Clinical Program Manager, will manage the successful completion of all IND and Post Approval clinical programs, as well as be responsible for assisting with the development of the program budgets and hitting both enrollment and spending targets.  Manage and ensure competency of Clinical Operations staff including their knowledge and compliance with SOPs. The Clinical Program Manager will build and maintain relationships with clinical trial sites and principal investigators plus develop and maintain tools for tracking progress against department goals and objectives. The Clinical Program Manager will participate in the strategy and development of new trials and the selection of trial sites, vendor selection and management. The candidate selected will have strong leadership and teambuilding experience.

Responsibilities:

•          Manage the successful and timely execution of all Dicerna clinical trials.

•          Select, train and manage all Clinical Research Associates, CTA and Clinical Project Managers including their training and compliance with all SOPs and associated regulations.

•          Lead the training, initiation and management of clinical trial sites.

•          Establish and manage trial budgets including enrollment targets. Report regularly on performance against plan including steps to overcome any shortfalls in enrollment or overages in spending.

•          Participate in the design and development of new trials.

•          Develop the clinical component of regulatory submissions

•          Develop and maintain individual training programs for all staff.

•          Develop and maintain strong relationships with principal investigators at clinical trial sites.

•          Manages all study-related activities to meet defined study timelines while ensuring that GCP/ICH guidelines and the relevant SOPs are met;

•          Oversees investigator recruitment/selection and the conduct of trials at investigative sites;

•          Establishes vendor management plans and manages CROs and study-related vendors accordingly (inclusive of quality plan);

•          Maintains primary responsibility for the content of and execution on all study-related operational plans, such as study operations manuals, vendor manuals, safety plans, project management plans, communication plans, and quality plans;

•          Tracks study progress ensuring timely data collection, monitoring and, in collaboration with data management, internal listings reviews; 

•          Manages and trains clinical research associates;

•          Reviews monitoring visit reports, informed consent forms, protocols and CRFs

•          Participates in site visits, evaluating CROs/contract monitors through co-monitoring visits and/or site audits;

•          Provides Senior Management with regular study updates/status reports on study execution; and

•          Acts as a liaison between departments within Dicerna for project-related matters.

Qualifications:

•          MS in life sciences or nursing.

•          5-10 years’ experience in clinical research management, preferably medical oncology and/or rare disease company  (CRA/Project Management)

•          Strong leadership skills

•          Demonstrated knowledge of and experience with ICH/GCP for all US and ROW clinical trials.  

•          Hands on experience in the preparation of INDs/NDAs regulatory submissions.

•          Strong Written and Verbal Presentation Skills.

•          Willing to travel up to 10%.

•          Excellent communication, problem-solving and organizational skills.

Responsibilities include but are not limited to the following:

•          Manages all study-related activities to meet defined study timelines while ensuring that GCP/ICH guidelines and the relevant SOPs are met;

•          Oversees investigator recruitment/selection and the conduct of trials at investigative sites;

•          Establishes vendor management plans and manages CROs and study-related vendors accordingly (inclusive of quality plan);

•          Maintains primary responsibility for the content of and execution on all study-related operational plans, such as study operations manuals, vendor manuals, safety plans, project management plans, communication plans, and quality plans;

•          Tracks study progress ensuring timely data collection, monitoring and, in collaboration with data management, internal listings reviews; 

•          Manages and trains clinical research associates;

•          Reviews monitoring visit reports, informed consent forms, protocols and CRFs

•          Participates in site visits, evaluating CROs/contract monitors through co-monitoring visits and/or site audits;

•          Provides Senior Management with regular study updates/status reports on study execution; and

•          Acts as a liaison between departments within DICERNA for project-related matters.

Qualifications:

•          BS/BA degree or equivalent (background in life sciences preferred).  Advanced degree is preferred.

•          6 + yrs of industry experience (biotech/pharma/ CRO) with at least 2 years of oncology project management experience.

•          At least 4 years monitoring experience, with ability to independently perform all types of monitoring visits.

•          Experience in managing global oncology trials from start-up to database-lock;

•          Experience in management of vendors and CRO's.

•          Strong understanding of ICH, GCP and relevant regulatory requirements.

•          Strong operational and management skills with attention to detail.

•          Excellent communication skills and proficiency with Microsoft Outlook, Excel, Word, PowerPoint and Project.

•          Ability travel globally up to 10% of time. 

Position Summary: 

The CMC Documentation and Stability Coordinator position will help to further establish, update and maintain Stealth’s drug substance and drug product stability programs.  Primary responsibilities of this newly created position include reviewing all stability data /reports, performing trend analysis, and writing reviews, updates, and drug substance/drug product specifications.  Position involves collaboratively partnering with and effectively managing multiple pharmaceutical vendors.

Responsibilities:

• Review all stability data /reports and update stability tables accordingly
• Perform trending analysis of stability data and facilitate timely investigation of OOT & OOS occurrences
• Compile and write Annual Product Reviews for products, as necessary
• Support drafting of stability updates for regulatory filings including IND’s and IND annual reports
• Provide support to coordinate completion of technical reports through contract research organizations (CRO’s) and contract development and manufacturing organizations (CDMO’s)
• Draft drug substance and drug product specifications and obtain signatures for approval
• Review and document test methods, batch records, stability protocols, method validation protocols and reports 
• Review and document manufacturing deviations supplied from CDMO’s and coordinate contributions from Pharmaceutical Development to Material Review Board, as necessary
• Review and document technical aspects of OOS investigations with analytical functions in CRO’s and CDMO’s

Competencies:

• Excellent written and oral communication skills, with the ability to communicate complex information
• Strong organizational skills with the ability to effectively multi-task and prioritize
• Ability to flexibly adapt to changing business needs and meet timelines
• Ability to analyze & interpret stability data
• Strong attention to detail
• Resourceful, self-starter and team player with a strong results orientation

Requirements:

• Bachelor's degree in a scientific discipline. Master's degree preferred
• 3 - 5 years pharmaceutical industry experience in Quality Control or Quality Assurance
• High proficiency with MS Excel & Word necessary
• Participation in regulatory agency inspections and experience with document management systems and Slimstat® shelf-life projection software a plus.
• Previous experience working with pharmaceutical vendors / collaborators highly preferred

Our client, located west of Boston, is looking for a Senior Specialist in Marketing with a focus on Social and Digital Media. The company is a global developer, manufacturer and marketer of medical devices. Their portfolio of products is used in a range of medical specialties. They are growing through new product development/launches and via acquisitions.  We are looking for someone who comes from a company or industry that is on the cutting edge of innovation.  Healthcare industry experience would be a huge bonus.  Bonus - the company provides free shuttle transportation from the Boston and Cambridge areas!

Profile

• Five-plus years of digital/social media experience from a corporation and/or agency.  Health care experience a plus.
• Creative marketer who brings a blend of big picture, strategic thinking and will be hands on in the execution; understands how digital/social works with other marketing and communications strategies to drive business results.
• Demonstrated interest in and knowledge of social media and multimedia (i.e. Facebook, Twitter, YouTube, email marketing, video production, etc.), digital advertising, SEM and SEO plus other channels to programs that drive results.
• On the cutting edge of new and emerging communications tools and digital channels.
• Has written content for traditional, social and online media. 
• Solid understanding of how to develop appropriate messages for a wide range of audiences, especially consumer.
• Strong in measurement and showing ROI.
• Strong business acumen.
• Strong communicator – verbally, in writing and with non-verbal cues, too!
• Bachelor's degree  

Lonza Portsmouth, has significant expertise in the field of mammalian cell culture and cGMP custom manufacturing and is active in the large-scale production of biopharmaceuticals. Concretely, Portsmouth is a custom manufacturer of therapeutic monoclonal antibodies and recombinant proteins using mammalian cell culture for mammalian biopharmaceutical. The facility has been in cGMP manufacture since 1996 and is dedicated to meeting the needs of our customers. The setup and performance of projects teams with experts from Lonza and our customers working together is unmatched in the industry.  We currently have a position open in our Mono-suite Capital Projects Department.

MES Electronic Batch Record Author; Capital Projects Lead (SF)-Portsmouth, NH

The electronic Batch Record Recipe Author (eBR RA) is a multilevel position interfacing with the Emerson Syncade system.  The spectrum of development responsibilities will include:

• Creation of electronic dispensing
• Ability to input equipment (e.g. reactors, scales, skids) and their associated statuses
• Configure Equipment Tracking module including creating and modifying classes and rules.
• Developing new electronic batch records (eBRs) and revising existing eBRs using a library of existing work instructions and operations.
• Capable of assembling new operations and work instructions.
• Develop and execute protocols for testing and validation

This position is a supervisory level position that will require people management, and have responsibility for delivering to the Capital Engineering project schedule.

At minimum the position will report progress against a known schedule.  Ultimately the eBR RA is expected to work closely with RA supervisor, manufacturing supervisors, operators, and process technologists to develop a detailed schedule for recipe completion, create Process Descriptions and work directly with the customer to resolve comments. 

The eBR RA is expected to support associated operations such as operator training, necessary SOP changes, and execution of Process Change Controls, The position will require knowledge of cGMPs and good communication skills.

Qualifications:

• Bachelors Degree in a Science Based Program
• 3-5 Years of Biotech or pharmaceutical manufacturing industry experience. 
• 3 Years Knowledge of eBR system preferably Syncade.

Excellent Communication Skills        

Ability to effectively communicate via writing and oral communication at all levels.  Express ideas effectively in individual and group situations (including non verbal communication).  Ability to communicate to internal and external personnel.

Analysis/Problem Assessment        

Ability to secure relevant information and identify key issues and relationships from a base of information.  Relate and compare data from different sources and identify cause and effect relationships.

Technical Knowledge        

Ability to evaluate engineering problems and be able to devise cause and effect relationships and propose solutions.

Ability to keep customers/requesters and management apprised of status of work under your direction.  Ability to maneuver around hurdles to accomplish goals/tasks

Planning/Work Management            

Ability to establish a project plan that outlines the course of action for self and/or others to accomplish a specific goal.  Monitor the activities of consultants, vendors, contractors and internal staff  to insure that resources are allocated properly in order to achieve project goals.

      M/F/Disability/Veterans

Please take virtual tour of the Portsmouth, NH site. Click here http://lonzavirtualtours.com/

We are seeking ambitious people to join our team and make an impact in an innovative and growing industry.  Courtagen is a privately held life sciences and molecular information company that converts genomic data into actionable clinical information for the diagnosis of critical pediatric neurological and metabolic disorders. Courtagen’s state-of-the-art Next Generation Sequencing clinical laboratory integrates genotype, phenotype, and disease mechanism data using cloud-based computing and custom analytical methods to provide the most comprehensive results for clinicians, patients, and their families to better understand and treat their disease.

Marketing Specialist 

Summary:

The Marketing Specialist is responsible for assisting with tactics plans to help drive sales, penetrate markets and support company profitability.  The Marketing Specialist will gain an in-depth understanding of the competitive product marketplace landscape, sales processes and developing plans to develop markets.

Responsibilities: 

• Work directly with the Senior Director, Marketing on tactical/operational projects
• Contribute to the development of marketing materials (e.g. brochures, flyers, etc.)
• Website content management
• Preparing /compiling launch materials for new products
• Digital marketing campaigns
• Maintain accurate, timely and effective records of all lead generation activity in NetSuite ERP
• Support conferences and trade shows

Minimum Education and Experience           

• 1-3 years of marketing experience, preferably in life sciences
• Experience writing marketing collateral would be helpful
• Ability to take initiative and complete tasks in a fast-paced environment
• Superior interpersonal and oral and written communication skills
• Ability to meet deadlines and manage multiple responsibilities
• Graphic design experience would be helpful
• Bachelor Degree

If this job sounds like a solid fit, you want to work in high growth company with proven success, and be part of an entrepreneurial organization that can create positive outcomes in the lives of the patients we test, send your resume right away.  E-mail you resume to careers@courtagen.com, and tell us why Courtagen Life Sciences should hire you.  Courtagen is located in Woburn, MA. 

Whitehead Institute for Biomedical Research is a leading, nonprofit research and educational institution that has defined the cutting edge of biomedical science, creating a legacy of research excellence and academic eminence since 1982. Wholly independent in its governance, finances and research programs, Whitehead shares a teaching affiliation with Massachusetts Institute of Technology (MIT), offering the intellectual, collegial and scientific benefits of a leading research university. Whitehead's Faculty Members and Fellows run pioneering programs in cell biology, cancer research, immunology, developmental biology, stem cell research, regenerative medicine, genetics and genomics--programs with a record of success.

Director David C. Page likens the Institute to an artists' colony. "What we do here at Whitehead is to attract the best possible intellectual capital and empower maximally creative--really wildly creative--individuals to realize their dreams within these walls". Whitehead offers a generous comprehensive benefits package which includes health and dental plans, retirement program, paid time off, reimbursement accounts (FSAs), short and long term disability and much more.

Reports to: Lab Materials Associate II

FLSA Status: Nonexempt

OVERALL RESPONSIBILITY

¨   Responsible for providing clean glassware for various laboratories and lab groups, following written and verbal protocols and established safety procedures.

CHARACTERISTIC DUTIES

¨   Washing and drying glassware (and plasticware, if applicable) and distributing to appropriate locations within laboratories

¨   Maintains glass washing facility, keeping it clean and swept up, including collecting and disposing of broken glassware

¨   May collect and autoclave biotrash

¨   Other related tasks as required

QUALIFICATIONS

¨      High School degree or equivalent experience

¨      0-2 years related experience

¨      Attention to detail required

¨      Must be able to work independently and as a team member

¨      Must be able to lift minimum of 20 pounds

Please send resumes to:

resumes@wi.mit.edu

OR

Whitehead Institute

Attn: HR

9 Cambridge Center

Cambridge, MA 02142

Scientist/Senior Scientist Immunology

SQZ Biotechnologies is a company spun out of MIT based on work done in the labs of Professors Klavs Jensen and Robert Langer. Our technology platform (“CellSqueeze”) enables the delivery of all types of biomolecules directly to the cell cytoplasm and has demonstrated much potential in clinical and research applications. The pioneering work of our founders has been highlighted in numerous publications, including PNAS, Nature, and Nature Methods. Scientific American also recognized our technology as one of the “Top 10 World Changing Ideas of 2014”. We are seeking to expand our team by recruiting a Scientist/Senior Scientist. The successful candidate will be working on the immunology team to drive high-impact projects focused on the development of novel immune-therapeutics. You will be responsible for designing, producing and testing engineered immune cell function using both in vitro and in vivo models. You will design and perform experiments for internally and externally-focused research programs. The candidate will effectively and routinely collaborate with colleagues on different projects as well as present scientific results to multidisciplinary teams and the leadership team at SQZ Biotechnologies. The Scientist/Senior Scientist will contribute to the external scientific visibility of the company through publications and presentations at key scientific meetings and serve as a subject matter expert in immunology.

Primary responsibilities:

 Design, characterize and test novel cell based immunotherapies that are created with the CellSqueeze platform

 Design and establish analytical methods for the characterization of engineered immune cells

 Design in vitro and in vivo experimental studies of complex biological systems including data analysis

 Manage and support external R&D collaborations as a technical expert

 Drafting of manuscripts for publication in peer-reviewed journals

Required Skills:

 Expertise in Dendritic cell, B cell and T cell isolation and culture and flow cytometric methods

 Experience with molecular biology techniques including RNA, DNA and protein analysis is a plus

 Experience with culture of tumor-infiltrating lymphocytes, TCR sequencing, and processing and characterizing of human tumors is a plus

Candidate must:

 Work independently and manage multiple projects simultaneously

 Set project strategy

 Demonstrate the ability to critically analyze and present data

 Keep up-to-date with the literature related to his/her field

 Demonstrate clear and professional verbal and written communication skills

 Have strong work ethic and a team orientation

 Attention to detail and a passion for winning

The minimum requirements for interested candidates are a PhD in Immunology, Biochemistry, Molecular Biology, or related fields with 2-7years of industrial experience. Potential applicants should send their resume to Tanesha.bland@sqzbiotech.com .

n this position, the candidate will be responsible for participating in and leading the development of new applications tailored for our novel next-generation sequencing platform.

Experience:

• Ph.D. in genetics, molecular biology, or related field w/3+ years experience
• Experience with sequencing technologies
• Laboratory skills including molecular biology, nucleic acid and protein biochemistry, genetics, and basic bioinformatics analysis

This individual will be responsible for assay development, optimization and transfer as well as periodic preclinical sample analysis.  The candidate have experience with extraction techniques such as HPLC separations and affinity enrichment of proteins, including immunoaffinity.  The candidate should also be able to independently design and execute targeted peptide quantitative methods using a triple-quadrupole mass spectrometer.

Basic Qualifications:

• The successful candidate should have a Ph.D. in Biochemistry, Analytical Chemistry, or related discipline with 3+ years of relevant industry experience in mass spectrometry based proteomics
• In-depth knowledge of and hands-on experience with LC-MS/MS based quantification of proteins
• Direct experience with the operation, maintenance, and trouble-shooting of triple quadrupole mass spectrometers
• Experience in proteomic sample preparation from biological matrices including primary blood

Senior research associated needed for clinical molecular diagnostics laboratory. Responsibilities include:

• Designing primers
• Sanger sequencing
• Assay design
• The ability to work very independently
• Confirm genomic results using next generation sequencing

Master's degree in life sciences preferred. Bachelor's degree with adequate experience may be considered.

We are looking for a Research Associate to join our Molecular Biology R&D team.  In this position you will be responsible for participating in the development of assays and applications tailored for our novel next-generation sequencing platform.

Responsibilities:

 Candidate will be responsible for developing molecular biology assays, sequencing applications and testing and optimizing biochemical reactions.

Qualifications: 

• Bachelor’s degree in biochemistry, biology, genetics or related field
• 1+ year experience
• Molecular biology laboratory techniques and in the use of laboratory equipment and materials including PCR, electrophoresis, and enzymatic reactions

Foundation Medicine is seeking a talented and highly motivated Benefit Investigation and Prior Authorization Representative to join its growing team. As a key contributor to the success of billing operations, the Benefit Investigation and Prior Authorization Representative will be primarily responsible for providing upfront benefit investigation and prior authorization for patients and clients. As an interface to our valuable customers it is critical that the successful candidate for this role is able to demonstrate integrity and commitment to values as well as have a core desire to provide excellent customer service.

• Responsible for processing benefit investigation upon request from the designated prior approval pilot client
• Monitor pre-accessioned cases daily to identify payers within the pilot and contracted payers that require prior approval
  • Initiate and obtain prior approvals as required by payer
• Coordinate with FoundationACCESS lead/program to ensure financial assistance needs are addressed along with benefits and coverage determination
• Resolve missing billing information
• Support appeals processes as needed
• Ad Hoc requests and special projects as necessary

• Must have excellent organizational and communication skills, ability to interact and communicate, both oral and written, with internal and external customers
• High level of accuracy and attention to detail
• Must be able to operate within a fast paced work environment while coordinating multiple tasks
• Ability to establish priorities and coordinate daily activity
• Must be able to demonstrate integrity and a commitment to values
• Commitment to meet deadlines
• Maintains HIPAA patient confidentiality standards for medical and financial information

Education/Experience

• High School Diploma or Equivalent required
• Minimum 2 years’ experience in medical billing (knowledge of prior authorizations is a plus)
• Knowledge of medical technology and third party billing preferred
• Proficient in Excel required

Apply Here

PI92452243

Foundation Medicine is seeking an attorney with knowledge and experience in corporate law, compliance and commercial transactions to work closely with the other members of the legal and compliance teams at Foundation Medicine. This attorney will have a key role in advising business units within Foundation Medicine and working with the contracts management team to draft and negotiate a broad range of contracts for various business units. The preferred candidate would be a corporate attorney with familiarity handling a broad range of life science issues, with prior work experience at a life sciences company and/or a law firm with life sciences clients. All candidates must be able to work in a dynamic, evolving and fast-paced work environment, with the confidence and abilities to work independently and to interact successfully with internal clients and external parties. The Corporate Counsel/Corporate Attorney will report to the Associate General Counsel.

• Assist Foundation Medicine’s legal and compliance teams with general corporate, compliance, regulatory and other legal matters relevant to Foundation Medicine’s operations, including U.S. and ex-U.S. operations.
• Draft, revise, and negotiate general corporate, operational and commercial agreements relevant to Foundation Medicine’s day-to-day operations, including services agreements, payor agreements, vendor agreements, research agreements, clinical trial agreements and consulting agreements.
• Collaborate with Foundation Medicine’s head of compliance to implement the compliance program, including developing and managing auditing programs.

• Collaborate with Foundation Medicine’s Senior Manager for Legal Services to manage Foundation Medicine’s contracting process.

Qualifications:

• Ability to quickly and effectively spot complex legal issues, research new legal issues, and provide advice in a manner that integrates legal risk management with Foundation Medicine’s business objectives.
• Experience drafting, revising and negotiating services and commercial agreements.
• Strong oral and written communication skills and sound business judgment.
• Ability to balance a variety of projects with deadline pressure and limited supervision, identify and escalate legal issues when needed, and work collaboratively with business unit and legal department colleagues.

Education, Experience and Bar Admission

• 2-5 years of legal experience with general corporate agreements. Ideal candidate would have experience as an in-house attorney at a life sciences company and/or experience in a law firm setting representing life sciences companies. Experience with the diagnostics industry and commercial products is a plus.
• JD and admission to the Massachusetts Bar.

Apply Here

PI92452626

Major Responsibilities:

• Perform analytical testing and peer review for release, stability and validation samples
• Maintain and troubleshoot analytical equipment
• Maintain compliance to commercial level cGMP
• Participate in quality systems investigations, quality incidents, and OOS’s
• Support validation, process development and manufacturing assignments

Qualifications:

• Bachelor’s degree in chemistry, biochemistry or any science
• 3-5 years of Quality Control experience in biopharma

Job ID: 27394
Date Posted: 12/02/2015
Location: Center for Life Sciences
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.

DFCI Lab Tech Recruitment - Fall 2015

Position description

The Sander laboratory explores a variety of questions about the treatment and evolution of cancer. By tightly integrating experimental biology with sophisticated computational analyses, we take a modern systems approach to better understand basic biology and build active bridges to clinical research. We are seeking a highly motivated Senior Laboratory Technician to assist with and drive molecular and cellular biology research projects, help with the establishment of the experimental laboratory, collaborate with computational biologists, and work closely with leadership to coordinate daily lab operations. Our ideal candidate has proven research experience as a technician, scientist, or lab manager working within molecular or cellular biology. The perfect applicant to join our team will be enthusiastic and passionate about solving scientific problems, and have a good work ethic, excellent organizational skills, and an open and collaborative personality.

Position details

Startup: Help facilitate the establishment of the Sander molecular and cellular experimental lab.

Coordinate with lab ops and facilities

Purchase and maintain essential equipment

Help to implement and optimize standard administrative procedures (ordering, online lab notebooks, etc)

Day-to-day

Develop and optimise research projects and/or lead research projects

Investigate and implement new technologies

Teach techniques to new lab members

Assist lab members with experimental projects

Work closely with Sander lab leadership to coordinate daily lab operations

Purchase and maintain essential consumable stocks

Solve problems related to daily lab function

Ideal education and skills

Proven research experience as a technician, scientist, or lab manager working within molecular, cellular, or cancer biology

Confront and independently tackle problems

Good work ethic and excellent organization skills

Prefer: higher education in molecular or cellular biology

Preferred experience with:

Molecular biology:

DNA: basic cloning techniques,PCR, ligations, digestions, transformations, viral preparations

Protein: western blots, mass spectrometry, reverse phase protein arrays

Cellular biology:

mammalian cell culture

drug perturbations

imaging

flow cytometry

High throughput screening techniques

Schedule

Schedule is Monday - Friday

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

PI92451021

Research Associate

EpiVax is a breakthrough biotechnology company located in the heart of downtown Providence in RI. We're actively seeking a Research Associate to add to our growing team. A career at EpiVax offers an opportunity to work in an exciting and creative environment with an interdisciplinary team of individuals who are passionate about what they do. Are you the next member of our team?

The Research Associate position will be responsible for executing scientific research in the laboratory specifically related to the development of vaccines, therapeutic proteins in addition to maintenance of general laboratory functions.

The Research Associate:

• Performs day-to-day experimental activities, maintains detailed up-to-date laboratory notebook, utilizes safe laboratory protocols;

• Maintains lab in clean and high-functioning condition;

• Adheres to experimental protocols required for product development and lab services for clients;

• Follows guidelines on data entry, conservation and sharing;

• Uses professional concepts to contribute to the development of the lab technology base and to achieve objectives in creative and effective ways.

The Research Associate will also be responsible for:

• Remaining current on relevant scientific and industry techniques;

• Interfacing with outside Associates on collaborative programs;

• Assisting the team with documenting and updating Standard Operating Procedures as needed;

• Other duties as assigned.

 Required Knowledge and Skills

The Research Associate should have strong theoretical and technical background of current laboratory assays and techniques in the areas of Immunology, Cell Biology, Virology and Molecular Biology. The Research Associate should have strong communication skills and be current on industry trends.  In addition the Research Associate will have:

• A strong attention to detail

• GLP documentation

• Aseptic Technique

• Strong background in mammalian cell culture required

• Familiarity with immunization protocols for studies in animal models desired

• Mouse handling, Mouse cardiac bleeds, Mouse splenectomy, Mouse spleen and Lymph node processing experience is strongly preferred

• Flow cytometry experience including sample preparation, flow cytometer set up and sample acquisition

• Flow cytometry analysis using FlowJo software

• SDS Page, HLA Binding Assays, ELISA, ELISpot, Fluorospot

• Proven capability to carry out and follow through complex research programs

• Proficient in Microsoft Excel, Word and Powerpoint

• Experience using Graphpad Prism software for data analysis

• Research Associates must also have a current driver’s license and be able to secure a Zipcar Membership to travel to offsite mouse facilities when necessary

Relationships

The Research Associate reports directly to the Lab Manager and indirectly to the CSO, COO and Scientific Directors. 

Qualifications

Bachelor of Science in immunology or related field is required. Relevant industry experience, proven track record of laboratory research and leadership as well as knowledge of current scientific techniques are a must.

At this time, EpiVax will not sponsor applicants for work visas. In compliance with federal law, all persons hired will be required to verify identity and eligibility to work in the United States and to complete the required employment eligibility verification document form upon hire.

Your expertise could have an immediate impact on our Quality Assurance team.  Our growing client located in the heart of the biopharma hub, has a need to add a Senior Specialist to the Quality Assurance department.  Not only will you guide conformance to establish QA standards and processes but you will also work on continually improving them.  This position will also be responsible for overseeing the current QA operations while in the end, you will work closely with the Senior Manager to streamline the department; creating an energized, efficient, and effective team.
• BA/ BS and a minimum of 5+ years in Quality Assurance
• Lean Six Sigma Green Belt – preferable but not required
• Strong knowledge of GxP regulations, quality systems, and guidance documents
• Demonstrated leadership within teams producing results
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™

Excellent leadership opportunity available to lead Process Characterization activities at a local A-list, mid-size, public company.  Based in the Kendall Square neighborhood of Cambridge, a short walk away from the Red Line, this rapidly growing company has exciting and innovative therapeutic programs in preclinical and clinical development.  

The main focus of this role is cell culture process characterization and process validation in preparation for commercialization activities. 

Responsibilities include but are not limited to;
•  Qualification of scale down models
•  Designing and conducting process characterization studies
•  Designing and executing BLA enabling studies
•  Authoring and review/approval of Process Characterization and Validation protocols and reports.

Formal descriptions can be supplied for interested candidates. 

Qualified candidates will have BS degree or higher (PhD candidates also welcome) and several years of late stage biologics development and/or product commercialization experience.  

Must be authorized to work in the US to be considered.   Relocation assistance available for qualified candidates.  

Resumes to nuno@hireminds.com to be considered.  All resumes will be kept strictly confidential until you choose to pursue a specific opportunity with one of our clients.

GENERAL SUMMARY OF POSITION:

Under the supervision of the Principal Investigator or designee, the Research Laboratory Technician I, performs a variety of specimen preparatory techniques, dry lab data collection, and routine laboratory maintenance.

MAJOR RESPONSIBILITIES:

• Perform a variety of laboratory experiments using both routine and special techniques and methods
• Assist in more complex laboratory tasks
• Collect, analyze, and process laboratory samples
• Record results, organize data, and perform basic computations
• Maintain laboratory supplies and equipment
• Comply with all safety and infection control standards
• Perform other duties as required.

REQUIRED QUALIFICATIONS:

• Bachelor’s degree in Biological Science or equivalent experience
• Knowledge of Microsoft Office products
• Ability to perform duties independently
• Judgment and action skills required to solve commonly encountered problems

SUPERVISION RECEIVED:

Under the supervision of the Principal Investigator or designee

SUPERVISION EXERCISED:

None

ENVIRONMENTAL WORKING CONDITIONS:

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

Apply Here

PI92457941