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Lab Head/Principal Scientist - Biology, Vascular Inflammation

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

Role Description
The candidate will lead biology efforts focused on therapeutic approaches involving vessel wall physiology and vascular inflammatory mechanisms in heart failure. This individual will leverage their depth of knowledge and hands-on expertise in studying pathophysiological mechanisms of the vascular system particularly as it underlies cardiovascular disease. This individual will be a key contributor in the cardiovascular group and expected to advance an innovative drug discovery portfolio spanning the continuum of drug development from target identification to advancing assets into the clinic and through Phase 2. The successful candidate will thrive in a fast-paced and goal-oriented, project team environment.

Responsibilities
* Contribute to identifying and advancing innovative new therapeutics approaches for the treatment of heart failure
* Drive preclinical biology through hands on research as well as effective management and mentorship of colleagues
* Effective project leadership built on collaboration with partner lines, vendors, and external experts to impact goals
* Colleague development and supervisory responsibility
* Innovative scientist who will identify and champion novel drug discovery approaches in the vascular inflammation and heart failure spaces.
* Requires excellent written and oral communication skills

Qualifications
* PhD or MD with 4+ years of post-doctoral experience, which may include 3-5 years of industry experience
* Strong record of scientific accomplishment
* Excellent verbal and writing communication skills

Technical Skills Requirements:
Technical proficiency with in vitro and in vivo models of vascular injury, particularly including some of the following:
* Experience in models of vascular injury which may include: atherosclerosis, ischemia reperfusion, myocardial infarction, stroke, wire injury, aortic constriction, pulmonary hypertension, vasculitis, angiotensin or isoproterenol infusion
* Experience with bone marrow transplant/ immune reconstitution techniques, intravital and confocal microscopy, leukocyte trafficking assays and/or preclinical histopathology techniques is desirable
* Experience with endothelial function assessment in preclinical species preferred
* Isolation and characterization of endothelial cells, smooth muscle cells and leukocyte subsets desirable:
* FACS
* Cell isolation from target tissue (atheroma, myocardium, spleen, bone marrow

EEO & Employment Eligibility
Pfizer is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status. Pfizer also complies with all applicable national, state and local laws governing nondiscrimination in employment as well as work authorization and employment eligibility verification requirements of the Immigration and Nationality Act and IRCA. Pfizer is an E-Verify employer.

Please apply at: Application URL:http://www.aplitrak.com/?adid=QWxpc29uLlR1dGx5cy4yNDQzMi4zMTY3QHBmaXplci5hcGxpdHJhay5jb20


Drug Product Design Candidate Selection Team Leader

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Org Marketing Statement
A career at Pfizer offers opportunity, ownership and impact.

All over the world, Pfizer colleagues work together to positively impact health for everyone, everywhere.Our colleagues have the opportunity to grow and develop a career that offers both individual and company success;be part of an ownership culture that values diversity and where all colleagues are energized and engaged;and the ability to impact the health and lives of millions of people. Pfizer, a global leader in the biopharmaceutical industry,is continuously seeking top talent who are inspired by our purpose to innovate to bring therapies to patients that significantly improve their lives.

Role Description
Reporting to the Global Head of the Research Formulations Group in Drug Product Design (DPD), the Group Leader will lead pre candidate selection DPD activities across formulation science, solid form and drug delivery assessments for the Research Units in Cambridge, MA. The group's responsibilities will encompass all areas from Lead Selection, Lead Development, through to Candidate Selection and will strive to position the compound for accelerated early development.

Responsibilities
* Starting at Lead Development, works closely with Medicinal Chemistry, Drug Metabolism, Biology and Drug Safety to ensure optimum candidate selection based on the envisioned Targeted Product Profile and indication. Ensure a clear experiment plan is in place to rapidly gain knowledge on a potential candidate to help optimize selection. Balances experimental data, with state of the art computational predictive tools to guide the medicinal chemistry.
* As a member of the Research Formulation group, will contribute to the strategic direction of the group as well as ensuring that there is good alignment between candidate selection, pre-POC activities and post POC development requirements.
* Provide insights into the required direction of the group by analyzing trends, future needs and feedback from key partners. Direct scientific and technology investments to address future needs and enhance our ability to predict candidate success from drug delivery and biopharmaceutics perspectives.
* Works closely with Chemistry Research and Development, Analytical Research and Development and Early Development Portfolio Management Group leaders on integration of activities within Pharmaceutical Science Candidate selection project teams and ensures candidates are well positioned to accelerate into the clinic.
* Contribute to portfolio prioritization across the global portfolio

Qualifications
EDUCATION AND EXPERIENCE :
* Advanced degree (PhD) or equivalent in Pharmaceutical, Chemistry or Life Sciences.
* Extensive management and technical experience in discovery support and early development.
* Successfully ran groups of similar size and complexity.

TECHNICAL AND LEADERSHIP CAPABILITIES:
* Experience in drug product design, especially in the candidate selection/Pre-POC stage of development
* Experience and awareness of drug product enabling, drug delivery technologies and computational predictive tools to help design and select high quality candidates.
* Proven track record in developing new technologies and/or computational tools to address future needs.
* Has a demonstrated ability to influence and lead in a matrix environment, and with senior leaders across the wider discovery organization
* Good at making calculated risk judgments without all the required information
* Excellent presentation skills - ability to distill, craft and present key messages in complex environment relative to the audience requirements
* Strong background in pharmaceutical sciences and good awareness of medicinal chemistry and drug absorption and metabolism
* Good interaction style with multi-disciplinary teams and associated team leaders
* Good self-awareness and seeks continuous improvement and change in both internal and external environment.
* Demonstrated ability to lead through change, ambiguity and without all the information needed
* Proven ability to develop colleagues and managing teams across different global locations.

LEADER BEHAVIORS:
* Strong focus on performance, team interaction, scientific/technical excellence and fostering open discussion and debate.
* Strong influencing and networking skills in a complex research environment with many key stakeholders
* Pace setting leadership style, driving issues to a win win resolution

PHYSICAL POSITION REQUIREMENTS:
* Frequent travelling (2-3 times a month) between Boston, MA and Groton, CT

EEO & Employment Eligibility
Pfizer is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status. Pfizer also complies with all applicable national, state and local laws governing nondiscrimination in employment as well as work authorization and employment eligibility verification requirements of the Immigration and Nationality Act and IRCA. Pfizer is an E-Verify employer.

Please apply at: Application URL:http://www.aplitrak.com/?adid=QWxpc29uLlR1dGx5cy4zNjIwMS4zMTY3QHBmaXplci5hcGxpdHJhay5jb20

Principal Scientist - Neuromuscular Disease Research

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Org Marketing Statement
A career at Pfizer offers opportunity, ownership and impact.

All over the world, Pfizer colleagues work together to positively impact health for everyone, everywhere.Our colleagues have the opportunity to grow and develop a career that offers both individual and company success;be part of an ownership culture that values diversity and where all colleagues are energized and engaged;and the ability to impact the health and lives of millions of people. Pfizer, a global leader in the biopharmaceutical industry,is continuously seeking top talent who are inspired by our purpose to innovate to bring therapies to patients that significantly improve their lives.

Role Description
Pfizer Neuromuscular Disease Research is part of the Pfizer Rare Diseases Research Unit and focuses on developing new therapies in rare neuromuscular disorders, such as Duchenne Muscular Dystrophy, Friedreich's Ataxia, and ALS. The Rare Disease Research Unit (RDRU) is part of Pfizer's Biotherapeutics Unit, one of the two major units in Pfizer Worldwide R&D responsible for advancing a large portfolio of R&D programs towards clinical proof-of-concept (i.e., Phase 2 completed). The Principal Scientist is responsible for driving scientific delivery of early-stage discovery and research programs to candidate selection, and then support of candidate molecule in pre-IND research activities. The Principal Scientist will also devote a small percentage of time to exploratory work in novel targets/pathways that may evolve into an entry into the RDRU portfolio.

Responsibilities
* Contribute to identification and validation of new therapeutic targets for the treatment of rare diseases
* Drive preclinical biology through hands on research as well as effective management and mentorship of colleagues
* Be able to work effectively as an independent scientist
* Actively contribute to departmental strategies and scientific depth through interactions with scientists and other colleagues within Pfizer
* Develop new research programs within Pfizer and assist in establishing productive collaborations with external academic and/or research partners.
* Exhibit the ability to communicate clearly and effectively, and demonstrated ability to collaborate and work as part of a team
* Effective project leadership built on collaboration with partner lines, vendors, and external experts to impact goals
* Colleague development and supervisory responsibility

Qualifications
* PhD or MD with 4+ years of post-doctoral experience, which may include 3-5 years of industry experience
* Strong record of scientific accomplishment (e.g., publication track record, fellowship/grants awarded, etc)
* In-depth, hands-on knowledge in a variety of molecular, cellular and/or in vivo techniques that would enable the candidate to design/implement necessary target screens for a variety of drug development programs.
* Knowledge in skeletal muscle biology/physiology, peripheral nerve function, and neuromuscular junction disease a plus
* Experience working collaboratively with external partners
* Experience working in matrixed teams
* Strong background in independent thinking, management, and leadership
* Excellent verbal and writing communication skills

Technical Skills Requirements:
Excellent working knowledge of basic molecular and biochemical techniques (e.g. PCR, cloning, RT-PCR and transcript profiling, immunoblotting etc.) required
* Experience in standard cell culture techniques needed, significant cell-based assay development experience an advantage
* Experience with primary muscle cell culture preferred
* In vivo model development knowledge a plus
* Capable of establishing new scientific and technical platforms in-house, to implement and validate methodologies, ability to troubleshoot technical assays, equipment, and protocols
* Has awareness of drug discovery and development processes and stage gate criteria
* Possesses scientific knowledge to drive the project scientific strategy and overall project execution (i.e., understanding of target, mechanism of action, etc.)
* Demonstrated ability to design experiments creatively
* Possesses critical thinking and quantitative analysis skills which will aide in quality decisionmaking
* Excellent communication skills able to present complex technical concepts to enable
understanding by colleagues from all disciplines/all levels

EEO & Employment Eligibility
Pfizer is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status. Pfizer also complies with all applicable national, state and local laws governing nondiscrimination in employment as well as work authorization and employment eligibility verification requirements of the Immigration and Nationality Act and IRCA. Pfizer is an E-Verify employer.

Please apply at: Application URL:http://www.aplitrak.com/?adid=QWxpc29uLlR1dGx5cy45NjIwOS4zMTY3QHBmaXplci5hcGxpdHJhay5jb20

Sr. Associate Scientist - Electrophysiology and cell-based

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Org Marketing Statement
A career at Pfizer offers opportunity, ownership and impact.

All over the world, Pfizer colleagues work together to positively impact health for everyone, everywhere.Our colleagues have the opportunity to grow and develop a career that offers both individual and company success;be part of an ownership culture that values diversity and where all colleagues are energized and engaged;and the ability to impact the health and lives of millions of people. Pfizer, a global leader in the biopharmaceutical industry,is continuously seeking top talent who are inspired by our purpose to innovate to bring therapies to patients that significantly improve their lives.

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

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

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

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

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

EEO & Employment Eligibility
Pfizer is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status. Pfizer also complies with all applicable national, state and local laws governing nondiscrimination in employment as well as work authorization and employment eligibility verification requirements of the Immigration and Nationality Act and IRCA. Pfizer is an E-Verify employer.

Please apply at: Application URL:http://www.aplitrak.com/?adid=QWxpc29uLlR1dGx5cy45NjIzMi4zMTY3QHBmaXplci5hcGxpdHJhay5jb20

Senior Scientist - Next Generation Sequencing, Antibody

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Org Marketing Statement
A career at Pfizer offers opportunity, ownership and impact.

All over the world, Pfizer colleagues work together to positively impact health for everyone, everywhere.Our colleagues have the opportunity to grow and develop a career that offers both individual and company success;be part of an ownership culture that values diversity and where all colleagues are energized and engaged;and the ability to impact the health and lives of millions of people. Pfizer, a global leader in the biopharmaceutical industry,is continuously seeking top talent who are inspired by our purpose to innovate to bring therapies to patients that significantly improve their lives.

Role Description
The qualified candidate will play a key role in building state of the art high throughput B cell cloning and sequencing pipeline in the cell-based Antibody Discovery Group. The candidate will collaborate with scientists within the organization to actively improve and drive therapeutic antibody discovery efforts by developing and employing state of the art molecular biology and sequencing technologies. The new hire will also participate in developing innovative technologies around cell-based therapeutic antibody discovery to address short comings of current technologies.

Responsibilities
Primary responsibilities include but not limited to:
* Establish efficient molecular cloning of immunoglobulin genes work flow on various species (e.g. hybridoma, single B cell)
* Establish and optimize rapid NGS workflow to study Immunoglobulin repertoire
* Analyze NGS data
* Drive novel antibody discovery technology development
* Establish robust method/process of genome editing (e.g. CRISPR)

Qualifications
* Ph.D. in immunology, molecular biology, virology, or computational biology with 3-5 years of industrial experience.
* Proven publication record in top tier journals
* Strong proven molecular biology skills
* Proven expertise in NGS Ig amplicon library generation and NGS sequencing work flow
* Hands-on experience in Illumina Sequencing platform
* Proven expertise in single B cell cloning in various species
* Knowledge and proven record of developing state of the art antibody discovery platforms
* Experience in applying proteomic in antibody discovery a plus
* Experience in various computational programming skills is a plus
* Strong organizational and project management skills
* Strong oral and written communication skills

PHYSICAL/MENTAL REQUIREMENTS
* Expertise in immunoglobulin alignment and sequence analysis packages
* Experience in molecular biology lab automation and process integration
* Expertise in single cell cloning and sequencing
* Experience in microfluidics is a plus
* Experience in proteomic is a plus
* Working experience in R, Perl, and other statistical packages is a plus

EEO & Employment Eligibility
Pfizer is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status. Pfizer also complies with all applicable national, state and local laws governing nondiscrimination in employment as well as work authorization and employment eligibility verification requirements of the Immigration and Nationality Act and IRCA. Pfizer is an E-Verify employer.

Please apply at: Application URL:http://www.aplitrak.com/?adid=QWxpc29uLlR1dGx5cy4zMDI4MS4zMTY3QHBmaXplci5hcGxpdHJhay5jb20

Associate - Project Coordinator

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Role Description
The Associate Project Coordinator will be a member of the Worldwide Research and Development Postdoctoral Program team. S/he will work closely with the Program Senior Manager on various projects, including managing postdoctoral progress reports and associated communications, web site design and maintenance, communications among the Program, postdoctoral trainees and scientific mentors, planning and execution of scientific meetings at various sites, and supporting the annual grant award process. S/he will be responsible for coordinating team meetings, preparing agendas and meeting materials, preparing communications including letters, slides, manuals and other materials. S/he will provide operational support to the team and work on projects and other goals as assigned.

Responsibilities
* Develop and implement new web page and other electronic materials internally and externally, including SharePoint refresh and maintenance.
* Support Postdoc Program governance team reviews
* Manage postdoc on-boarding/off-boarding activities
* Manage template development, distribution lists, meeting rosters, record management on SharePoint and other platforms.
* Support Postdoc Program leadership, governance team and work groups, and the Postdoc Advisory Council, by facilitating meeting set up, developing and distributing agendas, preparing and distributing meeting minutes, follow-up and follow-through on action items.
* Support professional development curriculum, by planning/coordinating seminars and workshops, facilitating meeting planning and set up, speaker engagement including contract negotiation, payments, distribution of presentation materials.
* Program promotion/communication, internal as well as external (announcements/newsletters; MyWorld and LinkedIn social networking; print/electronic ads; program brochure and other materials; SharePoint).
* Respond to inquiries about program from potential postdoc trainees and mentors, and organize informational sessions in person or via webex, internally and externally.
* Support scientific meetings, including the annual Symposium.
* Develop program assessment tools, including general and special event surveys, exit interview templates, track/report postdoc outcomes (external talks/poster presentations, publications, patents, special recognitions); prepare reports as needed.
* Budget management, including quarterly charge-backs and other accounting; monitor and forecast updates to Finance.
* Support annual grant application review for WRD-funded positions, including template management, compliance monitoring, team assignments, meeting coordination/facilitation, compilation of scores/rankings, and notification of awards.
* Maintain administrative manuals, SharePoint team materials; travel arrangements, T+E reporting, materials orders, payment processing.

Qualifications
* Bachelor's degree in a science related field (B.A., B.Sc.)
* Outstanding communication skills (written, on-line, spoken communications).
* Knowledge of professional application of computer skills, including building web pages and maintaining web sites; word processing, spreadsheet, presentation programs, project management, and databases.
* Outstanding interpersonal skills and ability to handle personnel matters in a confidential and professional manner.
* Operational skills integrating science, technology, communication and coordination of interdisciplinary work groups.
* Experience in writing and editing operational plans, internal and external announcements and communications, as well as promotional and branding materials such as brochures, flyers and meeting materials.
* Experience drafting and writing policies and procedures manuals and to implement on-line or in print.
* Experience with webpage design and maintenance, or comfortable learning these skills.
* At least 1 year experience in operational support of drug development operations.

PHYSICAL/MENTAL REQUIREMENTS:
* Self-starter; excellent with follow-through and follow-up
* Well organized; easily manages multiple projects simultaneously
* Can work independently, but enjoys working as part of a team
* Tech-savvy (social networking, website development, etc.)
* Excellent written and oral communication skills; willingness to speak in and to a group
* Project management skills
* Desire to take on new challenges
* Detail-oriented, but can see the big picture
* Change-agile
* Excellent interpersonal skills; a straight-shooter; enjoys fast-paced, varied work.

NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS:
Occasional non-standard work schedule (2-4 times / year) and travel (1-3 times / year).

Please apply at: Application URL:http://www.aplitrak.com/?adid=QWxpc29uLlR1dGx5cy43Nzc5Mi4zMTY3QHBmaXplci5hcGxpdHJhay5jb20

Sr Oncology Biomarker Sci

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The comprehensive analysis of cancer genomes is nearly complete, but major barriers exist in converting this information into patient benefit. Now, a critical goal in cancer research is to predict essential genes/proteins across a diversity of tumor subtypes. Such a capability would allow for the elucidation of the molecular targets against which therapeutics should be developed, and the identification of specific patient populations likely to respond to such targeted interventions.

We are launching a new initiative to screen small-molecules at an unprecedented scale in cancer models spanning the genetic diversity of human cancer, in order to identify compounds with genotype-specific patterns of killing. This initiative will generate an array of small molecule efficacy data across hundreds of genomically distinct cancer cell lines. It is anticipated that hundreds to thousands of potential hits will be uncovered over the course of this project. We are looking for a talented cancer biology expert to lead an effort to prioritize therapeutic leads based on pathway relevance to cancer, predictive biomarkers of sensitivity, and relative position in the clinical and pre-clinical drug landscape.

The ideal candidate would have a demonstrated expertise in oncology signaling pathways, preferably with early drug development experience and experience corroborating empirical data with multiple databases to uncover interesting compound effect/cell signaling pathway connections. He/she would deliver synergized hypotheses based on evaluation of these multiple data sources to develop a biological prioritization of compounds for follow up work.

This position would also have support from the computational chemistry team to help further refine priority lists with cheminformatic information and ease of synthetic optimization opinions. This position will be directly responsible for assisting project leadership evaluate and nominate top compound candidates and will have a direct impact on influencing subsequent drug development efforts at the Broad Institute. The Broad Institute provides a vibrant research environment with close links to top academic institutions across the Boston area and provides the potential for your contributions to be used and recognized worldwide.

CHARACTERISTIC DUTIES
Evaluate and prioritize oncology-related biomarkers of sensitivity of novel small molecule compounds for promising pathways of interest in oncology therapeutics space. Recommend selection of hit candidates for downstream validation and biological follow up including experimental design. Engage with the Broad Cancer Program subject matter experts to refine areas of particular interest and promise within the oncology therapeutic space. Correlate empirical screening data with pre-clinical and clinical databases including TCGA, CTD2, LINCS, Metacore, Cortellis, Integrity as examples. Assist Data Science team to develop a standardized analysis approach for basic high volume prioritization along with more focused manual review efforts on high value compounds.

QUALIFICATIONS
A MD or PhD in a biological discipline with demonstrated expertise in cancer biology with 3+ years experience in a pre-clinical drug discovery environment. In-depth knowledge of the underlying etiology and pathophysiology of various diseases within Oncology or Hematology area as well as familiarity with both current treatments and novel drug targets is required. Has a strong industry insight and strong secondary research skills especially scientific literature, patent searches, and previous experience and comfort level with pre-clinical and clinical database mining and analysis. Experience analyzing and evaluating genomics data sets with a proficiency in statistical analysis is a bonus. Proficiency with modern programming language such as R or Matlab, or a desire to learn is a bonus. Strong communication skills and ability to present findings to all staff levels.

EOE/Minorities/Females/Protected Veterans/Disabilities

To apply for this position, please CLICK HERE

Research Assoc, Cell Culture

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The Broad Institute of MIT and Harvard is the world’s leading biomedical research institute dedicated to the bold mission of using the full power of genomics to transform the understanding and treatment of disease. The Broad Institute seeks to describe all of the molecular components of life and their connections; discover the molecular basis of major human diseases; develop effective new approaches to diagnostics and therapeutics; and disseminate discoveries, tools, methods, and data openly to the entire scientific community.

Founded in 2004 by Eric Lander and philanthropists Eli and Edythe L. Broad, the Broad Institute includes faculty, professional staff, and students from throughout the MIT and Harvard biomedical research communities and beyond, with collaborations spanning more than a hundred private and public institutions in more than 40 countries worldwide. The Genomic Perturbation Platform at Broad is currently looking for a Research Associate to work as part of a team to execute high-throughput lentiviral CRISPR/Cas9 screens, including lentivirus production and infection of cultured cells.

Responsibilities include:
- Cell culture and screening in a high-throughput facility.
- Manages lab resources with respect to equipment repair, ordering and organization.
- Executes high-throughput lentiviral RNAi screens in a high throughput and automation environment.
- Performs cell culture on up to 20 cell lines, and must be able to accurately monitor for contamination and cell line fidelity.
- Operates and maintains laboratory equipment to complete investigations.
- Prepares, orders, and maintains stocks of necessary reagents, solutions and supplies.
- Documents, compiles, and may analyze experimental data. Reports data to supervisor in oral and written reports.
- Attends team meetings for experimental planning.
- Maintains and improves technical knowledge base.
- Other related tasks as required.

A bachelor's degree in biochemistry/biology or related field. Excellent critical thinking skills and attention to detail required. Experience with mammalian cells and tissue culture required. Must be able to use sound judgment to effectively solve problems and work independently. Ability to handle a variety of tasks under biosafety level 2+ preferred. Experience in a high-throughput research environment and interest in automation are pluses.

*Off shift and weekend work is required in this roleThe Broad Institute will not offer visa sponsorship for this opportunity.EOE/Minorities/Females/Protected Veterans/Disabilities

To apply for this position, please CLICK HERE


Research Laboratory Technician I - Neurology

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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

PI92402069

Research Associate - Neurology

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GENERAL SUMMARY OF POSITION:

Under the direction of the Principal Investigator or designee, the Research Associate I performs a variety of complex research experiments.

 

 

MAJOR RESPONSIBILITIES:

  • Perform complex laboratory experiments
  • Conduct in-depth analysis of research experiments
  • Interpret data, form conclusions, and decide on and plan the next experiments to be done with a high degree of independence
  • Write standard operating procedures, schedule work, analyze data, maintain accurate records, and write reports
  • Compile and analyze data. Perform computations using image analysis software, spreadsheets, graphing, and curve fitting software
  • May modify protocols and be responsible for a single, independent research project
  • May assist with budget and/or operational aspects of grant and contract proposals
  • Assist in writing the text of scientific publications and grants. Review literature
  • Train new laboratory personnel, students, and collaborators
  • Comply with all safety and infection control standards
  • Perform other duties as required

 

 



REQUIRED QUALIFICATIONS:

  • Bachelor’s degree in the Biological Sciences, or equivalent experience
  • 1 year of relevant research experience
  • Knowledge of Microsoft Office products
  • Strong ability to analyze complex visual data in a quantitative and objective manner
  • Judgment and action skills required to solve commonly encountered problems

SUPERVISION RECEIVED:

Under the direction of the Principal Investigator, or designee

 

SUPERVISION EXERCISED:

May functionally supervise aides, technicians, and associates

 

ENVIRONMENTAL WORKING CONDITIONS:

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



Apply Here

PI92402038

Scientist

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My biopharmaceutical client located in the heart of the biotech hub is looking to add an experienced and talented scientist to their team.  If you are skilled in cellular and molecular biology, your experience can have a considerable impact on leading the development of new class drugs.

Requirements:

  • PhD at the Scientist level, or experienced MS at the Scientist level
  • Experience in cancer discovery biology
  • Able to perform assays concerning apoptosis, cell-death, viability ELISA, Western, etc.
  • Experience and willingness to train others

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™

Inside Sales Representative

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STEMCELL Technologies Inc. is a privately-owned biotechnology company based in Vancouver that helps power leading-edge life science research around the world. Scientists performing stem cell, immunology, cancer, regenerative medicine and cellular therapy research are among those who rely on our cell culture media, cell separation products, instruments, ancillary reagents and contract assay services. We create novel, useful, standardized products of unfailing quality and deliver them to more than 70 countries via our many regional offices plus distribution centres in Vancouver, Seattle, Grenoble and Singapore.  Driven by our love of science and our passion for quality, we see ourselves simply as “Scientists Helping Scientists” – standing by our customers to provide outstanding products, technical support and training.  We have over 700 science-oriented employees globally, including 250 PhDs/MScs, with most others holding a BSc or engineering degree.  STEMCELL is proud to be the largest Biotechnology employer in Canada.

Currently we have openings for Inside Sales Representatives who will be based in our Boston, MA office.  The main responsibilities as an Inside Sales Representative is to find, develop, and grow new business accounts in the cell separation and cell culture product sectors.  Secondary responsibilities include growing existing revenue streams, supporting Field Sales Representatives, and assisting with administrative tasks.

DUTIES AND RESPONSIBILITIES:

  • Surpass revenue targets in assigned territory.
  • Be a pro-active, contributing member of the territory team.
  • Contribute to short and long term territory business plans through in depth understanding of revenue streams and potentials.
  • Develop and execute strategies to identify and target potential new customers through effective market, revenue, and literature analysis.
  • Engage with potential new customers through cold calls and emails.
  • Establish and maintain strong relationships with customers through sound scientific expertise and business acumen.
  • Provide excellent customer service by following through with prompt solutions to all customer inquiries.
  • Effectively work and communicate with other STEMCELL departments such as technical support, marketing, customer service, and business operations.
  • Assist Field Sales Representatives in responding to customer needs as they arise.
  • Rigorously document communications and keep up to date the customer relationship management (CRM) database.
  • Contribute to team and departmental initiatives outside of day-to-day selling in your territory.

QUALIFICATIONS:

  • BSc, MSc or PhD in Biotechnology, Stem Cell Biology, Immunology, Molecular Biology, Cell Physiology, or a related scientific field.
  • Hands on experience in an academic or biotech laboratory setting.  Mammalian cell culture or cell separation experience is an asset.
  • Familiarity with a variety of sales concepts, practices, and procedures is an asset.
  • Excellent time management and organizational skills.
  • Highly motivated and capable of working effectively as part of a dynamic team.
  • Demonstrated track record of being pro-active and assertive in accomplishing goals.
  • Proven ability to think strategically and problem solve.
  • Desire to work in a dynamic and fast paced environment.

This is an opportunity to work with highly motivated colleagues in a science-oriented, creative and dynamic environment. We offer a competitive salary, excellent benefits and significant career development opportunities. If you are interested in this challenging and rewarding position, please apply through our careers website.

Research Associate, Microbial Engineering

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Propel Careers Job # 02-287

Description of Company:  Our client company microorganisms to produce bio-based products. They work with partners in therapeutics, nutrition, energy and specialty chemicals to improve existing strains and develop novel ones. Their technologies harness and accelerate evolution – enabling them to build and screen genomic designs in massive parallel – resulting in unprecedented efficiency in strain engineering.

 

Position Responsibilities

  • Design and build DNA (plasmids, genomic constructs, etc.)
  • Execute long-term genome engineering projects and screens
  • Handle complex protocols, assist in experimental design, data analysis, and be able to summarize findings into technical reports
  • Support other team members in the laboratory for process development operations
  • Maintain professional, scientific, and ethical integrity
  • Communicate effectively within the group and with other functional      groups in the company
  • Be an excellent team member and highly competent at working      collaboratively
  • Must be flexible and willing to work during off hours,  weekends as and when required

 

Candidate Requirements:

  • Molecular cloning and plasmid construction: Isothermal assembly, Golden gate, restriction-based and/or homologous recombination-based cloning.
  • Experience w/ Snapgene is a plus.
  • Hands-on experience building S. cerevisiae, E. coli, and/or other microbial strains.
  • A good understanding of microbial physiology and/or fermentation is a plus.
  • Well-organized, self-motivated, and a quick learner who is able to handle multiple projects simultaneously.
  • Minimum Bachelors in Molecular Biology, Biochemistry, Biotechnology, Bioengineering, Biochemical or Chemical Engineering. Masters degree preferred.
  • At least 2 years of industrial experience.

 

Propel Careers is a life science search and career development firm focused on connecting innovative, entrepreneurial companies with like-minded professionals.  While our primary service offering is job placement, the networking events, career guidance, and mentorship programs we offer ensure continuous growth and relationship development within our network.  Our mission is to enable the critical human resource connections required to advance the life science industry as a whole as well as the growth and advancement of the companies and individuals we work with. Our expansive industry contacts, knowledge and experience working in the life science industry set us apart from other firms & offerings.  Our team brings more than 40 years of collective experience working in a range of life sciences business, including start-ups, venture capital, and commercial organizations. As a result, we are able to act as a hub making critical connections between academic institutions, industry, investors, service providers and talent. To learn more, visit www.propelcareers.com.

Vice President Business Development

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Purpose

In the role of Vice President, Business Development you would be a vital member of the executive leadership team in achieving the Company’s long-term objectives.  You would champion all business development activities in seeking out, assessing and developing synergistic business expansion opportunities and commercialization strategies.   

Essential Functions

  • Support the General Counsel & SVP in leading development of corporate business development strategies and tactics; assesses potential opportunities, future market demand and market conditions, regulatory and governmental impact, internal capacities and more.  Develop financial models and formulates an effective strategic approach.
  • Provide expert counsel on industry issues including developments with competitors, emerging technologies, customers, regulators and financial markets.  Conduct in-depth research of emerging modalities, commercial and intellectual property intelligence.
  • Identify and cultivate relationships with potential alliance partners, collaborative marketing partners, industry leaders, and key opinion leaders that advance product offerings and revenues.
  • Collaborate with the General Counsel & SVP, CEO, Board of Directors and other executive leadership team members in developing criteria for evaluating the strategic and tactical fit of potential candidates.
  • Conduct exploratory assessments and negotiations of potential business development candidates, alliances, and agreements.   Lead virtual teams in conducting research, generates complex commercial and financial modeling, and identifies key risk factors.
  • Drive deals to successful closure with the Board of Directors and the prospective partner’s leadership team.  Negotiate agreements to obtain favorable terms and minimize risk.   Ensure deals are structured for success.
  • Actively demonstrates the Lantheus values of accountability, quality, efficiency, customer service, collaboration and safety.

  Typical Minimum Skills and Experience and Education

  • PhD or Masters degree preferred, Bachelors in Science degree or equivalent
  • 15+ years of progressive business development management experience in the Life Sciences industries.

Other Requirements

  • Experienced and active in external outreach with potential alliance partners, collaborative marketing partners, industry leaders and key opinion leaders
  • Good visionary skills in assessing future emerging modalities, medical practice changes, reimbursement and payer practices, commercial and intellectual property intelligence to formulate an effective strategic direction for the Company
  • Advanced commercial, product and financial assessment skills.   Experienced in developing models that appropriately capture potential upside and risk factors
  • Demonstrated skills in leading internal assessment teams and effectively collaborating with peers and cross functional teams to appropriately vet opportunities
  • Skilled at formulating formal assessments into concise formal proposals that clearly articulate both the opportunity and risks
  • Comfortable presenting/engaging at the highest levels of corporate structure; strong “executive presence”.  Ability to effectively pitch proposals to the Board of Directors and gain consent from the partner’s side.
  • Transformative, “change-agent” leader who has successfully driven change in key executive roles to date
  • Strong results orientation and demonstrated track record in successfully leading negotiating and closing deals with terms favorable to the company
  • Prior experience in diagnostic imaging is a plus.

Associate Director/Director, Compliance (15-95)

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The Position:

Reporting to the Senior Vice President and General Counsel, this position will be responsible for overseeing, managing, and directing elements of the compliance program for the organization. This includes identifying and mitigating identified and evolving risks, through the design and implementation of appropriate standards and controls such as policies, Standard Operating Procedures (SOPs) and other guidance, and the design and implementation of effective communication and training for those standards and controls.Maintain a culture of integrity by communicating about (a) the company’s philosophy regarding the importance of compliance to the enterprise, (b) how the enterprise compliance process works, and (c) logistics for reporting compliance issues internally).

Primary responsibilities include:

  • Develops, initiates, maintains, and revises policies and procedures for the general operation of the Compliance Program and its related activities to prevent illegal, unethical, or improper conduct. Manages day-to-day operation of the Program.
  • Collaborates with other departments (e.g., Legal, Human Resources, Regulatory, etc.) to direct compliance issues to appropriate existing channels for investigation and resolution. Responds to alleged violations of rules, regulations, policies, procedures, and Code of Conduct by evaluating or recommending the initiation of investigative procedures. Develops and oversees a system for uniform handling of such violations.
  • Monitors, audits, and as necessary, coordinates compliance activities of other departments to remain abreast of the status of all compliance activities and to identify trends.
  • Identifies potential areas of compliance vulnerability and risk; develops/implements corrective action plans for resolution of problematic issues, and provides general guidance on how to avoid or deal with similar situations in the future.
  • Ensures proper reporting of violations or potential violations to duly authorized enforcement agencies as appropriate and/or required.
  • Works with the business to develop an effective compliance training program, including appropriate introductory training for new employees as well as ongoing training for all employees and managers.
  • Evaluates the performance of the Compliance Program and relates activities on a continuing basis, taking appropriate steps to improve its effectiveness.

Education and Skills Requirements:

  • Bachelor’s degree required; Master’s desired.
  • A minimum of 5-10 years’ experience in a healthcare organization, to include healthcare compliance experience. Familiarity with operational, financial, quality assurance, and human resource procedures and regulations is a must.
  • This individual will have substantial experience with a reputable pharmaceutical or medical device company, or played a high impact role within one of the large government agencies.
  • US Compliance experience is a must and Global Compliance experience is a plus
  • Proven ability to develop implement, audit and monitor policies, projects, processes, systems and controls across an organization

People management experience/skills:

  • Ability to work and influence cross-functionally, at all levels of the organization
  • Strong prioritization skills and the ability to effectively manage multiple tasks and priorities
  • Outstanding written and oral communication skills, especially with senior management
  • Superior ability to lead change with global, cross-functional teams

Associate Director, Patient Services (15-96)

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Primary Role:

The Associate Director Patient Services will work closely with the Director of Patient Services to develop and implement patient services for the launch of Eteplirsen. Tasks will include developing the case management process and partnering with vendor partners (hub, specialty infusion pharmacies, co-pay vendors) to implement services. The AD Patient Services will participate in building the case manager team and will develop and lead case manager training. The AD Patient Services will work closely with the Case Managers to troubleshoot issues and remove barriers to accessing therapy.

Key Responsibilities:

  • Implement the Patient Services Model, including; reimbursement hotline, patient assistance program and co-pay assistance programs
  • Develop and lead case manager on-boarding process and training program. Coordinate with Training Manager to incorporate existing training materials in the program
  • Coordinate with marketing to develop and maintain patient service materials, forms, talking points and other related materials
  • Participate in the development, testing and implementation of the Patient CRM system. Work with software vendor to implement the data feeds from service providers. Monitor ongoing operations of the data feeds and resolve issues
  • Manage daily operations of the service model. Partner with hub vendor and specialty pharmacy partners to troubleshoot issues and manage daily operations of the program. Hold regular meetings with vendors to trouble shoot issues and recommend areas of improvements
  • Partner with regional sales managers to educate the sales team regarding patient services. Lead training sessions with sales reps on all aspects of patient services program
  • Act in complete & total compliance with all laws, regulations and Sarepta policies

Qualifications

  • Bachelor’s Degree (general business, health sciences, public policy or other related degrees)
  • 5-7 years of patient services and healthcare experience including launch experience
  • Patient focused and emotionally resilient
  • Vendor management experience (hub providers and specialty pharmacies)
  • Strong reimbursement background and experience
  • Leadership experience
  • Detail orientated and highly organized
  • Ability to multi-task in a fast paced environment
  • Strong listening, verbal and written communications skills
  • Team orientated with a willingness to collaborate

Research Associate (temp to perm)

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Research Associate

Alcresta is a specialty pharmaceutical company that is developing innovative, point-of-care, and proprietary enzyme-based products for people suffering from compromised pancreatic function, such as exocrine pancreatic insufficiency (EPI) or nutrient malabsorption.  Alcresta’s core capabilities include expertise in adult and pediatric nutrition, as well as protein manufacturing expertise and regulatory experience that support the development and commercialization of its programs. The company’s platform is supported by the Alcresta team’s proven success in developing protein therapeutics.

 

JOB DESCRIPTION

 The Research Associate will contribute to all aspects of research and development of Alcresta’s products.

 Key responsibilities / activities:

  • Characterization and optimization of existing products
  • Contribute ideas to new product and research teams
  • Execute plate based assays, HPLC analyses, GC, titration assays, viscometry, enzyme immobilization, microscopy and product specific use tests
  • Cross functional collaboration with manufacturing, engineering, marketing and quality groups
  • Provide support for ordering supplies, instrument maintenance, and calibration schedules
    • Write test methods and document results in technical reports
    • Communicate data and results in team meetings

 

SKILLS AND COMPETENCIES

  •  Highly motivated, flexible and enjoy working in a team-based environment with a strong interest in contributing to the research and development of new products
  • Strong team player, results-oriented, willingness to work in a start-up environment, including a “roll-up-the-sleeves” attitude to perform diverse tasks necessary (and multi-tasking) to achieve objectives
  • Prior experience in biotechnology, pharmaceutical or medical device industries is a plus.
  • Experience working with food products is a plus
  • Strong analytical, quantitative and technical writing skills
  • Good working knowledge of Microsoft Office tools (Outlook, Word, Excel, PowerPoint, etc.)
  • Strong attention to detail.

 

EDUCATIONAL BACKGROUND

  • B.S/M.S. in biochemistry, biology, chemistry or equivalent.

 LOCATION

  • Natick, MA (primary)
  • Newton, MA

 

COMPENSATION

  • Hours and salary commensurate with experience, level of education, and competitiveness with market

 

Belfer Scientist (in vivo)

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Job ID: 25057
Date Posted: 09/03/2015
Location: Building HIM
Job Family: Laboratory/Research
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

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.

The Belfer Institute is dedicated to the discovery of cancer mechanisms essential for tumor maintenance, and translating basic discoveries into new effective therapies for cancer. The integration of basic research and drug discovery programs at the Belfer Institute has provided Dana-Farber with a unique opportunity to convert critical basic discoveries in the laboratory into novel targeted therapies that may prolong the lives of cancer patients. This highly integrated goal-oriented organization represents a new academic construct that provides an unprecedented opportunity to change the way anti-cancer therapeutics are discovered and developed. For more information please visit: http://belferinstitute.dfci.harvard.eduJob

Job Responsibilities

We are seeking a highly motivated in vivo pharmacologist to join the Cancer Biology and Pharmacology team at the Belfer Instituteto provide strong leadership, scientific and technical expertise for both internal and alliance partner driven in vivo studies. The candidate will independently design, execute and interpret in vivo studies to support target validation, drug discovery, biomarker and rationale supported combination studies to support Belfer portfolio. His/ her responsibilities include, but not limited to:

  • Oversee development and utilization of well characterized mouse cancer model platforms including xenografts, orthotopic, patient derived models and GEMMs.
  • Oversee design and execution of in vivo target validation, PK/PD, proof of mechanism and proof of concept in vivo studies, single agent and combination efficacy studies.
  • Determine patient response and pharmacodynamic biomarker response using various molecular and cellular biology techniques.
  • Act as a scientific leader in corporate partner collaborations.
  • Lead & coordinate multi-laboratory collaboration projects
  • Optimize results through collaborations with Dana-Farber Centers and scientists and work well with cross disciplinary teams.

• Mentor and manage a group of scientists to deliver innovative and timely results.

Job Qualifications

The ideal candidate will be collaborative, self-directed, results oriented and possess the following:

  • Ph.D. in biology or related field with 3+ years’ experience post-PhD
  • A strong understanding of in vivo models utilized in drug discovery & superior scientific & technical skills in in vivo pharmacology, including PK/PD/efficacy studies
  • A strong understanding of oncology biology, signal transduction, and emerging preclinical/clinical drug research
  • Experience identifying effective combination therapies in preclinical in vivo oncology models
  • Direct experience in target identification and validation for drug discovery
  • Experience in preparing data packages for IND filings is a plus.
  • Experience in advancing drug discovery programs through collaborations with external partners
  • Outstanding communication, organizational and leadership skills, with a successful publication track record





Schedule

Monday-Friday 8am-5pm evenings/wknds as needed



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 Affirmative Action/Equal Opportunity Employer - committed to diversity and inclusion in our workforce.




Apply Here

PI92410925

Senior Associate / Associate, Strategic Alliances

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Foundation Medicine is actively seeking a (Senior) Associate, Strategic Alliances to provide comprehensive operational and tactical support for the company’s pharmaceutical alliances. The candidate will be responsible for implementing, and monitoring the execution plans for each of our pharmaceutical relationships, including day to day project management, project tracking and resource management. The individual is expected to work primarily with internal and to some extent external resources to manage timelines, resource plans, critical path activities and risks.

  • Assists with management of the day-to-day operational and tactical aspects of our pharmaceutical customers
  • Ensures that appropriate progress is being made against defined strategies; proactively identifies and raises issues and provides recommendations for resolutions.
  • Regularly and proactively considers challenge points and opportunities for acceleration, and communicates to the stake holders.
  • Creates team agendas and documents meeting minutes.
  • Applies project management tools and techniques to support the establishment of detailed operational plans in alignment with program development strategies.
  • Supports collaboration with team members and assists in building presentations to support recommended courses of action.
  • Ensures appropriate follow-up of all team members in the execution of tactical objectives and escalates issues to the appropriate parties.



  • BS in a business or scientific discipline.
  • (Associate) 1+ year professional experience in the biopharmaceutical or diagnostic industry or a comparable position in clinical trials, regulatory affairs in an academic cancer center.
  • (Senior Associate) 2-3 years professional experience in the biopharmaceutical or diagnostic industry or a comparable position in clinical trials, regulatory affairs in an academic cancer center.
  • Confident, proactive individual capable of taking the initiative and driving to results.
  • Strong organizational skills in order to maintain a high level of productivity innovation, and setting priorities in order to complete assignments in a timely manner and within budget.
  • Demonstrated evidence of success working in a cross-functional environment; able to build strong relationships
  • Exhibits high initiative, strong drive and follow-through.
  • Competency in MS Office; expert in MS Project.



Apply Here

PI92420227

Build QA Validation function at an exciting company!

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Opportunity to help build the QA Validation function at local A-list, mid-size, public company.  Based in the Kendall Square neighborhood of Cambridge, a short walk away from the Red Line.  

Rapidly growing company with exciting and innovative therapeutic programs in preclinical and clinical development.  

The main function of this role is to establish validation/qualification programs and guide/provide technical review of protocols and reports (for equipment, test methods, computer systems, tech transfers, process validation, and shipping validation).

Responsibilities include but are not limited to;
•  Implementation of strategies for characterization and validation studies
•  Develop, review and report on internal audit and audits of external CMOs/partners
•  Author risk assessments and validation documentation 
•  Provide QA and Validation support to CMC and Tech Transfer teams
•  Review of deviations and investigations for equipment and validated processes
•  Development of process validation requirements for new product introductions through commercial scale.

Formal descriptions can be supplied for interested candidates. 

Qualified candidates will have a BS or MS degree in a Life Science or Engineering related field and 7+ years of experience.  Must also have varied experience around process validation, cleaning validation, method validation, shipping/cold chain storage, computer systems, and utility systems/equipment.  Must have strong GMP experience and knowledge of ICH Q7, Q8, Q9, Q10 guidelines.

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

All resumes will be kept strictly confidential until you choose to pursue a specific opportunity with one of our clients.

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