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Process Engineer II, Purification

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Description
Genzyme has pioneered the development and delivery of transformative therapies for patients affected by rare and debilitating diseases for over 30 years. We accomplish our goals through world-class research, collaboration with the global patient community, and with the compassion and commitment of our employees. With a focus on rare diseases and multiple sclerosis, we are dedicated to making a positive impact on the lives of the patients and families we serve. Genzyme's portfolio of transformative therapies, which are marketed in countries around the world, represent groundbreaking and life-saving advances in medicine. As a Sanofi company, Genzyme benefits from the reach and resources of one of the world's largest pharmaceutical companies, with a shared commitment to improving the lives of patients. Learn more at www.genzyme.com

Manufacturing Technical Service (MTS) is the keeper of the body of manufacturing process knowledge, supports the creation of the instruction set and ensures manufacturing operations stay aligned with the registered process. The Manufacturing Science Laboratory group within MTS is responsible for providing laboratory based technical support to both Framingham manufacturing facilities. The primary objective is to ensure manufacturing processes are capable, compliant, in control and continuously improved.  

The Manufacturing Sciences Laboratory is responsible for:
- Providing technical leadership in process-related investigations- Developing strategy for process validation activities
- Provide input to the Process Control Strategy and Operational Control Strategy
- Identifying and implementing commercial process/product life cycle improvements
- Defining relevant operational/technical standards and practices for the site
- Identifying and driving implementation of improvements to maximize throughput and capacity utilization
- Lead the proposal, initiation, testing and implementation of minor proposed changes to purification processes.
- Develop, transfer and maintain robust scale down models to support manufacturing operations
- Design and execute experiments using scale down models and laboratory capabilities to support effective root cause investigations for commercial manufacturing operations.
- Design and execute experiments using scale down models to expand design space knowledge for commercial manufacturing processes.
- Utilize this knowledge to effectively support root cause analysis, process validation, implementation of process improvements, and improvements in process control strategies.
- Utilize scale down models and laboratory capabilities to enable effective tech-transfer efforts
Position SummaryThe Process Engineer II works in the Manufacturing Science group to provide expert technical support to Commercial Operations at the Framingham Biologics site. Responsible for executing purification experiments in support of commercial GMP operations at Genzyme's Framingham Manufacturing Sites. This includes, but is not limited to, experimental support for deviations or manufacturing investigations, process troubleshooting, raw material evaluation, support of validation programs, exploration of process design space and continuous process improvement. This person is also responsible for analyzing and drawing accurate conclusions and recommendations from the experimental data.  

Core Responsibilities
 

This individual will work within the Manufacturing Science organization with the following responsibilities:

  • Primarily responsible for hands on execution of experimental work in the Manufacturing Sciences laboratory.
  • Interact with colleagues from the site MTS teams and other functions
  • Provide technical support to GMP operations in a multi-product cell culture and purification plant.
  • Partner with Manufacturing and Quality organizations in daily operations to maintain the process in a reliable state of control.
  • Develop process knowledge and ownership.
  • Perform process monitoring using a variety of data analysis methods and techniques (e.g., excel, JMP, etc.).
  • Provide technical support and analysis for the resolution of deviations, investigations and process issues.
  • Identify, own and resolve process issues proactively.
  • Lead the proposal, initiation, testing and implementation of minor proposed changes to cell culture processes
  • Completes technical investigations and provides technical expertise.
  • Generate documents (technical memos and reports, protocols, etc.,) related to process monitoring programs and non-conformances.
  • Participate in cross functional initiatives.
  • Keep abreast of new developments/technologies in areas of responsibility.

Initially, this position will be responsible for activities related to start-up and operational readiness of the Framingham Manufacturing Science lab. Responsibilities will include: designing and executing wet test, qualification and sterility studies, setting up automation and data systems and technology transfer of the small scale models and analytical methods into the Manufacturing Science lab. Lab start-up will culminate in proof-of-concept runs that demonstrate the ability to operate the qualified Scale down models in the Framingham Manufacturing Science lab.

Qualifications

Leadership Qualifications
An ongoing commitment to conducting our global business according to the highest legal and ethical standards, and to continually pursue excellence in the development and delivery of all of our products and services.

This includes:

  • Adhering to all applicable laws and regulations of the places in which we conduct business, as well as our own Company policies and procedures.
  • Being honest and treating people with respect and courtesy.
  • Constantly striving to make Genzyme a great place to work, and a company respected for the quality of its people and products.
  • Acting as role models for our fellow employees by acting responsibly, fairly, and honestly in our dealings and exercising sound judgment in performing our jobs.

Basic Qualifications

  • BS in engineering with at least 3+ years, or MS in engineering with at least 1+ years relevant experience in a cGMP manufacturing environment.
  • Hands-on laboratory experience in biotechnology protein purification processes.
  • Knowledge of large scale biotechnology unit operations, principles of SIP and CIP, principles of biochemical engineering, and process data analysis.
  • Understanding of compliance and cGMP considerations.
  • Demonstrated commitment to continuous improvement - at the individual, department and organizational levels.
  • Experience with high level data analysis and strong technical writing skills

Preferred Qualifications:

  • Experience in the scale up and operation of large scale biotechnology processes.
  • Hands-on experience with large scale biotechnology unit operations.
  • Process development experience is highly desirable.

To apply for this position, please CLICK HERE


Associate Director, Medical Communications (250-419)

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ARIAD is a Cambridge, Massachusetts-based biotechnology company focused on cancer. We are a cohesive team of talented people from diverse backgrounds with a shared vision: We seek to transform the lives of patients with breakthrough cancer medicines. This is our purpose. This is our passion. This is our promise.

 

Summary This position will report to the Director of Global Medical Communications within the Global Medical Affairs department at ARIAD pharmaceuticals Inc.  This is a strategic position supporting internal and external ARIAD customers.  The individual will primarily be responsible for preparation and accuracy review of content for ARIAD’s proprietary compounds for internal and external audiences.  Prior experience in Medical Communications is essential; oncology experience is preferred. Responsibilities
Oversee and manage all aspects of content management for Global Medical Communications, including budget planning and forecasting, vendor relations, and projects Preparation of content for Global Medical Communications projects including, but not limited to, advisory boards, steering committee and investigator meetings, field resource tools and training materials Preparation and review of content for other Medical Affairs departments including Medical Science Liaisons (MSLs), Medical Information, Outreach and Advocacy, and Health Economics and Outcomes Research (examples include slide decks, dossiers, and training materials) Serve as the medical reviewer on cross-functional teams to ensure the medical accuracy and approve the content of marketing and promotional materials, as well as scientific publications and MSL materials Maintain and update the scientific platforms for ARIAD proprietary compounds Provide strategic oversight and direction for ARIAD Knowledge Services, which incorporates the eLibrary, including regular review of processes and technology to promote sharing of information across the organization Critically evaluate the published medical and scientific literature related to ARIAD products and competitive products Provide regular updates on the competitive landscape and robust literature searches for medical affairs colleagues, as well as Clinical Research and Development departments such as safety, clinical and medical Oversee the distribution of literature search notification alerts to internal stakeholders, including communication of real-time news on publications relevant to ARIAD’s proprietary compounds Represent Global Medical Affairs at congresses and major meetings, as required Manage other Medical Communications personnel, as needed Assist the Director of Medical Communications with managing resources and priorities within and across the department, which includes publications, medical information, MSL training and content management Ensure compliance with all applicable laws, regulations and guidelines Serve as a role model for compliant behavior that is consistent with the mission, vision and values of the ARIAD organization.
Requirements
Advanced degree (PhD or PharmD) in a scientific discipline or equivalent 5 years or more of direct pharmaceutical industry experience in Medical Communications and Medical Affairs is essential Oncology experience strongly preferred Excellent ability to interpret and present medical, scientific and clinical trial data Experience with literature management applications that integrate with scientific/medical bibliographic databases and a literature document repository (eg, QUOSA) preferred Proficiency with standard software including Microsoft Office, PubMed, EMBASE, Endnote Excellent attention to detail and problem solving skills Initiative and ability to manage multiple assignments and maintain high level of productivity with minimal supervision Excellent interpersonal, verbal, and written communication skills Willingness and ability to travel Strong commitment to business ethics Understanding of, and experience with, regulatory framework applicable to interactions with health care professionals (HCPs), payers, advocacy and other business partners Understanding of, and experience with, regulatory framework applicable to interactions with HCPs, payers, advocacy and other business partners.

 

Submitting a resume online at a job site could cause valuable screening information to be missed.
Click here to apply: http://ariad-openhire.silkroad.com/epostings/submit.cfm?fuseaction=app.dspjob&jobid=250&company_id=16419&jobboardid=306
ARIAD is an equal opportunity employer. The Company's policy is to afford equal employment opportunities to qualified individuals without regard to race, color, religion, national origin, ancestry, citizenship, marital status, veteran status, physical or mental disability, sex, sexual orientation or age and to comply with applicable laws and regulations. All employment decisions will be consistent with the principle of equal employment opportunity.

Scientist

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ENTRY LEVEL POSITION

  • To develop and validate methods to purify cells from cell debris.
  • Must have a BS or MS in Cell Biology or equivalent.
  • No more than 0 to 1 year of industrial experience.
  • Be able to demonstrate the capacity to operate and maintain a small cell biology laboratory.
  • Must have a semester course in cell culture from an acredited university.
  • Must have a semester course in microscopy or equivalent.
  • Must demonstrate a capacity to maintain accurate records.
  • Must be able to demonstate the ability to schedule method development and validation activities.
  • Your cover letter should address each of these 8 points to be considered for employment.

Senior Pharmaceutical Sales Representative - San Francisco/Bay Area, CA

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Lantheus Medical Imaging is a global leader in developing, manufacturing and distributing innovative diagnostic imaging agents.  For more than 55 years, Lantheus has been dedicatedto creating and providing pioneering medical imaging solutions to improve the treatment of human disease. The company’s proven success in discovering, developing and commercializing innovative medical imaging agents provides a strong platform from which to bring forward new breakthrough tools for the diagnosis and management of disease.

Lantheus imaging products include DEFINITY® Vial for (Perflutren Lipid Microsphere) Injectable Suspension, the leading ultrasound contrast agent used in ultrasound exams of the heart, also known as echocardiographic exams; ABLAVAR® (gadofosveset trisodium), a first-in-class magnetic resonance agent indicated for the evaluation of aortoiliac occlusive disease in adults with known or suspected peripheral vascular disease; Cardiolite® (Kit for the Preparation of Technetium Tc99m Sestamibi for Injection), a cardiac imaging agent that is the most successful radiopharmaceutical ever introduced and; TechneLite® (Technetium Tc99m Generator).

Lantheus has approximately 600 employees worldwide with headquarters in North Billerica, Massachusetts, and offices in Puerto Rico, Canada and Australia.

Lantheus Medical Imaging is a global leader in developing, manufacturing and distributing innovative diagnostic imaging agents.  For more than 55 years, Lantheus has been dedicatedto creating and providing pioneering medical imaging solutions to improve the treatment of human disease. The company’s proven success in discovering, developing and commercializing innovative medical imaging agents provides a strong platform from which to bring forward new breakthrough tools for the diagnosis and management of disease.

Lantheus imaging products include DEFINITY® Vial for (Perflutren Lipid Microsphere) Injectable Suspension, the leading ultrasound contrast agent used in ultrasound exams of the heart, also known as echocardiographic exams; ABLAVAR® (gadofosveset trisodium), a first-in-class magnetic resonance agent indicated for the evaluation of aortoiliac occlusive disease in adults with known or suspected peripheral vascular disease; Cardiolite® (Kit for the Preparation of Technetium Tc99m Sestamibi for Injection), a cardiac imaging agent that is the most successful radiopharmaceutical ever introduced and; TechneLite® (Technetium Tc99m Generator).

Lantheus has approximately 600 employees worldwide with headquarters in North Billerica, Massachusetts, and offices in Puerto Rico, Canada and Australia.

The purpose of this position is twofold. First to market and sell our Definity and Ablavar products ices to key decision makers in assigned territories to achieve desired sales goals. Second is to support the development of sales professionals by providing sales and product training to field representatives. Sales training is estimated to account for approximately 30% of the incumbents time while 70% is to be dedicated to selling responsibilities.

Essential Functions:

  • Utilize your proved sales and business expertise to strategically communicate the details of our diagnostic imaging agents to various stakeholders within a complex hospital sales environment which includes multiple products and multiple hospital call points. 
  • Strategically plan overall sales strategy within your territory to maximize effectiveness and produce sales results. Carefully plan each sales presentation by anticipating customer needs and/or objections and your response to best close each opportunity.
  • Utilize strategic selling acumen and listening skills to uncover customer needs and opportunities.  Deliver clear, concise, relevant messaging to target audiences and provide solutions to health care providers concerns to drive desired outcomes and close the sale. 
  • Work cross-functionally with internal sales teams, marketing, medical affairs and externally as required to assemble resources for the benefit of patients and our customers.
  • Use computers and software programs as appropriate for effective communication, presentations, analysis and documentation.
  • Demonstrate passion for successfully achieving sales targets while adhering to all regulatory and budgetary guidelines and Lantheus policies.
  • Carefully plan, keep records and report activity and expenses in accordance with Lantheus policy and manager instructions. 

The incumbent will actively promote safety rules and awareness, will demonstrate good safety practices at all times, and take initiative to correct safety hazards.  Additionally, the incumbent will actively demonstrate and promote the Lantheus values of accountability, communication, customer commitment, entrepreneurial spirit, integrity, safety and teamwork.

 Skills and Experience:

  • BA or BS degree with a minimum of 5 years’ of successful hospital sales experience with related industry. 
  • Must possess a track record of success in selling within a hospital setting.
  • Must be self-motivated, passionate about selling health care solutions, and able to manage time effectively.  Knowledge of budget planning process helpful.
  • An understanding of managed care, GPO and IDN contracting preferred.
  • Understanding of contrast imaging systems, echocardiography, MRI/MRA, and vascular imaging preferred.

 Other Requirements: 

  • The candidate is expected to live within this territory.
  • Routine overnight travel based on business need.  Must have valid driver’s license, qualified vehicle and appropriate motor vehicle insurance
  • Must be able to secure key hospital credentialing and access within your territory.

The incumbent will actively promote safety rules and awareness, will demonstrate good safety practices at all times, and take initiative to correct safety hazards.  Additionally, the incumbent will actively demonstrate and promote the Lantheus values of accountability, communication, customer commitment, entrepreneurial spirit, integrity, safety and teamwork.

 To apply for this position please visit the Career page of www.lantheus.com

 

Senior Quality Engineer

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The Quality Engineer II supports all Quality Control functions for projects and programs within a Medical Device product development environment.  This role evaluates products and manufacturing processes and performs quality engineering activities, quality system training and procedure development and execution.  The Quality Engineer II is assigned responsibilities involving extensive professional interaction with cross functional disciplines inside and outside the company.

 

ESSENTIAL JOB FUNCTIONS AND RESPONSIBILITIES 

  1. Partner with engineers from product development and manufacturing to manage the launch of orthopaedic medical devices. 
  2. Provide support in the execution of Design Review, Risk Management and Design Transfer processes per FDA, ISO and/or applicable regulatory requirements.
  3. Work with Sr Quality Staff and Product Development guidance in understanding the clinical challenges that the product addresses and be able to explain how the new system works to others once it is defined.
  4. Follow a project and process planning and execution schedule to ensure regulatory requirements (e.g. design control) and process/product goals (e.g. process capability) are met.
  5. Work with multiple project schedules and manage competing priorities.
  6. Follow specification needs/requirements & assist with the creation of specifications.
  7. Support design transfer activities focused in development of gage design, inspection processes, GRR, capability studies and process validation.
  8. Facilitate Design Review activities of new products and work closely with product design teams to ensure quality considerations during all stages of product development.
  9. Facilitate training for quality control and manufacturing employee training programs.
  10. Work with suppliers, Quality Control Supervisors, Engineers and manufacturing personnel in the resolution of quality problems.  Also, assists each of the groups with capability studies and the application of statistical process control.
  11. Interfaces with manufacturing engineers to review processes for new products and coordinates process validations and capability studies.  Works with product introduction teams to recommend process monitoring devices where applicable. 
  12. Domestic and international travel (up to 25%)

Client Service Representative

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At Quest Diagnostics Incorporated, we understand urgency. But more than speed, we focus our energies on accuracy. Currently, we seek a Client Service Representative to work at our Cambridge location.

Hours:  Monday -  Friday or Monday - Saturday with one week day off.

The Client Service Representative II handles customer inquiries received by telephone, fax or email regarding reporting of patients results, inquiries of tests and services and other duties needed to provide superior services and follows-up with customers on issues that cannot be resolved immediately.  Handle more complex customer issues and ensures proper escalation, when appropriate.   Place outbound calls to clients in accordance with call log procedures and policies.  May provide coaching, training and support to other Client Service Representatives and Assistants.
Performs other duties as required to meet the customer requirements.
   
Basic qualifications:
Minimum of a high school diploma or equivalent, Bachelor’s Degree Preferred.
Previous health services experience is preferred.
Other Qualifications:
Effective customer service and interpersonal skills
Strong writing skills
Ability to work in a team environment and willingness to coach and/or mentor other representatives
Strong organizational skills
Problem Solving skills 
Demonstrated ability to operate basic office equipment and utilize proficient computer skills
Ability to handle multiple tasks and work in a fast-paced environment
Demonstrated Integrity and a commitment to values

The Client Service team as Quest Diagnostics is expanding.   If you are qualified and interested in this opportunity, please visit our website and submit your resume on-line.  The requisition number associated with this position is 3707888

http://www.questdiagnostics.com/home/about/careers

 

 

RA and Scientist

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We are a Cambridge based innovative new technology company that has several career opportunities for candidates with degrees in biochemistry, food science, chemistry, or polymer chemistry, to join our dynamic team creating edible forms of packaging for foods. 

As an RA you will support research, development, scale up, and partner projects.  In addition to a strong work ethic, our candidate needs great laboratory and communication skills.  Some level of experience in a laboratory and/or industry is required, and work with biodegradable materials or edible films would be highly desirable. 

The Scientist we are seeking will have an MS in biochemistry, polymer chemistry, chemistry or food science, plus 3 or more years in industry, with preference given to food industry experience.  Some exposure to biodegradable or edible films is required for this position.  Recipe formulation, and sensory/texture analysis is extremely desirable.  

We are a new entrepreneurial technology company that’s creating edible forms of packaging for foods.   These ground floor opportunities require a strong research laboratory background and accomplishments, along with excellent communication skills.

Education and Experience-RA:  BS/BA, in Chemistry, Polymer Chemistry, Biochemistry, or Food Science

Education and Experience-Scientist:  MS in Biochemistry, Polymer Chemistry, Chemistry or Food Science and 3+ years industry experience

We offer an attractive employee rewards package including competitive salary, bonus, stock option opportunities, in addition to health and dental insurance.  This is an opportunity to be part of an exciting and environmentally progressive technology and team.

PLEASE NO PHONE CALLS

Send a cover letter and resume or CV to jz@wikicells.com   Only those applicants who meet our requirements will receive a response.

(Senior) Research Associate

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The Cystic Fibrosis Foundation, a highly regarded national voluntary health services agency, is seeking a research associate for its growing R&D laboratory in the greater Boston area. The focus of the laboratory is on assay development and early discovery of small molecules that can modulate expression and function of mutant CFTR protein, which may lead to new treatments for Cystic Fibrosis (CF).

The (Senior) Research Associate is expected to make critical contributions to the electrophysiological assay/screening group.  CFFT Lab projects include state-of-the-art automation and encompass screening of chemical libraries using multiple formats and readouts from biochemical, biophysical, and cell-based assays (fluorescence, luminescence, label-free, etc.).  Primary job duties include: Mammalian cell culture, execution of low to medium throughput screening (incl. the use of robotic liquid handlers), data processing, QC and analysis. He or she will be responsible for operational excellence and data quality.  The candidate will join a small group of highly motivated scientists that are working on next generation approaches for CF therapeutics.

  • Bachelor’s or Master’s degree in life sciences and 0-5 years of R&D experience
  • Hands-on experience with mammalian cell cultures
  • In depth and hands-on experience with automated liquid handlers (strongly desired)
  • Track record delivering data of high quality and reproducibility  
  • Detail-oriented scientist capable of multi-tasking in a small dynamic team.

For immediate consideration, please visit the employment section of our websitewww.cff.org under jobs located in Boston and submit your resume and cover letter. The following link will also direct you to the applicant page: http://ch.tbe.taleo.net/CH12/ats/careers/requisition.jsp?org=CFF&cws=1&rid=2220


Senior Manager, Information Technology – Enterprise Applications

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This position will support the Ironwood user community in providing support on the ERP and related systems.  Directly coordinating the various support suppliers to insure seamless information and to provide service that meets the expectations of the support service level agreements.  This position will report to the Director, Enterprise Applications, ERP Service Owner.

 

Responsibilities:

  • Actively manage the ERP support queues insuring timely response to business colleagues and IT resources, insuring that service is delivered that meets the users expectations and agreed to service level.
  • Proactively manage the approved ERP support budget to insure that the delivered support meets the budget realities for Ironwood.
  • Prioritize service requests to insure that business colleagues are getting the appropriate support that adjusts based the realities of business cycles.
  • Align SLA’s and delivery expectations to fit the cost model for production support and meet customer service expectations.
  • Provide ongoing support of technology solutions that provide Ironwood business colleagues the right tools in a timely and consistent manner.
  • Proven ability to influence cross-functional teams and deliver small enhancement projects (under 80 hours effort) on time, on budget and that meet well defined requirements and deliver value;

Requirements:

  • 3-5 years of experience working in an IT organization supporting ERP business technology needs, with at least
  • 3-5 years biotech, pharmaceuticals or life science industry experience;
  • 3 years of experience in SAP supporting multiple business functions and configuration;;
  • Experience working with off-site and off-shore support and development models;
  • Experience in vendor management and support delivery metrics to a defined SLA’s.  working with delivery vendors yearly to define SLA’s for continuous improvements

Contract Recruiter

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Responsible for working directly with hiring managers to quickly and efficiently fill open positions with high quality candidates. Responsible for building an ongoing candidate pipeline using postings, employee referrals, research, networking and database information. High focus on creative sourcing and professional screening.

  • Develops applicant flow for key positions. Sources, screens and interviews candidates from both internal and external sources ensuring that recruiting practices comply with legal guidelines.
  • Maintains current knowledge of industry trends to identify current and/or potential issues that may impact applicant availability.
  • Maintains positive relationship with applicants through entire recruitment process to ensure high quality of candidate experience.
  • Maintains positive relationship with hiring managers to ensure the highest quality candidates are considered.

Requirements:

  • BS Degree or equivalent.
  • 7+ years’ experience in technical recruiting including at least 2 years in the biotech/pharmaceutical industry.
  • Strong consultative skills with hiring managers required.
  • Proven experience in assessing and selecting exceptional candidates.
  • Direct sourcing experience strongly preferred.
  • Strong sense of urgency required.
  • Other Human Resources experience is a plus.

Synageva BioPharma is a publicly traded biopharmaceutical company with headquarters, research and development facilities in Lexington, MA, and research and production facilities in Athens, GA. Synageva is dedicated to developing novel orphan treatments for rare diseases. Our lead program, sebelipase alfa (formerly SBC-102), an enzyme replacement therapy for LAL Deficiency, is in global clinical trials and has been granted orphan designation by the FDA, the European Medicines Agency, and the Japanese Ministry of Health, Labour and Welfare. LAL Deficiency is a rare, serious and devastating disease that leads to significant morbidity and mortality.  Synageva has additional orphan products in various stages of preclinical development. To ensure that these therapeutic candidates reach patients in need, Synageva has recruited a team with a proven track record of manufacturing, discovery, development, and commercial success within rare diseases.

Our mission is to deliver breakthrough medicines globally for patients suffering from rare, devastating diseases.  Achieving this will result in a sustainable business that can continue to positively impact the lives of patients and their families, healthcare providers and our employees.  Our success depends upon our ability to seek and retain principle-minded individuals who share our integrity, drive, energy and passion.

LC/MS/MS Method Development Chemist

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LC/MS/MS Method Development Chemist

Berg Diagnostics is a Boston based molecular diagnostics company that offers high-throughput omics-based molecular profiling, biomarker validation, and regulated bioanalysis to accelerate development of molecular therapeutics and diagnostics. Armed with the state-of-the-art instrumentation platforms, the company serves to catalyze project end-points in therapeutic and biomarker development

Description:

  • The candidate will be responsible for development and partial/complete validation of methods to quantify peptides from biological matrices.
  • The candidate is expected to contribute towards multiple projects and have the drive to think out of the box while facing challenges and solving problems.
  • The candidate will be required to write detailed reports and give presentations to the group and management as required.
  • The candidate will be responsible to maintain LC/MS/MS platforms, including regular cleaning, tuning, calibration as required.

Requirements:

  • An ideal candidate will have a B.S. with 5-7 years, M.S. with 2-4 years, Ph.D. with 1-2 years of experience developing methods for quantification of peptides from biological matrices such as blood, plasma, serum, tissues, etc. using LC/MS/MS platforms.
  • Candidate should be competent working with and maintaining LC/MS/MS instruments.
  • Candidate should have good written and oral communication skills.
  • Candidate should be willing to work in a dynamic, fast-paced environment, and adapt to challenges offered in a growing company.

In order to be considered for this position, please send your resume, cover letter, and references to hr@bergdiagnostics.com.

 

 

Principal Scientist / Sr. Principal Scientist, Nanotechnology

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Org Marketing Statement

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

Department Marketing Statement

The Rare Disease Research Unit of Pfizer is committed to the development of new therapies to address the unmet medical needs of those individuals with rare and neglected diseases. The unit is building upon Pfizer's biologics expertise to develop new therapeutics targeting a variety of rare diseases.

Role Description:
- Contribute to nanoparticle development for the delivery of nucleic acid-based biologics.
- Explore lipid and polymer-based formulations.
- Design, generate, and test nucleic acid constructions for delivery in vivo.
- Conceive and execute in vivo screening paradigms to measure assess the integrity and potency of biologic formulations.
- Expected to manage internal research collaboration with other Research Units and to identify, coordinate and manage external research relationships with CROs.

Responsibilities:
- The key responsibility for this role is to further the understanding of nanoparticle technology and its application for the advancement of biologic therapies at Pfizer.
- The successful candidate will be required to integrate technical knowledge of nanoparticles with a range of potential in vivo application in order to create a working biological system for technical evaluation of new platforms and to evaluate their merits in animal models of disease.
- Create a leadership profile within Research by establishing the best practices for evolving new technology
- Approximately 60% lab based work.

Qualifications:
- Ph.D. in chemistry, nucleic acid chemistry, or molecular biology and biochemistry with 5-10 years of industrial experience.
- Knowledge of lipids, lipid biochemistry or synthesis preferred.
- This position requires 60% laboratory work at the bench preparing and evaluating formulations and generating samples for outsourced animal studies.
- Knowledge of animal models and the design of experiments for the assessment biologics, e.g. nanoparticles, carrying nucleic acid cargos is essential.

TECHNICAL SKILL REQUIRMENTS:
- Knowledge of nanoparticle formulation for in vivo delivery. Knowledge of nucleic acids, their structure, and methods of synthesis by in vitro methods.
- Knowledge of protein structure and function.
- Experience developing ELISAs and analytical methods for studies on proteins and RNA.
- Ability to design lipids and to identify novel lipid structures for delivery.
- Facility with Zetasizer and HPLC chromatography for characterization and purification of proteins and nucleic acids
- Ability to conduct quality assessments of nucleic acid and proteins.

Equal Employment Opportunity

Pfizer is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status. Pfizer also complies with all applicable national, state and local laws governing nondiscrimination in employment as well as employment eligibility verification requirements of the Immigration and Nationality Act. All applicants must have authorization to work for Pfizer in the U.S.

In certain circumstances it may be advantageous to Pfizer to support the application(s) for temporary visa classification and/or sponsor applications for permanent residence so that a foreign national colleague can accept or remain in a work assignment in the U. S. For certain classes of temporary visas, the resulting work authorization may be specific to Pfizer and the specific job and/or work site.

Pfizer may at its business discretion decide to or refrain from obtaining, maintaining and/or extending the temporary visa status and/or sponsoring a colleague for permanent residency and /or employment eligibility, considering factors such as availability of qualified U.S. workers and the colleague's long-term prospects for securing lawful permanent residence, among other reasons. Employment applicants requiring immigration sponsorship must disclose, when initial application for employment is made, whether or not they are legally authorized to work for Pfizer in the U.S. and, if so, whether that authorization permits them to work in the job they seek.

In no case should Pfizer's support of a colleague's temporary visa application or sponsorship of a colleague for permanent residence be construed to guarantee success of that application or amend or otherwise invalidate the "at-will" employment relationship between the colleague and Pfizer.

To apply for this position, pleaseCLICK HERE

Quality Assurance (QA), Senior Specialist, growing gene therapy company

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bluebird bio (www.bluebirdbio.com) is a leading gene therapy company developing breakthrough treatments to transform the lives of people affected by severe genetic disorders. Our proprietary platform addresses the root cause of genetic diseases by placing a healthy version of the human gene into the patient's own extracted stem cells, and then transplanting these corrected stem cells back into the patient. bluebird bio is a clinical-stage company, and has established proof of concept for gene therapy in humans for two indications (Adrenoleukodystrophy and Beta Thalassemia) that illustrate the broad potential of our platform.

Join bluebird bio’s enthusiastic and collaborative team by contributing to the overall success of our novel gene therapy approach.  We seek a QA Senior Specialist to assist and support the organization with compliance and ongoing monitoring of conformance to established quality assurance processes and standards. The successful candidate will support project activities, change control, validation, training, deviations, investigations, and other quality systems relating to internal and external manufacturing and testing.    

 

Primary responsibilities:

  • Assist in the processes for creating, revising, implementing, and archiving of quality system documentation, including manufacturing batch records, SOPs, Test Methods, assay and equipment qualification/validation protocols, specifications, and other controlled documents within a GMP environment.  
  • Generate and publish metrics and reports related to quality systems performance.
  • Maintain training files and conduct new hire training.
  • Support efforts to continuously improve bluebird bio’s quality system management and change processes, which will lead to improved compliance and greater efficiency.
  • Minimal travel.

Requirements: 

  • Bachelor’s Degree required.
  • 3+ years GMP experience in pharma/biotech company, working within a quality system within a regulated GMP environment.
  • Must have a working knowledge of cGMP/ICH/FDA/EU regulations. Knowledge of GLP and GCP is a plus.
  • Experience with contract manufacturing and contract testing organizations is a plus.
  • Must be able to work collaboratively with cross-functional groups to ensure compliance and adherence to regulations and established procedures. 
  • Excellent organizational skills with a “do-what-it-takes” attitude.
  • Strong communication and writing skills.

 

This is an exciting time to join the field of gene therapy in general, and to become a part of the bluebird bio team in particular.  bluebird bio is a well-funded, privately-held, entrepreneurial company backed by prominent investors and recently named to the 2012 FierceBiotech Fierce 15. 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 include stock options, commuter/parking benefit, etc.

 

To be considered for this exciting career opportunity, please forward your resume with a cover letter to work@bluebirdbio.com.

bluebird bio, 840 Memorial Drive, Cambridge, MA 02139 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.

 

Sales Operations Manager

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Sales Operations Manager

Company Overview

Based in Cambridge, Good Start Genetics, Inc. conducts genetic diagnostic carrier testing for the reproductive market.  Our clinical molecular diagnostics laboratory is CLIA and CAP certified. Good Start Genetics is building a great team with experienced professionals. Please visit www.goodstartgenetics.com for more company information.

Good Start Genetics (GSG) is seeking a self-motivated professional to support 15 field- and office-based Sales & Marketing personnel in the areas of sales operations, sales supportand business operations.  We are seeking an individual with drive, vision and a track record of success to help build business for our novel and proprietary preconception carrier screening tests. 

The candidate must be an independent worker, enjoy working in a fast paced environment.   While this individual will be focused primarily on Sales & Marketing, s/he will coordinate with other departments in the company to develop and support strategies and tactics to maintain/ grow our carrier screening business across multiple markets.  This individual will report to GSGs National Sales Director or VP, Sales & Marketing

Job Description& Responsibilities

Development and Execution of Key Sales & Marketing Strategies

  • Assists the National Sales Director with design, planning, execution of core sales strategies and customer relationship building
  • Supports the Sales Force by developing strategic information plans, reports and tactics that help direct and the drive the business
  • Assists the Marketing team with the development and refinement of strategies and tactics

Sales Force Optimization

  • Customer segmentation, analysis, strategy and profitability assessments
  • Territory planning, alignments, optimization
  • Assists with training and utilization of Salesforce.com CRM system
  • Assist with quarterly business reviews, plans of action, etc.

Measurement

  • Drives sales analytics, i.e., review of RSM performance and trends, as well as of patterns in customer ordering, volume and reimbursement.  Assists with development of strategies and tactics to address and optimize.
  • Assists with sales comp planning, tracking, calculation and communicating with field
  • Assists with design of spiffs, contests, rewards, special programs

Client Conversions & Workflow Logistics

  • Assists the field sales force as needed with new client conversions, and plans, directs, coordinates and delivers technology and business solutions to individual and collective customers as needed, and assists with overall business processes and workflow customization;  e.g., Acts as go-to person for sales team in re initiation of new account onboarding (e.g., customer-specific paper, or digital [portal, EMR] interfaces).  Liaison between Sales & Marketing and IT and Customer Care departments to identify problems, design and implement solutions.  
  • Interprets and helps to address regional or account-specific phlebotomy challenges, etc.

 Other Departmental Activities

  • Assists, coordinates and participates in regular sales training programs internally (for GSG sales team) or externally (with account staffs)
  • Assists with internal meeting planning (e.g., sales meetings, monthly and weekly team update meetings, etc.)
  • Assists with budgeting, forecasting

 Requirements

  • Bachelor’s degree required
  • 5+ years of sales operations experience in the health care industry a must
  • Field sales experience strongly preferred
  • Experience in diagnostics, screening and/or IVF market a big plus
  • Start-up experience also a plus
  • Strong analytic skills and project management experience
  • Incentive Planning experience
  • Sales/Marketing Planning experience
  • Demonstrated ability to work collaboratively and effectively with peers and management across functions, as well as with external partners / vendors
  • Can bring creative and tactical insight to the team (e.g., ability to recognize internal and external business needs and translate them solutions)
  • Good listener, communicator and problem-solver
  • Excellent written, verbal and interpersonal skills

To Apply

  • To apply please submit your resume which specifically addresses why you are interested in this positions, why you are qualified, specific examples of success in similar positions, your work style, and when you are available to begin working to careers@gsgeneticscom
  • No phone calls please.  Resumes form third party vendors will not be accepted.

 Compensation 

  • Competitive salary, commensurate with experience
  • Benefits package available includes: Medical, dental, vision insurance, Life and disability insurance, 401(k) plan, bonus plan, paid vacation and holidays

Part-time to Full-time Receptionist/Admin

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Company Profile

Boston Biochem is a fast-paced, rapidly growing subsidiary of R&D Systems, Inc. with extensive expertise in the disciplines of protein biochemistry. Boston Biochem manufactures a full range of specialized reagents for the study of the ubiquitin-proteasome and related pathways. We also offer comprehensive custom services in the areas of fermentation, protein purification, protein expression, protein modification and characterization. Both divisions of the business facilitate the drug discovery efforts of the international biomedical research community.  

 

Job Description

Major responsibilities include:

  • answering phones
  • greeting visitors
  • receiving packages
  • getting mail
  • ordering office supplies
  • maintaining office areas and coordinating any minor facility issues
  • data entry and maintenance of customer database
  • basic accounts payable duties
  • coordination of tech support inquiry log for scientific staff follow-up
  • special projects assigned as necessary

*This is a 20 hour per week position for someone without a background in the life sciences industry.  For someone with a history in life sciences or the medical field that has a working knowledge of scientific terminology we can combine this position with our opening for a part-time administrative assistant.   

Required Skills

Successful candidates will have a customer service oriented attitude with excellent attention to detail and a desire and motivation to learn. Candidate must be comfortable using computers and have a working knowledge of Excel, Word, Outlook and ACT (or similar customer database).  Experience using Quickbooks and basic accounts payable skills are a plus.  Candidate must be highly organized, able to multitask, work independently and have good interpersonal skills.  Must be able to work in a fast-paced environment. Excellent communication, organization and collaborative skills are vital.

 

Educational Requirements

Candidate must have an Associate's Degree,  BA, or BS, and 1-2 years admin experience. 

 

Application Information

Boston Biochem offers an exciting flexible work environment with competitive compensation, benefits, and equity participation.  Boston Biochem is an equal opportunity employer.

 

Please send resume and a cover letter describing your experience to: 
Boston Biochem, Inc.

ATTN: Human Resources
840 Memorial Drive 
Cambridge, MA 02139
Fax: (617) 492-3565
e-mail: careers@bostonbiochem.com

*resumes submitted without cover letters will not be considered


Associate Director, Scientific Affairs

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ImmunoGen is in search of an Associate Director, Scientific Affairs to join its growing Clinical Development department.  This candidate will be responsible for managing a broad range of external activities related to our internal pipeline.

Primary Responsibilities:

  • Develop      and maintain relationships with clinical trial investigators and KOLs to      facilitate recruitment to ImmunoGen sponsored studies and to support      investigator-sponsored clinical and preclinical activities
  • Develop      and maintain relationships with external organizations including      professional groups, cooperative groups, clinical trial networks and      patient organizations
  • In      collaboration with Clinical Development, develop and implement a      publication strategy for ImmunoGen development products
  • Develop      and manage a process for review of educational grant requests
  • Support      organization and implementation of clinical advisory boards
  • Lead      development of appropriate medical information for response to questions      at professional meetings; act as a key resource for staffing booths at      professional meetings
  • Develop      SOPs for all activities above to ensure compliance with all applicable      regulatory and legal guidelines

Requirements:

  • A Bachelor’s degree is required.  An advanced degree or equivalent in life sciences/health care preferred
  • A minimum of 6 years experience in Medical Affairs or related roles in the pharmaceutical/biotechnology industry
  • Experience of managing relationships with external academic and non-profit partners
  • Ability to work independently, leading to the introduction of new capabilities to a growing organization
  • Proven experience in developing effective relationships with key investigators
  • Experience and knowledge of oncology and/or hematology
  • Willingness to travel

ImmunoGen, Inc. offers an excellent salary and benefits package including 100% paid health and dental insurance, 401(k) and tuition assistance.  Please send a detailed resume to:  Human Resources Department, ImmunoGen, Inc., 830 Winter Street, Waltham, MA 02451: Fax: 781-895-0611; E-mail: resumes@immunogen.com.  Please reference the ad source in your response.

 We are an Equal Opportunity Employer

Research Lab Coordinator

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GENERAL SUMMARY/ OVERVIEW STATEMENT: 

The Neuroprotection Research Lab at MGH is looking for someone interested in administratively supporting an exciting lab with a wide range of stroke and neurodegeneration-related research at the molecular, cellular, physiologic, and clinical levels. We are looking for someone energetic, reliable, responsible, and independent, who can take initiative while working well in a large lab team environment.  This position will require an ability to interact with research staff comprising professors, fellows, students, and visiting scientists.

This position will begin in early spring 2013.

PRINCIPAL DUTIES AND RESPONSIBILITIES:

 

  • Coordinating departmental communications with MGH and Partners Healthcare, educational and committee communications with Harvard University, and research communications with the National Institutes of Health (NIH)
  • Maintaining visas, as well as hospital and university appointments for all lab members.
  • Assisting with grant proposal preparation; Tracking and maintaining the status of all grants for our various research projects; Assisting with the submission of progress reports and animal protocols associated with these projects.
  • Helping to coordinate and support lab equipment and research supply use.
  • Organizing weekly lab meetings and visiting professor seminars
  • Assisting the Director with interactions/travel/communications with NIH, other universities, scientific societies, and industrial collaborators.
  • Helping lab members in research projects as time/effort/interest allows

Requirements:

SKILLS/ ABILITIES/ COMPETENCIES REQUIRED:

 

  • Attention to detail and confidentiality.
  • Very organized; Ability to prioritize multiple tasks.
  • Highly goal-oriented and self-motivated.
  • Ability to work independently, as well as in close coordination with a multi-cultural lab team.
  • Good communication skills across multiple levels of the MGH/Harvard/Partners organization.

QUALIFICATIONS: 

  • Demonstrated proficiency in Microsoft Office, Word, Excel, Powerpoint, email data systems, and internet applications.
  • Bachelor's degree.

Please email your resume and cover letter to jpoppe@partners.org or apply to Job ID 2235374 at www.massgeneral.org/careers

Accounting/Office Manager

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GnuBIO Inc is a start-up genomics company in Cambridge, MA. We are currently seeking a Accounting/Office Manager to handle day-to-day accounting, human resources and grant reporting. We are pioneers in the field of DNA sequencing technology for the diagnostic and scientific research markets. Our instrument is made possible by innovations in microfluidics and emulsion technology, licensed from Harvard University. The GnuBIO platform is the only fully integrated next-generation DNA sequencing platform. A single GnuBIO instrument encompasses all of the steps required for DNA sequencing into a single platform including target selection/ enrichment, DNA amplification, DNA sequencing and analysis.

Founded by leading scientists and business professionals, we are seeking motivated professionals to be a part of our team.

Job Description:

As the Senior Accountant, you will play a leading taking on full accounting and human resources responsibilities in a fast-paced environment. You must have at least 5 years experience working in a similar role and come with exceptional references. We are seeking someone that is able to work independently and has a strong breadth of HR and accounting knowledge in which to build upon. You must be hands-on as the group is very small and you must be flexible to do whatever is necessary within a fast-moving innovative biotech environment.

Requirements:

  • BS in Accounting or Business Administration, Masters preferred
  • 5+ years working in Finance & Administration capacity, biotech or financial services experience a plus
  • Able to work flexible schedule, some nights and weekends may be required
  • Understanding of Quickbooks Pro, able to manage multiple projects simultaneously, under tight deadlines and see them through completion
  • Able to work independently with little supervision, hands-on and able to execute without support staff
  • Willing to take on projects as needed, even if outside experience
  • Full-cycle accounting understanding, including month-end close and project account preferred. SBIR Grant accounting is a plus
  • Software implementation experience required

Please, no recruiters. If you are interested, please submit your resume and cover letter for consideration to careers@gnubio.com.  Salary range $60-65k + benefits + options

Microfabrication Technician

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Microfabrication Technician

Job Summary:
GnuBIO (www.gnubio.com) is seeking a hardworking, hands-on Microfabrication Technician with good attention to detail to work in a clean room environment fabricating photolithography molds and keeping accurate records. Additionally there is need for general lab and instrumentation support. Attendance and committment is an essential function of the job.

Desired Attributes:
Attention to detail
Fine dexterity
Strong mechanical aptitude
Ability to follow written and verbal instructions
Excellent punctuality and dependability
Organized

Desired Skills:
Familiarity with clean room operations and procedures
Ability to draft and edit procedures
Familiarity with techniques for silicon wafer handling and photolithography processes a plus

Qualifications:
High school diploma or equivalent, previous assembly or technician experience, 2-year technical degree or equivalent preferred.

Company Description:
GnuBIO is a fast-moving venture-funded start-up located in Cambridge Massachusetts developing life sciences products for the genomics industry.

Please email your resume and letter of interest to careers@gnubio.com

Administrative Assistant, Sales & Marketing

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Administrative Assistant, Sales & Marketing

Company Overview

Based in Cambridge, Good Start Genetics, Inc. conducts genetic diagnostic carrier testing for the reproductive market.  Our clinical molecular diagnostics laboratory is CLIA and CAP certified. Good Start Genetics is building a great team with experienced professionals. Please visit www.goodstartgenetics.com for more company information.

Description

The Administrative Assistant will assist up to 15 office- and field-based personnel on the Good Start Genetics Sales & Marketing team.  In this role s/he will provide logistical support to GSGs sales & marketing organization.

We are seeking individuals with drive, vision, and experience to help build upon the successful launch of our preconception carrier screening genetic tests.  While this individual will be focused on Sales & Marketing, s/he may support and coordinate with all departments in the company.  This position will report to the VP of Sales and Marketing.

Responsibilities

  • Maintain the master departmental calendar, proactively identifying opportunities and potential conflicts, communicate and resolve.
  • Assist with the development and maintenance of PR/IR calendar, interfacing with executive and Finance as needed.
  • Develop agendas and manage logistics for internal meeting planning (e.g., sales meetings, monthly and weekly team update meetings, etc.), which may include coordinating hotels, meals, special events, etc.
  • Assist with and drive strategic, tactical and logistical aspects of major company events, e.g., conferences, meetings, trade shows, advisory board meetings, etc.)
  • Assist Product Management with the execution of key marketing materials and programs, including traffic, vendor management, and other logistics.
  • Assist with the tracking and maintenance of certain databases, including competition, publications, etc.
  • Interface with other departments to facilitate and enhance regular communication.
  • Coordinate travel for the internal team, and assistance for the external team.
    Traditional administrative responsibilities.

Requirements

  • 5+ years of executive admin experience, preferably in the healthcare industry
  • Start- up experience preferred
  • Bachelor’s degree or equivalent required
  • Demonstrated ability to work collaboratively with peers and management
  • Strong project management skills
  • Demonstrates ability to work independently, and bring creative and tactical insight to the team
  • Excellent written and verbal communication skills, in addition to excellent interpersonal skills
  • Ability to effectively work cross-functionally and with external partners / vendors

Compensation 

  • Competitive salary, commensurate with experience
  • Benefits package available includes: Medical, dental, vision insurance, Life and disability insurance, 401(k) plan, bonus plan, paid vacation and holidays

To Apply

  • To apply please submit your resume which specifically addresses why you are interested in this positions, why you are qualified, specific examples of success in similar positions, your work style, and when you are available to begin workingto careers@gsgeneticscom
  • No phone calls please.  Resumes form third party vendors will not be accepted.
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