Sample Management Associate will be responsible for the storage, retrieval, replication and distribution of proprietary compound libraries to the screening organization.

Requirements

• Bachelor's degree and experience working with automation with an emphasis on compound inventory management and distribution utilizing automated systems.
• Should have knowledge of activities related to compound management, with familiarities to include acoustic dispense technologies.
• Experience working with automation systems and laboratory robotics.

Required Skills: sample management, automation. compounds

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

Email resume to: jobs@cwsciences.com

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.
http://www.cwsciences.com

Responsibilities:

• ·         Will be responsible for Design Transfer activities and Validation plans based on process transfer documents with external manufacturing partners.
• ·         Responsible for risk management activities and process transfer to external vendors.
• ·         Write process validation protocols and record all required data during validation.
• ·         Document all work according to cGMP.
• ·         Writes deviations and assesses validation impact of nonconforming data.

Background:

• ·  BSME or related degree and 5+ years process development experience.
• ·   Must have scale up/manufacturing validation in a GMP environment.

Required Skills: GMP, process development

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

Email resume to: jobs@cwsciences.com

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.
http://www.cwsciences.com

Research Associate - Molecular Biology will join a group dedicated to the discovery of therapeutics for neurological diseases.  Research Associate will be responsible for performing molecular techniques including rtPCR, cloning, primer design and DNA/RNA extraction.

Requirements:

• BS in Molecular Biology with 2+ years experience performing molecular techniques
• Must have experience with rtPCR, cloning, primer design and DNA/RNA extraction
• Experience with mammalian cell lines is a plus

Required Skills: primer, plasmid, cloning, molecular

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

Email resume to: jobs@cwsciences.com

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.
http://www.cwsciences.com

Downstream Process Development Associate will support the development of biologics.
This includes performing purification using AKTA systems.

Requirements:

• BS in Chemical Engineering or related field with 1+ years experience working in downstream purification
• Must have experience with protein purification chromatography techniques
• Experience with AKTA is a plus

Required Skills: downstream, GMP, AKTA, protein purification

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

Email resume to: jobs@cwsciences.com

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.
http://www.cwsciences.com

Microbiology Associate will be responsible for performing laboratory testing and analysis.   Performs calculations, prepares reports and assesses proper calibration and standardization of equipment and procedures. Maintains and organizes equipment and retains samples. Provides training to new hires in laboratory. Acts as a backup for reviewing and releasing of data.

Requirements:

BS in Microbiology with 2+  years experience working in a GMP/GLP setting. 

Required skills: microbiology, GMP, GLP, testing

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

Email resume to: jobs@cwsciences.com

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.
http://www.cwsciences.com

Job ID: 27365
Date Posted: 11/16/2015
Location: Dana
Job Family: Technician/Technologist
Full/Part Time: Full-Time
Regular/Temporary: Regular
About Dana-Farber

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

Overview

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

Our Core Values are:

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

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

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

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

Job Summary

We are seeking a highly motivated candidate to fill a full-time research technician position in David Weinstock’s laboratory at the Dana-Farber Cancer Institute. We are a translational leukemia and lymphoma research laboratory that uses a variety of biochemical, molecular, and cell biology approaches to identify new therapeutic targets and develop preclinical models of disease. The ideal candidate would be a technician who could straddle both the realms of mouse work as well as wet lab experiments. The technician would be responsible for cell culture, basic handling of DNA, RNA, and protein, PCR, Western blots, CRISPR design, molecular cloning, transfection and retroviral / lentiviral transduction of murine and human cells, flow cytometry, preparation of reagents and media used in lab experiments, operation and maintenance of standard lab equipment, and data analysis and recording of results. The position will also require proficiency handling mice and harvesting tissue samples including spleen and bone marrow from mice. Previous experience in the above techniques is preferred, but on the job training can be provided. Motivation to learn additional mouse techniques including injections, oral gavage, and phlebotomy is a plus. We are looking for candidates who have at least two years of availability. The job would provide great exposure to someone who was considering going to graduate school or medical school in the future.

Qualifications: Minimum of B.A./B.S. with experience in molecular biology. Some laboratory experience and experience handling mice is required.

Schedule

This is a full time position, 40 hrs / week, Mon-Fri.

How to Apply

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

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

Equal Employment Opportunity

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

Apply Here

PI92551635

Job ID: 27148
Date Posted: 09/25/2015
Location: 450 Brookline Ave
Job Family: Technician/Technologist
Full/Part Time: Full-Time
Regular/Temporary: Regular
About Dana-Farber

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

Overview

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

Our Core Values are:

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

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

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

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

Overview

The Center for Cancer Precision Medicine (CCPM) is a major institutional priority, being established across Dana-Farber Cancer Institute (DFCI), Brigham & Women’s Hospital (BWH), and the Broad Institute (Broad). The mission of this Center will be to catalyze the implementation and innovation of precision cancer medicine and medical science at these institutions. The Center will leverage a multitude of existing and new capabilities for comprehensive genomic characterization, computational analysis, and technology development. It will bring together DFCI and BWH resources to pioneer new approaches for tissue biopsies, with the goal of facilitating the generation and clinical interpretation of tumor molecular data from clinical trials. CCPM will integrate and coordinate various research and clinical disciplines, and establish joint capabilities across BWH, DFCI, and the Broad with the ultimate goal of creating a leading cancer precision medicine research enterprise.

Position Summary

The CCPM is seeking a research technician to perform studies focused on understanding the mechanisms of therapeutic response and resistance in cancer. The ideal candidate will assist develop and implement methods to apply new technologies and approaches that augment cancer precision medicine. The research technician will assist design and perform systematic or hypothesis-directed studies of tumor cell populations, genetic alterations and other molecular features that may inform clinical decision-making, resistance mechanisms or treatment response. These studies may include optimizing protocols for characterizing single cells isolated from clinical samples as well as establishing methods for the propagation and perturbation of patient-derived tumor/normal cell lines. This individual will also assist collecting, analyzing and interpreting data, designing and conducting follow-up experiments and preparing publications.

Job Qualifications

B.A. or M.A./M.Sc or equivalent degree in life sciences is required.

The ideal candidate should have:

• a background in cancer research and experience with molecular biology, biochemistry and cell biology.

• hands-on research experience and outstanding technical skills.

• Flexibility in working hours.

• Experience with microfluidic systems and in processing patient-derived samples (advantages, not requirements).

The ideal candidate will be motivated, detailed, goal-oriented and possess excellent organizational including the ability to handle a variety of tasks in a fast-paced environment. The candidate should have strong interpersonal, communication, and analytical skills.

We are looking for candidates who have at least two years of availability.

The Research Tech will work on the DFCI Boston Longwood campus and also at the Broad Institute in Cambridge.

position will work on the Longwood campus and at the Broad Institute in Cambridge

Schedule

Schedule

This is a full time, 40 hour per week position.

How to Apply

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

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

Equal Employment Opportunity

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

Apply Here

PI92551598

Seres Therapeutics, a dynamic biotechnology company in Cambridge MA pioneering innovative Ecobiotic(R) microbiome therapeutics, is seeking an accomplished scientist to plan and execute in vivo and in vitro studies to validate its Ecobiotic drug candidates. Seres has a promising program for treatment of recurrent Clostridium difficile infection and is well-positioned to become the first company to commercialize a new therapeutic modality comprising ecologies of commensal bacteria. Seres plans to enter the clinic with multiple new product candidates in a range of therapeutic areas including infectious disease, inflammation and metabolic disease in 2015 and 2016 and to build upon its field-leading portfolio of intellectual property and know-how.

Position Summary:

For the successful candidate, this is an opportunity to develop essential animal models for infectious disease, inflammatory and metabolic indications, and build value for patients and shareholders by furthering the company's pipeline of Ecobiotic candidates into the clinic. This is a hands-on position requiring a self-starter who is scientifically curious, energetic and adaptable to a fast-paced environment.

Responsibilities:

• Collaborate internally with other discovery functional areas and project teams to prioritize candidates for tertiary efficacy analysis screens
• Design and oversee the conduct of animal studies to demonstrate proof of concept and define mechanism of action of Ecobiotic drugs designed to modulate the GI microbiome
• Establish cell culture models as needed to explore interactions of Ecobiotics with relevant cell types and tissue
• Identify and manage external collaborators, both CROs and academics, to access models and develop data consistent with the company's therapeutic goals
• Work with external consultants to define relevant safety program; oversee necessary studies to support IND
• Contribute to regulatory filings through timely and thorough reports documenting efficacy, mechanism of action, and safety of candidates
• Manage work against corporate objectives and agreed upon budgets
• Contribute to intellectual property foundation through insights gained in studies

Qualifications:

• 3-5 years experience in biotech and pharmaceutical companies with proven expertise in the design and conduct of animal pharmacology; large molecule biologics or live attenuated bacterial vaccines; experience with inflammatory, metabolic and immunologic models preferred
• Ph.D. in relevant biological discipline
• Track record of successful contribution to corporate discovery efforts
• Excellent communicator with good writing skills
• Experience with preclinical regulatory reports to support IND and NDA filings
• Track record of innovation, as evidenced by inventorship on patents
• Experience and effectiveness in highly collaborative environments; able to incorporate views from complementary disciplines to improve quality and relevance of work

Apply Here

PI92558290

GENERAL SUMMARY OF POSITION:

Under the immediate supervision of the Animal Facility Supervisor (or Designee), the Animal Care Technician performs a variety of duties related to the care of laboratory animals. Primary responsibilities are to maintain a clean and healthy environment for laboratory animals and observe animals for their general health and well being.

MAJOR RESPONSIBILITIES:

• Observes, records, and reports atypical findings of the environment, physical plant, and animal health or behavior. These observations are to include but are not limited to sick animals, maintenance problems, safety hazards, mistreatment or inappropriate treatment of animals.
• Performs animal husbandry duties; e.g., feeding, watering, cage/pen cleaning.
• Sanitizes animal rooms, animal procedure rooms, animal corridors, cage-wash rooms, animal morgue refrigerator, and necropsy room.
• Handles restraint and sexing of laboratory animals.
• Maintains animal room records; e.g., census, sanitation, enrichment, feeding, and cage card animal identification.
• Prepares and distributes routine medications as directed by veterinary staff; e.g., medicated drinking water or feed.
• Sanitizes all animal care equipment
• Operates and performs routine maintenance on floor machines, rack washer, bottle washer, tunnel washer, autoclaves, and bio-safety cabinets / clean bench hoods.
• Assist Grade 13 or above personnel in the operation and maintenance of aquatic life support systems and or robotic cage wash equipment.
• Maintains validation records of cage-washer efficiencies and room maintenance records of assigned areas.
• Keep assigned work areas stocked with supplies needed for routine operation of the area.
• Removes and disposes of waste.
• Operates Shuttle Vehicles.
• Performs other related duties as assigned

Required Qualifications:

• Valid Class D State Drivers License
• High School Diploma or G.E.D.

Physical Requirements:

• Bending, stooping, and lifting (Must be able to lift 60 lbs.)
• Must be able to wear Personal Protective Equipment (PPE). Minimum required PPE; scrubs, exam gloves, head cover, dust mask, shoe covers. Additional PPE; e.g., safety glasses, face shield, jump suit, respirator may be required for some areas.
• Shower may be required

Apply Here

PI92559122

Summary

The IT and Informatics group at Jounce Therapeutics is looking for an experienced professional to manage Jounce’s IT infrastructure to support the discovery and development of novel therapeutics.  The individual will report to the Director of Informatics & IT and be responsible for managing the network infrastructure, Help Desk, and other IT functions.  This individual will work with the Director to build a long term IT strategy and manage IT spending within budget.  This is an exciting position in the dynamic field of immuno-oncology which provides opportunity for growth in a fast-paced, start-up environment.

Responsibilities may include, but are not limited to:

• Managing Jounce’s network infrastructure both on-premises and in the cloud to ensure efficient operations and negligible disruptions to the business
• Manage relationships with key IT vendors to execute IT projects and provide support
• Coordinate the Help Desk function with Jounce’s preferred MSP to ensure quality support for Jounce staff within Service Level Agreements.  Computing support includes both office and lab environments
• Act as the project lead on various IT initiatives including information security, Unified Communications, Cloud Computing, Windows 10 migration
• Manage IT support and project spending within 5% of budget
• Develop IT policies for monitoring controls according to COBIT framework

Requirements:

• HS with 10+ years of experience in industry setting or BS/BA with 8+ years of experience in industry setting or MS/MA with 6+ years of experience in industry setting
• Strong focus on customer satisfaction
• 5+ years project management experience with a proven track record to deliver value on IT projects working with cross-functional teams
• Ability to be flexible working on multiple projects with a variety of roles
• Experience managing vendors and third party contractor companies as part of the team
• Technical skills and experience working with CISCO network devices (switches, routers, firewalls), CISCO Unified Communications, Active Directory, PowerShell, Microsoft O365, Amazon Web Services (AWS), SharePoint, Mimecast

Desired Skills:

• Experience with Information Security technologies including intrusion detection, log management, MDM
• Experience with large company wide Windows migration and computing lifecycle refreshes
• LINUX System Administration
• Oracle Database Administration
• Experience working with scientists in the domains of protein sciences, translational sciences, oncology, and immunology
• Experience managing a department budget within tight confidence intervals
• Great negotiation skills especially on contract terms and pricing

To be considered for this role, please submit your resume to Careers@JounceTx.com with the job title in the subject line of your email.

We are an equal opportunity employer offering a competitive salary and benefits package.

All applicants should be legally entitled to work for any employer in the US.

Note to Employment Agencies: Please do not forward any agency resumes. The company will not be responsible for any fees related to resumes that are unsolicited.

Are you an experienced and creative research associate with biotech/pharmaceutical experience that is seeking a role that will value your technical and mental contributions? Are you tired of being treated as the standard "pair of hands"? If so you need to take notice of our clients opportunity to add an experienced Principal Research Associate to their growing Biology team. They want a valuable contributor to help advance their pipeline studies that can think collaboratively and work with little hand holding. Required and Desired Skills: Ability to think and contribute scientifically in group setting to add value to the organization. Success in prioritizing work for targeting, identifying, and validation of oncology therapies. Experience and expertise with oncology cell lines. Hands on experience with ChIP Seq, genetic screening (siRNA, shRNA, CRISPRs), and novel and phenotypic assay development. MS 5-10 years of industry experience. BS 10+ years of industry experience.

About StratAcuity
Whether you are seeking a career change or simply interested to become part of our network, you will appreciate the ethics guiding each StratAcuity team member. We build lasting relationships with exceptional scientists and take great care to protect your personal information. Upon receiving your inquiry, you may be directly contacted by a StratAcuity team member to discuss your career goals. We will not share your information with anyone without your direct prior consent.

CHEMISTRY IS EVERYTHING™

Sr. Research Associate will assist the development of therapeutics in the field of cancer immunology.

Responsibilities:

• Primary cell culture
• Protein expression/purification
• Flow Cytometry 

Requirements:

• BS/MS in Biology or related field with 2+ years experience in either immunology or oncology research.
• Must have experience with primary mammalian cell culture, PCR, western blotting, and flow cytometry.

Required Skills: primary cell culture, FACS, flow cytometry, Immunology, Oncology

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

Email resume to: jobs@cwsciences.com

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.
http://www.cwsciences.com

This position will require relocation to New York City area.

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

Research Associate II/III – Immuno-Oncology

Requisition Number: 5247BR

This is an ideal career opportunity for an experienced Immunology researcher to contribute to the discovery and validation of new oncology drug targets, and screening of therapeutic fully-human antibodies using preclinical disease animal models and primary immune cells.

Qualifications:

• Bachelor’s or Master’s degree in Immunology or life sciences related and 2-5+ years of work experience in the lab setting
• Isolation and characterization of primary immune cells from murine tissues/tumors and/or human blood
• Development and optimization of immune cell-based assays
• Experience performing multi-color flow cytometry, including cell staining, data acquisition and analysis; experience in panel design a plus
• Ability to design and perform complex in vivo experiments utilizing tumor models in both immuno-competent and immuno-deficient mice. Expertise with animal handling, different methods of compound administration, and tissue /sample collection

Scientist – Immuno-Oncology

Requisition Number: 5246BR

The successful candidate will independently lead research studies in the area of tumor immunology including discovery and validation of therapeutic cancer targets and development of therapeutic antibodies using cell-based assays and preclinical cancer animal models.

Qualifications:

• PhD with 3-5 years of post-doctoral training in academia or industry
• Outstanding research track record on functional, cellular and molecular immunology, as it applies to cancer
• Strong analytical and critical thinking skills
• Ability to work creatively and collaboratively, manage several projects simultaneously; and present research findings to interdisciplinary teams

Please submit your application online:

5247BR Research Associate II/III – Immuno-Oncology

https://sjobs.brassring.com/TGWEbHost/jobdetails.aspx?partnerid=25570&siteid=5080&jobId=579895&code=MassBio  

5246BR Scientist - Immuno-Oncology

https://sjobs.brassring.com/TGWEbHost/jobdetails.aspx?partnerid=25570&siteid=5080&jobId=579891&code=MassBio  

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

uniQure is dedicated to bringing innovative therapies or unmet medical needs to patients. In doing so each function in uniQure is directly or indirectly responsible for the lives of patients. This responsibility should be part of our day-to-day working lives by (i) living up to high quality standards and (ii) by recognizing the sense of urgency in areas of high medical need.

The IT Business Partner is responsible for building relationships with business as well as working to design business process, IT solutions and overall business architecture.

The IT Business Partner is the primary IT point of contact to business line executives and managers. S/he operates as the key business contact representing IT in promoting services and capabilities. The IT Business Partner provides overall direction, guidance and definition of business architecture to effectively support business strategy. He or she will strive to understand business challenges, priorities and competitive issues.

The IT Business Partner leverages enterprise capabilities and efficient usage of process, technology, data and people, and aligns these capabilities to the business strategy. The IT Business Partner defines current and future business models and influences the relationship between the business processes, technology, data and people.

Key result areas (major duties, accountabilities and responsibilities)

Business Architecture & Relationship Management

• Consult with management to identify strategic technology needs, offer guidance based on industry trends, and support business objectives
• Regularly interact with management to understand requirements for technology and to support and recommend associated business process improvements
• Translate business vision to enable shared understanding and rapid execution by business and IT personnel
• Scan competitive landscape to identify and present opportunities or recommendations for new processes, products or vendors
• Facilitate and participate in the design of strategic IT solutions
• Conduct requirements analysis, organizational readiness assessments, and impact analysis on business requests to identify opportunities to link programs, processes, and systems throughout the organization to achieve optimal efficiency
• Build credibility and trust between internal stakeholders and IT
• Facilitate effective cooperation between subject matter experts from the business, IT staff and vendors as appropriate
• Assist with IT prioritization activities within and across the business

Service Quality Management

• Develop success criteria with management and measure progress of IT initiatives against those factors
• Manage stakeholder expectations and take accountability for service delivery along with Project Management
• Monitor progress of IT projects associated to business in order to ensure successful implementation and continued development of credibility of IT area
• Ensure transparency to internal stakeholders of new or changing requirements and their impact on IT initiatives
• Manage external vendor relationships and SLA’s
• Strategic Planning and Alignment
• Assist the business in forecasting, documenting and planning for future IT needs
• Translate business strategy into IT project planning
• Support decision makers by providing timely, accurate, relevant, and thorough analysis
• Collaborate with management and other IT colleagues to develop strategies to align business groups where appropriate

IT Compliance

• System Implementation – Perform both pre-implementation and post-implementation reviews of the system development life-cycle and program change controls for new uniQure systems.
• Audit System Implementations & Upgrades – Assist with the implementations or upgrades of audit and monitoring software, documenting requirements, developing test plans, and perform User Acceptance Testing. This may include the development of new requirements for systems.
• Develop policy and procedure documents based on pharmaceutical industry standards
• Provide pharmaceutical related inspection readiness support for third party audits and regulatory inspections
• Identify and work closely with control owners to document IT controls as they relate to the pharmaceutical industry standards.
• SOX monitoring and review - Evaluate the design and effectiveness of automated application controls, evaluate segregation of duties, operate ERP system monitoring software, and review associated business processes. Review management’s ITGC testing and execute additional testing, as needed.
• Service Provider & Privacy – Perform a review of data privacy and contractual compliance of uniQure Service Providers, including detailed on-site audits and surveys. Work directly with legal attorneys and business owners in organizations throughout uniQure as part of the audit program.
• Perform various internal reviews as needed to evaluate privacy, infrastructure, security and retention reviews, working directly with individuals throughout the organization.
• Identify issues and perform root cause analysis and develop formal recommendations on improvements for management.
• Provide other IT quality/compliance related support as required

Qualifications & Skills

• 5 - 10 years of progressive experience in a technology role (Business Analysis, Consultancy, etc.) requiring significant interaction with business or business representatives
• Pharmaceutical or Biotech Industry experience is absolutely required
• Broad knowledge and strong understanding of IT and technology solutions
• Demonstrated broad technical awareness coupled with strong business process design skills
• Experience working on projects requiring the implementation of custom and vendor-supported technology
• Superior communication skills both written and verbal
• Experience in a multi-cultural international organization is preferred
• Ability to travel internationally up to 25% of the time

 Core competencies

• Ability to facilitate meetings and workshops in person and remotely
• Ability to influence and negotiate
• Ability to understand and analyze complex business challenges and impact in order to provide informed and appropriate consultation
• Ability to think conceptually using creative, comparative and inductive reasoning to apply to existing concepts or to define new concepts
• Ability to methodically analyze information, assess implications of solutions, and balance risk in building recommendations
• Flexibility to manage multiple business demands and projects simultaneously
• Ability to take initiative, think creatively and critically and teach and mentor others
• Detail-oriented with the ability to decisively solve problems, recognize sensitive business situations, and respond or escalate as appropriate

Click here to apply on our website: https://uniqure.has-jobs.com/global-it-business-partner-lexington-ma/71421/0

The Cystic Fibrosis Foundation, a highly regarded national voluntary health services agency, is expanding the staff of its newly built-out R&D laboratory in Lexington, MA (greater Boston area).  Focus of the lab is the development and testing of assays and technologies that may lead to new treatments for Cystic Fibrosis (CF).

The work at the CFFT Lab includes screening of chemical libraries using multiple formats and readouts from biochemical, biophysical, and cell-based assays.  Eventually the bioactivity of small molecules and other reagents needs to be validated in primary human bronchial epithelial (hBE) cells obtained from CF lung explants.  The Cell Bank Manager is expected to establish new in house capabilities for the isolation of hBE cells from lung tissue, expansion, banking and potentially distribution to other labs.  The cell bank may grow to include cells from other epithelial tissues.

Primary job duties (hands-on and as manager) include: dissection of human lung tissue, isolation of bronchial epithelial cells, cell banking, QC and genotype confirmation.  Research Associates may need to be trained or supervised.  The candidate will also interface with other groups at the CFFT Lab to coordinate cell supply.  She/he will work with a team of highly motivated scientists and will also be responsible for timely execution, operational excellence, and data quality. The candidate is expected to present work and progress at internal meetings.

Job Qualifications

• M.S. in life sciences and 5+ years of relevant experience, at least 2 years as a cell culture or cell bank manager.
• High level of attention to details and commitment to excellence.
• Prior work experience with primary cell isolation and bronchial epithelial cell cultures considered a very strong plus.
• Capable of multi-tasking in a small dynamic team.

For immediate consideration, please visit the employment section of our website www.cff.org under jobs located in Lexington, MA and submit your resume and cover letter. The following link will also direct you to the applicant page: https://chk.tbe.taleo.net/chk01/ats/careers/requisition.jsp?org=CFF&cws=1&rid=2667

The Cystic Fibrosis Foundation, a highly regarded national voluntary health services agency, is expanding the staff of its newly built-out R&D laboratory in Lexington, MA (greater Boston area).  Work at the lab focuses on developing and testing assays and technologies that may lead to new treatments for Cystic Fibrosis (CF).  For our molecular biology group we are looking for a scientist with proven expertise in using CRISPR/Cas9 gene editing in the generation of cell lines.  This Senior Research Associate or Research Scientist will join a growing group of highly motivated scientists that are working on next generation approaches for CF therapeutics.

The ideal candidate will have the following or comparable profile:  M.S. degree and 3 or more years of experience with molecular biology and cell line generation, including 2 years hands-on with gene editing technologies.  The position reports to a senior Ph.D. scientist group leader, and the candidate is expected to present progress and results at internal team meetings.

Job Qualifications

• M.S. in life sciences and 3+ years of relevant experience in academia or biotech, including 2 years of work with CRISPR/Cas9.
• Experience with other gene editing technologies considered a plus.
• 3+ years of mammalian cell culture.
• High level of attention to details and commitment to excellence.
• Very good oral and written communication skills.
• Capable of multi-tasking in a small dynamic team.

For immediate consideration, please visit the employment section of our website www.cff.org under jobs located in Lexington, MA and submit your resume and cover letter. The following link will also direct you to the applicant page: https://chk.tbe.taleo.net/chk01/ats/careers/requisition.jsp?org=CFF&cws=1&rid=2668

Primary Role:
The Sr. Lead Investigator II's responsibilities will be to lead mainly Level 2 & 3 deviations and some Level 1 deviations. Manage closure within the established timelines for the manufacturing department. Will lead cross-functional teams to conduct comprehensive investigations to determine potential product impact, identify root cause and implementation of corrective and preventative actions in accordance with established procedures and timelines.

Responsibilities:
50%:
Influence the organizational control of Quality systems:
* Author manufacturing deviations, particularly those with high visibility / impact to the organization
* Lead cross-functional investigation teams to identify root cause, evaluate technical impact, and provide recommendations to management on batch disposition
* Provide subject matter input for QC Out of Specification (OOS) and Out of Tolerance (OOT) events
* Resolve conflicts that arise, escalate as needed.

30%:
Work cross-functionally to assess and analyze highly technical, complex, high impact deviations and investigations to determine impact and root cause

10%:
Identify and initiate corrective and preventative actions for deviations

10%:
Track and identify Quality System and root cause trends and identify opportunities for operational improvements

Education & Experience Requirements:
* Bachelor's in Science or a related discipline, Master's preferred
* Minimum of 8 years related industry experience in the manufacturing and/or development of biologics, pharmaceuticals or devices preferred
* Previous technical writing experience preferred

Key Skills, Abilities, and Competencies:
* Strong written and verbal communication skills
* Demonstrate high-level of professional and business judgment when communicating with cross-functional teams and others at all levels of the organization
* Work is performed without appreciable direction. Exercises considerable latitude in determining objectives and approaches to assignment
* Ability to lead and influence investigation team members to coordinate work based on priorities
* Must be proficient with record management systems such as TrackWise (or equivalent)
* Must be proficient with Microsoft Office applications, including Word, Excel and Power Point.
* Experience with more advanced Microsoft applications including Visio, Project, and SharePoint a plus
* Strong data analysis skills, proficiency with more advanced statistical tools a plus (including but not limited to JMP and Statistica)
* Experience with other related applications a plus (e.g. LIMS, SAP, OSI/PI)

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.

Application URL:http://www.aplitrak.com/?adid=bGF1cmVuZC4xNTA3Ny4zMTY3QHNoaXJlLmFwbGl0cmFrLmNvbQ

The MIT-Broad Foundry is a cutting-edge synthetic biology facility focused on streamlining genetic design. To do this, we develop high-throughput methods for the design, construction, and analysis of complex genetic programs. We are in search of an experienced Research Associate to join the Foundry team and execute the newly developed Synthetic biology protocols. The ideal candidate must possess excellent communication skills and be a resourceful problem-solver who is highly motivated and thrives in a fast pace environment. This will be an integral role in process scale-up and increasing throughput capacity by providing valuable insight and feedback as the process end user.

OVERALL RESPONSIBILITY:

The primary focus is on executing Synthetic Biology related protocols at the lab bench (e.g., Molecular Biology, Biochemistry, and instrument operation). The desire to take an active role in method improvement, through investigation of process failures and suggestions for enhancement, is expected and the capacity to solve problems is required.

CHARACTERISTIC DUTIES:
- Develop and execute protocols related to Molecular Biology, Biochemistry, microbial cell culture and high-throughput automation
- Participate in assay development and optimization including generation/revision of SOPs and related documents
- Proactively engage in process optimization
- Attend group meetings share project plans, status and recommendations
- Maintain accurate laboratory notebooks

EDUCATION:
- Bachelor’s Degree in Molecular Biology/Biochemistry/Chemistry/Genetics/Biological Engineering or a related field with a minimum of 4 years laboratory experience post degree or Masters Degree with minimum of two years of experience.

SKILLS:
- Experience with Molecular Biology techniques including essential nucleic acid manipulation techniques (extraction/purification, cloning, assembly and analysis) required
- Experience with microbial culture techniques are essential
- Experience with Biochemistry/Chemistry assay execution for protein/chemical analysis essential
- Experience with some or all of the following: automated liquid handling, colony picking, plate handling, microscopy
- Experience with Next Generation Sequencing (NGS) and sample prep a preferred
- Mass Spec experience a plus
- Some course work and/or practical experience with basic Genetics to understand replication, transcription and translation components
- Highly organized and able to simultaneously maintain accurate records for multiple projects and large datasets
- Excellent communication skills and ability to effectively interact with all levels of staff
- Must be able to work effectively in a team setting yet also be motivated to work independently on primary tasks once appropriate training is given
- Basic computer skills including Microsoft Office and Google Drive documents, experience with LIMS and documentation/bug tracking packages a plus

The Broad Institute will not offer visa sponsorship for this opportunity.

EOE / Minorities / Females / Protected Veterans / Disabilities

To apply for this position, please CLICK HERE

First Light Biosciences is developing breakthrough automated medical diagnostic products for rapid, sensitive, automated, and cost-effective detection of the microbes that cause hospital infections. The products address the key medical need to rapidly determine the right antibiotic to cure these life-threatening infections.  Based on its proprietary MultiPath™ digital imaging technology, First Light’s products will combine the performance of the most advanced automated commercial laboratory tests with unprecedented affordability and ease-of-use.

First Light Biosciences is a well-funded Bedford, MA company offering growth potential and a stimulating environment with a culture of excellence in science, engineering, and business.

First Light Biosciences is seeking a detail oriented, dependable individual whose primary responsibility entails supporting Quality Assurance.  Working closely with our quality management consultant, the Quality System Specialist will be vital to the adoption of our quality system throughout the organization.

DUTIES & RESPONSIBLITIES

• Create and revise company work instructions (WIs) as required.
• Format, track and issue controlled quality system documents including protocols, test records and forms.
• Assist in review of quality system controlled documents as necessary.
• Issue and monitor CAPA activities.
• Provide support for the implementation and execution of design controls.
• Coordinate internal audits as required.
• Track master batch records as well as all batch production records and lot number issuance.
• Maintain design files (e.g. specifications, verification documents, engineering change controls).
• Communicate with other departments with regard to documentation requirements.
• Contribute to the development of training and deliver training as needed.
• Participate in quality audits (internal and external), troubleshooting efforts, and other Quality System processes.
• Archive and retrieve data as needed.
• Provide back up and support to quality management consultant as needed.

ESSENTIAL REQUIREMENTS 

• Bachelor's degree.
• 2-5 years' experience in design controlled environment performing Quality Documentation duties.
• Knowledge and expertise in principles and practice of current Good Design Practices (GDPs).
• Able to rapidly adapt to changing environment and circumstances requiring flexibility, tolerance and great sense of urgency while ensuring that all Quality and Regulatory requirements are met.
• Excellent organizational, verbal, and technical written communication skills.

Additionally, we prefer candidates that have:

• The ability to effectively build and maintain relationships with multiple departments in order to effectively solve problems.
• The ability to organize, prioritize and deliver tasks & projects with a sense of urgency under minimal supervision without neglecting attention to detail.
• The ability to enable and drive change while being focused on internal and external customers.
• The capability of managing multiple priorities.
• Proficiency in Excel, Word and Microsoft Outlook.

Competitive salary and benefits.  Title and compensation depends on experience and education.

Please apply by email only to jobs@firstlightbio.com. To insure proper processing include the Job Code QSSDEC15MBC in the subject line of the email.

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

The Pharmacovigilance and Risk Management (PVRM) team at Merrimack is an emerging consolidated function having been launched in Q3 2014. PVRM is tasked to provide pharmacovigilance/patient safety and risk management expertise in all phases of development for all compounds in Merrimack’s portfolio from first in man to post-approval.  

We are seeking a talented Pharmacovigilance and Risk Management Scientist to join the growing PVRM team. This position will be responsible for establishing and delivering post-approval pharmacovigilance expertise, participating in cross-functional clinical trials teams, performing CRO PV oversight, and assuring PV global compliance (e.g. 100% on-time submission). This key position reports directly to the Head of Pharmacovigilance and Risk Management.

Job Responsibilities:

• Provide Pharmacovigilance guidance, as needed to clinical and post-marketing cross functional teams
• Increase collaboration with clinical and post-marketing teams and communication of safety concerns
• Develop and maintain a vendor management/oversight plan
• Provide complete PVRM product life-cycle support for assigned product(s)
• Participate in the development of protocols, annual updates to the compound-specific Investigator’s Brochure (IB), contribute and review Informed Consent Forms (ICF), ensure safety oversight in cooperation/leadership of the clinical trial medical team, represent PVRM in SAE reconciliation, final CSR narrative writing/review and contribute to the review of the final clinical safety report (CSR).
• Perform any study-start activities, as necessary.
• PVRM Liaison with Merrimack call center, Merrimack quality, and Merrimack Medical Information/Affairs, Sales and Marketing.
• Acts as primary author for assigned product aggregate periodic reports such as the DSUR and PSUR.
• Perform on-going individual case quality review of representing company review in accordance with study Safety Management Plans, PV Agreements and Merrimack SOPs
• Identify Data Entry errors and document these errors as feedback to CRO(s)
• Effectively communicate with CRO on findings
• Identify case management processes that are inconsistent or not well defined and communicate this to the PVRM team/supervisor
• Provide input to PVRM team/supervisor on suggested improvements in case management processes
• Support the PVRM team/supervisor as needed in producing aggregate c PVRM reports for medical management team review.
• Monitor and communicate with Merrimack clinical team regarding cases that have exceeded the internal case flow timelines.
• Support PVRM team/supervisor in identifying areas of concern regarding case flow timelines.
• Work within a team environment
• Be familiar with global regulatory requirements for clinical safety data processing into individual case reports and related Merrimack procedures.
• Liaise with other Merrimack functions and participate in staff training, as needed
• Develop expertise in assigned products and therapeutic area
• Respond or coordinate response to standard and ad hoc safety queries.
• Alert appropriate management as soon as a potential signal or trend is recognized.
• Assist in developing and implementing PVRM standard processes and procedures
• Serve as a compliance role model that is consistent with the mission, vision and values of the organization. 
• Other items, as needed

Requirements:

• Bachelor’s degree (or equivalent) in health-care related field (strongly preferred) with Oncology experience preferred
• Minimum of three years industry experience with concentration in clinical safety highly desirable and/or advanced degree in related field.
• Minimum of five years post-marketing PVRM experience
• Minimally a basic working understanding of drug/device safety filing procedures as well as competent knowledge of domestic and international regulatory requirements highly desirable.
• Excellent writing and verbal communication skills.
• Must be experienced with standard word processing, spreadsheet, and safety data base packages.
• Proven ability to critically think through complex medical/safety reports and effectively summarize key information in a concise narrative presentation
• Experience in vendor management preferred
• Excellent oral and written communication skills
• Flexible, highly organized with the ability to prioritize and detail oriented
• Self-motivated with the ability to function well in a cross functional team
• Strong interpersonal skills
• Ability to manage multiple projects simultaneously and complete those projects on time while effectively demonstrating the ability to influence others and accomplish goals within a team environment
• Strong commitment to business ethics
• Passion for fighting cancer

If you are interested in a great opportunity at a fantastic company, please click the link to apply:

https://app.jobvite.com/j?cj=oCAD1fwA&s=Mass_Biotech_Council