Responsible for coordinating the cross-functional responsibilities for assay development projects of new and existing products on automated platforms and technologies within an FDA regulatory compliant environment.

Primary Responsibilities:

 Ensure effective use of material, equipment and personnel to maximize departmental output and ensure timely completion of process development cycles consistent with project team requirements

• Coordinate and collaborate with appropriate departments to ensure consistent progress and success of projects
• Monitors process data, assess process performance, and coordinates process optimization in order to maximize the success of commercialization
• Establishes detailed planning and reporting systems to allow efficient tracking and trending of department operations and performance
• Creates and executes project work plans according to internal Design Control procedures and revises as appropriate to meet changing needs and requirements
• Coordinate the transfer of new products from Development/Technology Transfer to Manufacturing.
• Coordinates Manufacturing, Quality Assurance and Development/Technology Transfer groups in the evaluation of technical problems and variances encountered in Manufacturing
• Provides technical input to the investigations, assess process impact, and contribute to identification and execution of appropriate corrective actions
• Identifies resources needed and assigns individual responsibilities.
• Effectively communicates relevant project information to superiors.
• Resolves and/or escalates issues in a timely fashion.

 Job Qualifications and Education:

 BS in Biological Science with 5+ years experience in project management in a FDA regulated environment OR MS in a Biological Science with 3+ years experience in project management in a FDA regulated environment

• Expertise in Microsoft Project
• Experience in and track record in taking projects from concept to regulatory clearance to commercialization
• Excellent interpersonal skills with effective verbal and written communication and comprehension is essential
• Efficient organizational and time management skills
• PMI certification a plus

 Interested candidates should forward cover letter and resumes to careers@intelligentmdx.com

Provide regulatory support to the company in order to obtain market authorization for commercial products.  Provide strategic support to currently marketed products, e.g. review of design and process changes, labeling, promotional materials and documentation for compliance and for changes requiring regulatory agency approval and notification, as pertains to US, EU and Canada.

 Primary Responsibilities:

• Manage and facilitate all registration related activities to ensure products meet worldwide regulatory requirements by supporting all assigned regulatory aspects of product approval and post-market compliance.
• Monitor the development of new requirements and regulatory procedures and advise senior management of the impact on the business or development projects.
• Update the quality system processes as new and revised regulatory requirements are published as it pertains to the US and EU. Other country international regulations will be incorporated into the quality system based on specific marketing requests from business partners.
• Coordinate and prepare product registration packages, independently or with a CRO, in the US (510K) and EU (CE marking).
• Complete Medical Device Vigilance (MDR) assessment and reporting on product incidents for the EU and US.
• Maintain product technical files and ongoing activities related to compliance with global regulatory directives and regulation.
• Educate and broaden the regulatory knowledge within the organization
• Negotiate company’s interests with regulatory bodies as directed
• Manage communications with Authorized Representative and / or FDA concerning any Correction and Removal, Medical Device Report or Field Safety Corrective Action.
• Develop and support a team environment and professional conduct.
• Interacts closely with R&D - Provide and coordinate regulatory support related to project core teams
• Complete all necessary training programs to maintain certification which are required.
• Resolves and/or escalates issues in a timely fashion.

 Job Qualifications & Education:

• Bachelor’s degree or  Masters in a biological science in particular focused on DNA
• Regulatory Affairs Certification (preferred) with a minimum 10 yrs. experience in regulatory or clinical affairs in IVD industry
• Experience in regulatory submissions, including pre-IDE, IRB, and 510(K)
• Strong software/PC skills (Word, Excel, Microsoft Project).
• Knowledge of global regulatory requirements for IVDs.
• Knowledge and understanding of FDA mechanisms and connections to the agency
• Strong understanding of molecular technologies and the impact on outcomes and diagnostics results 
• Must have a strong regulatory compliance history
• Demonstrated track record in successful FDA and ex-US submissions and registrations
• Leadership capabilities for working across varied cultures, expertise and backgrounds
• Demonstrated ability to effectively present information to top management and to regulatory agencies with experience in the design and development of formal meetings and presentations to FDA, including pre-IDE meetings and advisory committees
• Ability to strategically interpret and respond to requests from regulatory agencies
• Outstanding interpersonal and communication skills for bridging scientific and business participants, for negotiating timelines and for effective international collaboration
• Demonstrates strong ethics and integrity

Interested candidates should forward cover letter and resume to careers@intelligentmdx.com

Responsible for critical review and acceptance of scientific and technical facets of product design, development and performance to help ensure that all IntelligentMDx products are developed within the company’s Quality System. Provide broad scientific and technical guidance throughout the product development process to assist in maintaining product design and performance requirements. Assist in planning, reviewing and advising any necessary mitigation efforts required to correct development or performance issues. Responsible for drafting, reviewing and approving documentation pertaining to product design, development and performance. Also responsible for critical review and acceptance of performance data.

 Job Functions 

• Serve as the liaison between product development and manufacturing to transition the products from product development to manufacturing.
• Provide R&D review and final assessment of product development documents prior to handing to QA for review.
• Participate in each product development team to provide scientific and technical input during all phases of product development.
• Critically review product design for potential defects and advise project lead of findings and suggested mitigation in a timely manner.
• Provide scientific and technical advice and guidance on product performance requirements and on planning sufficiently robust studies to support product performance.
• In concert with Regulatory Affairs, research and identify product performance and use requirements and draft product Instructions for Use.
• Participate in design reviews, technical reviews and phase transition reviews.
• In concert with Project Management, perform all above functions so as to minimize negative impact of project scheduling.

 Qualifications & Education 

• BS in Molecular Biology, Cell Biology, Microbiology, Virology, or related discipline.
• 5+ years experience with IVD/CE IVDD products
• 10+ years of biotechnology industry experience, including at least 5 years at a Senior Scientist level with responsibility for independent product development.
• Experience using PCR technologies (including RT-PCR)
• Experience with Quality Assessment System for IVD Class I devices
• Experience with regulatory processes associated with FDA 510(k) filings
• Strong organizational, communication, interpersonal, and presentation skills
• Comfortable working within a fast-paced, fluid R&D and product development environment
• Experience with technology assessment for molecular assay development and for the development of nucleic acid test platforms

Please send resumes to careers@intelligentmdx.com with job code IMDx-1101

Description:

The Senior Safety Associate (SSA) is responsible for managing safety reports originating from the company's clinical trials, post-marketing observational studies as well as spontaneous reports in the post-marketing setting. The SSA will be responsible for the timely evaluation and processing of adverse event reports while complying with global safety guidelines and regulations. The SSA will also ensure accurate reporting of adverse event data to regulatory agencies and clinical trial investigator sites worldwide as applicable.

Qualifications:

Preferably nursing or pharmacy or other health related science.

Education: 

Minimum Bachelors level

Job Description:

This is a front line field position responsible for establishing, fostering, and maintaining relationships with nursing Key Opinion leaders (KOLs) to build outstanding product awareness and advocacy. Responsible for providing for scientific and clinical information to these KOLs.

 Act as the primary clinical/scientific resource for nursing KOLs to provide information pertaining disease state and clinical management of patients.

Provide clinical protocol expertise to investigators for use in company sponsored and investigator initiated trials and ensure that they are consistent with the company's objectives, FDA regulations, and necessary approvals.

Act as a clinical/scientific resource within the Medical Affairs organization for information pertaining to disease states and the company's products to ensure awareness and understanding.

Qualifications:

• Nursing or Physician Assistant background, with a minimum of 5 years clinical experience (Case management/chronic disease experience preferred)
• Minimum of 2 years relevant experience in Multiple Sclerosis, ALS, Neurology, or Hemophilia therapeutic areas (clinical or industry)
• Advanced nursing degree (eg MSN) or Nurse Practitioner (NP) preferred
• Ability to understand and communicate highly scientific and technical medical information
• Excellent communication/coordination/interpersonal skills
• Demonstrated relationship building and cross-functional teamwork skills
• Knowledgeable in regulatory, commercial and clinical issues affecting the pharmaceutical industry
• Ability to work independently in field location (with 60% travel)
• Have an understanding of clinical research/Good Clinical Practice preferred

Education:

Advanced scientific or clinical degree

As a key member of the Biologics organization, the Talent Acquisition Specialist will influence attraction, selection and hiring decisions using acute business acumen and organizational knowledge, combined with solid expertise of the external Biologics labor market. This role is responsible for developing and executing hiring plans and partnering closely with Manager, Biologics Talent Acquisition, Business Leaders and HR Generalists to efficiently fill vacancies with internal and external talent, utilizing best practices in full life-cycle recruitment, including effective use of the Recruitment Process Outsourcing (RPO) provider. This role will help support and drive our evolution to a Best in Class Biologics organization and will be a strategic advisor to the business. In order to achieve organizational hiring goals, additional responsibilities include: • Develop and implement talent acquisition strategies to achieve excellence in metrics focused on quality of hire, time to fill and diversity of slates. • Provides strategic advice on Talent Acquisition to business leaders and aligns strategies with the business unit goals. Participates in senior leadership meetings to increase knowledge and ability to differentiate BMS from key competitors. • Leverage resources to achieve high levels of performance and improve operational effectiveness. • Creates and manages specific talent pipeline for Biologics capabilities to acquire best in class talent. • Analyzes recruitment metrics to drive continuous improvement and to ensure the achievement of desired goals. • Ensures recruiting and hiring practices are in compliance with EEO guidelines and regulations, ensures all transactions in the recruitment process are in compliance with BMS policies and practices. This individual will be accountable for the talent acquisition strategy and execution, stakeholder collaboration, colleague relationships, candidate management and third-party partnerships to deliver desired results. They will function as a critical partner and owner of the recruitment business.

Bachelor's degree required. Prior experience in manufacturing, biology, chemistry or biologics recruiting is highly preferred. Minimum of 6 years professional experience in a talent acquisition, talent management or human resources role, including 4 years in a direct recruitment role. Prior success in developing and executing comprehensive hiring plans. Fluency in Taleo or similar applicant tracking systems and online sourcing networks is required. Strong contracting and consulting skills with hiring managers and leadership is required. Proven experience in assessing and selecting exceptional talent for the business. Candidates should have prior experience in effectively utilizing staffing resources.

Description:

This is a front line field position responsible for establishing, fostering, and maintaining relationships with nursing Key Opinion leaders (KOLs) to build outstanding product awareness and advocacy.
Responsible for providing for scientific and clinical information to these KOLs.

Act as the primary clinical/scientific resource for nursing KOLs to provide information pertaining disease state and clinical management of patients.

Provide clinical protocol expertise to investigators for use in company sponsored and investigator initiated trials and ensure that they are consistent with the company's objectives, FDA regulations, and necessary approvals.

Act as a clinical/scientific resource within the Medical Affairs organization for information pertaining to disease states and the company's products to ensure awareness and understanding.
Provide clinical protocol expertise to investigators for use in company sponsored and investigator initiated trials and ensure that they are consistent with the company's objectives, FDA regulations, and necessary approvals.

Act as a clinical/scientific resource within the Medical Affairs organization for information pertaining to disease states and the company's products to ensure awareness and understanding.

Qualifications:

Nursing or Physician Assistant background, with a minimum of 5 years clinical experience (Case management/chronic disease experience preferred)

Minimum of 2 years relevant experience in Multiple Sclerosis therapeutic areas (clinical or industry)

Advanced nursing degree (eg MSN) or Nurse Practitioner (NP) preferred

Ability to understand and communicate highly scientific and technical medical information

Excellent communication/coordination/interpersonal skills

Demonstrated relationship building and cross-functional teamwork skills

Knowledgeable in regulatory, commercial and clinical issues affecting the pharmaceutical industry

Ability to work independently in field location (with 60% travel)

Have an understanding of clinical research/Good Clinical Practice preferred

Education:

Advanced scientific or clinical degree

Sr. Developer - Bioinformatics. Cambridge, MA. Design, develop & deploy
scientific software & system solutions. Master's or foreign equiv. deg.
in CS, informatics, engineering or science related field & 5 years
experience in scientific software development & related skills required.
Mail resume to J. Rynak, H3 Biomedicine Inc., 300 Technology Sq., Fl. 5,
Cambridge, MA 02139.

SCIENTIFIC INVESTIGATOR I - DISCOVERY CHEMISTRY

Job Code: 1221-DC

Location: Cambridge MA          

This position is designed for a highly motivated entry-level Ph.D. synthetic organic chemist. As a member of the Discovery Chemistry team, he/she will independently contribute to the creation of a unique compound collection through traditional and parallel synthesis techniques, using a combination of diversity-oriented synthesis and rational design.  The applicant is expected to possess a strong synthetic chemistry background, excellent synthetic skills, good communication skills, eagerness to learn and the ability to work well in a multidisciplinary team.

Principal Duties and Responsibilities

• Design synthetic routes for the preparation of small molecules, including novel library scaffolds, as required.
• Conduct solution-phase parallel synthesis of compound libraries.
• Provide conceptual contributions toward project advancement.
• Identify and introduce new experimental techniques to address specific research problems.
• Communicate and relate research results within project context.
• Anticipate needs and plan for the purchase, use and maintenance of laboratory equipment.
• Present and efficiently communicate research results for company reviews.
• Utilize literature searches to solve specific and general research problems.
• Contribute to the preparation and submission of patents, scientific publications and/or regulatory documents as appropriate.
• Participate in the planning and recruitment of research staff
• Maintain high standards of laboratory safety, comply with the safety manual and complete required training courses.
• Perform research in compliance with all applicable regulatory and guidelines.
• Show flexibility to work on different projects as needed to achieve Team and Company goals

Job Qualifications

Ph.D. in organic chemistry or equivalent experience plus demonstrated ability to:

• Independently identify and solve significant problems.
• Independently plan and organize work to optimize laboratory productivity.
• Independently design efficient and well-controlled experiments.
• Excellent teamwork, collaboration and communication within team and across departments
• Evaluate and prioritize research efforts within broader team objectives.

H3 Biomedicine Inc. is a privately-held, uniquely-structured oncology discovery enterprise whose sole mission is to become a prolific source of new drugs that treat more human cancers with greater success. H3 Biomedicine is applying the expertise of leading scientists to the integration of insights from cancer genomics with innovative capabilities in synthetic chemistry and tumor biology to pursue the most promising current opportunity in cancer therapeutics: patient-based, genomics-driven, small molecule drugs

Interested candidates may forward a CV to h3_career@h3biomedicine.com

www.h3biomedicine.com

Scientists at One Cell Systems are developing novel stem cell and immunology assays that rely on micro-encapsulation and flow cytometry.  Test kits will be assembled with reagent companies.  If you enjoy learning innovative techniques to complement your knowledge of conventional assays, this is the perfect position for you.

You will learn flow cytometry, stem cell biology, methods for assessing secreted proteins, and techniques for performing proliferation assays.  You will also screen antibodies for inclusion in test kits. 

This is a 6 month contract position with opportunity to extend.

Qualifications:

Some cell biology and general laboratory experience a plus.

Location:

We are located in Inman Square in Cambridge, close to bus stops and the Central Square T.

Please e-mail cover letter and resume:  jobs@onecell.com

We are recruiting a Scientist (Post doc) with strong stem cell biology experience to work on developing novel quantitative assays for charactering cells during differentiation.  The position offers exceptional opportunities for cutting edge publications.

Qualifications

Ph.D. and strong research experience with cell biology, assay development, and flow cytometry required. Related experience a plus.

Company Background

One Cell Systems, Inc. is a small biotechnology company developing novel assays for research, clinical diagnostics, and therapeutic applications.  The Company is currently marketing and selling microencapsulation assay formats for use in assessing high secreting hybridoma and transfected cells.  The Companies revenue sources include: multi-year big pharma instrument leases, special studies, reagent sales, and NIH/NSF grants.

Location

We are located in Inman Square in Cambridge, close to bus stops and the Central Square T; on site parking is also available.

Compensation and Benefits:

Salary is commensurate with experience.

Please e-mail cover letter and resume:  jobs@onecell.com. No recruiters, no phone calls.

We are recruiting a Scientist (Ph.D.) with strong immunology and biochemistry experience to work on developing novel flow cytometry based assays for assessing surface markers and secreted proteins simultaneously.  Assays rely on Gel Microdrop (GMD) single cell encapsulation.  If you enjoy learning innovative techniques in a hands on environment which will complement your knowledge of conventional assays, this is the perfect position for you.  We are forming relationships with reagent suppliers to move cytokine/chemokine applications into the marketplace. 

Qualifications

Ph.D and strong flow cytometry, immunology, cell biology, and biochemistry experience required, including experience with: ELISA, Luminex, ELISPOT, colony forming assays, and magnetic separation.  Experience with screening and labeling antibodies and hands on experience fluorescence activated cell sorting is a plus.  Must be capable of working independently. Note molecular biology expertise is not the focus of this position.

Company Background

One Cell Systems, Inc. is a small biotechnology company developing novel assays for research, clinical diagnostics, and therapeutic applications.  The Company is currently marketing and selling a GMD assay format to the bioprocessing industry for use in isolating high secreting hybridoma and transfected cells.  A recent spin off is developing FISH assays for cancer detection. Revenue sources include: multi-year big pharma instrument leases, special studies, reagent sales, and NIH/NSF grants.

Location

One Cell Systems Inc. is located in Inman Square, Cambridge, close to bus stops and the Central Square T; on site parking is also available.

Compensation and Benefits

Salary is commensurate with experience.

Please e-mail cover letter and resume:  jobs@onecell.com, or fax 617-492-7921.

No recruiters, no phone calls.

One Cell Systems is developing and marketing a family of single cell assays that combine micro-encapsulation in agarose based gel microdrops (GMDs) and flow cytometry.  Using this novel, single cell assay format, we are screening transfected and hybridoma cell lines to identify high secretors as a service to biopharmaceutical companies. Using both analysis and sorting, we are also assessing extracellular secreted proteins for immunology and stem cell applications.  Quantitative clonal growth assays are performed for assessing drug toxicity and colony formation.  In situ hybridization applications have recently been spun off into a separate, rapidly expanding company.  If you enjoy developing new research and clinical assays, you will find this position of high interest. We offer a unique small company entrepreneurial environment where you can directly participate in all phases of commercialization activities.

Qualifications

BS/Ph.D with several years of flow cytometry experience in an academic or industrial setting.  Hands on sorting experience a strong plus.  Assist in managing the flow cytometry center that houses sorters, analyzers, and digital image equipment.  Evaluate new cytometry equipment.  Must enjoy interacting with collaborators and training customers.

Compensation

Competitive Salary and 401K.

We are an equal opportunity employer and value diversity in the workplace.

Contact

For immediate consideration, email resume to jobs@onecell.com or fax to 617-492-7921.  No recruiters, no phone calls please.

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.

Job Description: This position will be responsible for growing a variety of wild-type and lab strains of bacteria under varying conditions to support the discovery and yield optimization of secondary metabolites of interest.  This position will work as a member of an interdisciplinary therapeutics discovery and development team.

Responsibilities include:

• Cultivate wild-type and recombinant microbes under varied conditions
• Provide expertise and strategy to improve and engineer microorganisms in order to optimize expression and yield
• Integrate theoretical and practical aspects of fermentation technology into metabolic engineering research. 
• Generate pilot level quantities of natural products

Minimum Requirements:

• BS or MS in chemical engineering, microbial engineering, microbiology or equivalent
• 3-5 years of fermentation experience working with bacteria such as Streptomyces or related Actinomycetesrequired.  Previous experience working with yeasts/ fungi is highly desirable.
• Experience isolating and cultivating wild-type and engineered microorganisms, including yeasts and bacteria, under a variety of conditions
• Strong molecular microbiology background and understanding of techniques for cloning and expression in diverse organisms under a variety of conditions
• Proven expertise in optimization of media and fermentation conditions to maximize metabolite yields
• Ability to analyze and interpret fermentation data, as well as identify critical issues, and provide direction for strain development and metabolic engineering efforts
• Strong understanding of aseptic technique, quality control and best practices for GLP grade process development will be favorably considered
• Excellent attention to detail and strong documentation skills essential
• Experience working in multi-disciplinary teams of scientists in a fast-paced, multi-disciplinary environment to accomplish project and company goals
• Excellent verbal and written communications skills a must

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.

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.

Job Description:

Join a dynamic team of researchers conducting experiments to help discover hidden natural products to be revealed on the basis of their distinctive genomic signature.  You will develop new applications for large scale gene sequencing technology, as well as perform data mining and statistical modeling skills to analyze large data sets.  

Responsibilities include:

• Conducting applied research using computational biology
• Developing and maintaining bioinformatics tools for in-house analysis and development
• Analyzing and interpreting high-throughput data and generates computational models for biological processes
• Collaborating and working iteratively across organization to establish and test working hypotheses
• Planning and management of multiple projects / workflows
• Performing DNA/protein sequence analysis, interpretation of expression array data, and statistical modeling of assays

Minimum Requirements:

• Master's Degree and 10+ years' work experience or a Ph.D. and 6 + years relevant work experience in the biological sciences, computer science or computational science
• Experience with de novo assembly of microbial or metagenomic genomes from short read or single molecule data using tools such as Ray, MIRA, Velvet, Celera, ALLPATHS 
• Experience using assembly refinement and scaffolding tools such as AMOS, SSPACE, GapFiller
• Experience developing and maintaining tools in Perl utilizing BioPerl and other open source frameworks.  Python/BioPython will also be considered. Experience in programming in R a plus.
• Experience with short read data manipulation, analysis & trimming tools, e.g. samtools, BWA, FASTX, FLASH, Quake, KHMER, SMALT
• Experience developing SQL databases and executing complex queries (joins across many tables, recursive joins) on such.  Experience with NoSQL databases a plus.
• Experience working with Linux clusters, particularly the configuring and execution of jobs under Sun/Oracle Grid Engine. 
• Experience developing interactive web tools using HTML5.
• General sequence analysis background with extensive use of BLAST, HMMER, CLUSTAL, PHYLIP and similar tools.
• Excellent communication skills, including the production of clear scientific updates using PowerPoint and good scientific visualization skills
• Able to work collaboratively in multi-disciplinary environment to accomplish program and company goals.

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.

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 join our team in the Clinical Affairs Department. You will be coordinating and performing clinical support activities for all T2Biosystems clinical trials and you will report to the Manager of Clinical Affairs.

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

• BA/BS degree 
• Minimum of two years experience with project management
• Minimum of two years experience in medical device industry
• Familiarity with medical research practices.

CRITICAL KNOWLEDGE AND SKILLS:

• Must have excellent computer skills including experience with Word, Excel, and database management.

Your responsibilities will include:

Responsible for supporting of clinical trials/projects, inclusive of the following:

• Support the Clinical Affairs Manager in execution of all clinical studies.
• Responsible for collecting, processing and assisting in the compilation and verification of research data, samples, and/or specimens.
• Enter data from forms and documents into databases and other documents.
• Assist with routine data verification and quality control, ensuring data integrity and consistency with prescribed study protocol.
• Responsible for tracking all study screening and enrollment activity.
• Responsible for processing and tracking receipt of all clinical specimens.
• Prepare project status reports.
• Responsible for the management of all clinical study supplies, including shipment of supplies to study sites.
• Responsible for the preparation and maintenance of study master files.
• Work with data management team and Clinical Affairs Manager to facilitate resolution of all data management queries.

In addition, you will have:

• A high level of commitment and a track record of high quality work, with attention to detail.
• The ability to work well with teams in a fast-paced, dynamic environment with an eye always on the goal.

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.

Third Rock Ventures is launching an exciting new company focused on developing novel immunotherapies for the treatment of cancer.  This new biotech start-up will be based in Cambridge, MA.  The company will be developing protein-based therapeutics aimed at achieving durable anti-tumor immune responses for multiple cancer indications. Leadership includes an experienced management team provided by Third Rock, in concert with world-class advisors in the field of cancer immunotherapy.  As a company at the forefront of cancer immunotherapy, we are seeking highly motivated, hard-working, creative, and collaborative individuals.

Job Description:

The successful candidate will be an integral part of a team of scientists engaged in the discovery and testing of novel cancer immunotherapeutic candidates.  Responsibilities include designing and conducting experiments aimed at immunomodulation of leukocyte responses in vitro, including primary cell-based assays and ex vivo analyses.  Typical experiments may include isolation of immune cells from mice or human samples, immunophenotyping, and cellular functional assays.  Assays systems may include flow cytometry, multiplex ELISA, proliferation assays, quantitative PCR, reporter gene assays. The candidate will be responsible for data analysis, thorough documentation of the work, and clear communication of results in group settings.

Qualifications:

The applicant must have a Master’s degree in Immunology or a related field with 2-5 years of relevant laboratory experience (or a Bachelor’s degree with 5+ years experience) in an academic or industrial setting. Special consideration will be given to those individuals with experience in cancer immunotherapy. Experience with cellular immune assays is a must, ideally including work with primary cells and ex vivo analyses.  Familiarity with basic cell purification techniques and immunological phenotyping procedures is required. Experience with in vivo mouse models is a plus.  The ideal candidate will have extensive hands-on experience with one or more of the following: flow cytometry, isolation and manipulation of human blood and blood components, in vitro T cell functional assays. In addition, the candidate must be detail-oriented, reliable and conscientious, with excellent organizational skills and oral and written communication skills. He or she must be capable of contributing independently and able to thrive in a highly collaborative, fast-paced, team-oriented environment with colleagues from diverse disciplines.

To be considered for this role, please submit your resume to Careers@thirdrockventures.comwith Cancer Immunotherapy 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 responsible for any fees related to resumes that are unsolicited

Our client is a fast growth biologics company that is rapidly moving to commercialization. This is an ideal opportunity for a dedicated professional who enjoys a fast-paced, collegial environment where results are rewarded with career growth and financial incentives.

Responsibilities:

• Leads and/or manages programs in R&D by ensuring that the project scope is well defined, and resource estimates and project schedules are specified and appropriate to the project.
• Coordinates the efforts of project team members.
• Generates and maintains development schedules. Interacts with management in R&D, Clinical/Regulatory Affairs, Marketing, Operations, Quality Assurance, and Supply Chain to ensure successful product development and introductions.
• Drives to keep resources on task and on schedule, manage change, understand technical issues and ensure that they get prioritized, highlighted, and resolved in a timely manner. 
• Identifies and manages technical and schedule dependencies in the project and ensures that they are understood, planned for and executed.
• Provides regular updates to all stakeholders on project status.
• Contributes to improvements in product development process.
• Manages the overall risk of the project.
• Maintains currency of, and adhere to applicable GMP and ISO 13485 processes and procedures.
• Abides by state and federal employment laws including compliance with OSHA and EPA

Requirements:

• Undergraduate degree, MBA preferred.
• 8+ years of experience in product development, preferably in the biologics, medical device or pharma industries.
• 3+ years of experience in engineering management and/or technical lead in the life sciences field.
• Successful experience working cross-functionally in a collaborative, fast-paced and dynamic environment.
• Outstanding track record driving projects to completion on time, within budget and with high quality while building solid collegial relationships.
• Excellent written and oral communication skills.
• PMP certification a plus.

Please submit resume to: careers@biomedicalsearch.com

For more information, please visit: www.biomedicalsearch.com

We are scientists, researchers, biotechnologists, physicians, and businesspeople working to bring new medicines to market. Faster. Because we know this isn't about us. It's about the millions of patients waiting to benefit from our discoveries.Co-founded in 1994 by Garo Armen and Pramod Srivastava as Antigenics, our company has outgrown its name but never its raison d'être: to develop and commercialize breakthrough immunotherapies for cancer and infectious diseases. Today we’re reaching far beyond antigens and discovering new ways to speed our progress. Because we know the patient is waiting. At today’s Agenus (Nasdaq: AGEN), now more than ever before, we are inspired by the power of ideas, by the application of science, and by the deep convictions and commitment we share with our growing circle of partners and collaborators.

Responsibilities:

This is an exciting time at Agenus and due to recent growth we have added this newly developed executive administrative position that will provide high level support and assistance to 2 - 3 of the organization’s Executives. 

• Manages calendars; schedules meetings, makes travel arrangements and manages expense reporting  for executives and others.
• Accountable for meeting planning and organization (schedule attendees, books conference rooms, arrange catering, prepares presentations, compiles notebooks, meeting materials, handouts, etc.).
• Provides phone support; assumes responsibility for copying, faxing etc. 
• Creates and distributes general correspondence, letters, memos, charts, graphs, contracts, agreements, minutes, spreadsheets reports, and assists in presentation building.
• Proactively responds to questions, concerns, and requests for information and resolves routine questions and information requests.
• Manages the administrative priorities of senior executives, solves conflicting priorities.
• Ad hoc projects, as assigned, including involvement in Board meetings.
• Works on complex problems in which analysis of situations or data requires an in-depth evaluation of various factors.
• Exercises judgment within broadly defined practices and policies in selecting methods, techniques and evaluation criteria for obtaining results.

Desired Experience:

• Bachelor’s degree.
• Must have experience supporting senior level management in a biotechnology/pharma environment;  5+ years preferred.
• Extensive and advanced working knowledge of MS Outlook, Word, Excel & PowerPoint.
• Strong interpersonal skills; position continually requires demonstrated poise, tact, and diplomacy.
• Must be able to interact and communicate effectively with individuals at all levels of the organization up to and including Board level.
• Confident, self-starter who can work well with minimum supervision
• Requires strong attention to detail in composing and proofing materials, establishing priorities, scheduling and meeting deadlines
• Must be able to work in a fast paced environment with demonstrated ability to simultaneously manage multiple competing tasks and demands.
• Must be flexible in handling multiple tasks of a different nature and have the ability to prioritize efficiently.
• Problem solver who is quick to figure solutions and make things happen.
• Must be able to handle confidential information and issues effectively and without breach of confidentiality.
• Makes decisions concerning business priorities on Executive’s calendar, as well as decisions on operational arrangements for meetings.

OVERALL RESPONSIBILITY
The Research Chemist I will work in an extraordinary research environment that has state of the art capabilities in organic synthesis and small-molecule screening.

The successful candidate will
(1) carry out the synthesis, purification, characterization and medicinal chemistry research of biologically relevant small molecules, identified through high throughput screening (HTS) of our stereochemically and skeletally diverse screening collection, to become candidate therapeutics.
(2) work closely with biologists in triaging hits from high throughput screens and hit validation.
(3) Conduct relevant literature searches and participate in meetings with chemists and biologists. He/She may also work toward the design, optimization, and realization of synthetic pathways to construct libraries of biologically relevant small molecules or on projects designed to identify the biological targets of drugs/compounds discovered through HTS.

CHARACTERISTIC DUTIES
- Carry out synthetic strategies that address key project issues involving multiple variables that must be optimized simultaneously. For example potency, solubility, stability and other in vitro PK parameters.
- Evaluate and interpret SAR across multiple optimization parameters.
- Analyzes research data to identify and evaluate synthetic problems and determine appropriate solutions utilizing an array of analytical techniques including 1D and 2D NMR, reverse and normal phase HPLC, SFC, and LC-MS.
- Synthesize biologically relevant focused libraries, which can involve both solution-phase and solid-phase formats.
- Maintain high standards of laboratory safety and record keeping.
- Effectively communicate results in oral and written form, including publication in peer-reviewed journals.
- Perform other duties as necessitated by the position or as assigned.
- Ph.D. in chemistry
- 1-2 years of research experience in Medicinal chemistry analytical, synthetic and organic chemistry
- Scientific expertise with an emphasis on synthetic organic chemistry in addition to medicinal and analytical chemistry including various methods of purification.
- Demonstration of success in technical proficiency, scientific creativity and collaboration with others.
- Record of project contributions commensurate with experience.
- Demonstrated ability to work and succeed in a multidisciplinary, team-oriented, high energy environment.

To apply for this position, please CLICK HERE