Excelimmune, Inc. is a biotech start-up based in Woburn, Ma. focused on the discovery and development of sets of human recombinant antibodies to target infectious disease and cancer. These sets of antibodies mimic the natural polyclonal antibody response, thus enabling multiple antigens to be targeted simultaneously. Excelimmune’s human recombinant polyclonal antibodies (HRPAs) are designed to treat diseases where monoclonal antibody approaches have failed or are not suitable. We are looking for hard-working, creative individuals skilled in interdisciplinary cooperation and who are ready to contribute toward achieving our goals.

Qualifications

- The applicant must have Bachelor’s Degree in Biological Engineering, Biomedical Engineering, or related field
- 0-1 year of hands-on experience in the execution of protein purification processes; experience working with antibodies is a plus
- 0-1 year of FPLC and/or HPLC experience; experience working on a BioRad DuoFlow workstation is a plus
- experience writing technical and/or scientific reports
- experience with Microsoft Office or Apple iWork
- interest in working in a small, collaborative biotech environment
- the candidate must be a highly organized, detail-oriented self-starter with excellent verbal and written communication skills

Success factors

Successful candidates want to make a difference in the world and work in a dynamic, exciting start-up environment where they can make a major contribution.

Responsibilities

The main responsibility of the Research Associate will be antibody purification. They will be required to perform activities in accordance with Good Laboratory Practices, maintain notebooks and electronic files associated with each experiment, and prepare experimental reports and presentations. The ideal candidate must be able to take direction, as well as independently organizing and executing research projects.

Requirements

The main responsibility of the Research Associate will be to assist with antibody purification. Relevant responsibilities include, but are not limited to:

- rProtein A affinity and SEC-based antibody purification
- Membrane filtration: MF, UF/DF (TFF)
- Antibody quantification by spectrophotometry
- ELISA
- PAGE
- Contribution to project management: data management, material transfer, technical and scientific report writing

The position involves working closely with other scientists, research staff, and interns.

How to Apply

Please send your resume and cover letter to: jobs@excelimmune.com with RA-PBC in subject line. Principals only; recruiters please do not contact us.
Excelimmune, Inc. is an equal opportunity employer offering a competitive salary and benefits package including a 401(k) retirement plan, incentive stock options to a full time employees, as well as professional development in an open, growing, and supportive work environment.
All applicants should be legally entitled to work for any employer in the US.

Our client is seeking an experienced Regulatory Associate to join their team.  This position requires previous experience preparing IND’s for submission, preparing Investigative Brochure's as well as publishing experience.  Familiarity with CTD format (paper submissions) is required.  The position will be three days a week, but could be increased for the right person.

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.

StratAcuity, CHEMISTRY IS EVERYTHING.

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

The Field Support Specialist will provide technical, education, and case support within an assigned geography for current and/or potential customers. Works under moderate discretion with other Field Support Specialists and sales teammates to identify and capitalize on sales opportunities by promoting competency, comfort, and expertise in Shire Regenerative Medicine (RM) products and services. Performs work that requires a high degree of independence. Works cross-functionally with multiple departments, including sales, medical affairs, marketing, quality, regulatory, and professional education. Exercises independent judgment in planning, organizing, and performing work; monitors performance and reports status to their sales counterparts and Regional Director.

The position is field-based, requires frequent travel, and the candidate must reside within their assigned territory.

ESSENTIAL DUTIES AND RESPONSIBILITIES*:
- With direction from the Regional Director and Accounts Manager(s), serves as the primary resource for clinical case support and education of product usage during cases.
- Educates and facilitates training for Healthcare Professionals (HCPs) on technical aspects of Shire RM products and services.
- Coordinates one-on-one in-services with HCPs.
- Provides staff in-services and educational programs to support the current or future use of Shire RM products and services.
- Works closely with the Regional Director and Account Manager(s) to understand the account landscape, including key HCPs and staff, competitive activity, and expectations for supporting current business initiatives.
- Provides training and Company-approved resources for hospital staff to enable them to conduct training for their personnel (train-the-trainer).
- Manages logistics and coordination of product delivery for assigned cases.
- Completes all necessary paperwork and documentation required with customer service for pending orders, transfers, credits, and/or product complaints.
- Provides daily updates to Account Manager(s) on completed cases and notifies them of any required follow-up.
- Serves as a clinical resource to HCPs and related staff regarding Shire RM products and services.
- Manages inventory of consignment and/or trunk stock to support current customers, rotating inventory, and creating product utilization efficiencies.
- Assists with the integration of Shire RM products per the hospital's policy, including tracking, issuance, handling, and storage.
- Remains current with medical literature, clinical trends, and Shire RM products/services.
- Assists the Regional Director and in-house training department with education / training new Field Support Specialists and Account Managers.
- Conducts all business with customers in a manner that is concise, professional, ethical, and adheres to current Shire RM policies and FDA requirements.
* Other job related duties might be required and assigned as needed.

EDUCATION, EXPERIENCE, and QUALIFICATIONS:
1. A Baccalaureate of Science in Nursing or other equivalent scientific discipline degree required.
2. Minimum of 3 -5 years documented experience in a clinical setting, hospital outpatient, operating room, and/or wound care center.
3. Advanced knowledge of diabetes, wound care, vascular access, vascular surgery, and infection management preferred.
4. Previous experience as a commercial Field Support or Clinical Specialist within the medical device / biologics industry strongly preferred.
5. Strong time management skills with an ability to maintain several priorities and meet established deadlines.
6. Ability to build and maintain excellent business relationships with multiple constituencies, including both internal and external customers.
7. Proven success at performing responsibilities with a high degree of flexibility, objectivity, discretion, appropriate demeanor, and professionalism for different levels and types of interactions.
8. Excellent communication, presentation, organizational, planning and interpersonal skills in order to manage multiple objectives in a large geography.
9. Frequent travel required (60% - 70%).

Shire Regenerative Medicine is an Equal Opportunity and Affirmative Action Employer.

To apply for this position, please go to:
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Primary Role:
Reporting to the Director, Operational Excellence, this position will be a highly visible role partnering with clients on a daily basis across the various Technical Operations functions (Manufacturing, Global Supply Chain, Quality, Process Development, Facilities, Engineering & Site Services) at Shire HGT to help build and embed behaviors, methodologies and common tools of a continuous improvement culture. The incumbent will look both internally and externally for new and innovative ways to get work done and add value to the business. The position will work globally, cross-functionally and cross-sites, with senior management, line management, employees and external partners to define, train, implement and apply operational tools and best practices.
Responsibilities:
Provide coaching and facilitation to project teams, functions, and business process owners, employing OE/Lean/Six Sigma, problem solving methodologies, with effective change management techniques, todeliver business results (improved customer service, quality, reliability, productivity, safety, and financial performance). Identify change management needs and perform stakeholder analyses ahead of anticipated business and process changes to ensure appropriate interventions and communications are employed to ensure successful outcomes. Assess and track current status, progress & issues for all sanctioned improvement activities including the mentorship of OE Green Belts/candidates throughout the organization. Communicate proactively with stakeholders regarding progress, issues and plans for resolution. (70 - 80%) Assist in the development and execution of an operational excellence program and infrastructure (utilizing internal & external resources) integrated with the various Technical Operations business functions. Deliver training ranging from general awareness to lunch-and-learn sessions to specific tools and methods. Champion efforts that infuse the internal OE network with innovation & forward thinking mindset. (20 - 30%)

Education and Experience Requirements:
Bachelor's degree (BA/BS) in a technical background required (Engineering, Science, Business, Supply Chain); Advanced degree (MS/MBA) preferred. Completion of formal training in disciplines including lean/six sigma, operational excellence, business process management, supply chain management. Significant exposure to operational excellence training programs is required. Certified or proven technical expertise at Black Belt level including a blend of methodologies (Lean, Six Sigma). Minimum of 6-8 years progressive experience in technical operations functions (preference for experience in the biotech / pharmaceutical industries). Demonstrated experience in skill areas defined above. The individual must have thorough knowledge and experience in the application of industry best practices and methodologies (e.g. -Lean / Six Sigma). Proven record implementing tools, techniques & methodologies in a variety of business areas (product/process development, operations/supply chain & commercial). Proven record of excellence in delivering breakthrough business results. 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 and Affirmative Action Employer

To apply for this position, please go to:
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Primary Role:
This position will be responsible for supporting testing and validation activities for enterprise information systems of Shire HGT. Primary responsibilities include validation support for implementation of SAP system and maintenance of validated state post go live. Also responsible for validation support for other enterprise systems as required. Responsibilities: 40% - Develop validation plan, validation protocols, traceability matrices, acceptance criteria, conduct independent testing and compile data and results into final summary report. 20% - Provide guidance, training, and support to IT personnel / business users in their validation efforts, to ensure compliance. Coordinates the testing efforts of the IT and business teams with regards to requirements, resource planning, test coverage, test strategies. 15% - Review proposed changes to validated systems and identify the validation requirements necessary to maintain the system's validated state. Approve validated computer system related change requests. Manage the life cycle documentation. 10% - Participate in establishing and ensuring adherence to IT QMS. 10% - Provide expertise on testing methodologies as well as the use of automated testing tools (load testing, stress testing.). Conduct training on good documentation and good testing practices. 5% - Support internal and external audits.

Education & Experience Requirements:
Bachelor's degree in Computer Science or related degree. 5 or more years experience in the Life Sciences (Pharmaceutical, Medical Devices) and Healthcare industries 5 or more years experience in computer systems validation / QA within an FDA regulated environment with good understanding of cGxP (cGMP, cGDP, cGAMP, cGLP) standards required. Thorough knowledge of GxP and ERES (21 CFR Part 11 and Annex 11) regulations and guidelines. Experience with risk management practices and tools. This position requires excellent organizational and communication skills, and a thorough knowledge and understanding of FDA and international regulations (EMEA, ANVISA). Experience with SAP validation, Understanding of SAP, developing test script review and approval is required. Participation in at least one full life-cycle SAP implementation and post implementation support is preferred. Specific experience with automated testing tools (i.e.; HP Quality Center) a plus. Experience in Software Development Lifecycle (SDLC) and working with GAMP 5 and ITIL. Experience in QA Methodologies and software quality assurance. Experience designing, reviewing and approving Test Plans, systems and UAT test scripts and Test procedures. Experience with Change Control process. Experience in creation / review of SOPs. The incumbent must be self-motivated, able to correctly set his / her own priorities for projects and meet project deadlines and budgets. Teamwork and collaboration skills within the organization and working with consultants are integral to the position. 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 and Affirmative Action Employer

To apply for this position, please go to:
Application URL: http://www.aplitrak.com/?adid=YW5nZWxhZy4zMzc3NS4zMTY3QHNoaXJlLmFwbGl0cmFrLmNvbQ

Primary Role:
This position will be responsible for supporting testing and validation activities for enterprise information systems of Shire HGT. Primary responsibilities include validation support for implementation of SAP system and maintenance of validated state post go live. Also responsible for validation support for other enterprise systems as required. Responsibilities: 40% - Develop validation plan, validation protocols, traceability matrices, acceptance criteria, conduct independent testing and compile data and results into final summary report. 20% - Provide guidance, training, and support to IT personnel / business users in their validation efforts, to ensure compliance. Coordinates the testing efforts of the IT and business teams with regards to requirements, resource planning, test coverage, test strategies. 15% - Review proposed changes to validated systems and identify the validation requirements necessary to maintain the system's validated state. Approve validated computer system related change requests. Manage the life cycle documentation. 10% - Participate in establishing and ensuring adherence to IT QMS. 10% - Provide expertise on testing methodologies as well as the use of automated testing tools (load testing, stress testing.). Conduct training on good documentation and good testing practices. 5% - Support internal and external audits.

Education & Experience Requirements:
Bachelor's degree in Computer Science or related degree. 2 to 4 or more years experience in the Life Sciences (Pharmaceutical, Medical Devices) and Healthcare industries 5 or more years experience in computer systems validation / QA within an FDA regulated environment with good understanding of cGxP (cGMP, cGDP, cGAMP, cGLP) standards required. Thorough knowledge of GxP and ERES (21 CFR Part 11 and Annex 11) regulations and guidelines. Experience with risk management practices and tools. This position requires excellent organizational and communication skills, and a thorough knowledge and understanding of FDA and international regulations (EMEA, ANVISA). Experience with SAP validation, Understanding of SAP, developing test script review and approval is required. Participation in at least one full life-cycle SAP implementation and post implementation support is preferred. Specific experience with automated testing tools (i.e.; HP Quality Center) a plus. Experience in Software Development Lifecycle (SDLC) and working with GAMP 5 and ITIL. Experience in QA Methodologies and software quality assurance. Experience designing, reviewing and approving Test Plans, systems and UAT test scripts and Test procedures. Experience with Change Control process. Experience in creation / review of SOPs. The incumbent must be self-motivated, able to correctly set his / her own priorities for projects and meet project deadlines and budgets. Teamwork and collaboration skills within the organization and working with consultants are integral to the position. 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 and Affirmative Action Employer

To apply for this position, please go to:
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Role Description:
Provide Leadership for Pilot Operations for Biological Products in Europe

MAIN DUTIES:
- Ensure the smooth passage of biological projects from Research and Development through to Manufacturing
- Build and maintain an effective and high performing team and provide scientific and technical leadership for late stage Biological and Biopharmaceutical product development
- Ensure that the building and staff are compliant with site local, National and European regulations concerning Environmental Health and Safety, Good Manufacturing Practices and Biosafety Level 3 containment.
- Build and maintain a Network of collaborators that can enhance the VMRD portfolio.
- Actively seek grant opportunities through National and European partnerships
- Support and promote the VMRD Vision, Missions and Company values
- Provide strong leadership at the Louvain-la-Neuve site for Veterinary Medicine Research and Development (VMRD)
- Provide strategic direction for the VMRD staff at the site.
- Continually provide efficiencies and improvements in the manner in which the Pilot laboratories are managed and run.
- Actively engage with Regional VMRD and Manufacturing Leadership.

Qualifications:
- Minimum 10 years of relevant experience within the pharmaceutical sector
- Previous experience as People manager is required
- Fluency in French and English is required.
- DVM, PhD in the biological sciences or equivalent
- Proven Leadership skills
- Sound knowledge of Biological Product Development
- Knowledge of Good Manufacturing Practices
- Knowledge of disposable manufacturing solutions (Single Use Reactors, WAVE, filtration systems)
- Ability to work in challenging environments, juggling multiple projects and priorities
- Ability to interact with internal stakeholders in VMRD and Manufacturing (globally), as well as with Government and University officials and laboratories.
- Excellent verbal, written and interpersonal skills
- Strong IT skills (systems) -computer literate

To apply for this position, please go to:
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Role Description:
Intitulé de la fonction RESPONSABLE SCIENTIFIQUE PC
Division Direction Médicale Primary Care
Classification 7
Décembre/2012

MISSIONS:
- Contrôle et garantit la qualité de la communication sur les produits pharmaceutiques en santé humaine conformément à la réglementation, aux procédures internes et aux recommandations des autorités sanitaires afin de favoriser le bon usage du médicament
- Responsable de la coordination des projets IIR (Investigator Initiated Research) établis entre des promoteurs institutionnels et la Business Unit Primary Care

ACTIVITES PRINCIPALES:

CONTROLE LA CONFORMITE DE LA COMMUNICATION MEDICALE AVEC LA REGLEMENTATION:
- Evalue les supports promotionnels issus des équipes locales Primary care en cohérence avec la législation française, les recommandations de bonnes pratiques thérapeutiques, les chartes professionnelles et en assure la conformité afin de favoriser le bon usage du médicament.
- Identifie et prévient les risques potentiels encourus visant à éviter les sanctions des autorités sanitaires nationales.
- Contribue et veille au respect des modalités de validation par le Directeur Médical France et le Pharmacien Responsable de tout support nécessitant une approbation dûment documentée ainsi que des dispositions assurant la traçabilité.
- Interagit avec les équipes émettrices des matériels promotionnels ou d'environnement

COORDONNE L'ACTIVITE ADMINISTRATIVE SUR LES IIRs
- Est l'interlocuteur opérationnel principal des promoteurs d'IIRs, dans le respect de l'éthique, de la réglementation et des Procédures Opératoires Standardisées.
- Participe à la réflexion scientifique/faisabilité des projets en collaboration avec les KOLs d'une part et les RMR
- Supervise les démarches administratives vis-à-vis de Pfizer de tout nouveau promoteur potentiel, et le sensibilise à ses obligations en matière réglementaire et de pharmacovigilance.
- Participe au Comité d'Evaluation des Documents Cliniques (CEDC) et s'assure de la réalisation des modifications demandées avant la mise en place des projets.
- Supervise l'obligation contractuelle de reporting PV du promoteur vers la firme
- S'assure de la déclaration réglementaire du protocole et de ses amendements faite par les promoteurs (Assurance, ANSM, Comité de Protection des Personnes (CPP), Commission Nationale Informatique et liberté (CNlL), Conseil National de l'Ordre des Médecins (CNOM), Conseil National de l'Ordre des Pharmaciens (CNOP) etc.).
- En cas de fourniture de produits, coordonne l'approvisionnement en produits, supervise la commande globale des traitements de l'étude, l'approvisionnement des centres en Unités de Traitement et s'assure du réapprovisionnement des centres en Unités de Traitement, en collaboration avec le Coordinateur Produits Essais Cliniques (si applicable), le cas échéant avec le fournisseur des produits.
- Coordonne la rédaction des contrats et avenants en collaboration avec le service juridique.
- Elabore le budget initial du projet et de la fiche planning, en accord avec les budgets disponibles, en coordonne l'enregistrement, et supervise le suivi et valide les factures.
- S'assure de la mise à jour régulière et de l'utilisation optimale de l'outil informatique de gestion des IIRs : INSPIIRE (postage des documents initiaux, de suivi et de clôture; mise à jour du budget...).
- Est l'interlocuteur principal pour les questions générales concernant INSPIIRE, les formations aux mises à jour du système, aide à la résolution de problèmes d'utilisateurs…
- Est l'interlocuteur privilégié en cas d'audit sur les IIRs.
- Optimise la communication interne (diffusion de l'information) et externe (image Pfizer) autour des IIRs.
- Participe à la relecture du rapport final, des abstracts et publications afférents aux projets (si applicable).
- Se tient informé sur les produits Pfizer et leur environnement (participation à des congrès et symposiums, lecture de la littérature…).

COMPETENCES CLES:
- Adapter sa communication à des interlocuteurs différents et/ou cultures différentes, pouvant avoir des intérêts divergents
- Adopter une posture d'écoute el respecter les différents points de vue pour créer un climat de collaboration
- Etre rigoureux en appliquant les règles et les procédures dans un souci d'exigence de qualité et d'efficacité
- Faire preuve d'intérêt et de curiosité sur sa connaissance de l'organisation e/ou assurer une veille sur son environnement externe pour capter les évolutions et enrichir les pratiques Pfizer
- Sélectionner et formaliser les informations pertinentes pour en assurer une diffusion efficace
- Donner du sens et partager les informations pour garantir la fluidité de la communication
- Organiser et planifier ses activités, dans le respect des délais et des exigences client
- Fédérer et coordonner, autour d'un objectif partagé, une équipe pluridisciplinaire dont les approches diffèrent.

FORMATION ET/OU PRE-REQUIS

FORMATION DE BASE ET EXPERIENCE PROFESSIONNELLE:
- Pharmacien/Médecin ou équivalent avec de préférence un Master Il de Droit de la Santé
- Connaissance de la réglementation en matière de publicité pharmaceutique
- Bonne maîtrise de l'Anglais : orale et écrite
- Maîtrise des outils informatiques

To apply for this position, please go to:
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Org Marketing Statement:
All over the world, Pfizer colleagues are working together to positively impact health for everyone, everywhere. Each position at Pfizer touches and contributes to the success of our business and our world. That's why, as one of the global leaders in the biopharmaceutical industry, Pfizer is committed to seeking out inspired new talent who share our core values and mission of making the world a healthier place.

Department Marketing Statement:
The Inflammation and Remodeling department is seeking a Senior Scientist to join our Cambridge, MA Research group. The successful candidate will be a part of translation pharmacology group and will focus on biomarker discovery and translational studies to refine mechanistic understanding of molecular targets in inflammatory diseases.

Responsibilities:
- Design and conduct the experiments to support the mechanistic and disease biomarker discovery for in vitro and in vivo models
- Design and implement strategies utilizing clinically relevant human primary cells and ex vivo tissue analysis to provide confidence in rational for company assets
- Develop and execute cell based assays to support mechanism of action and target validation studies primarily focusing on human cellular system
- Supervise and manage the daily activity of technical laboratory personnel
- Maintain sustained lines of communication across Research and Clinical Translational Medicine

Qualifications:
- Ph.D. in biochemistry or cell biology with minimum 5 years postdoctoral experience
- A thorough understanding and hands-on experience with cell biology and cell signaling
- Hands-on experiences in culturing of primary structural human cells (e.g smooth muscle, epithelial, mesenchamal cells).
- Knowledge of wide range of bioanalytical techniques including protein (flow cytometry, western blot, luminex, ELISA, etc) and RNA expression (TaqMan analysis).
- Strong critical thinking and experimental skills with a proven track record of project contributions and solving complex challenge
- Superior scientific and strategic acumen and excellent publication record
- Ability to work independently and as part of cross-functional, multi-disciplinary teams while designing and implementing program strategy
- Candidates with In depth understanding of renal disorders will be given a preference

Equal Employment Opportunity:
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 employment eligibility verification requirements of the Immigration and Nationality Act. All applicants must have authorization to work for Pfizer in the U.S. In certain circumstances it may be advantageous to Pfizer to support the application(s) for temporary visa classification and/or sponsor applications for permanent residence so that a foreign national colleague can accept or remain in a work assignment in the U. S. For certain classes of temporary visas, the resulting work authorization may be specific to Pfizer and the specific job and/or work site. Pfizer may at its businessdiscretion decide to or refrain from obtaining, maintaining and/or extending the temporary visa status and/or sponsoring a colleague for permanent residency and /or employment eligibility, considering factors such as availability of qualified U.S. workers and the colleague's long-term prospects for securing lawful permanent residence, among other reasons. Employment applicants requiring immigration sponsorship must disclose, when initial application for employment is made, whether or not they are legally authorized to work for Pfizer in the U.S. and, if so, whether that authorization permits them to work in the job they seek. In no case should Pfizer's support of a colleague's temporary visa application or sponsorship of a colleague for permanent residence be construed to guarantee success of that application or amend or otherwise invalidate the "at-will" employment relationship between the colleague and Pfizer.

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Job Purpose: The Operational Alliances Director is responsible for establishing all external alliances required to execute on the current strategic goals of disease areas (DA) and functional areas (FA) in supporting their internal research programs. The Operational Alliances Director performs this role independently and with little or no oversight from the Head of Operational Alliances.

Major Accountabilities:

The Operational Alliances Director is a member of a global team, and manages the external alliance needs of multiple DA/FAs, often across multiple sites. He/she works with science leaders and laboratory investigators of each DA/FA to assess how a relationship with an external party can best be structured to meet the needs of a particular scientific research project. The Operational Alliances Director must then balance and synthesize the priorities of each DA/FA in order to provide business guidance and manage the execution of all necessary agreements. Responsibilities of the position include:
-Implementation and management of Research Agreements and Licensing Agreements
-Implementation and management of Confidentiality Agreements, Consulting Agreements and Material Transfer Agreements to support internal research programs
Completion of each of these functions will require the Operational Alliances Director to:
-Negotiate agreement structure and business terms
-Lead a cross-functional team of representatives from Legal, Patent, Finance and Science functions, to bring agreements through to successful implementation
-Provide strategic input to DA/FA members on business impact of contract-related issues
-Coordinate and synthesize the competing priorities of multiple DA/FAs for the purposes of providing appropriate business support to each
-Accurately record and update information in appropriate databases

Minimum Requirements:

The ideal candidate will have an advanced life science degree and completion of a business degree. The successful candidate will have at least five years’ experience in the pharma/biotech arena in a business role, interacting with both US and non-US based academic institutions and companies. Strong working understanding of the science of drug discovery is essential. Strong analytical and communication skills, and excellent skills in both prioritization and time management are required. The successful candidate will have a strong sense for urgency, be a team player, and bring a creative approach to problem solving. Reliability, independence, and initiative are essential. Finally the candidate must have a genuine passion for science, as well as personal determination for excellence and for finding new ways to perform his/her job better.

To apply please submit your resume directly to our website:

http://nibr.com/careers/jobs.shtml

Responsibilities:

To ensure the QC, publishing and technical quality of scientific documents, ensuring compliance with internal and external guidelines and supporting the timely compilation of submissions to HAs

Compile, integrate and publish nonclinical documents with state-of-the-art word processing, electronic publishing and document management systems in the company's development environment

Perform technical quality control (electronic functionality, adherence to internal and external document standards) of nonclinical and clinical documents

Conduct document issue resolution with customers and collaborators

Requirements:

At least 1-3 years' experience with electronic document management systems, publishing tools

Basic knowledge of document publishing / document management including CoreDossier, Adobe Acrobat, ISI toolbox and / ISI publisher

Basic knowledge of GxPs and OECD regulations

Basic experience in non-clinical and/or clinical report preparation and submission

Education:

Undergraduate degree, preferably in scientific field or related experience

Candidates must live local and be a US Citizen or Green Card Holder
 
Commonwealth Sciences is a professional recruiting firm specializing in Science, Engineering and Green Technologies. We unite industry professionals with exciting career opportunities by leveraging our technical expertise, advanced recruiting tools and years of staffing experience. CWS works with a variety of disciplines and levels from Research Associates to Scientists, Engineers, Managers and Directors.
Our clients value the basic integrity, customer service and industry expertise that defines our organization.
 
Commonwealth Sciences, Inc.
www.cwsciences.com

Our client is seeking a Research Associate with prior experience in providing LCMS data analysis and data collection support.  In this position you will be responsible for operating LCMS instrumentation (Agilent HPLC or Waters UPLC, coupled to ABI 4000Q-trap or Waters Xevo TQS triple-quad mass spectrometers) as well as the use of established informatics tools for analysis and quantification of complex mixtures of endogenous metabolites, and small molecule therapeutics (ABI Analyst and Multiquant software).  This position requires a BS in biological science with a minimum of two years experience in LCMS data acquisition and processing.  Direct hands-on experience with Thermo and ABI software programs, including Analyst and Multiquant is required. Direct experience with metabolomics research is required.  Familiarity with chemical informatics, electronic inventory, and Matlab systems would be a plus.

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.

StratAcuity, CHEMISTRY IS EVERYTHING.

T2 Biosystems is disrupting the landscape of clinical diagnostics with T2MR, the Company’s proprietary magnetic biosensor detector. The T2MR technology enables healthcare professionals to save lives and reduce costs by providing sensitive, accurate, and rapid diagnostic results. The company’s products can detect molecular or immunoassays targets and provide a robust menu of hemostasis measurements directly from unpurified clinical samples in hospitals, labs and physicians’ offices. We are seeking a talented and highly motivated individual to lead our Business Development  initiatives.

You may be the person we’re looking for if you have:

• 10-15+ years of experience in putting out licensed strategic business development deals in place, ideally inside an invitro diagnostic company.
• MBA and a BS/MS/Ph.D. in a related science field.
• Additional experience within an in vitro diagnostic company, venture capital firm, investment banking firm or consulting firm.
• Demonstrated leadership capability and ability to connect with executives in large companies.
• Excellent communication skills both verbal and written.
• Presentation experience to potential partners, board members, at conferences and meetings.

Your responsibilities will include:

• Leading the effort to develop the plan for pursuing strategic partnerships with in vitro diagnostic and therapeutic companies, including but not limited to joint ventures, licensing deals, co- development agreements etc.
• Working the existing pipeline of opportunities and developing a broader pipeline of opportunities. Networking to get to the right people in the right companies, developing relationships, utilizing the T2 Bio management team as appropriate, and driving the strategic partnership process from first meeting through closed agreement and managing the partnership to success.
• Pursuing government and not-for-profit grant opportunities including writing grants as appropriate.
• Selectively pursuing opportunities for the company’s technology outside of the in vitro diagnostics markets – food testing, environmental testing, etc.
• Analysis of markets, products, competitors, and new technologies.
• Participating in Board of Director meetings, investor meetings and presenting at industry conferences.
• Working with VP of Marketing in developing new product strategy

In addition, you will have:

• An executive presence and the ability to communicate and work with executives and scientists.
• Demonstrated ability to communicate and sell a vision and demonstrated ability to understand how strategic deals get done.
• Network of contacts and ability to network to get to senior level executives.
• Work at an aggressive pace and be deal oriented.
• Be able to travel as working the pipeline of strategic opportunities will require extensive meeting time.
• A high level of commitment and a track record of high quality work, with attention to detail.
• Demonstrable resourcefulness along with good analytical thinking, clear data analysis, and the ability to draw sound conclusions.
  • The ability to work well with teams in a fast-paced, dynamic environment with an eye always on the goal.

We are looking for a person who is a strategic thinker who can develop and close strategic deals. The candidate should have a broad network within the field and have a strong medical and biotechnology background.

The successful candidate will be highly motivated, results driven, exceptionally talented, analytical, and a team player. Please send your résumé and cover letter to careers@t2biosystems.com, and please identify the job title in the subject line

T2 Biosystems is an equal opportunity employer. We do not discriminate on the basis of race, color, religion, gender, pregnancy, national origin, age, military service eligibility, veteran status, sexual orientation, marital status, disability, or any other protected class.

Genzyme has pioneered the development and delivery of transformative therapies for patients affected by rare and debilitating diseases for over 30 years. We accomplish our goals through world-class research, collaboration with the global patient community, and with the compassion and commitment of our employees. With a focus on rare diseases and multiple sclerosis, we are dedicated to making a positive impact on the lives of the patients and families we serve.

Genzyme's portfolio of transformative therapies, which are marketed in countries around the world, represent groundbreaking and life-saving advances in medicine. As a Sanofi company, Genzyme benefits from the reach and resources of one of the world's largest pharmaceutical companies, with a shared commitment to improving the lives of patients. Learn more at www.genzyme.com.

JOB PURPOSE
This role is key for assessment of feasibility of clinical trials proposed or to be performed by the Clinical & Sciences Operation Platform (C&SOP) of Sanofi-Aventis R&D. The Feasibility Manager (FM) is the central point of contact for coordination and conduct of the feasibility assessments and provide reliable and consolidated results at the C&SOP level utilising wide sources of data (including but not limited to prediction of source of patients, rate of recruitment, predicted prescreen and screen fail rates).

This will include an appropriate geographic deployment for the conduct of a given indication or study to optimize the feasibility in the perspective of cost effectiveness, respect of timelines and quality.

The FM will also provide proposal regarding patients recruitment strategy and scenario modeling in order to improve the reliability of recruitment forecasting at region, clusters or country level. With the goal of optimal subject recruitment, he/she drives the development of processes and tools that integrate strategic study placement into sanofi-aventis clinical research practices.

He/she will work in very close collaboration with the Clinical Study Director assigned to the study and under supervision of the Lead Medical Operations for the domain or therapeutic area.Part of the Clinical Trial Team, he/she will be accountable for feasibility process and will collaborate and interact with Clinical Study Units or Clusters and especially and mainly with Medical Advisors.

To better serve some customers (Oncology, Diabetes, …), experience or qualification in a medical specialization will be required or at least appreciated.

SCOPE
All clinical studies or projects related to clinical development (excluding Clinical & Exploratory Pharmacology studies).
From a draft proposal (e.g. study synopsis) to end of study recruitment.
Deliver clinical study pre feasibility or feasibility assessments and proposals and patients recruitment strategies.

KEY INDIVIDUAL ACCOUNTABILITIES
- To provide Feasibility advice and strategic recruitment planning and site support for projects to be proposed to the C&SOP,
- To conduct the appropriate evidence based Feasibility for study/project with the CSD and other team members (especially Medical Advisors in CRUs),
- To prepare Feasibility Questionnaires, documentation required for the feasibility in collaboration with the CSD,
- To provide reliable feasibility assessment based on solid assumptions and risk assessment,
- To obtain an appropriate geographical deployment of a given indication or study in order to:
- ensure the feasibility of the implementation of study protocols
- improve the reliability of recruitment forecasting at regions/ country level
- To analyze continuously initiated clinical trials and implement action plans or back-up plans as needed,
- To maintain relevant systems, database and performance metrics,
- To analyze past performance, epidemiology and database data to produce accurate, robust and timely feasibility information,
- To prepare a recruitment strategy proposal at the CSU, Cluster and Region level for review and approval by Head of Region,
- To develop interaction with Medical Advisors in CSUs and Clusters for the best knowledge of the study, compound, protocol, …. in CSUs and participating countries,
- To provide appropriate and timely, high quality, customer focused proposals, tools, processes, develop training material in collaboration with the CSD and input for patient recruitment and retention strategy,
- To continuously research and communicate industry trends in global clinical trials including emerging markets and technology based innovations,
- To represent Department on cross-functional teams and task forces,
- To ensure components of feasibility strategy are fully implemented by stakeholders,
- To facilitate collaboration across regions/countries to establish appropriate subject allocation according to strategy,
- To facilitate communication of learnings and best practices among team members and across therapeutic areas,
- To support the CSUs to identify potential investigators and to develop network using and developing tools and data base.

KEY SHARED ACCOUNTABILITIES
- With CSD, feasibility results and support medical training to study team, CSUs (Medical Advisors, monitoring, …) and investigators,- With Business Office and Project Leader in the CSO Platform, assessment of cost effectiveness according to the geographical deployment of the study,
- With Trial Operations, patients recruitment timelines and applied patients recruitment strategy,

KEY LEADERSHIP BEHAVIORS
- Team spirit,- Clear and effective communicator,
- Expertise in the domain of assigned study/project
- Interest and ability to teach,
- Customers (medical project leader in Unit, …) & quality focused
- Negotiation skills
- Highly developed analytical skills
- IT literate

PARAMETERS FOR SUCCESS
Key Metrics
- Customer satisfaction (Units, …)
- Respect of timelines for feasibility
- Protocol amendments (low number)
- Sites participation and recruitment according to plan
- Minimal requirement to back-up or rescue plans

Organizational
- Develop parternship and team spirit with CSD, Project Leader and Study Managers and
- Strong collaboration and interaction with Medical Advisors in CSUs

DECISION RIGHTS
Owns
- Advice and Input on feasibility for a clinical study/project
- Conduct feasibility process
- Interactions with Medical Advisors in CSUs for Feasibility and other potential stakeholders (e.g. regulatory, marketing, market research).
- Influences- Best approach for study conduct
- Patient recruitment strategy
Vetoes- Non feasible proposals
- Non ethical proposal according to local practices

Qualifications
- Degree in Sciences or Pharma or Medicine.
- Experience in Clinical Development, especially relevant experience in multinational study management in a medical specialization would be appreciated.
- Knowledge in ICH, GCP and local regulations.
- Knowledge in Epidemiology or/and Data Management would be appreciate to develop new skills in feasibility process.
- Fluent in English.

To apply for this position, please CLICK HERE

Genzyme has pioneered the development and delivery of transformative therapies for patients affected by rare and debilitating diseases for over 30 years. We accomplish our goals through world-class research, collaboration with the global patient community, and with the compassion and commitment of our employees. With a focus on rare diseases and multiple sclerosis, we are dedicated to making a positive impact on the lives of the patients and families we serve.

Genzyme's portfolio of transformative therapies, which are marketed in countries around the world, represent ground breaking and life-saving advances in medicine. As a Sanofi company, Genzyme benefits from the reach and resources of one of the world's largest pharmaceutical companies, with a shared commitment to improving the lives of patients. Learn more at www.genzyme.com.

Job Responsibilities:
The Science Computing Group in the Genzyme R&D Center seeks a highly motivated individual to work in a dynamic and cross-functional team supporting genomics and informatics research. You will work in partnership with scientific colleagues in functional genomics and disease biology groups throughout Genzyme. Main responsibilities are to introduce and develop computational methodologies and approaches necessary to support leading edge genomic research.

You will work with researchers to design and perform in-depth statistical and quantitative analysis of genomics data, especially in the next generation sequencing area. As the computational specialist on project teams, you will be expected to effectively communicate analytical results with internal project collaborators through both presentations and one-on-one interactions. Additionally, you will participate in defining and supporting computational infrastructure within the group.

Qualifications
Basic Qualifications:
Ph.D. degree in bioinformatics, biological sciences, biostatistics or computational biology and 1-2 years of research experience in bioinformatics/genomic research. Experience must include analyzing next generation sequencing data or microarray data and expert use of relevant software.

Preferred Qualifications:
Knowledge of PERL, Python, JAVA, Spotfire, Pipeline Pilot, Matlab, SAS, JMP desired.

To apply for this position, please CLICK HERE

Genzyme has pioneered the development and delivery of transformative therapies for patients affected by rare and debilitating diseases for over 30 years. We accomplish our goals through world-class research, collaboration with the global patient community, and with the compassion and commitment of our employees. With a focus on rare diseases and multiple sclerosis, we are dedicated to making a positive impact on the lives of the patients and families we serve.

Genzyme's portfolio of transformative therapies, which are marketed in countries around the world, represent groundbreaking and life-saving advances in medicine. As a Sanofi company, Genzyme benefits from the reach and resources of one of the world's largest pharmaceutical companies, with a shared commitment to improving the lives of patients. Learn more at www.genzyme.com

Sr. Functional Administrator & Technical Coordinator

Position Summary:
Assists the department in various functional areas to support MTS activities and processes. Develop and utilize systems and processes to help streamline tasks and increase efficiencies while ensuring compliance readiness at all times.

Core Responsibilities
- Works closely with the Molecular Stewards to
- collect, organize and maintain technical documents in the Product Development File system, to evaluate and leverage existing knowledge management systems/processes elsewhere within GNZ/Sanofi to ensure proper knowledge management.
- establish an integrated -across biologics- PCS schedule, monitor progress and prepares status reports and flags issues
- supports the preparation of components of technical documents, such as schematics, graphics, diagrams, and tables from raw data or source information
- assist with sorting out, organizing and consolidating information/data in preparation of technical discussions
- assist with creation & maintenance of the product technical lifecycle plan, and derive from it a product specific project list of improvements. Helps to ensure alignment of the product specific project list with the project portfolio system.
coordinate and define agenda for PCS alignment-standardization forums, document and action follow-up.Leadership Qualifications:
An ongoing commitment to conducting our global business according to the highest legal and ethical standards, and to continually pursue excellence in the development and delivery of all of our products and services. This includes:
- Respecting the laws and operating within the applicable regulations of the places in which we conduct business, as well as our own Company policies and procedures.
Being honest and treating people with respect and courtesy.
- Constantly striving to make Genzyme a great place to work, and a company respected for the quality of its people and products.
Acting as role models for our fellow employees by acting responsibly, fairly, and honestly in our dealings and exercising sound judgment in performing our jobs.

Qualifications
Basic Qualifications:
- Bachelor's Degree with and 5 or more year's administrative experience or related experience in the biopharmaceutical technical environment.
- At least 3 years project management experience or project work with being the sole coordinator of information/data
- Advanced level experience with Microsoft Word, Excel, and PowerPoint.

Intermediate level experience with all other Microsoft Office products

Preferred Qualifications:
- Strong organizational, administrative, multi-tasking, and analytical skills.
- Excellent teamwork, collaboration, written and verbal skills.
- Highly organized.
- Ability to interact with all employees within the organization and respond to business needs in an effective and timely manner.

To apply for this position, please CLICK HERE

On June 7, 2012, Pfizer announced the next steps in the strategic alternatives review process for its Animal Health business. Preparations are underway to file a registration statement in the U.S. for a potential initial public offering (IPO) of a minority ownership stake in Animal Health. The name of the standalone company will be Zoetis™ (zō-EH-tis). Zoetis, will build on Pfizer Animal Health’s position as a leader in the discovery, development, manufacture and marketing of a diverse portfolio of animal vaccines, medicines, biopharmaceuticals, diagnostics and genetic tests to prevent and treat disease in livestock and companion animals. The business markets its products in more than 120 countries with operations in developed and emerging markets and provides comprehensive animal health solutions to veterinarians and the livestock farmers and companion animal owners they support. The business has an extensive research and development network and holds leading market positions across major geographic regions, including North America, Europe, Africa, the Middle East, Latin America, and Asia-Pacific.

Associate Director/ Director, Global Alliances

Pfizer Animal Health, Europe, Africa & Middle East (EUAfME)

Position can be located at any European Pfizer Animal Health office.

Preferred location : Paris

The Associate Director Global Alliances provides PAH with support for the creation, development and maintenance of strong external alliances across the Europe, Africa and Middle East region, with a primary focus on swine opportunities, particularly focused on academic, research institutes and government agencies.

The position manages a component of the regional Global Alliances (GA) budget. Strong collaborative relationships with Business Development (BD), New Product Marketing (NPM), Legal, Research and Development (VMRD) and the European Business Units are critical to success in this position.

The role will require significant (approximately 30% of working time) travel in Europe and the US.

Responsibilities:
- Secures new opportunities: identifies, assesses and secures new product or research opportunities, with a primary focus on swine health and production, working in collaboration with VMRD, NPM to enable external scientific partnerships in line with PAH strategy. Works with BD and legal teams to finalise collaborative partnership agreements.
- Encourages innovation: establishes partnerships with non-traditional partners to move from animal health products to customer solutions
- Manages research consortia: in collaboration with VMRD, manages research consortia and collaborations to address unmet needs in areas of major production loss.
- Provides operational support: provides support to the regional swine business through collaborative partnership with key opinion leaders, academic experts, research institutes and government. This includes collaboration with regional, national and species business leaders to identify and coordinate activities.
- Manages budget: ensures project payments are made within budget and on time.
Ensures effective communication of key GA activities and achievements across PAH.

Qualifications:
- Understands of the strategic needs of the European and regional animal health sector
- Familiar with key European and regional academic and government research institutions, ideally with an existing network of contacts with key opinion leaders
- Capable of discussing at a technical level with leaders in their specialist fields
- Experience in collaborating as an industry partner to secure access to publicly funded European animal health R&D opportunities
- DVM or PhD with 10+ years experience in the animal health industry
- Business Management qualifications will be a benefit
- Fluent written and verbal English is essential; a second language would be an advantage.

Business Acumen:
demonstrates the ability to be very creative, to find innovative technical opportunities to optimise growth of the swine portfolio in the EUAfME region, including in emerging markets. Drives new solutions.

Leadership skills:
demonstrates leadership in his/her interactions. Able to inspire and motivate people to enhance the team motivational drive for sustained success and positive development.

Change management:
a strategic thinker who brings creative ideas, has good judgment to detect innovative technical opportunities that will support the business and ensure growth in the PAH swine business. Flexible to the needs of a changing business environment.

Communication and Cooperation:
strong communication and cooperation skills; engages in effective partnerships, can facilitate effective brainstorming, project work activities. Able to manage multi-functional teams and transfer knowledge to local technical experts.

Influencing skills:
perceived as a convincing manager who can persuade and encourage others to step into mutual beneficial partnerships.

Acts decisively:
demonstrates the capability to anticipate, to move fast, to act decisively and to keep strong focus on achieving results. Sets high aspirations and expectations.

Strong analytical skills:
capable of developing robust opportunity analyses, followed by concrete action plans to secure implementation.

Diversity & Inclusion:
a good listener who incorporates the ideas of others into final strategies and decisions and shows respect for people and other cultures.

Integrity:
demonstrates the highest level of integrity in all business operations.

To apply for this position, pleaseCLICK HERE

Posting Title:

Associate Scientist I, Proteomics Sciences

Functional Unit:

Research and Development

Job Category:

Research and Development

Job Description:

Biogen Idec is seeking a highly motivated associate scientist to work in proteomics group. The primary role of this candidate will be help in developing and implementing modern LC/MS/MS based technology for discovery and targeted quantitative proteomics studies. The candidate will be particularly focused on optimizing and implementing biological sample preparation, and executing SOPed proteomics experiments to support biomarker discovery and verification from clinical samples, as well as maintaining relevant instrument or devices.

Position requires active interaction and collaboration with project team scientists. The responsibilities also include basic lab organization and maintenance, as well as excellent documentation skills.

Qualifications:

• Hands-on experiences in biological sample preparation, particularly for proteomics studies.
• Skills of operating LC/MS system are vital.
• Comprehensive understanding of protein biochemistry is highly desired.

Education:

A BS with >5 years of relevant industry experience in protein bio-analytics, protein biochemistry or equivalent field is required.

 Please apply to: 

https://sjobs.brassring.com/1033/ASP/TG/cim_jobdetail.asp?partnerid=169&siteid=5140&AReq=19095BR&Codes=MBC

Participate in study specific meetings, assist with cost tracking, assemble all necessary documentation for clinical trials, assist with regulatory and ethical regulations, and assemble/maintenance and archiving of the TMF.

Requirements:

BS/MS in Biology or related field with 2+ years experience in a clinical setting.
Must have experience assembling, maintaining, and archiving TMFs
Must have experience with budget reconciliation

Candidates must live local and be a US Citizen or Green Card Holder

Commonwealth Sciences is a professional recruiting firm specializing in Science, Engineering and Green Technologies. We unite industry professionals with exciting career opportunities by leveraging our technical expertise, advanced recruiting tools and years of staffing experience. CWS works with a variety of disciplines and levels from Research Associates to Scientists, Engineers, Managers and Directors. Our clients value the basic integrity, customer service and industry expertise that defines our organization.

Commonwealth Sciences, Inc.
www.cwsciences.com

Warp Drive Bio is driving the reemergence of natural products in the era of genomics to create breakthrough treatments that make an important difference in the lives of patients. Built upon the belief that nature is the world’s most powerful medicinal chemist, Warp Drive Bio is deploying a battery of state-of-the-art technologies to access powerful drugs that are now hidden within microbes.

At Warp Drive Bio, we are building a proprietary “genomic search engine,” where the search query line consists of DNA sequences that encode the chemomeme within biosynthetic gene clusters, and the search space is defined by the universe of all accessible bacterial genomes. We are focusing this innovative search engine on chemomemes having high pharmaceutical pedigree, novel and profound biological effects that tap into areas of high unmet medical need, and the ability to access targets that abiotic small molecules and monoclonal antibodies cannot.

In this role, you will help drive the discovery of compounds from identification through validation and optimization working with a multi-disciplinary team of scientists.  You will perform isolation, identification and structure elucidation of new natural products using bioassay-guided fractionation, perform chemical modification of natural products, and the development of new separation methodologies.

Minimum Experience:

• Ph.D. in chemistry or related discipline with 5-10 year industry experience in natural products chemistry
• Recognized as an expert in natural products chemistry by the scientific community with a strong publication/ patent record
• Working knowledge of natural products biosynthetic pathways
• Expertise in isolation and purification of natural products from natural sources as well as the structure characterization of isolated material.
• Strong expertise in structural determination of complex organic molecules by  NMR and mass spectrometry methods.
• Development of novel methods for natural product derivatization
• Experience working in multi-disciplinary teams of scientists in a fast-paced, multi-disciplinary environment to accomplish project and company goals
• Experience with project leadership and setting milestones, as well as experience holding self and others accountable.
• Excellent verbal and written communications skills

To be considered for this role, please submit your resume to careers@warpdrivebio.com

Note to Employment Agencies: Please do not forward any agency resumes. Warp Drive Bio is not responsible for any fees related to resumes that are unsolicited.

Warp Drive Bio will only accept job applications from candidates who are properly documented with authorization to work in the United States.