Position Overview & Responsibilities:

As the Scientist/Senior Scientist, Drug Delivery, you will determine the requirements for inner ear drug delivery, and develop approaches and “working” vehicles suitable to all preclinical and clinical programs. Working with R&D team, you will develop and implement an in vitro drug diffusion / PK / PD system for inner ear drug delivery and measuring in vivo drug diffusion, PK and PD. Additionally, you will determine the feasibility and usefulness of an in vitro organoid model for the inner ear for drug and drug delivery screening and modeling. As one of the key early hires for the company, you will work in close collaboration with the management team to ensure that delivery options for our programs (pre-clinical and clinical) are based on solid scientific foundations, accurate feasibility assessments, and grounded in clinical and commercial realities.

 Requirements:

 PhD in Chemistry, Chemical Engineering or Bioengineering with 3 to 5+ year’s relevant experience or BA or MA with 12 to 15+ year’s relevant industry experience

• At least 5 years of experience working on early-stage and IND-enabling teams within the pharmaceutical industry. Specific experience with advancing implantable devices into clinical trials a plus
• Strong record of publications relevant to drug delivery/inner ear function or anatomy in peer-reviewed academic journals
• Demonstrated ability to assess, prioritize, resource and shepherd programs forward
• Ability to function equally well in self-starter mode as well as a matrix-team
• Outstanding interpersonal and communication skills

Knowledge, Skills, and Abilities:

Preference will be given to candidates who additionally have:

• Broad scientific expertise relevant to drug delivery in closed spaces (inner ear as a strong preference, ophthalmology and joint space as surrogates)
• Breadth of drug delivery line function vocabulary across therapeutic areas
• Deep understanding of existing and potential drug delivery options to the inner ear and inner ear anatomy and pharmacokinetics
• Demonstrated experience with formulations development, assay development
• Facile vocabulary re inner ear imaging techniques, inner ear histopathology, cochlear function, single cell recordings
• Detailed familiarity with inner ear anatomy and function

Position Overview and Responsibilities:

As the Senior Scientist, you will be expected to work equally well in self-starting mode as well as a member of a matrixed team within Decibel. Your initial focus will be to develop, implement and execute appropriate in vivo and/or in vitro assays required for the advancement of both specific high priority projects as well as Decibel’s inner ear platform. As one of the key early hires for the company, you will work in close collaboration with the management team and scientists to ensure that our pre-clinical programs and technology platform are based on solid scientific foundations, accurate feasibility assessments, and grounded in realistic, corporate aligned goals.

Requirements:

• PhD in pharmacology, neurobiology, molecular and/or cell biology with 3 to 5+ year’s relevant experience or BA or MA with 12 to 15+ year’s relevant industry experience
• At least 5 years of experience working on early-stage and IND-enabling teams within the pharmaceutical industry
• Hands-on experience in diverse, in vivo and in vitro experimental model systems, histology and RNA/protein expression techniques
• Deep expertise in regenerative medicine strategies, preferably in the inner ear
•  Broad vocabulary that encompasses significant (publications and/or INDs) experience in other hearing-related fields (e.g. at least one of tinnitus, noise-induced hearing loss, ototoxicity, presbycusis, genetic disorders relevant to hearing)
• Proven track record in new assay and high-through put assay development
• Strong problem-solving skills
• Ability to be productive in a fast-paced, team-work, multi-task environment
• Ability to function equally well in self-starter mode as well as a member of a matrixed team
• Outstanding interpersonal and communication skills

Knowledge, Skills, and Abilities:

• Independently design, execute, troubleshoot, and interpret biological experiments in support of program objectives
• Prepare protocols and SOPs for diverse assays
• Maintain accurate documentation of experiments
• Interact and communicate results and conclusions within the biology/pharmacology group and cross functional project teams
• Review the scientific literature to remain abreast of developments in relevant fields

      Preference will be given to candidates who additionally have:

• Expertise in in vitro (cell lines and explants) models relevant to the inner ear with proven track record in assay development, implementation and execution
• Detailed familiarity with cochlear anatomy and physiology, in vivo and/or in vitro models of inner ear function, inner ear imaging techniques, inner ear histopathology, electrophysiology
• Deep expertise in regenerative medicine strategies, preferably in the inner ear

Position Overview & Responsibilities:

As the Senior Research Associate, you will be expected to work equally well in self-starting mode as well as a member of a matrixed team within Decibel. Your initial focus will be to develop, implement and execute appropriate in vivo and/or in vitro assays required for the advancement of both specific high priority projects as well as Decibel’s inner ear platform. As one of the key early hires for the company, you will work in close collaboration with the management team and scientists to ensure that our pre-clinical programs and technology platform are based on solid scientific foundations, accurate feasibility assessments, and grounded in realistic, corporate aligned goals.

 Requirements:

• BS or MS in pharmacology, biology, molecular and/or cellular biology
• At least 3 to 5 years of hands-on experience with in vivo models, cell culture, RT-PCR, Elisa, protein analysis, DNA prep
• Demonstrated ability to thrive in a team environment
• Strong experimental background and bring a rigorous, analytical approach to problem solving
• Ability to function equally well in self-starter mode as well as a member of a matrixed team

 Knowledge, Skills, and Abilities:

• Prepare protocols and SOPs for diverse assays
• Independently design, execute, troubleshoot, and interpret biological experiments in support of program objectives
• Maintain accurate documentation of experiments
• Interact and communicate results and conclusions within the biology/pharmacology group and cross functional project teams
• Review the scientific literature to remain abreast of developments in relevant fields

 Preference will be given to candidates who additionally have:                                                                                                                   

• Expertise in in vitro (cell lines and explants) models relevant to the inner ear with proven track record in assay development, implementation and execution
• Familiarity with cochlear anatomy and physiology, in vivo and/or in vitro models of inner ear function, inner ear imaging techniques, inner ear histopathology, electrophysiology
• Familiarity with regenerative medicine strategies, preferably in the inner ear
• Demonstrated experience with assay development
• Facile vocabulary re inner ear imaging techniques, inner ear histopathology, cochlear function, models of cochlear dysfunction
• Familiarity with inner ear anatomy and function
• Ability to be productive in a fast-paced, team-work, multi-task environment
• Outstanding interpersonal and communication skills

Position Overview and Responsibilities:

As the Assoc. Dir/Director of Program Management, you will oversee Decibel’s R&D portfolio and create the company’s global project management and resource capacity planning capability, tools, and metrics in order to enhance the efficiency and effectiveness of Decibel’s matrix operating model, and support the company’s growth.  You will oversee broad program management for pipeline programs and will be responsible for the hands-on management of program operations. You will work collaboratively with the program teams to manage and integrate the diverse R&D of drug development and operational activities through interactions with Research, Pharmacology, Translational Research, Clinical Operations, Finance, and Business Development. By ensuring the appropriate use of tools and metrics, you will enhance project and program delivery and information dissemination to the business; ultimately aligning program activities with corporate strategy and driving value creation and results.

Requirements: 

• BS/BA, MSc, PhD and/or MBA preferred
• 15+ years’ experience in life sciences industry, with 10+ years of demonstrated program management experience managing cross-functional product development efforts
• The candidate will be expected to thrive in a fast paced, dynamic, and nimble environment of an emerging company that depends on strong links and collaboration with external stakeholders (research organization, clinical sites, manufacturing vendors, etc.)
• Outstanding leadership skills and demonstrated passion for creating new medicines, including excellent verbal and written communication skills, an innovative approach to problem-solving, and an integrated view of business and scientific issues
• Demonstrated project management skills; must have high degree of energy, accuracy and attention to detail

Knowledge, Skills, and Abilities:

• Ability to thrive in a fast paced innovative environment while remaining flexible, proactive, resourceful and efficient are essential
• Ability to work independently and successfully in a matrix environment, and to prioritize and manage multiple tasks simultaneously
• Ability to integrate cross-functional issues and balance competing priorities effectively
• Excellent analytical and organizational skills (resources, timelines, cost/risk/benefit analysis)
• Fluency with project management tools (GANTs, Excel, etc.)
• Strong communication skills (PPT presentations, writing, etc.)
• Able to influence cross-functionally and successfully negotiate desired outcomes

Click to apply:  https://career012.successfactors.eu/sfcareer/jobreqcareer?jobId=117002&company=merckgroup&username=

Job Title: Scientist, Protein Engineering and Antibody Technologies Department

Ph.D. without industrial experience, or with up to 3 years of experience (including Post Doc experience)

Conducts experiments with limited supervision.

The candidate will contribute to the Discovery projects portfolio by planning, executing and drawing conclusions from experiments to evaluate the clinical potential of antibodies and of engineered biotherapeutic candidates. The candidate will contribute to evolving our antibody discovery and protein engineering programs to the next level by testing and executing ideas for new Biotherapeutic and Discovery approaches. Through hands-on lab work will run assays to characterize antibodies and proteins, including quantitative measurements of binding to cells, protein-protein interactions, and activity in cell-based assays. The group focuses on protein and antibody design, optimization and characterization for early stage development of biologics.

The candidate will interact with other members of the Protein Engineering and Antibody Technologies department as well as the Protein and Cell Sciences groups.

Key Tasks and Responsibilities:

• Flow cytometry
• Measurements of protein binding (Biacore, Octet, ELISA)
• Cell culture and mammalian cell-based assays including plate-based or microscopy-based analyses
• Cell-based assays (proliferation, cytotoxicity, signaling, internalization, ADCC &CDC)
• Proven ability to implement in vitro assays in medium to high throughput mode
• Molecular biology (PCR, subcloning) and protein expression/purification experience in different hosts an asset
• Proven track record of independently designing, executing and troubleshooting experiments based on protocols provided by the literature, seminars, or other scientists
• Present experimental results, conclusions, and future plans clearly and in context of larger organizational goals to own department, project team members and project teams
• Ability to work with and pro-actively engage with a multi-disciplinary team of diverse scientists
• Write clear and concise lab notebook entries and presentations to summarize key results
• Autonomously write study reports and scientific papers that require minimal revisions
• Read and critically evaluate the literature in specialized scientific field, and share relevant topics with team
• Train staff from other groups or projects in own area of expertise
• Search for expertise relevant to scientific area available both inside and outside the company
• Effectively operate a range of laboratory instrumentation and recommend modifications/upgrades

PROFESSIONAL SKILLS & EXPERIENCE

• Good publication record required
• Demonstrated experience using in vitro biochemistry assays such as: cell binding via flow cytometry, Kinexa or other methods; affinity determination via label-free methods (SPR, Interferometry) or fluorescence based methods (fluorescent probes, anisotropy, FRET) or equilibrium methods; ELISA or chemiluminescence (MSD)
• Protein analysis (SDS-PAGE, SEC)
• Good knowledge of protein biochemistry (structure, stability, and protein-protein interactions)
• Experience with protein stability studies an asset
• Specific experience in antibody structure/function studies or other biotherapeutic types an asset
• Mammalian cell culture and cell transfection
• Assays with primary cells such as PBMCs an asset

PERSONAL SKILLS & COMPETENCIES

• Ability to work in intense, fast paced, matrixed work environment
• Strong sense of initiative and interest in learning new technologies
• Excellent oral and written communication skills
• Good interpersonal skills essential to effectively work with colleagues

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.

Overall Responsibilities:
The Zhang Lab at the Broad Institute of MIT and Harvard is looking for a highly-motivated individual to work as a full-time Research Associate within a highly creative and dynamic research team of scientists, engineers, and life science entrepreneurs. The individual will participate in research projects for a new faculty member. The laboratory uses a wide range of techniques including molecular, optical, computational, biochemical, electrophysiological and genetic approaches to develop and apply new technologies to the study of brain function and diseases and novel genome editing techniques.

SPECIFIC RESPONSIBILITIES INCLUDE:
1) working closely on a specific project with a senior graduate student
2) Molecular cloning, DNA/RNA purification and high throughput in vitro assays related to the project
3) Routine maintenance of mammalian cell lines. The position offers an excellent opportunity to directly participate in an exciting and fast-paced field of research. The individual should have previous research experience, good organizational and communication skills, a knack for precise work and a strong desire to learn.

Characteristic Duties:
- Must have mastery of basic molecular biology skills, including nucleic acid purification, DNA cloning, PCR, and gel electrophoresis
- Help carry out experiments on a daily basis
- Maintenance of basic cell cultures (mammalian cell lines)
- Experience with protein purification or in vitro biochemistry a plus but not a requirement

A bachelor's degree in molecular/cellular biology, neurobiology, chemistry, or a related field. Basic computer skills and previous laboratory experience is required.
Experience in molecular biology, cloning, and cell culture is highly desirable.
Must be independent and self-motivated, yet able to work as part of a research team.
A minimum of 2 year commitment is required.

The start date is as soon as possible.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

APPLY HERE: http://grnh.se/hr4odi

COMPANY:

The development of CRISPR/Cas9 gene editing technology opens a new frontier in biomedical research and clinical intervention. Adapted from a natural cellular process, CRISPR/Cas9 permits the editing of any gene in any organism with unprecedented simplicity and flexibility. Intellia Therapeutics was founded in 2014 by Caribou Biosciences and Atlas Venture, along with a consortium of leading scientists who have helped define the space. Intellia Therapeutics holds exclusive access to a broad intellectual property portfolio covering the application of CRISPR/Cas9 technology for human therapeutic use. As we build our team, we’re looking for people who share our commitment and energy to make a difference. 

SUMMARY:

Intellia is seeking highly skilled and motivated cell and molecular biologists to join our growing team. The primary responsibilities for this position will be to support the identification and prioritization of lead candidates through cell-based assays and next-generation sequencing (NGS) screening.

GENERAL RESPONSIBILITIES:

• Maintain and generate tissue culture cells for NGS analysis
• Purify genomic DNA for NGS library preparation
• Assist in optimizing NGS library preparation protocols
• Perform NGS library preparation for multiple programs
• Operate and maintain NGS sequencing instrument
• Support discovery projects to develop novel molecular biology techniques
• Execute experiments to troubleshoot and optimize protocols
• Communicate research and development findings with internal teams

REQUIRED SKILLS:

• Extensive experience with cell culture and transfection techniques
• Experience and knowledge with standard molecular biology techniques
• Ability to perform cell-based assays in high-throughput formats

  PREFERRED SKILLS:

• Experience with NGS library preparation and/or operating sequencing machine
• Hands-on experience with robotic liquid handling system

QUALIFICATIONS:

• B.S. in biochemistry, molecular biology, or related field with at least 3 years of industry experience, or M.S. in biochemistry, molecular biology, or related field with at least 1 year of industry experience.

COMPETENCIES:

• Attention to detail
• Ability to follow Standard Operating Procedures (SOPs)
• Exceptional time management
• Effective communication skills (both written and verbal)
• Ability to work independently and collaboratively

APPLY HERE: http://grnh.se/hr4odi

POSITION: Full-Time, Exempt

LOCATION: Cambridge, MA

EEOC Statement: Intellia believes in a diverse environment, and is committed to equal employment opportunity for all its employees and qualified applicants. We do not discriminate in recruitment, hiring, training, promotion or any other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, marital or veteran status, disability, or any other legally protected status. Intellia will make reasonable accommodations for qualified individuals with known disabilities

Fermentation and Plasmids Manufacturing, Scientist I/II

Clinical-stage, fast-growing gene therapy company

With our lentiviral-based gene therapy and gene editing capabilities, we have built an integrated product platform with broad potential application to severe genetic diseases and T cell-based immunotherapy. Our clinical programs include Lenti-D™, currently in a Phase 2/3 study, called the Starbeam Study, for the treatment of childhood cerebral adrenoleukodystrophy, and LentiGlobin®, currently in three clinical studies: a global Phase 1/2 study, called the Northstar Study, for the treatment of beta-thalassemia major; a single-center Phase 1/2 study in France (HGB-205) for the treatment of beta-thalassemia major or severe sickle cell disease; and a separate U.S. Phase 1 study for the treatment of sickle cell disease (HGB-206). We also have ongoing preclinical CAR T immuno-oncology programs, as well as discovery research programs utilizing megaTAL/homing endonuclease gene editing technologies.

Join bluebird bio’s enthusiastic and collaborative team and contribute to the overall success of our novel gene therapy approaches.  bluebird bio seeks an outstanding scientist to manage plasmid DNA production activities, a critical starting material to the generation of our lentiviral vector.   You will have the opportunity to work collaboratively with multiple CMOs to ensure the clinical supply of plasmids, as well as validate the plasmid manufacturing process.  We seek candidates with proven ability to successfully work independently and collaboratively across functions to achieve optimized project plans, with the ultimate goal to deliver therapies that transform the lives of patients.

About the role:

• Manage all plasmid production programs for the company, as both the technical expert and the operational lead. 
• Work with internal teams to transfer plasmid candidates to CMOs for GMP productions.
• Oversee all GMP production activities at CMOs.  Includes all activities from initial cell banking through final fill/finish. 
• Author quality system documentation to allow for GMP-grade material release – including change controls and associated deviations, investigations, and CAPAs.
• Lead a CMO through the characterization and validation of a plasmid process for commercial supply.  This includes the design and application of DOE studies.
• Work with supply chain function to ensure the clinical supply of plasmids for lentiviral vector manufacturing.
• Interface with internal process development groups to ensure plasmid supply for all internal research and development activities.
• Provide the technical expertise around plasmids for regulatory submissions and other technical reports.
• Generate, manage, evaluate, and maintain critical data in a highly organized manner. Author technical reports, tech transfer documents, and prepare scientific presentations as needed. Write/revise SOPs as needed.

About you:

• BS in (bio)chemical engineering or biological sciences with 8+ years, MS with 6+ years, or a PhD with 0-2+ years of industrial experience in bacterial fermentation.
• Experience with microbial fermentation and downstream processing is required.
• Experience with producing and purifying recombinant DNA products, including plasmid DNA is strongly preferred.
• Experience with GMP manufacturing is strongly preferred.
• Experience with technical transfer or vendor management is preferred.
• Experience with process characterization and validation a plus.
• Should be highly motivated, have excellent organizational and communication skills, and be able to multitask in a fast-paced environment with changing priorities.
• Must be able to work both independently and as part of a multi-disciplinary team.
• Must be willing to have a flexible schedule based on experimental and company needs (including possible travel)
• Excellent communication skills and ability to influence across multiple functions.
• Be ready to embrace the principles of the bluebird bio culture:  b colorful, b cooperative, and b yourself

bluebird bio is a publicly traded company on the NASDAQ  Global Select Market and trades under the symbol BLUE.  We offer a fast-paced, dynamic, collaborative, colorful, and scientifically rigorous environment, with all the fun and passion that a start-up provides, plus an excellent benefits package that includes stock options, commuter/parking benefit, etc.

bluebird bio, 150 Second Street, Cambridge, MA 02141 www.bluebirdbio.com

bluebird bio will only accept job applications from candidates who are properly documented with authorization to work in the United States.

Note to Employment Agencies: Please do not forward any agency resumes. bluebird bio is not responsible for any fees related to resumes that are unsolicited.

GENERAL SUMMARY OF POSITION:

The Program in Molecular Medicine at the University of Massachusetts Medical School was established in 1989. Faculty include both clinical investigators and basic scientists, many of whom focus their research on human disease processes. The laboratory groups and core facilities that compose Molecular Medicine represent many disciplines in the bio-medical sciences. This diverse scientific environment provides exceptional education, training, and professional development opportunities for our staff, who in turn greatly enrich our scientific environment.

The laboratory in the Program in Molecular Medicine addresses mechanisms of insulin signal transduction, metabolic regulation and insulin resistance in obesity and type 2 diabetes. The Principal Investigator's (P/I) laboratory has applied RNAi-based technologies to discover functions of adipocyte proteins in regulating whole body metabolism and to develop therapeutic strategies for alleviating inflammation and metabolic diseases. The P/I has authored approximately 300 publications, has served on several editorial boards and NIH Study Sections, and is a member of Scientific Review Board of the Howard Hughes Medical Institute.

Under the general direction of the Principal Investigator or designee, the Research Associate II performs a variety of complex research experiments and is responsible for overseeing laboratory operations within the Department.

MAJOR RESPONSIBILITIES:

• Perform complex laboratory experiments and conduct in-depth analysis of research experiments
• Write standard operating procedures, schedule work, analyze data, maintain accurate records, and write reports
• Report the status of projects and observations to the Department Chair
• Ensure departmental computer resources remain functional and provide on-site support to Investigators as requested
• Design and execute protocols and experiments, modify protocols as needed, and may be responsible for own research project
• Manage laboratory research staff
• Responsible for overall laboratory organization including oversight of safety protocols and the maintenance of related records
• May assist with budget and/or operational aspects of grant and contract proposals
• Long-range planning for laboratory and departmental equipment maintenance and replacement. Assist in procurement of departmental equipment. Responsible for physical inventory of all equipment, and maintaining records of all equipment acquired, moved off-site, or discarded
• Oversee and coordinate the use of centralized departmental facilities
• Work with Facilities Engineering, Environmental Health and Safety, and Radiation Safety to ensure department facilities and laboratories are in compliance with federal, state and institutional regulations
• Assist in writing the text of scientific publications and grants. Review literature
• Oversee and assist in the training of new laboratory personnel, students, and collaborators
• Comply with all safety and infection control standards
• Perform other duties as required

REQUIRED QUALIFICATIONS:

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

PREFERRED QUALIFICATIONS:

• Masters Degree
• Experience with in vivo experiments wth mice
• Experience with molecular techniques such as DNA cloning, PCR, Western Blotting
• Experience with cell biology techniques such as confocal mocroscopy

Apply Here
PI92164595

We are currently seeking an Associate Director, Quality Assurance to assist with developing and maintaining Momenta’s quality assurance programs. Primary responsibilities in this position include internal and external audits The successful candidate will conduct external audits of CMOs, MROs, and CLSs. Strong knowledge of drug development from early phase development through commercialization is required. The successful candidate will also oversee the validation function at Momenta, including computer system validation and equipment qualification. The successful candidate will write, review, approve and implement quality related policies and SOPs as required. The successful candidate will also assist the Director of QA with hosting inspections and negotiation of Quality Agreements.

Required Skills

Requirements 

• BS in life sciences with 10+ years experience in the pharmaceutical or biotechnology industry.
• Experience with audits and FDA inspections as well as a strong understanding of qualification and validation requirements.
• Strong knowledge of FDA guidelines and regulations regarding cGMPs.
• Outstanding written and verbal skills as well as problem solving skills.
• Demonstrated team player with experience contributing to multi-disciplinary project teams and ability to work with minimal supervision.
• Strong initiative and ability to assume significant project management skills.
• Ability to work in a fast-paced, dynamic, environment.
• Domestic and International Travel is required for this position (approximately 25%)

Job ID: 27269
Date Posted: 10/22/2015
Location: 450 Brookline Ave
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

Bachelor of Science or Bachelor of Arts degree with scientific specialty required. Previous experience working in a medical or scientific research setting is preferred. We are looking for candidates who have at least two years of availability.

Research Technician: Full-time research assistant with duties that include working with laboratory mice and conducting basic molecular biology and cell biology techniques. Basic procedures include but are not limited to: pipetting; cell and tissue culture, handling of small laboratory animals, etc. The incumbent should be self-motivated and an independent worker. There will be continuous learning opportunities and the position will be a good stepping stone for those interested in biomedical research.

Schedule

Full-Time

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
PI92165248

We are seeking candidates who will assist in the design, synthesis, purification and scale up production of nucleotides. The successful candidate will be integral part of the NGS consumables department and will be responsible for design, implementation and optimization of synthesis pathways, scale up and development of SOPs as well as transferring manufacturing procedures to operations. This person will be interacting closely with the operations/manufacturing team as well as sequencing chemistry and enzyme development team.

The Scientist will:


• Plan and execute complex synthesis of proprietary nucleotide triphosphates at micro to milimolar scale
• Perform scale up of synthesis and purification of nucleotide triphopshates up to milimolar scale
• Interface with manufacturing and operations to ensure transfer of procedures
• Develop improvements in the design, synthesis and purification of nucleotide triphosphates
• Contribute to the development of intellectual property
• Collaborate closely with sequencing chemistry development group and other functional areas to meet project objectives
• Write technical reports and scientific publications/posters
• Produce and maintain proper project documentation in accordance with internal and external requirements

REQUIREMENTS

• MS or PhD or equivalent in Organic Chemistry
• Relevant industry experience: at least 3+ years industry experience
• Strong hands-on experience in complex multi-step organic synthesis and synthesis purification of nucleotides
• Experience with Sequencing by Synthesis technology
• Experience with nucleotide triphosphate synthesis and purification at micro/milimolar scale
• Extensive experience with chromatographic purification techniques, such as ion-exchange, reverse phase and analytical methods such as LC-MS and NMR
• Proven ability to design, execute and correctly intepret complex experiments
• Excellent verbal and writing skills, Excellent organizational skills
• Strong technical writing and presentation skills, prepare data for presentation and present data in lab meetings and to internal collaborators
• Good troubleshooting and problem solving skills
• Experience with product development under design control is preferred
• Minimal travel required (up to 10%)


Working Environment Mechanical hazards, chemical hazards, biological hazards
Physical Requirements Sit, move, speak, hearing acuity
Lifting Requirements Sedentary work (exerting up to 10 pounds of force)

We are an Equal Opportunity Employer and do not discriminate against any employee or applicant for employment because of race, color, sex, age, national origin, religion, sexual orientation, gender identity, status as a veteran, and basis of disability or any other federal, state or local protected class.

Senior Director Commercial Models

Cambridge based, fast-growing gene therapy company

Join bluebird bio’s enthusiastic and collaborative team by contributing to the overall success of our novel gene therapy approach. This position reports to the SVP Commercial and will be responsible for the development and execution of the commercial go to market launch model.  The role works closely with Pharmaceutical Science, Manufacturing, Market Access, Market Insights, Medical, Finance, Legal and Brand Leads to develop the bluebird bio Centers of Excellence Customer Models.  This is an opportunity to work at the forefront of gene therapy, defining and executing innovative and patient centric solutions delivering potentially transformational care for patients with serious rare and ultra rare disease.

About the Role:

• Collaborate with a cross functional team to identify and prioritize critical elements of a successful go to market customer model.
• Lead the generation of actionable deep insights informing the optimal local and regional infrastructure
• Superior quantitative and qualitative analytical capabilities with ability to communicate concise implications to bbb organization
• Define the initial and scalable solutions across first and subsequent therapy indications including:
  • Prioritized Geographies
  • Bluebird bio commercial infrastructure
  • Patient and stakeholder care models
  • Network planning, tracking and performance management
  • Work with bbb team to build and test model implementation and seamless operationalization
  • Continually source innovative answers to realize exceptional experience for patients and families

About You:

• Bachelor Degree (MBA preferred)with 8+ years experience  in biotech/pharma with a track record demonstrating accountability, sense of urgency and cross functional leadership.  Global and/or EU experience necessary.
• Knowledge, experience and proven track record of using deep customer insight to deliver innovative patient centric business solutions
• Strong analytical, communication and project management skills to effectively translate ideas and insights into actionable plan
• Excellent organizational skills, sufficient to multi-task in an extremely fast-paced environment with changing priorities
• Excellent communication skills and ability to influence across multiple functions.
• Be ready to embrace the principles of the bluebird bio culture:  b colorful, b cooperative, and b yourself

Senior Scientist, Enzyme Engineering, NGS Technologies will be responsible for development of novel improved enzymes that will be used in Qiagen’s NGS workflows. These enzymes include sequencing enzymes for the sequencing by synthesis processes as well as novel enzymes used for nucleic acids amplification. In this role Senior Scientist, Enzyme Engineering will focus on near and long term improvements to existing Gene Reader workflows as well as perform research on novel internal and external technologies which will expand the range of applications and capabilities supported by future NGS workflows/platforms. The positon will have a key role in bringing innovative solutions to current and future NGS platforms and expanding the range of applications served by these platforms. Senior Scientist will be working closely with Sample Prep and Sequencing teams as well as Engineering, to ensure seamless integration of novel enzymes into QIAGEN’s NGS portfolio.

In this role Senior Scientist, Enzyme Engineering, NGS Technologies will:

• Investigate and develop technologies and approaches (internal and external) to development of novel sequencing enzymes with improved properties including mutaganesis, in silico design and in vitro evolution which significantly improve performance and capabilities of the Gene Reader workflow
• Work closely with Sequencing Chemistry developers to integrate novel sequencing enzymes into the Gene Reader workflows
• Evaluate external technologies and engage in external collaborations to bring novel technologies to QIAGEN’s NGS portfolio
• Play a key role in the development of future improvements,  technological advances in the QIAGEN NGS platform and expansion of intellectual property
• Participate in collaborations with key external partners (industry and academia)
• Mentor and develop staff
• Deliver key insights into product application opportunities for the QIAGEN NGS platform

REQUIREMENTS

 PhD in Biology, Chemistry, Biochemistry, Bioengineering or related fields
• At least 5-10 years of relevant industry experience (NGS and adjacent technologies)
• Extensive experience with protein engineering based on rational design, mutagenesis, in silico design, and enzyme in vitro evolution
• Experience with protein purification and enzymatic activity measurements/assays
• Experience with diagnostic assay development and regulatory environment is a plus
• Excellent understanding of the underlying technical principles of next generation sequencing chemistries and workflows, associated instrumentation platforms and data analysis and interpretation algorithms
• Mandatory experience in next generation sequencing (NGS) technology development (DNA amplification, sample preparation, chemistry, instrumentation)
• Very good troubleshooting and problem solving skills
• Proven leadership and successful decision-making qualities
• Strong technical writing and presentation skills
• Moderate travel required (up to 10%)

Working Environment Mechanical hazards, chemical hazards, biological hazards
Physical Requirements Sit, move, speak, hearing acuity
Lifting Requirements Sedentary work (exerting up to 10 pounds of force)

We are an Equal Opportunity Employer and do not discriminate against any employee or applicant for employment because of race, color, sex, age, national origin, religion, sexual orientation, gender identity, status as a veteran, and basis of disability or any other federal, state or local protected class.

Summary

Provide a quality framework within the Quality System for overseeing and ensuring robust processes for product quality complaints, metrics reporting, exception reporting, CAPA/Change Control tracking systems, annual product review and internal audits.

Key Responsibilities/Essential Functions

• Lead the management of Product Quality Complaints by directly interacting with various internal and external organizations, initiating investigative tasks, compiling and interpreting investigation results, and following up with external customers.
• Compile, report and maintain periodically Quality metrics both internally and externally as needed.  This would include, but is not limited to Complaint Handling, CAPA, Change Control, and Audit activities.  From these metrics, generate trend data and interpret these trends to provide recommendations and improvement plans to processes and systems.
• Plans and executes compliance audits of internal operations as they relate to GMPs.  Assures follow up and CAPA closure for all observations noted during audits;  Recommends and implement improvements to the Internal Audit program induced by new regulations, agency guidance documents, industry standards, new technologies and internal needs
• Lead activities required to obtain, interpret and prepare product performance data to fulfill Annual Product Quality Review requirements.
• Participate in the identification, management, and follow up on product field actions including Field Alerts and product Withdrawal/Recall.
• Provide training and guidance on the use of Quality Systems applications (i.e. ProcessCompliance, CATSWeb).
• Performs comprehensive Quality review of new and revised documents, which includes reviewing document content and changes/reasons to assess change control level per applicable procedures, and ensuring that document content/change(s) supports closure requirements of referenced quality systems (i.e. Complaint Handling, CAPAs).
• Participate in identification, validation, and implementation of software applications used in Quality Systems activities associated with work activities.
• Participates in communications and activities associated with U.S. and international regulatory agency inspections of the Billerica manufacturing site.
• Actively demonstrates the Lantheus values of accountability, quality, efficiency, customer service, collaboration and safety.
• * In the case of absence, the reports to Manager above or a peer incumbent will function as a backup for this position.

Basic Qualifications

• BS/BA degree in a scientific discipline with a minimum of 8-10 years of experience in a pharmaceutical industry or related GMP environment, or equivalent.
• Quality Systems and Complaint experience is required.
• Knowledge of pharmaceutical and medical device product manufacturing, analytical testing, and good documentation practices is required.

Other Requirements

• Experienced professional is able to use concepts and company objectives to resolve complex issues in an effective manner.
• Excellent time management and communication skills, including the ability to resolve a wide variety of issues in creative ways while following regulatory requirements.
• Knowledge of electronic systems including any of the following: QMS, ERP/MRP, and LIMS desirable.
• Can independently carry out complex assignments, with few errors or omissions
• Demonstrates a strong understanding of department and business goals and contributes by prioritizing own tasks
• Keeps informed of industry-related, and technical  knowledge; applies this to day-to-day responsibilities
• May act as a technical representative/subject matter expert on QMS processes or systems
• Occasional overnight travel based on business need.  May require exposure to potentially hazardous chemical, radiological and or biological materials during audits/inspections.  Required to follow all safety procedures, and use personal and protective equipment provided.

The Director of Enzyme Development is responsible for all activities related to the discovery and development of new enzyme tools. This position is responsible to support both internally and customer-sponsored enzyme development projects, providing a range of expertise from feasibility assessment to the technical support of launched enzyme products. The Director will lead a team of scientists dedicated to the development and characterization of enzyme products, and will analyze project risks and report to senior management.

Job performance will involve a variety of activities including:

- Feasibility assessment of the potential technical, legal, and toxicity risks associated with enzyme-related projects.
- Manage enzyme development projects according to defined timelines/budget while ensuring that outputs meet internal Quality and efficiency standards.  Department responsibilities include protein engineering, development/optimization of recombinant expression constructs,  optimization of growth conditions (including scale-up through outsourced partners as needed), functional test method, and selection/development of appropriate contaminant tests
- Work closely with the Custom Business group on  externally-sponsored enzyme development projects
- As needed, work with Directors of QC and Manufacturing to design/optimize methods and troubleshoot problems
- As needed, work with the Applications team on reagent product development projects
- Conduct scientific due diligence on new enzyme technologies and opportunities.
- Manage external research collaborations related to enzymology and protein expression.
- Work with laboratory safety consulting firm to ensure continued knowledge of and compliance with applicable statutory and regulatory requirements, and communicate any changes to Director of Quality Assurance
- Additional duties as assigned.

REQUIREMENTS

- PhD plus a minimum of 10 years experience in industrial Molecular Biology, protein engineering, or a related field and/or equivalent combination of education and experience.
- Deep knowledge of recombinant DNA techniques and industrial E.coli growth optimization
- Profound understanding of general molecular biology applications and performance optimization through the application of enzymology principles
- Demonstrated protein engineering experience (rational design, crystal structure analysis, directed evolution, random mutagenesis)
- Proven team leadership experience in a fast-paced, complex environment.  Leads by example, solid team mentor, comfortable organizing team’s activities to deliver maximum results in minimum time.

PERSONAL REQUIREMENTS

- Drive and Determination
- Strong Molecular Biology Applications background
- Positive external and internal relationship management skills
- Ability to participate with others as a member of the team to ensure that demanding and difficult projects are handled smoothly and cooperatively to enhance success of project and maintain strong relationships within all parts of company
- Strong communication and presentation skills
- Proven Ability to thrive in a change oriented environment
- Self Starter
 - Driven to perform
 - Self-directed: needs little explicit direction and no hand-holding
 - Able to organize and prioritize a diverse set of responsibilities to ensure that focus on growth and success of company is achieved
- Proven coaching, mentoring, team-building and leadership skills

Working Environment Mechanical hazards, chemical hazards, biological hazards
Physical Requirements Sit, move, speak, hearing acuity
Lifting Requirements Sedentary work (exerting up to 10 pounds of force)

We are an Equal Opportunity Employer and do not discriminate against any employee or applicant for employment because of race, color, sex, age, national origin, religion, sexual orientation, gender identity, status as a veteran, and basis of disability or any other federal, state or local protected class.

Company Overview

Aegerion Pharmaceuticals is a biopharmaceutical company dedicated to the development and commercialization of innovative, life-altering therapies for patients with debilitating often fatal, rare diseases.

Position Description

The Staff Accountant will be a key member of the finance team.  This position will be responsible for accounting support for segments of the business.  General ledger and month end responsibilities include but are not limited to preparing journal entries and balance sheet reconciliations as well as assisting with financial reporting, internal and external audits.  

This position will interact with all levels of management.  This is a hands-on position and the ability to multitask and work with others is essential.

Key Responsibilities

• Assist with the month-end close functions in accordance with the financial close schedule.
• Prepare and post journal entries with appropriate documentation.
• Ensure that reconciliations and supporting schedules are completed timely and in accordance with the monthly closing schedule.
• Understand, develop, and enforce proper accounting practices and controls.
• Assist in the coordination of SOX compliance documentation and testing.
• Assist in the coordination of external audits.
• Other ad hoc reporting and projects as assigned.

• Correspond with other departments to ensure proper accounting for      purchases and month end accruals.

Qualifications and Experience

• BA/BS with a major in Accounting, CPA a plus but not required.
• Oracle E-Business Suite R12 experience a plus.
• 2+ years of general ledger experience; pharmaceutical industry experience a plus.
• Solid understanding of accounting concepts required.
• Understanding of internal controls, accounting processes and procedures
• Proven attention to detail, an ability to provide professional customer service to internal and external customers alike.
• Ability to interact with co-workers and various levels of management needed.
• Team player and solid communicator; strong interpersonal skills.
• Enjoy working in a fast paced, high volume environment.
• Ability to meet deadlines.

Resumes from third party vendors will not be accepted.

Aegerion Pharmaceuticals is an Equal Opportunity/Affirmative Action Employer: Minorities/Females/Disabilities/Veterans

RESPONSIBILITIES

Assist and define an overall platform strategy for NGS workflow

Inspire the NGS product portfolio strategy and product roadmap for a comprehensive view of all components in the NGS workflow

Establish customer requirements for NGS Workflow with an emphasis on hardware and software
Collaborate with NGS marketing team to ensure alignment

Network with key opinion leaders

Develop and drive implementation of successful global marketing campaigns

Guide and support our sales and market development  teams and secure continuous business success in a competitive and fast changing environment

REQUIREMENTS

Masters degree in Molecular Biology or related fields with a minimum 3 years lab experience

Minimum of 5 years proven sales and marketing experience in a multinational business

Deep knowledge of NGS technologies, applications, and markets
  
Good understanding of the molecular diagnostic market and key segments

An ambitious and autonomous performer with strong leadership and self-motivation skills who can build relationships and work in teams

Fluency in English, excellent written and verbal communication and presentation skills

Willingness to travel internationally (~25%)

We are an Equal Opportunity Employer and do not discriminate against any employee or applicant for employment because of race, color, sex, age, national origin, religion, sexual orientation, gender identity, status as a veteran, and basis of disability or any other federal, state or local protected class. 

About Veristat

Join a team that works on groundbreaking compounds and profoundly impacts patients’ lives! Veristat is a distinct, full-service contract research organization with offices in California, Massachusetts, and Quebec. Due to our growth and investment we have recently relocated our headquarters to Southborough, MA. Veristat is serious about scientific integrity and has a dynamic company culture, including a focus on work-life balance. 

Veristat’s Value Proposition for You

• Flexible work schedule.

• Proven potential for professional growth.

• A community of brilliant minds at your disposal.

• The stability of working for a robust, financially sound CRO that is growing at a sustainable pace.

• Exposure to more than 20 therapeutic areas, including cutting edge therapies such as immuno-oncology, biosimilars, gene therapy, and new molecular entities.

As the Associate Director of Corporate Compliance You Will…

• Oversee quality management and training. Encourage problem-solving processes leading to solutions for leverage across departments. Ensure sharing of initiatives and ideas across these same groups.

• Direct the internal auditing function and, under the direction of senior management, assist departments with external audit readiness.

• Monitor the development, approval, periodic review, revision, version control, and historical archival of all Standard Operating Procedures (SOPs) and supporting documents.

• Ensure that Veristat has appropriate corporate policies, procedures, and infrastructure and that staff adhere to SOPs and are qualified to perform regulated tasks.

• And more!

Education and Experience

• Bachelor’s degree in a science or related field. Master’s degree preferred.

• At least five years of relevant industry experience in Quality Assurance/Compliance. Two or more years of management experience recommended.

Development Lead, Nucleic Acid Amplification will be responsible for leading development of novel, streamlined methods of nucleic acid processing and amplification compatible with Qiagen’s NGS workflows. In this role Senior Scientist will focus on near and long term improvements to existing Gene Reader workflows as well as perform research on novel internal and external technologies which will expand the range of applications and capabilities supported by future NGS workflows/platforms. The position will have a key role in bringing innovative solutions to current and future NGS platforms and expanding the range of applications served by these platforms. Development Lead will be responsible for delivery of all technical performance aspects of the clonal amplification process as defined by product requirements. Development Lead will work collaboratively with the Library Preparation, Sequencing and Engineering teams to integrate clonal amplification into the overall Gene Read workflow. .


In this role Development Lead, Nucleic Acid Amplification will:

• Direct the development of all aspects of the clonal amplification segment of the NGS workflow, including chemistry and disposables and work closely with hardware and software as well as assay integration) to develop overall GeneRead NGS workflow from sample to insight
• Ensure that all development activities within his area are compliant with QIAGEN’s Good Development Practices and Global Development Procedures
• Lead the Clonal Amplification Development Team in a matrix leadership role
• Deliver the required technical performance of the sequencing process according to specification, on time and within budget
• In collaboration with the Program Management Department, develop an overall Project Plan with specific work packages for the cross-functional sequencing team, including a concise description of activities, roles and responsibilities and a timeline with milestones
• Mentor and develop staff under their direction
• Participate in) collaborations with key external laboratories/institutions
• Deliver key insights into product application opportunities for the QIAGEN NGS platform

REQUIREMENTS

• PhD in Biology, Chemistry, Biochemistry, Bioengineering or related fields
• At least 7-10 years of relevant industry experience (NGS and adjacent technologies)
• Extensive experience with solid phase nucleic acid amplification and detection technologies
• Experience with various nucleic acid amplification schemes/enzymes
• Experience with diagnostic assay development and regulatory environment is a plus
• Excellent understanding of the underlying technical principles of next generation sequencing chemistries and workflows, associated instrumentation platfoms and data analysis and interpretation algorithms
• Mandatory experience in next generation sequencing (NGS) technology and product development (chemistry and hardware) with a documented record of success in the life sciences and/or molecular diagnostics markets
• Strong management skills with a track record of increasing responsibilities and the management of medium to large groups in both direct and matrix management environments; international experience preferred
• Very good troubleshooting and problem solving skills
• Proven leadership and successful decision-making qualities
• Strong technical writing and presentation skills
• Moderate travel required (up to 10%)

Working Environment Mechanical hazards, chemical hazards, biological hazards
Physical Requirements Sit, move, speak, hearing acuity
Lifting Requirements Sedentary work (exerting up to 10 pounds of force)

We are an Equal Opportunity Employer and do not discriminate against any employee or applicant for employment because of race, color, sex, age, national origin, religion, sexual orientation, gender identity, status as a veteran, and basis of disability or any other federal, state or local protected class.