological research, including through extensive collaboration with external investigators, as well as recognition by the external scientific communities as an expert in areas relevant to drug development, pharmacovigilance, and commercialization, from early development through life cycle management.


    * Preferred: experience with GI/neuroscience/psychiatric epidemiology, orphan drugs, HEOR, PROs, comparative effectiveness research, personalized medicine, direct interaction with regulatory authorities, patient risk management program evaluation, business development due diligence, and/or international market access issues.

    Shire's Brave culture offers employees with diverse backgrounds the opportunity to enable those with life altering conditions to lead better lives.

    Shire is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by applicable law. US Applicants who require accommodation in the job application process may contact 484-595-8400.


    Please apply at: Application URL:http://www.aplitrak.com/?adid=amRpZXR6LjYwODUwLjMxNjdAc2hpcmUuYXBsaXRyYWsuY29t


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  • 10/30/15--00:59: R&D QA & Compliance Manager
  • Primary Duties:
    Under the direction of the Head of Internal Process & Technology QA & Compliance, the primary responsibility of the CSV and Process QA & Compliance Leader will be to support the R&D Quality Assurance & Compliance function by assuming primary responsibility for implementing, managing and/or coordinating R&D QA&C support of computer system validation (CSV) activities in Research & Development. The CSV and Process QA & Compliance Leader will assure compliance with applicable GxP regulations and Shire standards (SDLC); advising the R&D IT Business Partner and R&D system owners/management on risk-related matters pertaining to R&D systems; and conducting audits to identify overall trends and areas of risk for systems in use within Shire R&D as well as those externally in use by R&D service providers.

    Key responsibilities for this role are to provide professional expertise and strong leadership in applicable regulations including but not limited to 21 CFR Part 11, Annex 11, GAMP 5 as applicable to Shire's R&D GxP environment (GCP, GLP, GPvP, GDP). Additional duties include but are not limited to liaising with various internal R&D functions, IT, and contract auditors; contributing to the Master Audit Plan (MAP) and Master Validation Plan (MVP); and assists stakeholders in maintaining systems within a state of compliance while providing recommendations for process improvement.

    Responsibilities:

    40%
    Delivery of Validation Support
    Facilitates the R&D QA&C support of the R&D IT Business Partner and R&D system owner initiatives as a member of a project team for the implementation of new systems or major upgrades to existing systems.
    Leads by determining the appropriate level of validation to be applied for new and existing R&D systems and resulting CSV deliverables.
    Reviews and approves validation deliverables/documentation during
    the validation process.
    40%
    Audit Conduct
    Leads the planning and execution of CSV related audit activities associated with external application providers, external service providers, and internal systems with related processes. Collaboratively works with key stakeholders from R&D and IT to ensure the optimal audit scope planning as well as ensuring appropriate corrective and preventive actions are completed in a timely manner.
    Leads and conducts audits in collaboration with appropriate SMEs and oversees the need for the prioritization and timely completion of identified audits.
    5%
    Change Management
    Supports ongoing change management for R&D systems in conjunction with the R&D IT Business Partner and R&D system owners as required by Shire procedures. Reviews and approves change requests based on risk / business need.
    10%
    Management / Strategy
    Manages key components of the R&D QA&C CSV program as directed by management. Provides regular consultation to various the R&D Business Partner and R&D stakeholders on CSV related matters. Contributes to the MVP and MAP.
    Negotiates Quality Agreements and Service Level Agreements with external and internal parties respectively.

    5%
    Regulatory Agency Support
    Assists with preparing, hosting and responding to regulatory agency inspections as needed for GCP site, GLP site, PV site, and clinical investigator inspections (GCP).

    Education and Experience Requirements:
    x Bachelor's degree in a life science or computer science required; Masters Degree in management or scientific discipline a plus.
    x At least 7 years of pharmaceutical experience. 5+ years of validation and audit program management
    x Ideal candidate will have broad experience in quality assurance/compliance, computer system validation within the pharmaceutical/biotech arena (ideally within the clinical and/or non-clinical areas), the management and conduct of audits, stakeholder focus, and strong knowledge of regulatory requirements.

    Other Job Requirements:
    Some domestic and international travel required. Must have a global mindset.

    Shire's Brave culture offers employees with diverse backgrounds the opportunity to enable those with life altering conditions to lead better lives. Shire is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by applicable law. US Applicants who require accommodation in the job application process may contact 484-595-8400.


    Please apply at: Application URL:http://www.aplitrak.com/?adid=amRpZXR6LjU1MjA4LjMxNjdAc2hpcmUuYXBsaXRyYWsuY29t


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    The Analyst Lead provides expertise in data manipulation, metrics, report generation and expertise in the analysis and interpretation of data to deliver actionable performance intelligence to the organization. The Analytics & Reporting team has a strong focus on asset and portfolio analytics, process quality analytics, performance benchmarking (including Balanced Scorecard), tracking delivery against plans, and cycle times.

    Responsibilities
    *Interface/negotiate with benchmarking vendors
    -Evaluating their tools, bringing proposals
    *Build a best in class benchmarking program that would support excellence in analytics and support all functional areas across DevOps
    *Lead survey work across functional areas (e.g. Investigator Satisfaction)
    *Liaise across other lines to integrate study level cycle time metrics with asset level benchmarks
    *Partner with Competitive Intelligence Community of Practice to integrate available insights into Development Operations
    *Generate summary and specified dashboard and metrics which represent operational data in brief and intelligible format, suitable for the target audience, which includes executive leadership, department managers and data analyst
    *Track and report on industry standards, benchmarks
    *Participate in gaining consensus on guidelines and metric definitions
    *Perform consistent quality review of data and report results
    *Perform analysis utilizing Business Intelligence tool
    *Deliver measurements of performance against key indicators and benchmarks using internal data/dashboards and external benchmarks
    *Provide accurate and insightful information to assist stakeholders to define meaningful and measurable business cases for organizational performance improvements congruent with current organizational strategy
    *Apply business expertise to the definition and use of performance metrics that measure, control and improve operational processes across the portfolio of studies.
    *Partner with CoEs across Development Analytics to enhance and optimize suite of deliverables to encompass insights across areas
    *Develop & maintain guidance documents on reporting/metrics process, expectations and conduct training for stakeholders (both internal Pfizer and Vendor colleagues)
    *Apply strong attention to detail on all work products to ensure consistency and accuracy for a senior audience
    *Detailed oriented and knowledgeable about underlying data. Able to work with Information Management and Clinical Trial Solutions colleagues to define data requirements
    *Analyze data to get a clear understanding of our current performance and trends across multiple perspectives including – but not limited to – quality, speed and cost.
    *Enable sound decision making within Teams, Leadership and Governance by providing performance analyses, business insights and recommendations.
    *Develop strategies to improve processes and delivery through the appropriate application of performance data (cycle time, volume, productivity and quality) spanning Study, Asset, Portfolio, DevOps Divisional Breakout and Business Unit.
    *Champion a work environment that encourages innovation and strong relationship management.
    *Foster a performance-based culture within Pfizer where study/asset delivery, project management, decision-making, process control and risk mitigation are based on actionable metrics and a sound performance achievement methodology.

    The Business Performance Focused Analyst Will:
    *Develop appropriate process and network for creation of both WSR & DevOps Monthly Operations Report
    *Develop process, data and metrics for consistent delivery of WRS Balance Scorecard and DO KPI Dashboard

    Position can be filled at Cambridge, Groton, New York, or Collegeville sites.

    Qualifications
    Education and Experience:
    *MS/BS in a relevant discipline
    *10+ years working in Pharmaceutical industry with at least 5 working in an analyst capacity
    *Extensive experience of drug discovery and development in a global matrix organization
    *Detailed knowledge of clinical trial operational processes and supporting systems and tools
    *Detailed knowledge of data and reporting systems
    *Effective verbal and written communication skills in relating to leaders, colleagues and associates both inside and outside the organization. Effective communicator and presenter.

    Technical Skill Requirements:
    *Strong track record of delivery and organizational skills
    *Strong facilitation, negotiating and presentation skills. Able to work with all levels in the organization (technical teams through to Senior Leadership)
    *Able to work effectively across divisional, functional, site and CRO boundaries.
    *Able to work in ambiguous situations to identify and resolve complex problems
    *Excellent collaborator able to partner across stakeholders
    *Recognized metrics and business performance analytics expertise.
    *Demonstrated ability to be a trusted partner across Lines and through tiers of the organization.
    *Contributes to a learning environment by sharing knowledge and best practices within and across the organization
    *Able to work in a fast pace, evolving business environment

    Please apply at: Application URL:http://www.aplitrak.com/?adid=c3VzYW4ubS5kaXBhZ2xpYS45NTUzMC4zMTY3QHBmaXplci5hcGxpdHJhay5jb20

     


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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
    Pfizer is developing small-molecule compounds to treat the basic defect in cystic fibrosis (CF) which involves misfolding of the CFTR chloride channel. We are seeking a Senior Associate Scientist to measure the activity of CFTR modulators using electrophysiology assays.
    The candidate will evaluate compounds using electrophysiology assays on primary airway cells from CF patients. The work will involve designing experiments, dosing compounds, performing assays, analyzing the results, and assessing the reproducibility of the data. The candidate will help optimize cell-based assays and maintain prototype instrumentation. The candidate will work closely and collaboratively with other colleagues, requiring proactive communication and a teamwork mentality. Electrophysiology experience is desirable but not required. A strong candidate will have experience in mastering multiple cell-based assays in a drug discovery setting, preferably requiring the use of lab automation, and a demonstrated track record of learning and applying new skills.
    She/he will be responsible for delivering high quality data to the project team, presenting results at meetings, and adapting work flow to the needs of the program. The successful candidate will make use of problem solving, critical thinking, and effective written and oral presentation skills in a dynamic, multidisciplinary team environment.

    Responsibilities
    1) Design experiments in consultation with supervisor.
    2) Independently perform electrophysiology experiments.
    3) Report results at team meetings.
    4) Maintain a compound inventory and testing queue
    5) Train and collaborate with junior colleagues and student interns.

    Qualifications
    Required:
    M.Sc. in Biology with >2 years experience in a drug discovery setting
    B.Sc. in Biology with >4 years experience in a drug discovery setting

    Preferred:
    M.Sc. in Biology with >5 years experience in a drug discovery setting.
    B.Sc. in Biology with >10 years experience in a drug discovery setting.

    NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS
    Weekend work will be required occasionally. Occasional travel to meetings and conferences is involved.

    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.

    Please apply at: Application URL:http://www.aplitrak.com/?adid=QWxpc29uLlR1dGx5cy4yNDk2Ny4zMTY3QHBmaXplci5hcGxpdHJhay5jb20

     


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  • 10/30/15--01:09: QC Specialist II
  • 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
    This position will support the Andover LabWare LIMS (LWLIMS) System
    *Maintain and support the LWLIMS master data process
    *Provide helpdesk support for troubleshooting and resolving LWLIMS issues
    *Support change controls, investigations and site projects as they relate to the LWLIMS System

    Assure all activities are performed in compliance with cGMP and other regulatory requirements. The qualified candidate must have the experience and ability to participate in multiple projects simultaneously.

    Responsibilities
    *Work as a Systems Analyst supporting the LabWare LIMS system and the LabWare LIMS Master Data process
    *Troubleshoot and resolve issues/problems related to LabWare LIMS and interfaced Enterprise systems
    *Work with the Business Owners to develop user requirements for new or modified master data objects
    *Work with the Business Owners to demonstrate new object functionality
    *Design and configure master data objects in support of Andover site needs using approved source documentation, Pfizer procedures, conformance standards and division directives
    *Develop and execute test scripts for master data objects as needed
    *Provide support to building or modifying Site Configurable Master Data objects and work in collaboration with BT
    *Support the site change control process with regards to ensuring the integrity of the LabWare LIMS system
    *Support Investigations/CAPAs related to LabWare LIMS
    *Assisted in validation type activities to support the system including OQ & PQ test script development and review
    *Support the business owners during several project implementations as a Subject Matter Expert of LabWare LIMS and represent QCLS as a project team member
    *Incorporate Human Performance error proofing elements into LIMS builds
    *Maintain compliance to GMP, and safety regulations

    Qualifications
    *Bachelor's degree in Computer science or related field with 2-4 years or MS with 0-2 years of industry experience, preferably in the biopharmaceutical industry.
    *Experience writing code (Visual basic, LIMS Basic or even complex Microsoft Excel formulas) or
    *Experience working with database objects (LIMS, Oracle or even Microsoft Access) or
    *Experience writing SQL code or SQL queries
    *cGMP experience is preferred
    *A dedicated and team oriented individual, who is highly motivated, proactive with strong organization/prioritization skills
    *Applicant must have strong computer skills; a strong background using a LIMS system is desirable
    *Applicant must be able to work effectively independently as well as in a group
    *Applicant must be able to quickly learn the process and basics of the LIMS Database configuration and management process
    *Applicant must be able to apply knowledge of the LIMS database to configure objects that perform the function necessary to meet the needs of the requestor
    *Applicant must be able to work in a demanding fast paced environment managing multiple requests to completion simultaneously
    *Applicant must be able to communicate effectively with people with varying knowledge of the LIMS system

    PHYSICAL/MENTAL REQUIREMENTS:
    Position is primarily office work.

    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.


    Please apply at: Application URL:http://www.aplitrak.com/?adid=dHJveS5icmVubmFuLjY0MTM0LjMxNjdAcGZpemVyLmFwbGl0cmFrLmNvbQ

     


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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
    Pfizer Hematology research is part of the Rare Disease Research Unit and focuses on developing new therapies in the field of Hemophilia, Hemostasis and other blood related conditions including Sickle Cell Disease and beta-Thalassemia. The RDRU is part of Pfizer's Biotherapeutics in Pfizer Worldwide R&D. Pfizer Hematology research applies a heavily externalized model; the team advances internal programs in a matrix environment and to a significant degree collaborates with external partners in academia, industry and at commercial service providers. The candidate will be responsible for delivering high quality data to the project team and presenting results at project team meetings. The successful candidate will make use of problem solving, critical thinking, and effective written and oral presentation skills in a dynamic, multidisciplinary team environment.

    Responsibilities
    The ideal candidate will be a highly motivated, dynamic laboratory scientist and will have demonstrated experience and expertise with in vitro, cell based and high throughput assays. The candidate is expected to contribute to and support project advancements in the Hematology Research group. Applicants must have experience in a wide range of biochemical and cellular assays. The work will involve the independent design and performance of assays, analyzing the results as well as assessing and maintaining the reproducibility of the data generated. Ability to explore literature and introduce new technologies into the group's work. The candidate will work closely with other team members to deliver high quality data.

    Qualifications
    *B.Sc. with >10 years experience in a drug discovery setting, or, M.Sc. in Biology with >5 years experience in a drug discovery setting or PhD. Prior experience working within laboratory setting in Biomedical Sciences, Biochemistry, Biotechnology, Biology, or related field within a pharmaceutical setting; experience in vitro assays, including work with primary cell systems.
    *Demonstrated excellence in the development, implementation, and execution of in vitro assays, including cellular and high throughput assays.
    *Demonstrated skills in working with cells, including in vitro cell culture skills, and working with primary cells.
    *Expertise in in vitro assays, ELISA, qRT-PCR, molecular and cell biology (transfection, SDS-PAGE, Western blot analysis, immunoprecipitation) is required.
    *Background in hematology, gene therapy, gene editing or in vivo models is desirable
    *Excellent organizational, interpersonal, written, accurate data recording, and verbal communication skills.
    *Self-motivation and the ability to work independently, as well collaborate as part of internal and external cross-functional teams.

    PHYSICAL/MENTAL REQUIREMENTS:
    Will require standard laboratory physical work.

    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.


    Please apply at: Application URL:http://www.aplitrak.com/?adid=amVmZnJleXN0b25lLjUxMTE0LjMxNjdAcGZpemVyLmFwbGl0cmFrLmNvbQ

     


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    GENERAL SUMMARY OF POSITION:

    Under the supervision of the Principal Investigator or designee, the Clinical Research Assistant is responsible for performing delegated tasks and procedures involving human subjects in support of clinical research protocols.

    MAJOR RESPONSIBILITIES:

    • Assist PI in development of protocol-specific tools to aid in study documentation
    • Assess eligibility of research subjects in accordance with the approved protocol and all applicable regulations including HIPAA
    • Obtain patient consent and Human Subject Committee approvals for minimal-risk studies as delegated by IRB-approved protocol
    • Collect, record, evaluate, update, and store/transport pertinent data and samples in relation to protocol
    • Track study enrollment and completion of milestones
    • Summarize research findings and prepare presentations
    • Perform literature searches
    • Schedule patient tests and/or interviews
    • Conduct patient telephone follow up
    • Stock, inventory, store, and order samples/supplies as needed to maintain appropriate operations
    • Review medical records and medical record abstractions for consistency and completeness
    • Comply with established policies, health and safety regulations and requirements, procedures, and department objectives
    • Maintain patient and study subject confidentiality
    • Perform other duties as required.

     



    REQUIRED QUALIFICATIONS:

    • Bachelor’s degree in a scientific or health care field, or related experience
    • Experience in using computer-based tools (Word, Excel, Access, Outlook, PowerPoint, etc.)
    • Oral and written communication skills
    • Excellent organizational and interpersonal skills required.



    Apply Here

    PI92200962


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    GENERAL SUMMARY OF POSITION:

    The Gastroenterology division at UMass Memorial Medical Center is dedicated to excellence in patient care, research and medical education. Our staff is committed to providing the highest quality of care to individuals as well as to the community. We strive to advance patient care through excellence in clinical, basic and translational research, and to educate future health care professionals. The high standards set by the division and the scope of services available ensure that patients will receive the best care possible for a wide variety of gastrointestinal and liver diseases.

     

    This position supports a multicenter study in a collaborative effort of four medical centers. The ultimate goal of this cooperative research project is to transform the clinical treatment of the disease being studied by rapidly translating novel and innovative basic science discoveries into clinical practice.

     

    Under the direction of the Principle Investigator or designee, the Clinical Research Coordinator is responsible for all aspects of collection and management of data for complex treatment, ancillary, and prevention protocols regulated by the FDA or DHHS, and sponsored by federal agencies, foundations, industrial sponsors or UMass Medical School in support of clinical trials.

     

    THIS POSITION IS SCHEDULED FOR 32 HOURS PER WEEK.

    MAJOR RESPONSIBILITIES:

    • Participate in the development of protocol specific tools, (e.g., treatment data and/or therapeutic checklists) to aid with data submission
    • Extract and transcribe treatment data from hospital and clinical records required to complete study patient’s record and sponsor’s case report forms. Monitors quality and timelines of data submissions
    • Monitor status of all studies in database and ensures that all patient data (on-study and follow-up) are submitted, and respond to data queries from sponsoring organization, in a timely manner
    • Track and maintain accurate data of studies, accrual, and patient status activity in database
    • Maintain effective working relationships with research nurses and investigators participating in the study
    • Monitor strict adherence to protocols. Assure that cases are being finalized and reviewed by appropriate clinician
    • Review protocol requirements with physicians and research nurses. Identify and resolve issues with protocol compliance. Keep principal investigator and research nurse aware of any issues on compliance
    • Ensure that protocol document has current amendments. Inform staff and updates database
    • Provide data to study investigators as requested and submits data for analysis. Run quality control checks on data prior to transfer
    • Serves as a resource to physician and nurses to locate information for special reports and treatment decisions
    • Adheres to Good Clinical Practice (GCP) guidelines and all human subject protection practices
    • Participate in all office staff meetings. Present current status of studies assigned
    • Participate in regularly held Protocol Review Committee meetings
    • Participate in the documenting work procedures specific to new studies
    • Perform other duties as required

     

     



    REQUIRED QUALIFICATIONS:

    • Bachelor’s degree in a scientific or health care field, or equivalent experience.
    • 1-3 years experience in on-study data management and data collection in a research organization.
    • Ability to read and understand complex protocols.
    • Excellent computer skills including: proficiency in word processing; proficiency in relational databases.
    • High degree or organizational and analytical ability to manage data collection and protocol adherence.
    • Excellent interpersonal and oral communication skills
    • Good writing skills with the ability to compose correspondence

    PREFERRED QUALIFICATIONS:

    • CITI human research Certification preferred
    • Biohazardous shipping certification preferred

     

    SUPERVISION RECEIVED:

    Under the direction of the Principle Investigator or designee

     

    SUPERVISION EXERCISED:

    None

     

    ENVIRONMENTAL WORKING CONDITIONS:

    Usual office environment, laboratory, medical, surgical, and off campus study sites



    Apply Here

    PI92201633


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  • 10/30/15--08:43: Bioinformatics Scientist
  • Foundation Medicine is dedicated to helping bring personalized cancer medicine into routine clinical practice. Harnessing advanced technology, Foundation Medicine is developing clinical laboratory tests that will broadly capture the most relevant tumor genomic and other molecular information, and connect it with relevant scientific and medical knowledge to help oncologists determine the right treatment for each patient.

     

    The Bioinformatics Scientist will be responsible for development of clinical diagnostic assays and biomarker signatures for pharmaceutical partners through research, implementation, and validation of advanced computational methods. The successful candidate will possess strong analytical skills, solid programming experience, a high level of professional maturity, and ability to consistently meet deadlines under pressure.


    Primary Responsibilities and Essential Duties
    • Development, analysis and testing of advanced computational methods to enhance FM’s clinical diagnostic platform with an emphasis on rigorously validated results and robust procedures to bring methods to the operational level.
    • Delivery of novel biomarker signatures based on NGS to pharmaceutical partners and academic collaborators, with an emphasis on accuracy and timeliness.
    • Development and validation of clinical diagnostic assays for pharmaceutical partners based on massively parallel sequencing (NGS) data.
    • Assume responsibility for developing annotated genomic profiles of somatic aberrations based on NGS, in the context of studies of cancer-patient samples.
    • Collaborate with other technical teams in specifying requirements for tools to enhance workflow efficiency and robustness
    • Assist with drafting and completing manuscripts for publication; manage data analysis and interpretation of study results throughout manuscript publication process from draft through submission and acceptance.

     

    Education and Required Experience
    • Either PhD or MS in Bioinformatics, Computer Science, or a related field with a significant quantitative base.
    • For MS, requires 3+ years’ experience in the biopharmaceutical/diagnostics industry or similar academia research
    • Possess extensive scientific understanding of cancer genetics and genomics and show a strong capacity for independent thinking
    • Track record of achievement in developing computational biology methods, preferably Python
    • Highly desirable experience in software engineering, writing production level code with rigorous testing
    • Confident, proactive individual capable of taking the initiative and driving to results.
    • Strong organizational skills in order to maintain a high level of productivity innovation, and setting priorities in order to complete assignments in a timely manner

     

    Desired Skills and Experience
    • Working knowledge of cancer genetics and experience with Next-Generation Sequencing (NGS)
    • Experience with bioinformatics tools and databases (NCBI, UCSC Genome Browser, IGV)
    • Familiar with UNIX environment and use of clusters to parallelize the execution of computational methods
    • Experience working within a CLIA certified clinical diagnostics laboratory



    Apply Here

    PI92201695


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    GENERAL SUMMARY OF POSITION:

    We are seeking a highly motivated candidate for a position in a basic science cardiovascular research laboratory. Currently we are investigating mouse models of cardiovascular disease including atherosclerosis, hypertension, and peripheral artery disease.

    This position will require a basic knowledge of molecular biology (PCR, western blotting, cell culture, etc.) and organization skills to aid in general lab maintenance. Mouse experience will be an asset, but all applicants are encouraged to apply. A successful candidate will be interested in working as part of a team and be highly self-motivated.

     

     

    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.

     

     

    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:

    • Experience with Mouse colony management, Animal Surgery
    • Molecular biology, Cloning
    • Generation of genetic mouse models

     

     

    SUPERVISION RECEIVED:

    Under the supervision of the Principal Investigator or designee

     

    SUPERVISION EXERCISED:

    None

     

    ENVIRONMENTAL WORKING CONDITIONS:

    Wet chemistry laboratory, and may require appropriate contact with biohazards, radionuclides, toxins, animals, and human specimens.



    Apply Here

    PI92201901


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  • 10/30/15--08:56: Director of Operations
  • JOB TITLE:  Director, Business and Technical Operations                                                           GRADE:  Non-Exempt

    DEPARTMENT:  Sr. Management

    REPORTS TO:   President/ CEO
    ORIGINAL DATE: 12/14/14                        LAST REVISED: 11/15/15

     

    BASIC SUMMARY: Oversight and responsibility for the development of technical operations, technical organizational structure, and technical staff. Define management processes for technical staff via service area managers.  Expand infrastructure to expand service areas, support company growth and enhance technical skills and technical excellence.  Partner with S&M to identify and market new services.  Partner with scientific and veterinary directors to train personnel and support growth.  Identify and implement operational efficiencies to improve operating surplus on new and existing product lines.  Ensure compliance to regulatory conditions governing GLP compliant operations.  Enhance sponsor communication and satisfaction.  Partner with S&M to promote corporate image, PR, and publications.

     

     

     

    ESSENTIAL DUTIES AND RESPONSIBILITIES:

     

    • Promote corporate mission, vision and objectives and foster a culture of professionalism, quality, excellence, and team work.
    • Identify and develop new service offerings, new technologies and novel models to diversify CBSET service portfolio
    • Develop business and financial models for service offerings including pricing, marketing, scheduling, creation of streamlined deliverables, sales promotions, client communication, and client interaction
    • Create operational budgets for service area’s including identification of cap-ex and equipment necessary to implement and enhance service area growth.
    • Drive effective teamwork, communication and collaboration (internal and external)
      • Responsible for the oversight of CBSET’s technical operations and develop metrics to track and improve process efficiencies
      • Improve operational efficiency in current service offerings via streamlined deliverables and efficient staff management.
      • Supervise team (technical managers/supervisors and scheduling) to promote positive interactions with clients and laboratory staff to enhance image of institutional professionalism
        • Develop comprehensive job matrixes, IOB and OJT programs to promote staff development and satisfaction for service areas
        • Promote staff satisfaction through efficient time management and training opportunities
        • Manage the business operations and scheduling to optimize revenue and operating surplus and enhance sponsor satisfaction
        • Organize and lead identification of business processes technical solutions (e.g. software) to improve efficiencies, equipment validations, resource scheduling, service area performance metrics
          • Responsible for the oversight and implementation of operational compliance to protocols, GLPS, SOPs, FDA, and all other applicable governing agencies.
          • Work to build strategic relations with vendors and clients
          • Create presentations for internal and external use to promote staff training and marketing of service areas
          • Support company presence via attendance at scientific meetings, direct sales, and other events
          • Provide technical information for externally focused marketing literature and website
            • Assist with writing manuscripts and abstracts.
            • Work with external project manager for future facility expansions
            • Perform other related duties as required

     

     

     

     

     

     

    QUALIFICATIONS:

    Education: Minimal BS required, MS or MBA preferred

     

    Experience: Required 8-10 years scientific experience within the Biotech or Pharmaceutical setting.  CRO experience preferred.  Confident, innovative, insightful client and business focused service oriented professional with scientific knowledge of preclinical drug and device research, animal and surgical models, technical equipment and assays, and FDA and OUS regulations governing preclinical safety and efficacy assessment. Requires extraordinary organizational and communication skills. 

     

    Certification/Licensure: N/R

     

     

     

     

    PHYSICAL DEMANDS:  

    Will require wearing of safety equipment (PPE) according to OSHA regulations and company standards

     

     

    WORK ENVIRONMENT:

     

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

     

     

    COMMENTS:


    • This position will require performing duties on weekends and/or holidays.

     

     

     

    All employees are required to satisfactorily perform the essential duties and responsibilities of their position. Theessential duties and responsibilities listed above are not intended to be construed as an exhaustive list of all responsibilities, duties and skills required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions of this job.


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  • 10/29/15--22:00: Clinical Assay Supervisor
  • Clinical Assay Supervisor (Needham, MA)

    Overview:

    This position will manage direct reports in clinical sample analysis in the Needham GLP lab.  Duties include delegating work assignments, performance management and talent development.

    Position Responsibilities:  

    Supervisor/Manager role:

    • Supervise technical staff.
    • Plan and direct projects.
    • Lead and inspire team. 
    • Author and approve technical documents, such as protocols, methods, procedures and reports

     

    Management of Clinical Trial Sample Receipt and Analysis:

    • Develop and execute laboratory work plans/schedules for team
    • Ensure GLP compliance, coordinate with Quality Assurance group on audits and audit responses of sample receipt, in-phase audits and data transfer audits, and on the maintenance of the Master Schedule
    • Manage multiple projects, with responsibility for project outcome and interaction with Celldex Clinical team
    • Review raw data for accuracy, completeness, data integrity and compliance with protocols and standards
    • Identify and independently drive department level enhancements.

     

    Education/Experience:

     

    • Experience must include technical and management roles in the biotechnology or pharmaceutical industry supporting the development and/or commercialization of therapeutic recombinant proteins.
    • Must have scientific and management/leadership experience in a lab setting dedicated to the bioanalysis of clinical samples.
    • Must have practical experience working with sample receipt and accessioning (experience with LIMS a plus).
    • Knowledge of immunoassay methods (ELISA, etc) and their applications in characterizing therapeutic proteins with respect to, for example, pharmacokinetics and immunogenicity
    • Statistical data analysis experience is required (SoftMax Pro, GraphPad Prism)
    • Supervisory experience of 2+ personnel is required 
    • Strong verbal and written communication skills
    • BS/MS/PhD in biological sciences with 6+ years relevant experience  

     


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    ARIAD is a Cambridge, Massachusetts-based biotechnology company focused on cancer. We are a cohesive team of talented people from diverse backgrounds with a shared vision: We seek to transform the lives of patients with breakthrough cancer medicines. This is our purpose. This is our passion. This is our promise.

    Summary:
    The successful candidate will lead the development of regulatory CMC strategy and objectives in alignment with direct line management  and will principally be responsible for overall execution of agreed upon strategies in support of corporate goals.  The qualified individual will also be responsible for managing regulatory CMC personnel, including training and/or development needs.  The individual will be expected to keep abreast of evolving regulatory procedures and practices ensuring that ARIAD plans for optimal regulatory CMC strategies globally and interacts with regulatory authorities appropriately.

     

    Duties and Responsibilities: 

    • Manage, train and mentor regulatory CMC staff
    • Lead development of regulatory CMC strategies in alignment with direct line management; execute accordingly to ensure timely approval process globally. Communicate effectively with teams and senior managers.
    • Prioritize, plan and lead the preparation, review, and approval of compliant regulatory documents throughout the product lifecycle.
    • Review, interpret and provide team guidance regarding regulatory correspondences.
    • Review and provide regulatory advice for documents prepared by other departments.
    • Interact proactively with other ARIAD functions, contract research/manufacturing organizations and health authorities as required.
    • Promote the growth and development of regulatory CMC personnel; facilitate their achievement of department and/or corporate goals
    • Work effectively with regulatory colleagues specializing in liaison and operations to continuously improve regulatory systems, teamwork, and efficiency
    • Contribute to improvements in department operating procedures.
    • Remain current with evolving regulatory CMC regulations, guidance, procedures and practices, and provide guidance to ARIAD project teams.

     

    Requirements:
    Minimum of 8 years pharmaceutical / biotechnology regulatory CMC experience, including at least 2 years of management experience.  Experience with small molecule development and commercial stage products are strongly preferred. Excellent working knowledge of current Good Manufacturing Practices.  Expert project management and interpersonal skills is a requirement, as well as excellent written and verbal communication ability.  Direct experience working with electronic document management and submission platforms.   Bachelor’s degree or higher in a science related field.

    Submitting a resume online at a job site could cause valuable screening information to be missed.

    Click here to apply:
    http://ariad-openhire.silkroad.com/epostings/submit.cfm?fuseaction=app.dspjob&jobid=596&company_id=16419&jobboardid=306

    ARIAD is an equal opportunity employer. The Company's policy is to afford equal employment opportunities to qualified individuals without regard to race, color, religion, national origin, ancestry, citizenship, marital status, veteran status, physical or mental disability, sex, sexual orientation or age and to comply with applicable laws and regulations. All employment decisions will be consistent with the principle of equal employment opportunity.


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  • 10/29/15--22:50: Shipper/Receiver
  • JOB DUTIES & RESPONSIBLITIES

    • Complete purchase orders by accurately retrieving pharmaceutical goods to be shipped, preparing items into appropriate packaging, and ship all outgoing goods
    • Accurate preparation/process all shipping documents including packing slips and shipping labels for goods to be shipped
    • Receiving pharmaceutical goods from contract manufacturer, including incoming QC check against packing slip and CutisPharma SOPs
    • Maintain warehouse temperature/humidity monitoring program
    • Load and unload pharmaceutical goods on transportation vehicles
    • Maintain safe and clean work environment by following standards and procedures
    • Accomplish warehousing shipping and receiving tasks by completing related functions including general maintenance such as keeping stairs and loading dock area free from ice and snow as needed
    • Maintain inventory of shipping supplies
    • Maintain life truck daily check and maintenance records
    • Assist in maintaining pest control monitoring program with TERMINEX
    • Support all functional groups within Cutispharma with incoming and outgoing shipments, as well as, tracing, and distributor shipment inquiries
    • Performs other related duties throughout the Company as assigned.

    ESSENTIAL REQUIREMENTS 

    • Excellent knowledge of pertinent SOPs, GMPs, and related compliance regulations and guidances.
    • Life truck experience/certification, Drexel narrow isle fork lift
    • Experience with UPS/FedEx is desirable
    • IMS software experience
    • Computer skills using Word and Excel
    • Excellent verbal /writing skills
    • Able to execute multiple tasks
    • Good interpersonal communication skills/able to work in a team environment
    • Self-motivated
    • Ability to work flexible schedule and overtime as required by the Company

     

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

    • Competitive compensation package as well as bonus incentives for excellent performance
    • Competitive medical, dental and vision insurance
    • Paid time-off program, Vacation
    • Tax-advantaged savings plans [401(k) with match and deferred savings plans]
    • Company-paid life insurance
    • Anniversary Service Award program

    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


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    CutisPharma 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, save time, and provide consistent quality.              

    We are seeking a talented, motivated and hands-on Director-Level Scientist to join our team. The successful candidate will play an important role in supporting CutisPharma’s drug development team in its quest to bring new medicines to patients. This individual will work closely with internal cross-functional teams to ensure clarity of strategy, to develop and manage program plans, and to facilitate communication across all parties. The ideal candidate will have an analytical chemistry background. 

    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.

    Duties and Responsibilities:

    Assist in directing the overall strategy for developing and obtaining FDA approval of the Company’s 505(b)(2) New Drug Application clinical development programs.

    Lead technical/research activities associated with the Company’s pipeline programs, including but not limited to validated method development, stability data review/interpretation and scientific support.

    Assist in creating raw material and product specifications.  Participate in project team meetings and discuss/present project progress.

    Ensure that copies of all analytical or other reviews related to new product development, including stability data are properly maintained.

    Generate and document all activities to the level necessary to comply with Current Good Manufacturing Practices (cGMP).

    Coordinate and/or assist with the acquisition, procurement, fabrication, qualification and validation activities when new raw materials or components are required to transition new products through the phases of development and validation.

    Create, maintain and manage agreed upon timelines for new product development projects and improvements or revisions to existing products.

    Perform literature reviews and research activities to gain expertise and insight into new and existing technologies that are applicable to the Company.

    Provide input for the CMC section of IND/NDA submissions.

    Participate in the selection and management of CROs with key leadership role in selecting and managing analytical, as well as bioanalytical laboratories to support the Company’s development programs.

    Build and maintain rapport with contract analytical laboratories and CMOs as deemed necessary.

    Take leadership role in securing IP for technology generated by the Company’s research and development activities.

    Review various types of DMFs and interpret pertinent information.

    Work to effectively ensure collaboration between R&D and Quality Assurance.

    Required Skills and Qualifications: 

    • Advanced degree in relevant scientific discipline required, Ph.D. is preferred.
    • 7-10 years pharmaceutical development experience with exposure to all stages and aspect of pharmaceutical product development
    • Solid working knowledge of cGMP and GLP requirements.
    • Strong verbal and written communication skills
    • Ability to foresee potential product development issues during the formulation and package processes and circumvent them.
    • Ability to handle multiple projects simultaneously
    • Strong understanding and working knowledge of analytical chemistry, instrumentation and methods (USP  chemistry and microbiology) as they pertain to the manufacture and testing of pharmaceutical products
    • Technically proficient in Microsoft Office Products and personal computer skills
    • Knowledge and application of good documentation practices
    • Good interpersonal communication skills/able to work in a team environment 

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

    • Competitive compensation package as well as bonus incentives for excellent performance
    • Competitive medical and dental insurance
    • Paid time off program, including paid vacation, sick and holidays
    • Tax-advantaged 401(k) plan with employer match
    • Company-paid life and disability insurance
    • Anniversary Service Award program

    Qualified candidates should submit their resume, cover letter 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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    My client, focused in rare disease and specializing in a novel chemistry platform with a pipeline that spans multiple modalities, is looking for an Associate Director of GMP Quality Assurance. This individual will need to be comfortable with a wide range of GMP Quality Assurance functions for programs in early stage through commercialization.

    •  A degree in a relevant field such as chemistry, biochemistry, biology, chemical engineering, pharmaceutical sciences, or other directly related field
    • Full understanding of FDA regulations, ICH guidelines and cGMP’s
    • Works with scientist, study directors, management and others to ensure quality practices are followed.

    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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