Job Title: Pharmacovigilance (PV) Scientist

Job Location: Waltham, MA

Description:

The PV Scientist represents a key position in Pharmacovigilance/Drug Safety and is responsible for providing functional area day-to-day oversight and hands-on participation for programs currently in both Post Marketing (PM) and clinical development settings. This cross-functional role includes active involvement on and timely contributions to Investigator Sponsored Trials (IST), PM teams, oversight of the daily PM PV operational aspects of safety monitoring, assurance of timely preparation and submission of individual regulatory safety reports, assistance in aggregate report generation, periodic compilation and review of safety data and other PV operational support, as needed.

This position requires an educational and clinical background in Health Care, preferably in oncology and specific experience in both PM and clinical trial Pharmacovigilance within a pharmaceutical/biotechnology company. Additionally, the candidate must be able to clearly communicate good PV practices and standards both in writing and verbally, including the proven ability to present complex clinical/safety scenarios in a clear, concise, logical and medically sound manner. The candidate must possess the ability to review information and provide timely feedback on next steps, function in a team environment, deliver on timelines and have a detailed knowledge of the activities and procedures involved in PV operations. This position will report directly to the Sr. Dir. Pharmacovigilance/Drug Safety.

The PV Scientist is responsible for ensuring accuracy and completeness of PM safety reports received by vendor/vendor oversight; compilation of data for aggregate reports and signal detection; maintenance of PV inspection readiness; and compliance to regulatory reporting obligations.

Responsibilities:

• Management of Pharmacovigilance operational activities with regard to post marketing case processing and reporting. Includes management of Contract Research Organization safety staff as appropriate to ensure that safety-related project milestones are met within required timelines.
• Oversee PM case completion to ensure relevant event information, data entry and maintenance of cases in safety database, development of safety data collection forms and tracking reports, reconciliations of serious adverse events between the safety and PM call center databases, and summarization of PM cases for regulatory authorities and business partners.
• As needed, assist with the coordination of preparation of data for safety review committees including, relevant cumulative listings/tables, product profile and case summaries, and analyses based upon safety review committee recommendations.
• Maintain up to date knowledge with regard to current and proposed changes to domestic and international safety reporting requirements. Provides insight into operational changes required to meet current and future regulatory obligations.
• Contribute to development of standard operating procedures for PM safety surveillance processes (e.g., creation of Safety Master File, etc.)
• Maintenance of safety files and documentation that are compatible with the departmental and corporate document management system.
• Function as a Product Safety representative at product team meetings as appropriate.
• Contribute to timely and accurate communications with other parts of the organization regarding expedited safety reports and compliance.
• Assist in preparation of aggregate reports (e.g. DSUR) including running of listings and authoring document.
• Maintain and evaluate Product Safety metrics including running of metric reports, creating summaries of metrics, identify any possible issues and creating an action plan.
• Provide quality review of documents, as necessary.
• Collaborate with clinical and data management in the coding of adverse events, medications and medical history in the clinical database.

Abilities:

• Strong technical/analytical skills to identify and solve problems.
• Self-motivated, assertive, and self-confident with the ability to act with urgency and passion.
• Proven ability to work with a high level of integrity, accuracy, and attention to detail.
• Strong organizational skills in order to maintain a high level of productivity, innovation, and priority-setting in order to complete assignments on-time and on-budget.
• Excellent oral and written communication skills for effectively interfacing with all levels of management and departments within the company.
• Willingness to work collaboratively by incorporating diverse perspectives and appropriately managing relationships in order to strength decision-making.
• Ability to manage several high-priority activities within required timelines.
• Ability to manage processes to meet departmental and corporate objectives.
• Ability to work independently with minimal supervision, but seek appropriate involvement from senior management regarding complex issues within and beyond position scope.
• Solid knowledge of applicable domestic and international safety reporting requirements. 

Job Requirements:

• Nursing, Pharmacy or equivalent degree preferred.
• At least 10 years of drug safety experience which includes both PM and CT surveillance.
• Excellent oral and written communication skills – ability to effectively represent Drug Safety in meetings and interact with managers in other departments to complete tasks and resolve issues; experience with medical writing and summarization of clinical safety information is required.
• Experience with post marketing reporting requirements (aggregate and ICSR). Experience managing external vendors.
• Intermediate computer skills including word processing and safety database management.
• ARISg experience, a plus.
• Comprehensive knowledge of medical and oncology terminology, a plus.

Grant Writer (part-time)

ALS Therapy Development Institute has an immediate opening for a part-time (approx. 20 hours per week) Grant Writer who will be responsible for conducting the full range of activities required to prepare, submit, and manage grant proposals to foundation and corporate sources on behalf of ALS Therapy Development Institute.

Major Responsibilities:

• Compile, write, and edit all grant applications exhibiting strong expository writing skills and a high-level command of grammar and spelling
• Research grant-making organizations and analyze them to identify likely funding sources for The Institute
• Develop individual grant proposals in accordance with each grant-making organization's preferences and follow exactly each grant-making organization's guidelines
• Keep in contact with grant-making organizations during their review of a submitted grant application in order to be able to supply additional supportive material
• Maintain current records in database and in paper files, including grant tracking and reporting
• Prepare reports and proposals in a complete and timely manner
• Research new government and foundation funding opportunities
• Establish professional relationships with foundations and corporate contacts for potential funding opportunities
• Develop a Grant Planning Calendar and review process of proposals; track funding proposal deadlines for follow-up

Knowledge and Skills:

• Bachelor's degree or higher in English, Journalism or related field
• 3-5 years of grant writing/fund raising experience in Life Sciences, Biotech or Non-profit arena
• Strong oral & written communication skills; ability to write clear, structured, articulate, and persuasive proposals.
• Strong organizational skills and attention to detail
• Diplomatic team player with the ability to manage multiple tasks simultaneously
• Project management skills
• Technical experience required in Excel, MS Word and PowerPoint
• Knowledge of fundraising information sources

About ALS TDI
The ALS Therapy Development Institute (ALS.net) and its scientists actively discover and develop treatments for ALS. ALS.net is the world's first and largest nonprofit biotech focused 100% on ALS research. Led by ALS patients and their families, the charity understands the urgent need to slow and stop this horrible disease. ALS.net, based in Cambridge, MA, has served as one of the leaders in sharing data and information with academic and ALS research organizations, patients and their families. For more information, visit www.als.net.

To Apply
Please visit http://als.applicantpro.com to apply.  No phone calls please.

ALS TDI is an equal opportunity employer.

Job Title: Clinical Project Leader

Job Description:

Responsible for the overall adequacy of conduct, data quality, compliance and adherence to timelines for their assigned trial(s).

Interface with corporate CTOMs, CRA Team, MAs and CSDs for operational input for feasibility, trial design/methodology, standard medical practice and data capture

Develop and manage the trial budget. Overall responsibility for negotiation of financial aspects of clinical trial.

Collaborate with medical function in the safety evaluation of study subjects in ongoing trials.

Ensure all aspects of study site management i.e. recruitment of qualified investigators, site initiations, conduct investigator meetings, ensure enrollment criteria are met and other aspects of the study management as appropriate.

Responsible for mentoring and team cohesion. CPL mentoring as needed

Facilitate development of study tools and appropriate tracking systems for coordination of trials, grants, enrollment status and clinical supplies. Ensures adherence to contractual obligations of local vendor relative to the service provided, as appropriate. Contribute to operational details in specifications for local vendor contracts, as needed.

This position can be remote based.

Basic Qualifications:

Bachelor’s degree and 8+ years of clinical research experience; 1-2 years of field monitoring experience; prior demonstration of an ability to manage people and projects.

Working knowledge of clinical study development, FDA regulations and ICH/GCP guidelines.

Operational planning experience.

Excellent interpersonal and communication skills (verbal and written), including proficiency in medical terminology.

Professional demeanor with ability to interact effectively with scientists and managers from multiple disciplines; serves to provide internal operational expertise on assigned area and liaise with external organizations specific to clinical trial.

Strong organizational and time management skills. Self-motivation and attention to detail.

#LI-SA

Company:  121Bio LLC

Job Description:

We seek an innovative scientist with hands-on experience in protein chemistry and/or antibody engineering to join the Discovery Team. The successful candidate will lead the company’s single-domain antibody discovery efforts with initial focus on its application in oncology PET imaging.

Primary R&D activities and responsibilities include:

• Working within a collaborative and multidisciplinary team with core competencies in bacterial protein production, purification, bioconjugation, cell biology, immunology and flow cytometry.
• Advancing the company’s key technology platforms into commercial products.
• Playing a leading role in the experimental design, planning, generation, evaluation and validation of single-domain antibody-based scaffolds and derivatives specifically tailored for oncology imaging applications.
• Analyzing experimental data from protein engineering projects and proposing and implementing technical, methodological and conceptual improvements.
• Providing creative solutions to advance project goals and foster innovation.
• Functioning as an independent expert and resource on advanced theory and current developments in the field of protein chemistry, and providing technical leadership and mentorship to the Discovery Team.
• Collaborating across internal R&D teams, and with external academic and industry partners, to test and utilize the antibody-based scaffolds and derivatives, and develop new products and applications.

Qualifications and experience:

• Ph.D. in biochemistry, molecular biology, immunology, biotechnology or biomedical engineering with 2+ years of postdoctoral research, and/or 2+ years industrial experience.

• Demonstrated leadership and independent scientific productivity, rigor and excellence as evidenced by publications in peer-reviewed journals, patents and pipeline contributions.
• A strong understanding of immunobiology, biotherapeutics, enzymology, and protein engineering with expert knowledge in protein characterization assays.
• Outcome-oriented with attention to details, effective organizational skills and the ability to interface constructively with other members of the R&D team, external partners, and customers to drive multiple projects and timelines within a rapidly changing start-up environment.
• Expertise with the development of non-native antibody architectures, and/or humanization of antibodies is considered a plus.
• Expertise in synthetic organic chemistry is considered a plus.        

• Proficiency in current molecular biology techniques, standard protein chemistry and purification protocols, with a track record of antibody screening, and characterization particularly in prokaryotic systems in a pharmaceutical or biotechnology setting.

Regulatory Compliance Officer-1

In the liable business area pertaining to compliance monitoring of timelines for processing/regulatory reporting of safety reports, the primary function of the Regulatory Compliance Officer's (RCO) role is to :
• Contribute to the development, production and maintenance of the appropriate tracking and compliance tools, reports, plans, tasks and activities pertaining to the management of the GPE compliance management system.
• Perform investigation of deviations and monitoring of Corrective actions &
preventive actions (CAPA) relating to non compliance issues and findings and propose appropriate long-term strategies to line management.
• Perform compliance analysis and Contribute to development, production and maintenance of adequate reporting methods to the hierarchy to detect and monitor any significant compliance deviations to the company quality standards and/or regulatory requirements
• Track and communicate on compliance Ensure tasks and activities are performed according to the work instructions, procedures and Policies in place.
• Contributes as an author or a reviewer to GPE Quality Documents developed within the Company and relating to compliance monitoring.
• Interface with internal and external stakeholders and ensure that the appropriate contact points are established with the other groups (within Quality, Training & Compliance or outside) to respond and address gaps or compliance issues that need resolution by team specialists.
• Support Affiliates on compliance matters as required
• Support the conduct of PV audits/regulatory inspections
• Participate to the Development of compliance programs and quality tools to enhance GPE global quality and adherence to SOPS and Regulations.
• Escalate issues / problems to management

MAJOR DUTIES & RESPONSIBILITIES

1. In the liable business area pertaining to compliance monitoring of timelines for processing/regulatory reporting of safety reports:
- Ensure the development of methodology and tools for compliance monitoring (proactive and retrospective monitoring of individual and periodic report timelines). This ensures implementation of the most appropriate compliance programs & tools locally or globally.
- Develop Compliance Plans and Continuous Improvement Tools to measure Compliance.
- Ensure compliance with pharmacovigilance regulatory requirements and internal quality documents (Directives, OQS, SOP)
2. Conduct compliance activities and tasks:
- Run compliance investigations and Root Cause Analysis, jointly with affiliates, GPE stakeholders or external partner,
- Monitor GPE/affiliates Performance
- Identify Trend
- Participate to the remediation of compliance gaps in collaboration with stakeholders owning the corrective and preventive actions (CAPA)
- Follow up on CAPA taken by stakeholders
- Maintain metrics and KPIs for relevant business functions.
- Analyze data for improvement proposals
- Document compliance assessment
- Maintain the repository of investigations
- Perform periodic compliance analysis and reports according to the instructions in place
-Develop appropriate auditable documentation (i.e. SOP, work instructions, and related training)
3. Contribute to the development / improvement of new/existing tools used in compliance to ensure company compliance with regulations and internal business processes, appropriate reporting to the hierarchy for resolution of compliance gaps and related business issues, inspections or internal audits readiness, adequate level of quality in compliance.
4. Contribute to regular compliance meetings for review of late submitted cases), associated root causes and implementation of appropriate CAPA in presence of stakeholders (CAPA owners), GPE MT members and GPE Head.
- Ensure regular compliance oversight of the PV network (local PV units)
- participate to the partner compliance review meeting
- prepare and track related minutes

5. Track and document CAPA resulting from compliance monitoring and provide compliance analysis to ensure a complete documentation and monitoring of compliance findings and respond during inspections and audits when required

Basic Qualifications
-Bachelors Degree and 5+ years with at least two years experience in Pharmacovigilance/Pharmaceutical environment and safety in an international environment.
-In depth understanding of international pharmacovigilance requirements/updates in particular EU/FDA requirements/international guidelines, e.g. ICH/CIOMS, Clinical development methodology and knowledge of Clinical Trial guidelines (GCP) and regulation

-Can be based in Waltham, MA or Bridgewater, NJ

#LI-SA

OVERALL RESPONSIBILITY
The Senior Science Writer must employ excellent research and writing skills to tell the story of the Broad Institute on a variety of media platforms. Responsible for researching, reporting, and writing science stories, blog posts, and other communications about the Broad’s scientific programs, events, staff, and research as needed, for diverse audiences. Works with digital imaging specialists and visual designers on content for multimedia communications. Represents the Broad at internal and external functions as assigned.

RESPONSIBILITIES
- Write stories as assigned about news, research, and events related to the Broad as assigned
- Plan and write long-form enterprise stories that showcase different aspects of the Broad and drive publication across multimedia platforms
- Drive internal communications strategies, using multimedia platforms to help administrative and scientific groups craft messages, events, and publicity campaigns
- Act as an internal connector, establishing relationships across programs, platforms, administrative groups, and affiliated researchers that help feed a steady stream of information to all our communication channels
- Analyze and interpret scientific papers and write clear, compelling, and accurate stories - meeting specified deadlines - for multiple audiencesDirect the work of other writers, digital imaging specialists, and visual designers as required
- Edit and copy edit content as needed
- Other communications duties as required

QUALIFICATIONS
- Bachelor’s degree in science, or in communications/journalism with a minimum of 5 years of science writing experience
- Excellent writing, editing, proofreading, and verbal communications skills
- Must be able to translate difficult science concepts for multiple audiences
- Must be adept at gathering information through interviewsFamiliarity with publication on social media platforms
- Comfortable in a highly visible role, with the ability to interact professionally with all levels of employees
- Must be flexible and able to drive deadline-driven projects to completion
- Must be able to work independently and as part of a team

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

EOE/Minorities/Females/Protected Veterans/Disabilities

To apply for this position, please CLICK HERE

OBJECTIVES:

The Clinical Scientist represents and may lead clinical science on the regional (US) clinical development of assigned Takeda pipeline compounds. Leads a multi-disciplinary, , matrix team ensuring that scientific issues are appropriately considered with respect to highly complex data findings. This individual has the responsibility for influencing the creation, maintenance, and execution of a clinical development plan that will result in the regulatory approval of the compound in multiple regions.

ACCOUNTABILITIES:

Clinical Development team participation and leadership:
• Represents Clinical Science on US/EU Development Teams and may serve as leader of this team. Supports the Global Development Team (US, EU, Japan) to ensure that the US/EU Development Team activities are aligned with the global strategy.
• Responsible deliverables producing the Development Strategy, with significant contributions to assign sections of the Clinical Development Plan and Clinical Protocols.
• Participates in recommending scope, complexity and size, and influence the budget of all aspects of a program.
• Provides continual critical evaluation of the development strategy to maintain a state-of-the-art development plan that is competitive and consistent with the latest regulatory requirements, proactive identification of challenges, and development of contingency plans to meet them for those areas assigned.
• Contributes to high impact global decisions: monitoring and interpreting data from ongoing internal and external studies and making recommendations that impact regional and global development such as “go/no go” decisions or modification of development plans or study designs that may have a significant impact on timelines or product labeling.

Synopsis / Protocol Development, Study Execution, & Study Interpretation:
• Assumes primary responsibility for the completion of protocol synopsis, obtaining scientific and corporate review committee approval including presentation and defense of the Synopses during review committee meetings, review and approval of documents related to study Protocols (e.g. Statistical Analysis Plans and Safety Management Plans) for assigned sections. Provides scientific contributions and overall content approval of written responses required by IRB / Ethics Committees and critical study training meetings (e.g. Investigator Meetings). Responsible for review of study data, interpretation of results and communication of study conclusions within the company for assigned sections.
Trial Medical Monitoring:
• Manages collection of necessary information to assess issues relating to protocol conduct and/or individual subject safety. Provides preliminary assessments to Medical Monitor for review and approval.
• Reviews and assesses overall safety information in conjunction with Pharmacovigilance and Medical Monitor of record.

External Interactions:
• Successfully contributes to interactions with regulatory authorities / agencies and key opinion leaders relevant to assigned compound and participate in meetings with representatives of the regulatory organizations and the identification / contact / maintenance of strong Company relationships with key opinion leaders. Influences establishment of strategy for the compound, and the development of documents required to outline the Company positions on research programs or regulatory applications (e.g. briefing reports), materials used for meeting presentations, and formal responses to communications received by the Company. Responsible for successful incorporation of advice / recommendations received from organizations or specialists into the design of clinical studies / programs as appropriate.

Leadership, Task Force Participation, Upper Management Accountability:
• Interacts directly with research division based on pertinent clinical and development expertise to provide knowledge / understanding of market environment in line with status as Development scientific content matter expert for assigned compounds. May represent clinical science on internal task forces. May lead internal teams as appropriate.

Please note that the requirements specified in this posting are the basic qualifications required for the Clinical Scientist; however, job title will be dependent on the candidate’s level of experience in those requirements.

EDUCATION, EXPERIENCE, KNOWLEDGE AND SKILLS:
• Bachelor’s degree and 9 years of clinical research and/or clinical development experience within the pharmaceutical industry, CRO health-related consulting company, or biomedical/clinical experience within academia (or a combination of afore mentioned.)
• Master’s degree and 7 years of clinical research and/or clinical development experience within the pharmaceutical industry, CRO health-related consulting company, or biomedical/clinical experience within academia (or a combination of afore mentioned.)
• PharmD degree and 6 years of clinical research and/or clinical development experience within the pharmaceutical industry, CRO health-related consulting company, or biomedical/clinical experience within academia (or a combination of afore mentioned.)
• PhD and 5 years of clinical research and/or clinical development experience within the pharmaceutical industry, CRO health-related consulting company, or biomedical/clinical experience within academia (or a combination of afore mentioned.)
Skills:
• Superior communication, strategic, interpersonal and negotiating skills
• Ability to proactively predict issues and solve problems
• Ability to drive decision-making within a multi-disciplinary, multi-regional, matrix team
• Diplomacy and positive influencing abilities

Knowledge:
• Therapeutic area knowledge relevant to mechanism of action
• Regional/global Regulatory requirements
• GCP/ICH
• Emerging research in designated therapeutic area

TRAVEL REQUIREMENTS:
• Willingness to travel to various meetings or client sites, including overnight trips. Some international travel may be required.
• Requires approximately 10-20 % travel.

Job ID: 27262
Date Posted: 10/21/2015
Location: Mayer
Job Family: Technician/Technologist
Full/Part Time: Full-Time
Regular/Temporary: Regular
About Dana-Farber

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

Overview

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

Our Core Values are:

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

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

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

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

Job Description

Description:

The Anderson lab is working on cancer immunotherapy. We are seeking a highly-motivated Research Technician who will be responsible for tissue culture work, in vitro cells analysis and assisting lab work. Primary responsibility includes performing immunology related various assays, analyzing patients’ samples run, and assisting with other lab tasks as needed. This involves the skill to work in sterile condition, freezing and thawing cell lines and primary cells, preparation of cells and experiments for screening and validating novel biologically-based drugs by standard cytotoxicity tests, proliferation status and flow cytometry. Additional responsibilities include processing patient peripheral blood and bone marrow samples. The successful candidate will be very organized, a team player, and able to work flexible hours in order to accommodate experimental needs.

Requirements:

A minimum of a Bachelors Degree or Master Degree is required, preferably in the Immunology or Biological Science. At least 1 year of lab work experience after the degree is required . Experience in flow cytometry and analysis (DIVA, FLOWJO) is preferred. The ideal candidate will be motivated, detailed, goal-oriented and possess excellent organizational, communication, and analytical skills.

Schedule

M-F schedule

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

PI92140627

Foundation Medicine is dedicated to helping bring personalized cancer medicine into routine clinical practice. Harnessing advanced technology, Foundation Medicine has developed clinical laboratory tests that broadly capture the most relevant tumor genomic and other molecular information and connect it with relevant scientific and medical knowledge to help oncologists determine the right treatment for each patient. This is a diverse, fast-paced, team oriented environment integrating laboratory science, cancer genetics and genomics, process data metrics and clinical data.

Candidates should be a strong communicator, confident with multi-tasking, and attentive to details. This position’s primary focus will be the supervision and leadership of two unique teams: Histo-Pathology and DNA/RNA Extraction. The position will be responsible for all aspects of the operation of a highly complex clinical diagnostic laboratory that meets CLIA, CAP, and NYS regulatory requirements. The Manager will also work directly with R&D, IT, and Commercial teams to implement process improvements and operationalize additions to FMI’s testing portfolio including, but not limited to, circulating tumor DNA and FDA regulated assays.

• Demonstrate commitment to quality and continuous improvement
• Review and write SOPs as needed
• Train new team members
• Scheduling of team members
• Collect and track personnel performance metrics
• Be a trusted team member; be considered as a “go-to” person to field questions
• Perform complex testing according to established SOPs
• Ensure performance of daily, weekly, monthly and as needed equipment maintenance checks
• Lead the team in reagent and assay quality control and validations as needed
• Flexibility to cover scheduling gaps as needed and to be included in the on-call rotation for additional weekend and/or holiday technical support.

Required Skills and Experience

• Previous team management experience
• Experience working in a regulated laboratory environment (CLIA/CAP)
• Extensive knowledge of laboratory safety protocols
• Previous experience with nucleic acid extraction from FFPE and/or experience with a histology lab handling and preparing a diverse array of tissue and specimen types
• Familiarity with high through-put platforms and common molecular laboratory equipment (pipettes, thermocyclers, liquid handlers, etc.)
• Experience with Laboratory Information Management System (LIMS)
• Experience with ensuring and maintaining integrity and quality of the lab (sample processing, equipment, SOPs)
• Proficiency utilizing Microsoft Office Suite

Education or Experience

• BS in a Biological or Life Science + 7 years or MS + 5 years of relevant experience in a CLIA/CAP lab
• Qualifies as a Technical Supervisor according to CAP/NYS regulations
• QSR compliant lab experience preferred but not required

Apply Here

PI92148665

Foundation Medicine is leading a transformation in cancer care, where each patient’s treatment is informed by a deep understanding of the molecular changes that contribute to their disease.

The QA team at Foundation Medicine works collaboratively with groups throughout the organization to ensure compliance with regulatory requirements and support a diverse array of projects and initiatives. This is a unique opportunity to contribute to QA activities across multiple quality system requirements (CLIA/CAP and FDA regulated environments).

The QA Specialist role requires strong regulatory knowledge and the ability to deliver results on schedule in a fast-paced and dynamic environment. Candidates must be detail-oriented with excellent organizational skills, able to assess new challenges and prioritize accordingly.

Located in the heart of Cambridge, MA—the world’s preeminent biotechnology hub—Foundation Medicine offers competitive salaries, generous benefits and ample opportunities for professional growth.

Primary Responsibilities and Essential Duties

• Support and work in tandem with the clinical laboratory team to maintain continuous compliance with regulatory requirements.

• Perform routine internal audits of procedures, policies, records, and laboratory facilities. Report findings and track follow-up actions.

• Review batch records, reagent QC, and other process documentation.

• Assist in review and handling of complaints, incidents and deviations.

• Demonstrate strong proficiency in the application of the Corrective And Preventive Action (CAPA) system.

• Prepare and submit renewal applications and change notifications to state and professional agencies as required to maintain and/or update licensure status.

• Ensure that equipment and instruments are properly maintained, cleaned and inspected on a routine basis per SOPs and CLIA and FDA/GLP standards. Review records of associated activities including IQ/OQ, service, annual PM, and routine daily/weekly/monthly maintenance.

• Monitor pre-analytical, analytical, and post-analytical quality indicators.

• Oversee proficiency testing process.

• Contribute to other QA activities as needed.

  Desired Skills and Background

• Experience in the clinical or diagnostics industry

• Scientific background in molecular biology and/or NGS

• Experience with QA activities across multiple quality system requirements (e.g. operating under both FDA part 820 and CLIA/CAP)

  Education And Experience

• Bachelor’s degree with at least 5 years of experience in the diagnostic, medical device, pharmaceutical, biotechnology, or life sciences industries, at least 2 of which should include direct QA experience.

Apply Here

PI92148657

Seeking a technical and data organization resource for product development activity.  Get into an amazing company with this ground floor opportunity. My client, a specialty pharmaceutical company focused on improving patient nutrition, is looking to add a database manager to their amazing team.  Put your basic knowledge of biochemistry and engineering principles to work by managing testing and the master database as it’s related to technology projects at various stages of development as well as maintaining inventory and manufacturing parameters.   You will also assist project leaders in providing summary information to CDMO’s, internal teams and other venues as needed.    
Requirements:

• BS/BS in a Life Science.
• Outstanding interpersonal  & organizational skills.
•Solid understanding of the science and technology associated with biopharmaceutical product development, manufacturing and clinical use.
• Superior software skills, including trend analysis using Excel.
• Statistical software experience or interest in learning.

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™

Acorda Therapeutics Inc. is a pharmaceutical company whose mission is to develop therapies that restore neurological function and improve the lives of people with neurological disorders.

The Quality Control Analyst III (or Senior QC Analyst)  is responsible for executing QC testing and related analytical activities supporting product development, release and stability. This individual conducts routine and non-routine chemical and physical analyses of raw materials, in-process materials and drug products according to standard operating procedures. The Quality Control Analyst III compiles data for documentation of test procedures that may include stability program testing and formulation studies, participates in the preparation of investigations, summaries and reports, and reviews data obtained for compliance to specifications and reports out-of-trend and/or out-of-specification results. The Quality Control Analyst  III revises and updates standard operating procedures as needed.  This individual may supervise a small group of QC Analysts.

 *Essential Duties and Responsibilities include the following. Other duties may be assigned.

• Operates analytical instrumentation (i.e. HPLC, UPLC, GC, UV-vis, FTIR, laser diffraction, KF).
• Statistically and critically analyzes data for trending and reporting into regulatory filings. 
• Participates in Laboratory and/or Quality Investigations.
• Monitors equipment and instrumentation used on a daily basis to ensure proper operation and calibration.
• Participates in the construction and/or revision of SOPs. 
• Assists in the writing and updating of analytical test procedures, protocol, log books and checklists. 
• Responsible for identifying, alerting and proposing solutions to issues on instruments and/or test executions; leads and implements recommended solutions and/or corrective actions.
• Independently organizes work flows to accomplish objectives, provides guidance and support to colleagues as needed, promotes new policies and programs tactfully and authentically, and may author/document performance reviews and/or evaluations. 

Education and/or Experience:

• Bachelor’s Degree in Physical or Chemical Sciences (life sciences) required.
• Minimum of 3-5 years of experience in a cGMP regulated environment required.
• Experience in MDI/DPI analytical test methods (i.e. Andersen Cascade Impactor and Emitted Dose techniques) preferred.
• Ability to troubleshoot and repair analytical instrumentation, experience with HPLCs is required.  Experience with UPLCs preferred.   Chromatography skills using Empower and/or ChemStation required.

 Qualifications:

• Extensive experience with executing QC test methods, generating associated data packages, auditing data packages generated by others, troubleshooting instrumentation, trending data and statistical analyses required.
• Demonstrated ability to lead projects and/or teams independently
• Ability to author investigations to determine root causes of OOTs and/or OOSs according to cGMP standards required.
• Experience with analytical method development and validation preferred.
• Familiarity with executing Standard Operating Procedures in a GMP setting required.
• Critical understanding of the importance of documentation and data traceability required.
• Working knowledge of cGMP’s and their application to Quality Control required.
•  Experience with MS  Office Suite

Other Skills and Abilities:

• Excellent oral and written communication skills.
• Ability to effectively manage time and prioritize tasks independently to meet tight timelines and shifting priorities.
• Demonstrates dedication to documentation/data traceability and strong attention to detail.
• Demonstrates appropriate safety consciousness.

 If you are qualified for and interested in a QC Analyst III opportunity, please visit our website www.acorda.com/careers and submit your resume on line. 

GENERAL SUMMARY OF POSITION:

The Child Protection Program (CPP) and Foster Children Evaluation Service (FaCES) of the Department of Pediatrics is committed to addressing the emotional and behavioral needs of children and families impacted by trauma. We are seeking an individual with trauma training and experience to be a trauma educator for the children and families we serve. This will include conducting trauma screenings for children seen at CPP or FaCES, addressing needs of caregivers with caregiver strain, engaging families and providing support to caregivers of children with trauma symptoms, and providing consultation and training to community professionals working with children who have experienced trauma.

MAJOR RESPONSIBILITIES:

• Screen children and families for symptoms of trauma and strain
• Explain trauma impact, recognition and treatment to children, adolescents, and families, and coordinate referrals for trauma specific services
• Work with families, agencies, and clinicians trained in evidence based trauma treatments; coordinate and schedule referrals for evidence based trauma treatment
• Responsible for the documentation of services provided to individuals and families
• Manage and track referrals to and from the Child Protection and Foster Care Program and maintain the database
• Communicate with staff regarding tracking of data and data management
• Assist in developing and ordering all marketing materials
• Prepare for all training activities
• Process all financial requests, including mileage reimbursements, travel, etc. 
• Perform other duties as required.

REQUIRED QUALIFICATIONS:

• Bachelor’s degree in Social Work, Counseling Psychology, a related field, or related experience
• 3 years of relevant experience 
• Ability to travel to off site locations.

 PREFERRED QUALIFICATIONS: 

• Master’s Degree in Social Work, Counseling Psychology, or related field
• Experience in the field of childhood trauma

For more information, go to: http://www.cwsciences.com/Current-Openings/Scientist-HighThroughput-Screening

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

Email resume to: jobs@cwsciences.com

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

Commonwealth Sciences, Inc.

www.cwsciences.com

For more information, go to: http://www.cwsciences.com/Current-Openings/Analytical-QC-Chemist

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

Email resume to: jobs@cwsciences.com

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

Commonwealth Sciences, Inc.

www.cwsciences.com

For more information, go to: http://www.cwsciences.com/Current-Openings/Associate-Scientist-Protein-Purification

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

Email resume to: jobs@cwsciences.com

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

Commonwealth Sciences, Inc.

www.cwsciences.com

For more information, go to: http://www.cwsciences.com/Current-Openings/Clinical-Coordinator

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

Email resume to: jobs@cwsciences.com

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

Commonwealth Sciences, Inc.

www.cwsciences.com

For more information, go to: http://www.cwsciences.com/Current-Openings/Clinical-Coordinator

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

Email resume to: jobs@cwsciences.com

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

Commonwealth Sciences, Inc.

www.cwsciences.com

Come join our growing team!

Cytrellis Biosystems, Inc. is a clinical-stage medical device company developing powerful new medical devices to improve the quality and appearance of human skin. Our company has developed proprietary technology that harnesses the power of plastic surgery to produce unprecedented results with a minimally invasive, in-office procedure. We are a Boston-based venture capital backed company.

The position of Medical Sciences Director, Clinical Development will support early stage pre-clinical and clinical studies to advance the company’s product platform technology and products.  The successful candidate will demonstrate the flexibility and capability to function at a high level across the clinical areas of dermatology and aesthetic plastic surgery and will integrate a deep understanding of the basic biology of skin.  Activities include direct responsibility for clinical and pre-clinical study design and execution as well as interpretation of data from key clinical studies.  This individual will interact with key members of the company’s management team including the heads of engineering and marketing, the company’s medical advisors, external stakeholders in the medical community and global regulatory authorities.

Responsibilities:

• Provide medical and strategic leadership for programs that integrate the individual’s extensive knowledge in basic and clinical science with input from the medical community around the world
• Develop approaches to characterize and understand fundamental mechanism of action of Company’s technology product platform and improving product’s effectiveness and safe usage profile.
• Integrate scientific rationale, regulatory requirements/risks, product development plan and commercial goals to build a solid strategic framework for the clinical development plan
• Establish clinical strategy to demonstrate clinical aesthetic impact of Company’s technology
• Design and oversee studies that address anticipated regulatory risks
• Maintain strong and effective relationships with heads of engineering and marketing and external regulatory and clinical consultants

Requirements:

• MD or PhD required. Subspecialty in dermatology or plastic surgery is desired
• 3-5 years experience in laboratory or clinical research
• Industry experience in clinical development required
• Proven track record for clinical and scientific leadership in development of medical technologies
• Demonstrated leadership and team building skills. Ability to perform effectively in a dynamic small company environment
• Demonstrated strategic and critical thinking
• Excellent communication skills (oral and written). Excellent organizational skills
• Capacity and willingness to work as part of a cross functional team
• The ability to lead directly and by influence, including strong problem solving skills, conflict resolution, and analytical skills

Cytrellis Biosystems is conveniently located in Boston’s Innovation District

Senior Administrative Assistant

Location: Cambridge, MA

Kanyos Bio is searching for an Senior Administrative Assistant to provide excellent administrative support to the Kanyos senior management team.  This individual will work with a high degree of autonomy and manage work with a high degree of autonomy and manage multiple administrative tasks for several executives, as well as assist the entire Kanyos team in our general operations. The individual will gain a unique experience working with colleagues in Europe and Asia, and become an essential part of a cutting-edge immunotechnology company striving to deliver therapies for patients with autoimmune disorders.

Responsibilities:

The successful candidate will provide various levels of support to the entire organization, and accomplish the following responsibilities:

• Supporting several executives with calendar management, expense reporting, and travel arrangements
• Answering telephones and screening calls as appropriate
• Scheduling meetings and teleconferences, including scheduling conference rooms, managing A/V needs and coordinating catering
• Prioritize and manage multiple projects simultaneously, and independently follow-through on issues in a timely manner
• Expense reconciliation and reporting using various electronic expense report systems
• Greeting and welcoming partners, visiting scientists, collaborators and other guests
• Administrative activities such as data entry, photocopying, scanning documents and filing

• Establish procedures and monitor document management and record keeping, including ensuring confidentiality of data
• Lead all office management activities, including supplies and coordinating external service providers

Qualifications:

• Bachelors degree and at least 5 years of experience with demonstrated mastery of all secretarial and administrative skills, at an executive level
• Excellent communication skills: written composition, oral, and interpersonal
• Exceptional attention to detail, follow-through and interpersonal skills
• Strong knowledge of software for office operations, including MS Office and Lotus Notes
• She or he should be a dynamic, independent, flexible, well-organized, pro-active, collaborative-minded individual interested in contributing to a fast-paced entrepreneurial environment.

Contact:

To apply, please send your cover letter and resume to: careers@kanyos.com (Job Reference KEA-01-2015-08)

Applicants should be legally entitled for employment in the United States.

Kanyos Bio is an early-stage immunotechnology company focused on developing targeted therapies for type-1 diabetes and celiac disease. Our technology originated at EPFL (Ecole Polytechnique Fédérale Lausanne) in Switzerland with our sister company, Anokion.  Kanyos and Anokion are collaborating in this effort with Astellas Pharma.  As an independent affiliate, Kanyos aims to develop antigen-specific, disease-modifying therapies for patients with type-1 diabetes and celiac disease by leveraging the immunotechnology expertise of Anokion and the clinical translation experience of Astellas.