Batavia Biosciences is a Contract Services Company dedicated to adding value to its partners by providing high quality research, development and manufacturing services for all major classes of biopharmaceuticals including recombinant proteins, viral vaccines and viral vector based products.

The company focuses on transitioning products from discovery to the clinic with services ranging from DNA cloning, mammalian and microbial cell line/strain generation, upstream process development (mammalian, microbial & insect cell platforms), purification development, product characterization, assay development and clinical manufacturing. Headquartered in Leiden, The Netherlands and with a growing operation in Woburn, USA, Batavia Biosciences is privileged to have strong client relations all over the globe.

We are looking for an experienced Scientist with extensive knowledge in cell culture process development for our R&D department in Woburn, MA. The Scientist will be responsible for day to day laboratory operations with customer projects and in-house research, using cell culture sterile techniques, running bioreactors, and flask experiments, working with both stable cell lines and transient transfections. The Scientist will be required to design experiments, make presentations, interact with clients and perform technical transfer. Minimal travel at present.

The Scientist will join a stimulating group of international researchers in a very collaborative environment. As part of this group, your personal as well as your scientific growth are encouraged and developed. This position will report to the Associate Director and may take direction from other senior staff.

Your letter of motivation and CV should show that you have:

• Bachelors or Masters level degree in engineering, life sciences or similar;
• 5-7 years’ experience  with cell culture process development in a research, biotechnology, biopharmaceutical, or contract manufacturing environment;
• Experience with small and large scale process development using, but not limited to, CHO, HEK, PerC.6, Vero, Sf9,  for production of proteins, antibodies, vaccines or viral vectors;
• Experience with suspension cultures and micro-carrier cultures;
• Experience with statistical design of experiments;
• Technical transfer and client relations experience is desired;
  • Experience with media development, assay development or purification is advantageous.

In the interviews it will be clear that:

• You are enthusiastic and comfortable in a dynamic environment;
• You are capable of working independently and participating with the team;
• You have excellent communication and documentation skills;
• You enjoy and are capable of complex troubleshooting/problem solving;
• You are capable of keeping meticulous track of experimental data and results in lab notebooks, have an understanding of the necessary work and are able to meet deadlines;
• You can work under pressure and do not have a 9 till 5 mentality, occasional off hours, evenings, or weekends may be required for which there is compensation
• You enjoy both hands-on, theoretical work and developing/investigating new technologies.

You can send your application letter and resume to Mrs. Mirjam Bollema, HRM Manager, by email m.bollema@bataviabiosciences.com. Acquisition regarding this position is not appreciated.

The Associate Director, Pharmacovigilance (PV) Physician will oversee clinical safety across various compounds in clinical development. This person needs to be highly motivated and is expected to provide innovative, critical, and strategic input and leadership.                                                    

Primary responsibilities include:

• Provide safety and PV expertise in-house and by consultation with outside vendors for assigned development programs.
• Author or co-author initial and updated versions of safety signal detection and management plans (SSDMPs) for global developmental products to support and enhance appropriate signal detection activities and robust safety evaluation.
• Perform or oversight of literature review for signal detection, signal assessment reports and other safety evaluation projects.
• Facilitator and presenter for Safety Management Team (SMT) meetings, Signal Detection meetings and other PV meetings as assigned.
• Contribute to preparation and assessment of safety data submitted as part of an NDA or BLA submission.
• Be accountable for identification, assessment and communication of potential safety signals; generate and analyze trend analysis reports.
• Collaborate with PV vendors and Regulatory Affairs to ensure appropriate reporting of PV and drug safety information to regulatory agencies and prescriber community.
• Lead development of SOPs for PV and drug safety monitoring.
• Provide medical safety expertise and input for review of new or on-going safety documents that ensure compliance with domestic and international regulatory requirement, such as protocols, safety summaries and regulatory reports.
• Oversee preparation and quality control activities for key safety documents.
• Give key input in review and finalization of clinical protocols and other study related documents.
• Collaborate with a team of professionals who provide medical monitoring support for ongoing clinical trials.
• Develop relationship with and capture drug safety info from key groups, including partner companies, physicians, nurses and patient advocacy groups.
• Provide input to potential in-licensing opportunities and PV agreements with commercial partners.
• Perform other departmental duties as assigned.

Education and Skills Requirements:

• Medical Degree (MD) or international equivalent   
• At least 3 years of experience in drug safety/PV in a pharmaceutical or biotech company, CRO or regulatory agency
• Familiarity with premarketing and postmarketing PV
• Excellent verbal, written and presentation skills
• Ability to build relationships and influence across disciplines and all levels
• Demonstrated experience as a member of a product or project team
• Familiarity with Drug Development and Phase 1-4 clinical trials

Your role: The successful candidate will be the primary expert and scientific contact for all GED-related scientific activities, and is accountable for all aspects of a project. He/She will lead the GED Team composed of GED scientists mainly from Drug Disposition, Quantitative Pharmacology, Nonclinical Safety, and Enabling Clinical Sciences. As a functional expert and scientist, the GED lead will provide scientific leadership to the program/project team by integrating individual GED contributions to develop the GED strategy and instills a sense of urgency with a strong can-do attitude in the project core team as well as GED team. This is a highly visible and interactive role requiring broad scientific understanding across the GED sciences and drug development alongside excellent teambuilding, actively collaborative & strategic capabilities. The GED Lead will participate in Project Review Meetings with the top R&D leaders of the company. Understanding and addressing stakeholder needs is crucial.

Who you are:

• Ideally, MD / DVM / PhD in life sciences or equivalent training
• Several years of professional experience in at least one of the GED areas (>10 years).
• Excellent knowledge of drug development & discovery processes. Exposure with rare diseases and/or anti-infective drugs is ideal.
• Excellent knowledge of NBE & NCE work packages (non-clinical and clinical) including predictive biomarker and good understanding about translational sciences

Click to apply:  https://career012.successfactors.eu/sfcareer/jobreqcareer?jobId=122580&company=merckgroup&username=

EMD Serono is the biopharmaceutical division of Merck KGaA, Darmstadt, Germany, a global pharmaceutical and chemical group. We strive to create value and benefit patients by transforming medical science into breakthrough solutions in our core therapeutic areas of neurodegenerative diseases, fertility and metabolic endocrinology, as well as oncology and autoimmune/inflammatory diseases as emerging areas of expertise.

Equal Employment Opportunity

The Company is an Equal Employment Opportunity employer.

No employee or applicant for employment will be discriminated against on the basis of race, color, religion, age, sex, sexual orientation, national origin, ancestry, disability, military or veteran status, genetic information, gender identity, or any other classification protected by applicable federal, state, or local law.

This policy of Equal Employment Opportunity applies to all policies and programs relating to recruitment and hiring, promotion, compensation, benefits, discipline, termination, and all other terms and conditions of employment. 

Any applicant or employee who believes they have been discriminated against by the Company or anyone acting on behalf of the Company must report any concerns to his/her Human Resources Business Partner, Legal, or Compliance immediately. The Company will not retaliate against any individual because he/she made a good faith report of discrimination.

Design and develop new tools for internal and external web users

Enhance and maintain existing software tools used by the larger organization

Build highly optimized responsive web pages and interfaces

Create, edit or modify templates for a Django-based web platform

Collaborate with R&D and business teams to create the best possible user experience

Be a front-end developer who is passionate about user experience and visual storytelling

Conduct data visualization projects for internal clients

Proficient with a front-end javascript library (Angular.js, Backbone.js, etc.)

Requirements

You've developed highly optimized, responsive websites and have examples to show for it.

You know how to slice and dice to create clean markup with the latest in HTML, CSS, and JavaScript libraries (jQuery) including:

• Knowledge      of the semantic meaning of HTML elements.
• Best      practices in CSS file organization and structure.
• Knowledge      of the operators, variables, datatypes, objects, properties and methods.
• Familiarity      with control structures such as objects, functions, conditional      statements, arrays, loops and expressions.
• Forms      and regular expression validation and submitting data.
• Knowledge      of how to apply logical operators and conditional statements.
• Knowledge      of HTML objects and their properties.
• Knowledge      of how to employ the jQuery library for visual effects, event handling,      and document manipulation.

Methods to ensure browser & device compatibility

Methods for degrading gracefully for older browsers and displays

You have basic knowledge of any server-side language (PHP, Perl, Ruby, C#, etc)

Familiarity with modifying Django templates to display data

Understanding how to utilize Python to filter, process and output html, json, xml

You have an eye for details that make a great user experience

Ability to communicate with the research team, obtain requirements, find solutions and implement them in a clean and concise way

Experience designing and developing static and dynamic visualizations (e.g. ggplot2, d3.js)

An interest in immunology and cellular biology

Strong quantitative, analytic and problem-solving skills

Ability to adapt to an ever-changing environment

Master's or Bachelor's degree in related field

The Regulatory Submission Delivery Manager is responsible for the coordination of publishing deliverables, in line with the strategic direction of the programs/products. Act as the primary point of contact for publishing staff, managing day to day workload and responsibilities. Act as point of contact for various regulatory functions (i.e. CMC, Development, and Labelling) as appropriate in the products lifecycle. Partner with planning and tracking to ensure submission deliverables are incorporated and visible to all stakeholders. Ensure hand offs and deliverables from authoring community are on time in line with the submission standards and expectations of quality.
• Primary point of contact for all operational activities (e.g., allocate and track publishing, formats, templates,, technical requirements)
• Oversee publishing deliverables on a day to day basis to ensure successful execution of operational activities for assigned products
• Coordinates and tracks delivery of required content with content owners for routine / maintenance submissions in all markets


Requirements:
• 8 years Regulatory submissions experience with expertise in eCTD submissions
• Experience with Liquent tools is preferable
• Ability to manage competing priorities and fast-moving requirements

We have an exciting opportunity for an outstanding Ph.D. scientist to lead CMC development efforts in a dynamic, successful pharmaceutical company.

About the Position

The position reports to the CSO.

The position requires that the successful candidate have a good understanding of all the facets of pharmaceutical CMC development for small molecule drug candidates as they apply to the different phases of drug development, including:

• Process chemistry development and scale up
• Formulation design, development and scale up
• Analytical method development
• Quality by Design
• Validation
• Specification setting

The successful candidate should also have relevant experience in most of the following functions:

• Preparation of CMC sections of IND filings
• Taking a compound from preclinical to human clinical studies
• Managing contract development and manufacturing organizations (CDMOs) conducting manufacturing under cGMP
• Working with and managing colleagues across different disciplines to advance company projects efficiently
• Working with consultants/advisors to fill important CMC roles on a contract basis

Responsibilities:

• Provide project leadership and technical oversight on all CMC-related development activities
• Coordinate the strategy for the API supply to meet clinical development timelines and regulatory requirements
• Initiate, negotiate and manage external contracts and collaborations for cGMP manufacture at CDMOs
• Oversee in-house kilo-lab preparation and CDMO manufacture of API for toxicology studies and cGMP API for clinical use
• In collaboration with internal staff and/or external consultants, create and direct programs to provide the necessary formulations and clinical supplies to achieve the clinical development objectives, and meet the required timelines
• Author and/or coordinate the preparation of the drug substance and drug product sections of IND filings

 Qualifications and knowledge:

Ph.D. in pharmaceutical sciences, organic chemistry or other suitable discipline with substantial experience in the CMC area working in the development of human drug candidates

• Track record of moving compounds from preclinical toxicology studies to IND filings and human clinical studies, including preparation of CMC sections of INDs
• Experience in initiating, negotiating and managing CRO and CDMO manufacture of drug substances and drug products
• Current knowledge of the GMP rules and regulations for the manufacture of APIs and pharmaceutical finished products for human clinical use
• A good understanding of either process chemistry or formulation science, together with a general understanding of the other discipline
• Knowledge of the CMC requirements for IND filings covering all the clinical development phases
• Knowledge of analytical chemistry and basic pharmacokinetics would be an added advantage
• Mid to small biotech experience a plus

 Other requirements:

Highly motivated self-starter who is able to work well in a team environment

• Excellent interpersonal and communication skills
• Effective problem solving skills
• Experience in managing and working with scientists and other staff
• Results oriented
• Ability to effectively manage multiple projects to meet timelines and quality requirements
• Flexibility and the ability to work effectively with scientists in other disciplines
• Comfortable working in the dynamic type of business environment found in small companies

 How to Apply:

 Interested Candidates may apply online via the following link:

 https://theapplicantmanager.com/jobs?pos=et126&fs=1.0em

 Please include the following attachments with your application:

• Cover Letter
• CV
• Summary of relevant CMC experience

For more information on this position, or to see other current openings, log into our website at http://www.enanta.com/careers/.

Enanta offers employees a competitive total compensation package including a competitive base salary, bonus, stock options, and a comprehensive benefits package. 

All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability, protected veteran status or any other class protected by law.

Enanta Pharmaceuticals is an EO employer – M/F/Veteran/Disability

Enanta is seeking an enthusiastic and highly motivated Scientist who will lead biological assay development to support Enanta drug discovery/development in the nonalcoholic steatoheptitis (NASH) /metabolic disease areas.  The individual will be expected to conduct experiments in the laboratory and provide scientific and strategic input into the target portfolio, preclinical animal models and novel in vitro techniques supporting the programs.  The successful candidate must have in depth knowledge of metabolic pathways of nuclear receptors.  Excellent written and oral communication skills, as well as strong organizational skills are essential.  Flexibility and adaptability are also necessary.

Primary Responsibilities:

• Design and implement experiments, analyze data, interpret and communicate results to drive scientific innovation and enable effective decision making in the NASH/metabolic disease drug discovery projects
• Address and resolve the in vitro assay development issues arising in drug discovery programs
• Interact with multidisciplinary teams to meet project goals and timelines
• Communicate unambiguous critical and significant project information to various bodies including project teams and Enanta leadership as required

Qualifications and Requirements:

• Ph.D. with post-doctoral experience in Physiology, Biology, Biochemistry, Molecular Biology, Pharmacology, Metabolic Disease or a related discipline, along with a strong track record of publication in the area of nuclear receptors, nonalcoholic fatty liver and/or metabolic diseases is required
• Exceptional knowledge of basic and emerging concepts in nonalcoholic fatty liver /metabolic diseases, particularly pathways that regulate glucose metabolism, insulin resistance and/or cholesterol synthesis and metabolism
• Demonstrated success in the in vitro assay development and execution (biochemical, receptor and/or cell based), compound screening, and statistical analyses of data.
• Strong problem solver who is highly organized with the ability to thrive and to lead in an environment with rapidly changing priorities
• Excellent interpersonal skills with an ability to work effectively in a team setting/matrix-type organization
• Excellent oral and written communication capabilities

How to Apply:

Please send cover letter and CV to https://theapplicantmanager.com/jobs?pos=et133&fs=1.0em.

For more information on this position or to see other current openings log into our website at http://www.enanta.com/careers/.

Enanta offers employees a competitive total compensation package including a competitive base salary, performance bonuses, stock options, and a comprehensive benefits package. 

No phone calls please.

ENANTA Pharmaceuticals, Inc. is an Equal Opportunity Employer – M/F/Veteran/Disability.  All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability, protected veteran status or any other class protected by law.

OBJECTIVES:

1. Regional Physician contributes to the strategy for the regional clinical development in the assigned area, taking into consideration the medical, scientific, regulatory and commercial issues. Contributes to a multi-disciplinary, regional, matrix team through complex decisions.
2. This individual may serve as lead author or key contributor to clinical documents, including clinical trial documents, reports and publications and integrated clinical documents for regulatory submissions, as well as external presentations.
3. Has responsibility for programs or may be solely responsible for program, and has accountability to the Regional Medical Director. Supports the Regional Medical Director in the administrative and operational requirements of the Development team and in people management where appropriate.
4. In addition, the Regional Physician has also the overall responsibility in the proper conduct of clinical trials in agreement with Takeda Standards and GCP guidelines according to the clinical development plan.

  ACCOUNTABILITIES:

Clinical Development team participation

• Works in a matrix team with other colleagues (other clinicians, statisticians, clinical trial and program managers ...), to ensure that the development teams are proactively identifying contingencies, potential risks and strategies to address future hurdles.
• Supports the Development Strategy, Clinical Development Plan and Clinical Protocols. Recommends scope, complexity and size, which influence the budget of all aspects of a program. Supports continuing evaluation of the strategy to maintain a state-of-the-art development plan that is competitive and consistent with the latest regulatory requirements with proactive identification of challenges, and development of contingency plans to meet them.
• Contributing to regional decision making: monitoring and interpreting data from ongoing internal and external studies, assessing the medical and scientific implications and making recommendations that impact regional development. Considers how a given product will fit in with current treatments, standard of care, and unmet medical need i. e. medical/clinical significance.
• Support initiatives in order that the regional/country medical needs and practices (current treatments, standard of care, unmet medical needs) are taken into account when elaborating global clinical development plans.
• Participates in the country and site/investigator selection process
• Supports feasibility assessment at regional and country level, also providing input into the study protocol as it is developed.
• Provides medical input in regional/local study documents for submissions (ICF, information letters, etc) and overall medical advice to the Development Delivery Group.
• Suports critical issues management (which have a time/budget/relationship impact) linked to the investigator and his team and if appropriate manages the escalation process.
• Contributes to the regional development team (including the Development Delivery members).

Synopsis / Protocol Development, Study Execution, & Study Interpretation

• Supports Clinical Development activities and clinical development plans, clinical trial protocols designs, Clinical Study Reports and publications of high scientific, operational and ethical standards. Ensure consistency of data within program and across trials in the region.
• Supports preparation of the Investigator Brochure and Common Technical Documents (including updates) and the Annual Safety Reports (DSUR and if applicable PSUR’s) to Regulatory Agencies as applicable
• Supports preparation of study budgets and internal budgets; co-responsible for study budget compliance
• Supportive in clinical liaison to IDMCs
• Has the co-responsibility for quality of all related clinical trial documents
• Reviews appropriate documents prepared for the submission package according to local regulations (e. g. submissions to Health Authorities and Ethics Committees)
• Responsibile for identification of and contact with potential sites and negotiation of budget proposals
• Controls trial site activities (e. g. by the review of deviations, monitoring listings).
• Interprets data from an overall scientific standpoint as well as within the context of the medical significance to individual patients.
• Responsible for the interaction with study investigators and presents clinical trial results.
• Liaises with PV to develop RMPs (Risk management plans), Core safety data sheets and serves on SMT (safety management team). In clinical trials, together with PV analyses potential safety signals and escalates accordingly.

Trial Medical Monitoring

• Oversees medical monitoring activities (including but not limited to Data Listing review for the medical portion of data listing), assures medical consistency within a trial and across trials within a program, assessing issues related to protocol conduct and/or individual subject safety. Assesses the overall safety information for studies and vaccines in conjunction with Pharmacovigilance. Pays special attention to serious adverse events, pregnancies, AESI’s (adverse events of special interest) and potential safety signals.
• Serves as a counterpart of vendor physicians to ensure alignment of clinical trial activities (including, but not limited to, scientific and medical issues as well as subject safety)

Medical Affairs

• Contributes that the regional/country medical needs are taken into account when elaborating Medical Affairs strategies.
• In coordination with Medical Affairs takes the lead for the set-up and management of a regional network of KOLs which will be instrumental in advising and supporting the adequate development of Takeda’s vaccines in the region.
• Support of country/region specific medical affairs activities as appropriate

Epidemiology

• Provides input in the epidemiology plan making sure that the regional needs and specificities are taken into account.
• Participates in the initiation, set-up, oversight and reporting of country/region specific epidemiology trials in collaboration with the Development Delivery Group.
• External Interactions
• Supports interactions with regulatory authorities/agencies and clinical development and key opinion leaders relevant to assigned products. Serves as an advisor to the other clinical scientists engaged in these activities

KOL and Investigators management

• Supports set-up, develop and manage a regional network of KOLs and Investigators who will successfully support development of Takeda’s key products candidates in the region.
• In collaboration with the program team, sets-up and participates in Regional/Local Scientific and Clinical Advisory Board Meetings.
• Contributes to the initiation, set-up, oversight and reporting of country specific Phase IV trials.
• In collaboration with the Development Delivery Group, supports the set-up and medical oversight of postmarketing commitment trials.
• Supports the oversight of Investigators’ Initiated Studies in the assigned region.

Compliance

• Ensures that the medical activities in the region/country are compliant with all applicable local and regional regulations and obligations as well as in line with Takeda’s own Ethical Guidelines and Business Practices.

Due Diligence, Business Development and Alliance Projects

• Supports to the evaluation of potential business development opportunities with regard to clinical development. Assesses scientific, medical, and development feasibility, evaluating complete or ongoing clinical trials, assessing regulatory interactions and future development plans.
• Might serve as clinical contact point for ongoing alliance projects and interfaces with partner to achieve Takeda’s strategic goals while striving to maintain good working relationship between Takeda and partner.

Leadership, Task Force Participation, Upper Management Accountability

• Interacts directly with specific divisions based on pertinent clinical and development expertise to provide knowledge/understanding of regional market environment in line with status of the scientific content matter expert for assigned products.
• Manages, mentors, motivates and develops staff to support assigned activities.

Qualifications 

EDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS:

• Medical Degree or internationally recognized equivalent with the relevant industry experience and 3 years of clinical research experience within the Vaccines industry or CRO health-related consulting company, or biomedical/clinical experience within academia (or a combination of afore mentioned).
• Experience and demonstrated ability to lead and manage highly trained medical, scientific and technical professionals preferred

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 teams
• Diplomacy and positive influencing abilities across multinational business cultures
• Knowledge
• Therapeutic area knowledge relevant to mechanisms of action of compounds involved
• Regional/global Regulatory requirements
• GCP/ICH
• Emerging research in designated therapeutic area
• Working proficiency in English, Spanish and Portuguese

PHYSICAL DEMANDS:

• Manual dexterity required to operate office equipment (i.e. computers, phones, etc.).
• Carrying, handling and reaching for objects.

TRAVEL REQUIREMENTS:

• Ability to drive to or fly to various meetings or client sites, including overnight trips. International travel will be required.
• Requires approximately 25% travel.

we are driven to improve people's lives

 www.takedajobs.com

Takeda is an EEO employer of minorities, women, disabled, protected veterans. For more information, visithttp://www.takeda.us/careers/EEO_Policy_Statement.aspx  

No Phone Calls or Recruiters Please.

*LI-KB1

ScheduleRegular Full-time

Foundation Medicine is seeking a highly experienced Receptionist with superior organizational, verbal, and written communication skills to provide high-level administrative support to our team. The candidate must ensure a warm reception on the phone and in person. Also needed is a strong sense of business etiquette, including but not limited to appearance, poise and discretion, high attention to detail, a strong sense of urgency and good judgment, and the ability to work well independently with minimal supervision. The Receptionist/Administrative Assistant must be a resourceful, self-starter, capable of handling multiple tasks while also being meticulous and conscientious.

• Reception and General Office Duties
  • Greet and direct visitors, deliveries and food purveyors to appropriate personnel or meeting room location
  • Accurate screening, handling and correct routing of phone calls, or taking messages when required
  • Ensure shipment, receipt of distribution of all packages and mail in a timely fashion
  • Maintain/clean office, copy, and kitchen areas
  • Coordinate ordering and receipt of office supplies, kitchen supplies, stamps, catering and special orders
  • Conference room maintenance
• Additional Duties
  • Under the direction of the EA for the technology team, provide back up support to the Technology team
  • Calendar management
  • Arrange travel and assist with expense reports as needed
  • Special projects as assigned

• Bachelor’s degree or equivalent work experience required
• 3-5 years of Reception/Administrative Assistance experience preferred
• Demonstration of extensive experience using Microsoft Outlook, Excel, PowerPoint, and Word
• Strong interpersonal skills with the ability to interface effectively with a wide variety of internal and external clients
• Excellent verbal and written communication skills
• Excellent judgment and discretion when managing e-mail and confidential informahttp://www.Click2Apply.net/fdbn93xws4tion
• Strong organizational, administrative, and analytical skills
• Ability to manage and prioritize multiple tasks with strong attention to detail in a business with changing priorities
• Maintain confidentiality in all aspects of staff and company information
• Ability to execute independent judgment

Apply Here

PI92317289

Job ID: 25737
Date Posted: 06/16/2015
Location: 44 Binney St, Boston
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.

About CCGD

The mission of the Center for Cancer Genome Discovery (CCGD) at Dana-Farber Cancer Institute is to facilitate genome discoveries in human cancer by basic and translational research. The CCGD has established technology platforms to assist researchers in both genome-wide and gene-focused efforts such as next-generation sequencing, genotyping, somatic mutation detection and copy number analysis. We strive to be at the cutting-edge of cancer characterization, utilizing novel technologies and adapting existing technologies for the advancement of cancer research and personalized cancer treatment. Technologies are selected and developed with a view to discovery-oriented ventures, as well as translational medicine and clinical relevance.

Role and Responsibilities

We are seeking a highly motivated research technician for the CCGD genomics platforms. The successful candidate will use cutting-edge technologies for cancer mutation discovery and tumor profiling, including Illumina Next Generation Sequencing. The position involves molecular biology techniques such as DNA isolation and quantification, QPCR, library preparation and high-throughput massively parallel sequencing. Duties include operating and maintaining equipment, analyzing data to identify mutations in cancer samples, completing projects in a timely fashion, giving presentations at weekly meetings, and working in a collaborative, exciting and fast-paced team environment.

Requirements

Bachelors of Science with experience in molecular biology or biochemistry. Prior experience in laboratory research is highly preferred; high-throughput experience in automation, genotyping or sequencing is a plus. The candidate will be self-motivated, detail oriented, responsible, and flexible and possess excellent organizational and analytical skills. Recent graduates with lab-experience who aspire to attend graduate or medical school are encouraged to apply, as this position is excellent preparation for school admission. Candidates are required to have a GPA of 3.3 or above to be considered. Also, at least 1 year of independent lab experience (either in college or post college) is required.

Schedule

Full time, 40 hours per week

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

PI92317900

Summary

Responsible for providing leadership and technical management of QC Microbiology services. Manages the activities and performance of Microbiology laboratory staff members including: hiring, training, developing, evaluating work performance and addressing performance issues and ensuring a safe working environment.  Assures sampling and testing procedures are established in accordance and followed in accordance with cGMP, Safety requirements and training programs.  Ensures laboratories and microbiological support activities are always in a state of compliance and inspection ready.    

Key Responsibilities/Essential Functions

• Participate on a variety of project teams or program initiatives.  Act as a technical resource.  Communicate information both internally across departments and externally with vendors and business partners, as appropriate.
• Maintains necessary oversight for multiple laboratory areas: sterility testing, microbial identification, facility monitoring, raw material testing; provide microbiological support to R&D, ensuring effective training program is established and followed.
• Ensures all microbiological release testing requirements are performed in a timely manner while ensuring compliance with testing standards, SOP’s, validation guidelines and regulatory requirements to met supply chain timeline and customer demands.
• Coordinates the activities of staff members, including microbiology supervisor.
• Consult with and advise internal staff and third party manufacturers regarding investigations into the causes of Quality events; ensure investigations are conducted per all applicable internal procedures and external regulatory requirements; implement and facilitate corrective measures.
• Manages and controls departmental spending; ensures operations are within budget for lab supplies, expenses and capital equipment, participates in budget headcount forecasting and cost savings initiatives;  Determines merit salary actions for staff.
• Represents QC Microbiology during audits and inspections.
• Maintain current knowledge of GMP and internal policies, procedures, technology, systems and processes, and all related external regulatory requirements.  Ensure staff and department activities align with internal policies and are in compliance with US and appropriate global regulatory requirements ensuring a state of inspection readiness.  Update internal policies and procedures to ensure compliance.
• Actively promote safety rules and awareness, demonstrate good safety practices at all times, and take initiative to correct safety hazards.  Actively demonstrate and promote the Lantheus values of accountability, quality, efficiency, customer service and safety.
• Responsible for data review, data trending, reporting and analysis and for issuing trending summary reports, test cycle time and metrics reports per site requirements.; assures that all data is reviewed timely, is filed appropriately and archived per procedures.
• Demonstrates the ability to multi-task by allocating time effectively for employee development and coaching, achieving quality, performance, and safety standards.
• Ensures all areas of manufacturing and support systems under microbiological control are maintained in a state of control.
• Monitors key performance metrics and communicates them to management team.

Area Specific Requirements

• Requires scientific expertise related to microbiological testing and environmental monitoring specific to current regulatory regulations 
• Manages multiple laboratory areas: sterility testing, microbial identification, facility monitoring, raw material testing, bioburden testing and endotoxin testing.

  Basic Qualifications

• Typically requires 7-10 years of previous experience in the pharmaceutical industry, related GMP environment, or equivalent.
• Requires a BA/BS degree in a related scientific discipline (e.g. microbiology, biology, chemistry) or equivalent combination of education and experience. Master’s degree in Microbiology preferred
• 3-5 year of supervisory skills and experience working in an environment with exposure to potentially hazardous chemical, radiological and biological materials required.

Other Requirements

• Some non-routine travel may be required.
• Flexibility with scheduling requirements-may include shifts, overtime, weekends and holiday coverage, including during adverse weather conditions. Responsible for overseeing staff coverage as needed.

Position description:

This hands-on position will be responsible for managing the monthly and quarterly accounting close cycles and will play a key role in business process improvement initiatives. This position will manage and maintain the financial aspects of the Company’s ERP system and unleash its full potential. The right candidate will lead by example and will be an integral part of the core Accounting team. The proven manager will report to the Associate Director, Accounting and will work closely with the Corporate Controller and the entire Finance organization. 

Responsibilities:

• Manage all aspects of a timely and accurate monthly/quarterly close; motivate the Accounting team to achieve goals and excellence
• Review balance sheet and profit and loss account reconciliations and produce meaningful and concise analysis
• Prepare monthly financial statements (B/S, P&L, Equity Statement and Cash Flows) including multiple levels of support and compliance to GAAP; support SEC filings by drafting and reviewing footnotes and disclosures
• Manage the effectiveness and efficiency of the general ledger as well as other financial modules of the Company’s ERP system; maintain and control master data used for financial reporting
• Directly responsible for more involved areas such as inventory and debt accounting; responsible for multiple areas of collaboration accounting (revenue, expense, analysis, operational) including interaction with our external collaboration partners
• Integral role in supporting Sarbanes-Oxley 404 key controls and external reviews and audits
• Identify and implement business process improvements; lead as the financial subject matter expert and business champion on projects and initiatives
• Develop and maintain a customer service culture throughout the organization 

Requirements:

• Demonstrated staff leadership and management skills
• Self-motivated professional with ability to effectively balance multiple priorities
• Strong attention to detail, SOX awareness, utmost integrity
• Experience maintaining financial ERP reporting and systems (SAP is a strong plus)
• 8+ years of relevant work experience; CPA is required (Big 4 or large regional firm)
• Flexible and collaborative work style with ability to thrive in a fast-paced entrepreneurial environment (life science industry is a plus)
• Individual must have strong analytical and communication skills.

Position description:

This key finance position will have oversight of the monthly and quarterly financial statements and accounting close cycles. The seasoned professional will have technical experience in a wide variety of accounting areas and will also have a breadth of business and operational experience. This position will manage a team of seven talented individuals in the core Accounting function and will serve as a resource to guide their training and development. The right candidate will partner with all levels throughout the organization and will interact extensively with outside auditors and advisors. The proven leader will report to the Corporate Controller and will work closely with the SEC reporting team and with all of Finance. 

Responsibilities:

• Direct and oversee all aspects of a timely and accurate monthly/quarterly financial close; motivate and influence the Finance team to achieve goals and excellence
• Review financial statements, account reconciliations, footnotes, disclosures and other support
• Prepare comprehensive analysis and financial presentations for senior management and audit committee
• Directly responsible for more involved accounting areas such as stock-based compensation and those which involve significant judgment and technical expertise; assess new and complex business transactions
• Managing role in supporting external reviews and audits; integral role in Company’s Sarbanes-Oxley 404 compliance program and audits
• Manage core accounting team, including Accounts Payable; direct work activities, set priorities, train and develop staff
• Improve and build appropriate systems and processes to facilitate timely and accurate closing of monthly financial statements
• Manage and forecast operating cash, assist with treasury and investment operations 

Requirements:

• Strong technical accounting background, extensive SOX experience
• 10+ years of relevant work experience; CPA is required (Big 4 or large regional firm)
• Demonstrated business leadership and management skills
• Self-motivated professional with ability to effectively balance multiple priorities, strong attention to detail, utmost integrity
• Flexible and collaborative work style with ability to thrive in a fast-paced entrepreneurial environment (life science industry is a plus)
• Individual must have very strong analytical and communication skills.

Position Description

Reporting to the Vice President, Regulatory Affairs, the Director of Regulatory Affairs is responsible for developing the overall regulatory strategy for NCE development programs in assigned therapeutic area, assuring that regulatory documents are in compliance with health authority regulations and interacting with US and international health authorities. 

Responsibilities:

Act as leader for assigned therapeutic area, including: 

• Maintain regulatory expertise and serve as internal consultant on relevant global regulations and guidelines, current regulatory environment and regulatory precedent; 
• Ensure effective department procedures, including creating and reviewing SOPs as needed; 
• Provide regulatory due diligence and regulatory advice for potential new product opportunities; 
• Provide guidance on regulatory mechanisms to optimize product development; 
• Supervise and mentor direct report(s) 

Act as regulatory representative for assigned NCE program(s); including: 

• Develop regulatory strategies aimed at achieving marketing authorization and appropriate product labeling; 
• Serve as primary regulatory representative for cross-functional teams and lead regulatory sub-teams; 
• Plan, manage and execute regulatory activities, including submission and maintenance of US and international regulatory filings; 
• Serve as primary liaison with regulatory authorities, including overseeing the writing of pre-meeting briefing materials, leading the preparation for and facilitating sponsor interactions at regulatory meetings, and ensuring appropriate follow-up; 
• Participate in the CRO selection process, particularly evaluating regulatory competency and capacity to support international submissions. 

Requirements:

• Bachelor's degree in life sciences or chemistry with 10 + years of regulatory strategy experience required.  An advanced life science degree (MS, Ph.D) is preferred;
• Solid working knowledge of drug development process and knowledge of FDA regulatory requirements; EU, Canada, and ROW experience desirable;
• Knowledge of domestic and international regulations and guidelines regarding drug development, regulatory submissions and corresponding regulatory agency interactions;
• Application experience and proven ability to lead collaborative teams;
• Strong strategic and analytical abilities, diplomacy, negotiation and excellent oral and written communications skills;
• Ability to mentor staff in NCE drug development.

Responsibilities:

• Synthesize and purify peptides using automated peptide synthesizers and purification systems to support the development of cancer vaccines.
• Manage chemical inventories and maintain laboratory instruments.
• Contribute to the development and management of peptide database.
• Develop new methods for high throughput peptide synthesis and purification.
• Work cross-functionally with analytical, quality, computational and biology groups to achieve company objectives.

Qualifications:

• B.S. or M.S. in organic chemistry or a related discipline.
• Minimum of 1 to 3 years of industry experience in peptide synthesis and purification.
• Expertise in solid-phase peptide synthesis.
• Experience in peptide synthesizers and purification/analytical instruments including preparative HPLC, analytical HPLC, MS, etc.

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

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

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

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

Responsibilities:

• Conduct bench activities for analytical characterization and purification of peptides to support the development of cancer vaccines.
• Develop peptide characterization and purification methodologies to increase the efficiency of peptide synthesis.
• Establish laboratory capability of peptide analysis, characterization, stability study, and QA/QC, etc.
• Contribute to the development and management of peptide databases.
• Work cross-functionally within the organization, including synthetic and computational biology groups to meet company objectives.

Qualifications:

• B.S. or M.S. in analytical chemistry or a related discipline with 5+ years of industry experience.
• Proven experience in peptide analysis, characterization, purification and QA/QC.
• Expertise in analytical techniques including HPLC, UPLC, MS, HPLC-MS, GC, elemental analysis, etc.

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

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

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

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

Position description:

We are looking for a highly motivated and talented individual to join the Discovery Pharmacology team. The successful candidate will be a key member of interdisciplinary drug discovery teams, contributing effectively and independently at the bench and thinking strategically about drug discovery projects and ideas. This role requires a significant proportion of time devoted to laboratory bench work as part of multidisciplinary project teams, developing and running novel in vitro assays to characterize compound pharmacology and mechanism of action. This individual should have a passion for discovering and developing innovative medicines and should be able to work in a challenging environment, bringing intellectual leadership to the projects in which he/she is involved. This position reports to the Senior Research Fellow in Discovery Pharmacology

The successful candidate will work as part of a multidisciplinary team to develop and run novel in vitro and in vivo assays to characterize compound pharmacology and mechanism of action. 

Responsibilities:

• Develop and characterize in vitroand in vivo pharmacology of Ironwood compounds to support the mechanism of action studies and biomarker analysis
• Independently design, execute, troubleshoot, and interpret biological experiments;
• Communicate results and conclusions within the pharmacology and cross functional project teams.
• Provide strategic leadership within the pharmacology group and broadly across project teams.
  • Review the scientific literature to remain abreast of developments in relevant fields.           

Requirements:

• MS or PhD in Pharmacology, biochemistry, molecular/cellular biology, or related fields.
• Experience with a range of target/assay types (e.g., GPCR, enzyme, cell-based, biochemical) and a solid understanding of biological processes;
  • Industrial experience in areas of Inflammation, cardiovascular diseases or fibrosis preferred.
  • Experience conducting both in vitro and in vivo pharmacology studies is strongly preferred.
  • Must be flexible to be able to apply his/her knowledge to new areas of study, thrive in a fast paced team environment. 
  • Possess excellent communication skills (both written and oral), as well as superior organizational skills.

Responsibilities:

The successful candidate will participate in working on a T cell program that aims to develop a novel T cell-based therapeutic approach that leverages neo-antigen biology in cancer immunotherapy. They will be responsible for setting up and conducting tests, assays, and other protocols under the direction of a scientist following Standard Operating Procedures (SOPs) and Good Laboratory Practices (GLPs).

Additionally, they will be responsible for isolation and culturing of primary cells, expression, and purification of recombinant proteins, and performing antibody staining and flow cytometric analyses.

Qualifications:

• B.S., B.A., or M.S. degree in biology or relevant field
• Strong background in cell biology, molecular biology, virology, biotechnology, immunology, or stem cell biology.
• Primary cell culture, preferably with T cells.
• Experience with basic molecular biology and biochemistry techniques.
• 3+ years of relevant research experience; experience in oncology.
• Demonstrated mastery of flow cytometry assay development and cell sorting.
• Ability to organize and tabulate data.
• Excellent attention to detail.
• Ability to maintain inventories of equipment, supplies, and related research materials.
• Strong organizational and record-keeping skills.
• Excellent written and oral communication skills.
• Independent, flexible, self-motivated.

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

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

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

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

Position Description

Reporting to the Vice President, Regulatory Affairs, the Director of CMC Regulatory Affairs will be responsible for developing and implementing CMC regulatory strategies as well as coordinating all aspects of CMC regulatory submissions. This person will represent the function of CMC regulatory on project teams within Ironwood as well as serve as the regulatory CMC liaison with partners on development projects and commercial products.

Responsibilities:

• Direct the function of CMC regulatory;
• Develop and implement CMC regulatory strategies for investigational, and ultimately, commercial drug products;
• Lead activities, including planning, writing and reviewing CMC (chemistry, manufacturing and control) sections of all regulatory submissions (INDs, NDAs, CTXs, meeting requests, and briefing documents) to support clinical trials and product registration. This will require the development and management of project timelines;
• Coordinate the preparation of responses to regulatory agencies;
• Act as primary regulatory representative at internal meetings as well as at meetings with business partners and regulatory agencies for all CMC related issues;
• Assess and communicate CMC regulatory requirements to ensure all development activities are in compliance with applicable regulations and guidelines;
• Monitor changes to development plans and provide regulatory guidance to teams to bridge changes into the clinic;
• Assess post-approval changes for existing commercial products and provide guidance on regulatory impact.

Requirements:

• A minimum 4-year degree in Chemistry, Biochemistry, or related pharmaceutical science required; advanced degree desirable;
• 10 years of industry experience in pharmaceutical product development, with a minimum of 5 years in Chemistry, Manufacturing and Control (CMC) regulatory environment;
• Excellent communication and interpersonal skills;
• Work well with employees across the entire organization;
• Discerning and intuitive regarding how to best use your talents and the talents of your team with an ability to work under tight deadlines;
• Solid working knowledge of drug development process and in-depth knowledge of FDA regulatory requirements; EU, Canada, and ROW experience desirable;• Previous experience in leading submission teams for marketing application and/or clinical trial applications and direct experience in interacting with regulatory authorities;
• Strong knowledge of current Good Manufacturing Practices (cGMP).

Positions available in the Urological Diseases Research Center, Boston Children’s Hospital

Postdoctoral research positions are available in the Mauney laboratory within the Urological Diseases Research Center at Boston Children's Hospital. Studies in our laboratory are focused on the design of silk fibroin grafts for hollow organ tissue engineering including tissues of the urinary and digestive tract. Both small (rodent) and large (swine and sheep) animal models of tissue repair in the bladder, urethra, small intestine, and esophagus are employed.  In addition, our laboratory explores the mechanisms of constructive remodeling of tissue engineered constructs by delineating how host tissue microenvironments interact, populate, and integrate into scaffold environments in vivo.  Our group synergizes the expertise of clinicians, bioengineers, and molecular biologists in a dynamic research environment to produce clinically-viable biomaterials. Experience with small/large animal surgery and husbandry is required.  Pathology, biomaterials, and/or immunological expertise is recommended.  The candidate should be able to work independently as well as with a team of investigators. Excellent communication skills, both oral and written, are essential and an established publication record in tissue engineering is desired. English proficiency is required. This is an outstanding opportunity for persons interested in ultimately pursuing a medical and/or bioengineering career path. Applicants must have an MD, PhD, and/or DVM.  The positions are available immediately. Interested candidates should send a CV, a brief summary of research experience and interests, and names of three references to:

Joshua R. Mauney, Ph.D.

Urological Diseases Research Center

Enders Research Building, Rm 1009

Boston Children’s Hospital

Email: joshua.mauney@childrens.harvard.edu