Looking for a Chemistry Technician to join a research group to perform analytical testing.

Requirements:

BS/MS in Chemistry with 1+ years of research experience in an academic or industry setting performing analytical techniques including HPLC, GC, ion chromatography, etc.

Must also have experience with wet chemistry including titrations and solution prep.

Experience with LabVIEW programming is a plus

Recent graduates with strong undergraduate research experience focused on analytical chemistry are encouraged to apply.

Candidates must live local and be a US Citizen or Green Card Holder
 
Email resume to: jobs@cwsciences.com
 
Commonwealth Sciences is a professional recruiting firm specializing in science, engineering and green technologies. We unite industry professionals with exciting career opportunities by leveraging our technical expertise,advanced recruiting tools and years of staffing experience. CWS works with a
variety of disciplines and levels from Research Associates to Scientists, Engineers, Managers and Directors. Our clients value the basic integrity, customer service and industry expertise that defines our organization.
 
Commonwealth Sciences, Inc.
www.cwsciences.com

Responsibilities:
• Meet the weekly and daily production schedules.
• Characterize the manufactured batches of materials using various techniques (ie. wet chemistry and various spectroscopic methods).
• Troubleshoot process problems and follow all safety and housekeeping policies rigorously.

Requirements:
• BS in Chemistry.
• 2+ years experience working in a GMP manufacturing environment.
• Must have demonstrated outstanding communications skills working within a team environment.
• Background in ERP systems is a plus.

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

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

Commonwealth Sciences, Inc.
www.cwsciences.com

Reproductive Technologies Specialist/Reproductive Technologies Advanced Specialist

There is a regular full-time Reproductive Technologies Specialist/Reproductive Technologies Advanced Specialist position available in the Reproductive Sciences (RS) R&D group.  The level will be determined based on experience.  This position is funded by the KOMP grant and will focus on improving the efficiency of the KOMP pipeline.   

The Reproductive Technologies Specialist works under direct supervision.  The incumbent will be fully trained in a range of lab techniques which may include pipetting, embryo handling, PCR, surgery, colony maintenance, cryopreservation, cell culture, etc.

The Advanced Reproductive Technologies Specialist works under minimal supervision and is able to troubleshoot and identify common problems and issues and suggest potential resolutions. The incumbent has an increasing level of technical expertise and independence in performing duties and responsibilities and may provide guidance to other RS staff members assigned to the work area.  The Advanced Reproductive Technologies Specialist will provide hands-on training on specialized, innovative techniques, as well as plan and conduct experiments.

The work schedule for the incumbents is established based on operational demands and may fluctuate based on the changing needs of the group.

Minimum Qualifications:

•             For Reproductive Technologies Specialist -  Two year associate, vocational or technical degree, completion of an apprenticeship program or equivalent work experience (3 years in an animal care program or equivalent work experience) – BS preferred

•             For the Advanced level, BS in applicable field of study or 2-year degree and 2+ years applicable animal care work experience – BS preferred.  Interpersonal relationship skills sufficient to allow incumbent to function as an effective leader for subordinates and to allow incumbent to be fully aware of interpersonal and organizational implications that accompany business relationships

•             Knowledge of college level Mendelian genetics that can be obtained through a genetics course at an accredited college or university or through successful completion of the Jackson Laboratory genetics course, “ Beyond Basic Genetics I & II”. 

•             Strong written and oral communication skills sufficient to permit clear and effective exchange of information with people representing a wide diversity of disciplines and levels of sophistication

•             Demonstrated, excellent computer software and database skills in Word, Excel, Outlook, etc and all other appropriate software used in Jackson Laboratory operations

•             Ability to work in a fast-paced team environment while consistently maintaining a positive and professional demeanor

•             Ability to be flexible and multi-task

All interested individuals should apply on-line at www.jax.org/careers referring to job requisition #3485. 

There is a regular full-time Reproductive Technologies Advanced Specialist/Reproductive Technologies Senior Specialist position available in the Reproductive Sciences (RS) R&D group.  The level will be determined based on experience.  The RS R&D group performs basic and applied research with the goal of developing new product/services and improving efficiencies within RS. 

The Advanced Reproductive Technologies Specialist works under minimal supervision and is able to troubleshoot and identify common problems and issues and suggest potential resolutions. The incumbent has an increasing level of technical expertise and independence in performing duties and responsibilities and may provide guidance to other RS staff members assigned to the work area.  The Advanced Reproductive Technologies Specialist will provide hands-on training on specialized, innovative techniques, as well as plan and conduct experiments.

The Reproductive Technologies Senior Specialist is defined by the ability to work independently, to take on special projects with little direction, and to analyze data, interpret results and report findings to the Supervisor and/or Manager.  The incumbent may direct the work of others and make operational decisions in the absence of the supervisor. The incumbent can perform these activities while maintaining a full workload.  Senior Specialists take on the role of assisting in the training of other RS staff. In addition, they may schedule work flow, design and conduct experiments, communicate findings and makes recommendations through presentations, seminars, publications and other methods.  The Reproductive Technologies Senior Specialist requires the ability to manage cross-functional teams and interacts with internal and external customers/personnel at all levels in an organization.

The work schedule for the incumbents is established based on operational demands and may fluctuate based on the changing needs of the Reproductive Sciences Department.

Minimum Qualifications:

• For the Advanced level, BS in applicable field of study or 2-year degree and 2+ years applicable animal care work experience – BS preferred
• For the Senior level, BS in applicable field of study and a minimum of 5 years applicable work experience in a laboratory/animal care setting. Three years hands on experience of veterinarian surgical procedure and 2 years wet bench experience
• Interpersonal relationship skills sufficient to allow incumbent to function as an effective leader for subordinates and to allow incumbent to be fully aware of interpersonal and organizational implications that accompany business relationships
• Knowledge of college level Mendelian genetics that can be obtained through a genetics course at an accredited college or university or through successful completion of the Jackson Laboratory genetics course, “ Beyond Basic Genetics I & II”. 
• Strong written and oral communication skills sufficient to permit clear and effective exchange of information with people representing a wide diversity of disciplines and levels of sophistication
• Demonstrated, excellent computer software and database skills in Word, Excel, Outlook, etc and all other appropriate software used in Jackson Laboratory operations
• Ability to work in a fast-paced team environment while consistently maintaining a positive and professional demeanor
• Ability to be flexible and multi-task

All interested individuals should apply on-line at www.jax.org/careers referring to job requisition #3485.  .

Lab Support has an opening in the field of environmental services! We are seeing an ICP analyst with 1-2 years of experience in an environmental laboratory. Responsibilities would include analysis of trace metals in environmental samples, instrument calibration, and routine instrument maintenance in accordance with applicable regulations.  One to two years of laboratory and ICP experience is required.

Required skills:

If you are a self-starter who is organized and motivated by team success, have great attention to detail and would thrive in a dynamic work environment, then we would like to hear from you.  A Bachelor’s Degree in a physical science is required, along with experience with Microsoft Office applications, especially Excel.

Headquartered in Lexington, Massachusetts, Cubist Pharmaceuticals, Inc. is a biopharmaceutical company focused on becoming a leader in the discovery, development and commercialization of novel acute care therapies for use in hospitals and other acute care environments.

Position Summary:  
This person will provide statistical leadership and expertise in support of the clinical development of Cubist's products. This person is expected to contribute strategically to project decisions with a focus on pre-study planning, protocol development, sample size/power calculations, Statistical Analysis Plan preparation/review, data quality reviews, development of tables/listings/figures, preparation/mapping of clinical study data for regulatory submission, and integrated safety and efficacy reporting.

This person will apply complex and innovative statistical approaches to their work (e.g, modeling and simulation, adaptive design/Bayesian statistics) and mentor junior staff in the use of these approaches. This person will participate in meetings and teleconferences with regulatory agencies and prepare written responses to agency questions. This person will also provide interpretive and analytical support to Cubist publications, safety surveillance, PK/PD, and pharmaco-economic initiatives. Finally, this person will work independently and as part of a multifunctional team.

Minimum Basic Qualifications:  
* PhD in Biostatistics, Statistics or related field
* At least 7 years of pharmaceutical, biotechnology or equivalent experience
 
Preferred Qualifications and Experience:   
* Comprehensive knowledge of statistical theory and methods and demonstrated ability to apply it to all phases of clinical trials
* Expertise in SAS programming including statistical analysis, data manipulation and scientific graphing.
* Prior experience communicating with and presenting to the U.S. (FDA) and European Regulatory Authorities.
* Prior experience contributing to content of INDs/NDAs/BLAs with eCTD formatted NDA/BLA submissions.
* Demonstrated knowledge of all relevant statistical regulatory guidance and standards (e.g, FDA, ICH and EMEA).
 
Competencies:  
* Experience in oversight/management of biostatistical services provided by CROs and/or contractors.
* Ability to prioritize and effectively manage several projects simultaneously.
 
Work Environment:   
* Office setting with high-volume, fast paced customer-focused environment.
* Collaborative and team oriented.
* Deadline and results-oriented.
 
Physical Demands:   
* Perform the job safely by demonstrating full awareness of his/her surroundings.
 
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily within the context of the representative work environment and physical demands described above. Likewise, qualifications listed are representative of the knowledge, skills, and abilities required to perform the position's essential functions. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

To apply for this position, please CLICK HERE

Headquartered in Lexington, Massachusetts, Cubist Pharmaceuticals, Inc. is a biopharmaceutical company focused on becoming a leader in the discovery, development and commercialization of novel acute care therapies for use in hospitals and other acute care environments.

Position Summary:  
The Director of Clinical Operations will provide operational and implementation expertise to the product/project teams. S/he will be responsible for overseeing the conduct of all phases of trials, including global pivotal studies over multiple indications and/or therapeutic areas. Oversight will include that of both niche and strategic CRO partners and ancillary vendors. In addition, the Director of Clinical Operations will serve as mentor and direct supervisor to more junior trial management and clinical operations staff.

Clinical Operations:
In conjunction with the VP Clinical Operations, the Director of Clinical Operations will manage all aspects of clinical operations for assigned programs to assure the highest standards of clinical trial execution and GCP. Activities include:   
* Ensure oversight of clinical trial site management in conjunction with selected CROs  
* Ensure appropriate oversight of clinical trial site monitoring including source documentation verification process
* Drive development and maintenance of SOPs, guidelines and systems  
* Assist in development of Clinical Operations departmental budget and forecasting analysis
 
Clinical Study and Program Development:
In conjunction with cross-functional team leaders, the Director of Clinical Operations will be a key clinical contact. Activities include:   
* Participate in protocol design development and provide advice on logistical issues  
* Provide input on patient informed consent document templates
* Guide in selection of CROs and ancillary vendors  
* Oversee operations management of selected CROs and ancillary vendors  
* Ensure appropriate operational involvement in preparation and revisions of Investigational Drug Brochures (IBs)  
* Preparation and management of clinical trial budgets  
* Contribute to development of regulatory documents including briefing documents, CTAs, and regulatory meeting briefing documents as requested  
* Oversees INDs and IND annual operational trial information updates  
* Support clinical study report preparation and assist in data interpretation and ensure CSR e-publishing readiness
* Assist in preparation of Investigator Alert letters and SAE reports as required and ensure reporting timelines are met
* Oversee data clarification process as needed in conjunction with selected CRO and insure database lock according to agreed timeline
 
Process Improvement:  
* Key role in the development of clinical SOPs, guidance and quality management plans consistent with GCPs and other applicable government and regulatory agency standards
* Participate in development of clinical operations performance standards  
* Participate in and/or drive recruitment and selection of additional Clinical Operations staff  
 
Minimum Basic Qualifications:   
* Bachelors degree required
* 8 years experience in Clinical Trial Management
* Previous staff/line management
 
Preferred Qualifications and Experience:  
* Advanced degree (MS/PhD) with sciences major preferred, but will consider direct relevant experience plus BA/BS in lieu of advanced degree.
* Highly advanced knowledge of Clinical development process  
* 10 or more years R & D experience in biotech, Pharmaceutical or relevant clinical CRO experience.  
* Experience in execution of complex in-hospital clinical trials preferred, including experience ranging from small Phase 1 studies to large multi-center global trial programs  
* Well versed in GCP and applicable FDA/EMA regulations required  
 * Ability to prepare and present clinical trial and departmental updates to senior management
 
Competencies:   
* Able to incorporate a broad understanding of industry issues into plans/strategies in order to capitalize on ideas and initiatives that will drive success of the Clinical Operations department now and in the future   
* Considers how present policies and practices might be affected by future developments and trends within the global regulatory and compliance landscape
* Effective in building relationships and networks with others across and beyond Cubist
* Works constructively across organizational boundaries despite differences in interests, perspectives, and needs
* Tailors influence strategy and approach using knowledge of target audiences
* Able to adapt influence to specific audiences, to ensure an integrated approach in pursuit of organizational growth and anticipation of future needs
* Capable of creating alignment within Cubist, both vertically and horizontally, by making a case for one's approach
* Provides ongoing clarity as needs change, keeping stakeholders and contributors aligned with changes both in the external environment and across Cubist  
* Able to compile, analyze, and present data in a concise manner, in both written and oral context
* Demonstrates ability to enlist input from stakeholders and constituents to make key decisions (e.g. tactics to accomplish goals), while ensuring final decisions are reached quickly and effectively
*  Able to provide both positive and tough performance feedback to both direct reports and staff who may report to others
* Identifies development opportunities for staff, both within and outside of Clinical Operations
* Comfortable stretching people in order to help them grow  
 
Work Environment:   
* Office Environment
 
Physical Demands:   
* N/A
 
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily within the context of the representative work environment and physical demands described above. Likewise, qualifications listed are representative of the knowledge, skills, and abilities required to perform the position's essential functions. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

To apply for this position, please CLICK HERE

Headquartered in Lexington, Massachusetts, Cubist Pharmaceuticals, Inc. is a biopharmaceutical company focused on becoming a leader in the discovery, development and commercialization of novel acute care therapies for use in hospitals and other acute care environments.

Position Summary:  
This position works in a team oriented environment and will have the primary responsibility for:   
 * Completes data entry of incoming reports from clinical trials and post marketing sources
 * Completes triaging of incoming reports for initial assessment of seriousness, expectedness, causality, and reportability for reports from clinical trials and post marking sources in accordance with local work instructions, US FDA regulations, and international guidelines and regulations  
 * Performs active follow-up via verbal or written contact with healthcare professionals and consumers
 * Coordinates with other departments, external organizations, and corporate partners to develop and implement industry standard procedures and processes for Pharmacovigilance activities
 * Contributes to tracking and documentation of training of department standard operating procedures, work instructions and required international regulations  
 * Contributes to Archiving of Documents in line with 21Part11 compliance and international regulations
 * Works independently to accomplish objectives within deadlines
 * Contributes to regulatory submissions (IND and NDA), reviewing case report form data for safety issues, reconciling clinical trial data, and participating in clinical protocol development
 * Works with external teams by assisting with implementing overall planning, development, and data entry specifications for clinical trials or post marketing projects
 * Assists with monitoring compliance and additional quality metrics
 * Assists with writing and maintaining standard operating procedures and guidelines for case processing operations
 * Any other assignments as assigned
 
For Specialist:  
Minimum Basic Qualifications:   
* A clinical degree (Pharm. D., RN) is required and/or minimum BS in a life science degree with previous experience in a healthcare setting
* At least 1 year in Pharmacovigilance
 
Preferred Qualifications and Experience:  
* Minimum of 1 year to 3 years of experience in Pharmacovigilance is preferred
* Previous experience with data entry into a validated safety database
* Familiarity with US/ICH regulatory safety reporting requirements/guidelines, commercial safety database systems, and MedDRA coding are preferred
 
Competencies:  
* Must be detail-oriented and have strong organizational and communication skills
* Works independently to accomplish individual and department objectives within deadlines
* Demonstrates a capacity for accountability in his/her projects
* Employee will constantly demonstrate his/her positive attitude, reliability, and will strive for adherence to best practices.  
* Employee will support establishment and implementation of goals and policies.
* Demonstrates ability to work as a collaborative member of a team
* Ability to work effectively as an individual contributor and as project team member; collaborative spirit
* Ability to independently identify problems and effectively offer solutions  
* Excellent interpersonal, communication, and personal organization skills; ability to prioritize workload and work effectively, sometimes within resource constraints
 
For Senior Specialist:  
Minimum Basic Qualifications:   
* At least 3 years of Pharmacovigilance experience within the biopharmaceutical industry
* At least two years experience in clinical medical environment or similar experience providing strong knowledge of general medicine and drug therapy  
* Data entry experience
* Quality Review experience
* MedDRA coding experience
* Inspection readiness experience
 
Preferred Qualifications and Experience:  
* Employee will constantly demonstrate his/her positive attitude, reliability, and will strive for adherence to best practices.  
* Employee will support establishment and implementation of goals and policies.
* Ability to independently identify problems and effectively offer solutions  
* Excellent interpersonal, communication, and personal organization skills; ability to prioritize workload and work effectively, sometimes within resource constraints
* Ability to act as mentor and/or trainer
 
Competencies:  
* Must be detail-oriented and have strong organizational and communication skills
* Strong writing skills
* Ability to work effectively as an individual contributor  
* Ability to act as project team member and/or lead; collaborative spirit
* Works independently to accomplish individual and department objectives within deadlines
* Demonstrates a capacity for accountability in his/her projects
 
Work Environment:   
* This is a Lexington-based position that requires significant interactions with internal colleagues from other departments and with external colleagues and consultants. Works within Cubist's established policies and procedures and ensures alignment of their work with Cubist's values.
 
Physical Demands:   
* Minimal travel may be required
 
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily within the context of the representative work environment and physical demands described above. Likewise, qualifications listed are representative of the knowledge, skills, and abilities required to perform the position's essential functions. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

To apply for this position, please CLICK HERE

Headquartered in Lexington, Massachusetts, Cubist Pharmaceuticals, Inc. is a biopharmaceutical company focused on becoming a leader in the discovery, development and commercialization of novel acute care therapies for use in hospitals and other acute care environments.

Position Summary:  
This individual will provide statistical programming leadership and expertise for clinical trials, projects and submissions together with other development projects at Cubist.

The Principal Statistical Programmer will lead clinical programming support to Cubist's Clinical Development/Medical Affairs (CDMA) department and other functional areas upon request. Working as part of a multifunctional team, the Principal Statistical Programmer will mentor and oversee a programming staff. Activities will include, but are not limited to, leading and/or overseeing other study team members on programming specifications, and developing/validating SAS programs and macros in support of clinical studies, ad-hoc statistical analyses, safety surveillance, and departmental data standards initiatives. The Principal Statistical Programmer may also lead other departmental initiatives which involve programming (e.g., data/information integration).  

The Principal Statistical Programmer will:  
* Lead the statistical programming function within Cubist in the production and validation of output and derived data sets.
* Collaborate with project biostatisticians, clinical data managers and other colleagues in the creation, implementation, and maintenance of statistical programming deliverables for each project.  
* Account for timelines, resources, and quality assurance for all statistical programming project work.
* Lead the effort to continuously improve Cubist processes to conform to evolving industry standards, and participate in the ongoing review and development of quality systems and processes, including CDISC implementation, ADaM datasets, and other standards initiatives.  
* Oversee the work of other programmers and guide them in implementing programming methodologies for highly complex situations.
* Participate in the evaluation, selection and project management of CROs which provide statistical programming support.  
* Represent the Statistical Programming function of Biostatistics within inter-departmental meetings and committees.
* Review and critique case report forms, CRF annotations, dB structures, edit checks, and SAPs
 
The Principal Statistical Programmer may participate in meetings and teleconferences with regulatory agencies, prepare responses to agency questions, and may also provide or coordinate the statistical programming support to Cubist publications, safety surveillance, PK/PD, and pharmaco-economic initiatives.  

Minimum Basic Qualifications:   
* M.S. in Biostatistics, Statistics, Mathematics, Computer Science, or a related field. B.S. with leading multiple filings for Statistical Programming can also be considered.  
* At least 10 years of experience leading statistical programming initiatives, projects, and teams within the drug development industry (pharmaceutical, biotech, or CRO)
* At least 12 years of SAS programming experience.
* Experience in developing industry standards for database design as defined by Clinical Data Interchange Standards Consortium (CDISC).
* Excellent working knowledge of Base SAS, SAS/STAT, SAS Macro language and SAS SQL
* Experience in leading the programming effort in NDAs/BLAs with eCTD formatted NDA/BLA submissions.  
* Experience communicating with the U.S. FDA and/or European Regulatory Authorities.  
* Excellent analytical, problem solving, and organization skills, with the ability to work on multiple tasks within a collaborative environment.
* Excellent communication and interpersonal skills.
* Knowledge of relevant regulatory guidelines and standards (e.g., FDA, ICH and EMEA).  
 
Experience Required:   
* Experience in leading the development and implementation of statistical programming standards
* Experience mentoring less experienced staff and managing statistical programming contract staff
* Demonstrated dedication, professionalism, and flexibility in responding to changing priorities, time pressures, and novel challenges.  
* Demonstrated ability to prioritize and effectively manage multiple projects simultaneously.
* Demonstrated ability to establish and articulate a plan to ensure focus and direction for a team.
* Experience in managing Statistical Programming services provided by CROs (i.e., preferably in a partnership)
* Experience in managing staff and/or contractors.
 
Competencies:   
* Targets one's efforts on discovering and meeting an internal or external customer's needs
* Leverages a deep understanding of oneself in order to increase one's effectiveness  
* Works cooperatively with colleagues for the good of the business overall  
* Demonstrates respect for others by seeking to understand how they think about issues and perceive problems and opportunities  
* Demonstrates belief in one's convictions  
* Recognizes opportunities and/or issues and applies analytical and creative thinking to maximize performance
 
Work Environment:   
* Office setting with high-volume, fast paced customer-focused environment.
* Collaborative and team oriented.
* Deadline and results-oriented.
 
Physical Demands:   
* Position primarily involves sitting/working at a computer terminal; walking between offices.
 
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily within the context of the representative work environment and physical demands described above. Likewise, qualifications listed are representative of the knowledge, skills, and abilities required to perform the position's essential functions. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

To apply for this position, please CLICK HERE

Headquartered in Lexington, Massachusetts, Cubist Pharmaceuticals, Inc. is a biopharmaceutical company focused on becoming a leader in the discovery, development and commercialization of novel acute care therapies for use in hospitals and other acute care environments.Position Summary:  

This position coordinates various multi-disciplinary teams to meet clinical trial objectives. With the goals for the entire development program in mind, provides substantive contributions to the strategic design and execution of a clinical trials program. The Sr. CTM continuously evaluates the progression, quality, and cost of the various operational steps involved in planning and execution of a clinical program. Additionally, (s)he independently formulates corrective actions for identified issues and drives the implementation thereof.  

Dependent on the level of trial outsourcing, the Sr. CTM will appropriately adjust the degree of CRO/vendor oversight. The Sr. CTM may oversee a portfolio of studies being managed by a strategic/preferred CRO provider

At the departmental level, the Sr. CTM will contribute to the development and revision of relevant SOPs and internal processes. The Sr. CTM will formulate recommendations to departmental heads on complex and important problems as they arise. The Sr. CTM will take on a leadership role by acting as a resource and providing mentorship to less experienced colleagues.

Key Responsibilities:  
* Oversee clinical trial planning  
* Contributes to clinical development planning as it relates to operational considerations
* Develops operational study implementation and execution strategy  
* Identifying resourcing needs for assigned projects, including internal and external outsourced services (i.e., CROs, laboratories, contractors, in-house staff, etc.); participates in the request for proposal process including defining expectations and deliverables; assesses qualifications and experience, and participate in final selection process  
* Defines site qualification criteria and oversees the identification of potential investigators and clinical sites; oversees, performs or participates (as needed) in pre-study site visits, reviews evaluative reports; participates in the final selection of study sites
* Defines the site approval process with respect to critical document requirements, Institutional Review Board (IRB) approvals, IRB questions, site informed consent review, and review of contracts, in conjunction with relevant internal departments (as necessary)
* Develops Program/Study/Investigator Budgets, and performs ongoing analysis related to study progress and/or work being performed by outside vendors (CROs, CRAs, centralized laboratories, etc)
* Oversees and participates in Investigator Meetings
* Ensures timely development of clinical trial documentation (e.g. informed consent documents, case report forms (CRFs), CRF guidelines, statistical/ pharmacokinetic analysis plans, monitoring plan, data management plans including edit check specifications, CTA template, etc)
* Develops Investigator Relationship & Maintenance Plan
* Assesses project related internal/external educational needs  
* Assesses study drug requirements and shipment logistics; contributes to labeling strategy.
* Develops oversight plan for Clinical Operations; ensures Data Management and Safety Oversight plans are developed; ensures appropriate sponsor oversight documentation is generatedMonitors clinical trial progress
* Assesses adequacy and comprehensiveness of study / program tracking systems
* Responsible for all performance metrics and quality of deliverables in a clinical trial
* Oversees the day-to-day activities of the clinical trial and associated resources (CROs, CRAs, centralized laboratories, etc)
* Identifies and evaluates issues related to the project and coordinates resolutions
* Continuously evaluates compliance to applicable SOPs and the quality of site monitoring and associated documentation; develops corrective action plan if indicated
* Ensures appropriate transmission of CRF data to data management team and reviews queries as necessary  
* Identifies data deficiencies and discrepancies, and coordinates corrective action as required
* Ensures adequate Serious Adverse Event reporting including documentation, tracking and follow-up
* Assists in the site audit process and coordinates the audit responses to ensure conformance to industry and company standards
* Oversees close-out processes and ensures final site issues are addressed appropriately
* Coordinates CSR writing, review and approval process including the compilation of all required sections
* Drives successful study completion
 
Minimum Basic Qualifications:   
* Bachelors degree in scientific/clinical related discipline is required
* 7 years relevant industry experience in a clinical research setting, including but not limited to CRO oversight for large-scale international programs
 
Preferred Qualifications and Experience:   
* 8+ years of relevant industry experience (sponsor and CRO)  
* Has managed and led multiple cross-functional processes involved in Clinical Research, specifically trial management
* Knowledge of the infrastructure and operational characteristics of CROs and centralized services
* In-depth understanding of industry standards including ICH guidelines, GCPs, compliance, and the CFR.
* Technical expert in the various aspects of the clinical trial process
* Has significantly contributed to the success of planning and executing clinical trials in support of an overall clinical development plan
* Proficient in development of clinical trial documentation (e.g. informed consent documents, case report forms (CRFs), CRF guidelines, statistical/ pharmacokinetic analysis plans, monitoring plan, data management plans including edit check specifications, CTA template, etc)
* Understand the roles/responsibilities and inter-dependencies for key functions involved in clinical development
* Familiarity with study / program tracking systems
 
Competencies:   
* Ability to anticipate what will be needed in the future and take initiative to meet those needs  
* Strong work ethic with perseverance to achieve results  
* Ability to break down complex problems into lists of actionable items  
* Keen understanding how the Sr. CTM interacts with others’ roles to most effectively advance trial objectives  
* Excellent communication, writing and presentation skills  
* Ability to lead and organize team meetings.
* Ability to foster effective relationships with vendors, investigators and colleagues.
 
Work Environment:   
* Office
 
Physical Demands:   
* Occasional overnight travel
 
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily within the context of the representative work environment and physical demands described above. Likewise, qualifications listed are representative of the knowledge, skills, and abilities required to perform the position’s essential functions. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

To apply for this position, please CLICK HERE

Vertex Pharmaceuticals, Inc. is seeking a Senior Clinical Safety Quality Specialist to join the Global Patient Safety (GPS) team to focus on quality, standards, and training.  This key role is responsible for managing multiple activities and coaching others within GPS while providing oversight of the development, implementation and maintenance of relevant quality initiatives and activities supporting (GPS).

Key Responsibilities
- Coordinate implementation of new and/or updated global PV legislation and ensures that Vertex processes and procedures align with new requirements- Participate in a regulatory inspection, audit, or due diligence activities, as requested
- Authors, reviews, and/or approves Policies, SOPs, Work Instructions, forms and templates
- Provides innovative solutions and guidance to complex compliance issues
- Effectively influences others on project teams regarding quality or compliance concerns
- Independently oversees, facilitates, and provides quality insight into GPS deviation investigations
- Collaborates with both internal and external stakeholders in the remediation of identified risks
- Independently drives and/or manages safety-related projects/teams
- Independently generates and presents quality metrics to GPS management
- Participates in the development, implementation, and oversight of quality activities within GPS. These activities include, but are not limited to the following:  Training, GPS Deviation Investigation Management, PV Intelligence, PV Agreement Maintenance, Ad-hoc/Aggregate Report QC, ICSR QC, Reconciliation, GPS Documentation Management, and Audit/Inspection Readiness
- Provides support to GPS Operations, as requested
- Effectively performs other duties as assigned

Minimum Qualifications
- B.S. in a scientific or health field and 6+ years of experience in Pharmacovigilance
- Prior experience in biotech/pharmaceutical industry

Preferred Qualifications
- Exhibits an advanced understanding of pharmacovigilance
- Experience serving in a Pharmacovigilance Quality role
- Experience developing and executing training
Significant experience with Microsoft Office applications (MS Word, MS Excel, MS PowerPoint)
- Clearly demonstrates an extensive understanding of quality and regulatory compliance as well as the application of these concepts to Pharmacovigilance
- Independently determines the best and most appropriate methods and procedures on new assignments
- Independently leads projects and/or teams on projects of moderate complexity and scope
- Demonstrates ability to appropriately plan and execute on moderately advanced tasks and/or projects within their technical expertise
- Effectively operates in a matrix environment to ensure completion of cross-functional quality initiatives
- Creates and conducts presentations of quality issues, initiatives and projects
- Effective communication skills, both verbal and written
- Ability to navigate and be successful in a fast-paced environment
- A desire to be part of a highly innovative company aimed at transforming the lives of people with serious diseases, their families and society
- Embody the Vertex Core Values of Uncompromising Commitment to Patients, Fearless Pursuit of Excellence, Innovation is Our Lifeblood and “We” Wins
- Effective communication skills, both verbal and written
- Ability to navigate and be successful in a fast-paced, highly-matrixed work environment
- A desire to be part of a highly innovative company aimed at transforming the lives of people with serious diseases, their families and society

Vertex creates new possibilities in medicine. Our team discovers, develops and commercializes innovative therapies so people with serious diseases can lead better lives. Vertex scientists and our collaborators are working on new medicines to cure or significantly advance the treatment of hepatitis C, cystic fibrosis, rheumatoid arthritis and other life-threatening diseases. Founded more than 20 years ago in Cambridge, Mass., we now have ongoing worldwide research programs and sites in the United States, United Kingdom and Canada. Vertex has consistently been recognized as one of the industry's top workplaces by leading publications such as Science magazine, The Boston Globe, Boston Business Journal, San Diego Business Journal and The Scientist. For more information and to view Vertex's press releases, please visit www.vrtx.com.

Vertex is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person’s race, color, gender, age, religion, national origin, ancestry, disability, veteran status, genetic information, sexual orientation or any characteristic protected under applicable law. Vertex will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law.

To Apply for this position, please CLICK HERE

Headquartered in Lexington, Massachusetts, Cubist Pharmaceuticals, Inc. is a biopharmaceutical company focused on becoming a leader in the discovery, development and commercialization of novel acute care therapies for use in hospitals and other acute care environments.Position Summary:

The responsibilities for the Scientist / Sr. RA-2/ involve leading the microbiological activities during clinical trial development by working closely with the Clinical Development and the Biostats/Data Management Teams.  

In addition, this individual will cover interaction with KOL program of pre-clinical studies (in vitro micro/PK/PD studies both model and in animals).  

The individual will be responsible for initiating contracts with key opinion leaders (KOLs) in support of pre-clinical studies (in vitro microbiology as well as pharmacology studies. This individual will be responsible for initiating contracts with KOLs and developing protocols for reference laboratories in order to carry out pre-clinical studies necessary to support NDA application. These efforts continue into later phase drug development and launch.. This last function requires interactions with legal, publication, Clinical Development/Medical Affairs, and regulatory groups.
Duties and Reponsibilities:  
* Responsible for providing guidance/support to the Clinical Operations and Data Management team during protocol development, start up of a clinical trial, review of all pertinent study documents, aggressive data monitoring/QC verification and preparing the data at the end of study for final analysis in all phases of clinical development.  
* Responsible for data quality from Central Microbiology Lab/regional laboratories chosen for a particular clinical study and all susceptibility testing data.  
* Specifically, manage request for central lab proposal, work closely with team developing trial documents –clinical microbiology laboratory manual(s) and isolate requisition design and once trial is ongoing-- review data monthly. Monthly data monitoring includes identifying CRF to Central lab data discrepancies, gaps, and working with data management for query resolution. Leading the study team on the statistical analysis plan and the tables and listing design for integration of data. At conclusion of trials, lead the team oversight of data analysis and sponsor review.
* Lead team in susceptibility testing development on different commercial devices. Provide support for development of key tests to support launch and eventually key automated systems in hospital clinical microbiology laboratories.
* Lead on microbiology sections of regulatory filings such as package insert drafts, investigator’s brochure, IND, NDA , PSUR reports and annual updates.  
 
Minimum Basic Qualifications :  
* B.S./ M.S. with work experience equivalent to advanced degree (Microbiology/Virology)
* 7-10 years experience working in Pharma industry part of which could be experience in research or clinical microbiology laboratory.
 
Experience Required:  
*Ph. D or work experience equivalent
*4-8 years experience working on clinical trials in Pharma industry.

Desired Competencies and Qualifications:  
* Clinical microbiology/virology expertise including diagnostics of infectious diseases.  
* Ability to take leadership responsibility for external collaborations.  
* Key driver for group or team projects—aid development of strategic direction for group/team.
* Good interpersonal skills, ability to work well in a team environment—able to form, impact and lead cross-functional groups.  
* Presents/prepares project summaries or reports—including company- wide projects to leadership teams and external experts.
 
Work Environment:   
* Office
 
Physical Demands:   
* None
* Travel required
 
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily within the context of the representative work environment and physical demands described above. Likewise, qualifications listed are representative of the knowledge, skills, and abilities required to perform the position's essential functions. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

To apply for this position, please CLICK HERE

Primary Role:
The individual will be responsible for leading technical support in clinical and commercial drug product manufacturing operations conducted by contract manufacturing organizations (CMOs). This includes process transfer and improvement, process monitoring, and change management. In addition, this individual will take a leadership role in manufacturing troubleshooting and GMP investigation for critical manufacturing discrepancy and exceptions. This individual will also lead in new project initiatives and be able to effectively drive resolution of issues and foster collaboration throughout the organization and with our external partners.

Responsibilities:
Author in-process trend analysis reports to meet the compliance requirements for commercial drug products manufactured by CMOs. (15%) Monitor process performance against expectations for clinical and commercial drug products. (15%) Provide technical support for deviations, complaints, change controls, and GMP investigations for both clinical and commercial products manufactured by CMOs. (20%) Identify and manage process improvement activities for clinical and commercial manufacturing practices. (15%) Provide technical assessment in evaluating new technologies and contract partners for external manufacturing projects. (15%) Author and review development, quality and regulatory documents to support product release, regulatory submissions, and regulatory responses to agency questions. (20%)

Education and Experience Requirements:
*  Minimum, M.S. degree in engineering, pharmaceutics, chemistry, or related science.
*  Minimum, 5 years industry experience in pharmaceutical development and manufacturing technical support.
*  Technical expertise in pharmaceutical development and drug product manufacturing operations for injectable biologics and other pharmaceuticals.
*  Thorough knowledge and understanding of global GMP regulations and guidance, and quality operation system. Shire's Brave culture offers employees with diverse backgrounds the opportunity to enable those with life altering conditions to lead better lives

Shire is an Equal Opportunity and Affirmative Action Employer

To apply for this position, please CLICK HERE

Sanofi, a global and diversified healthcare leader, discovers, develops and distributes therapeutic solutions focused on patients’ needs. Sanofi has core strengths in healthcare, with 7 growth platforms: diabetes solutions, human vaccines, innovative drugs, consumer healthcare, emerging markets, animal health and the new Genzyme. Through the acquisition of Genzyme, Sanofi has strongly reinforced its footprint in rare diseases.

Procurement Materials and Subcontracting Lead Buyer Projects

The Procurement M&S Lead Buyer Projects is:
Responsible for implementation of the global sourcing strategy specifically for clinical packing, clinical investigative product, active pharmaceutical ingredients, comparators, clinical ancillary supplies, early development building blocks, chemical libraries and subcontracted scientific procurement and contracting activities which includes:

o Contract initiation, execution and life-cycle management; supplier relationship management; RFXs, negotiation of pricing and proposals, trending, benchmarking and monitoring of the applicable commodities in the marketplace.
o Implementing the North America procurement strategies as defined by Category Management.

The procurement function aims at enabling the Sanofi strategy by leveraging the supplier markets and delivering added value throughout operations performed within Central, Global, and Regional Units, pillars of its organization.
- The Central Unit is in charge of setting a vision and objectives aligned with the strategy of Sanofi and ensuring functional excellence by identifying and implementing the most advanced best practices in Resource Management, Sourcing, Process & Systems, Communications and Performance Analysis.
- Global Procurement Units are in charge of designing and implementing the procurement strategies per category aligned with the business LRPs through a worldwide network of lead buyers and category managers.
- Regional Procurement Units are in charge of executing and implementing the global purchasing strategies locally, developing active relationships with regional and local stakeholders, and contributing to the integration of the newly acquired business.
These units have a common goal of business partnering, managed at strategic and operational levels, designed to set deep collaborative and innovative relationships with the business and central functions.
In order to boost procurement efficiency and performance, the procurement organization fosters the right level of globalization through a category management oriented operating model leveraging the management of resources through competencies, localization, internal mobility’s and talent development.

ESSENTIAL JOB KEY ACCOUNTABILITIES AND RESPONSIBILITIES:
 The Purchasing Manger’s key sourcing strategy duties/responsibilities are but not limited to:
• Assist the Head of M&S in defining the yearly action plan including, budget forecasting, mapping exercise, coverage and savings targets, strategies for sourcing and business integration
• Develop clearly defined strategic orientations in relation to the supplier and technology market analysis
• Assist the Head of M&S in the action plan review/validation with the global category management team
• Lead the efforts in finding new supplier and technology market opportunities within his/her perimeter
• Lead supplier relationship management activities with strategic suppliers for his/her perimeter of spend
• Develop strong partnerships with their main internal customers and business stakeholders
• Build sourcing strategies and operational action plans for his/her Procurement segments
• Develop reports, activity dashboards and relevant KPIs to monitor and manage his/her activities
 The Purchasing Manager’s key management duties/responsibilities are but not limited to:
• Ensure that all needs and key projects are identified and challenged for his/her perimeter of responsibilities
• Manage all operational and functional activities related to his/her spend perimeter and/or assigned project(s)
• Propose improvement plans to Head of M&S which are aligned with the Supplier Diversity & Sustainability goals
• Develop the strategies for the management of team(s) and/or project(s) and/or critical purchasing activities
• Manage and optimize when required/relevant the human resources to fulfil the teams target
• Lead and conduct RFP process with ad-hoc procurement and internal customer support
• Identify and leverage the level of expertise and maturity of his/her network by facilitating exchange of information
REQUIRED EDUCATIONAL BACKGROUND AND JOB-RELATED EXPERIENCE:
Bachelor’s degree from an accredited four-year college or university
Area of specialization: business or scientific

This position requires 7 - 15 years purchasing experience.
Additional Responsibilities include
o Coordinating regional interactions with other sites to implement proper procurement strategies.
o Ensuring business partner functions are properly aligned with Category Management strategy and Regional Procurement processes are understood and implemented.
o Ensuring internal client has clear understanding of procurement best practices, policies and guidelines.

 

A career at Dyax is more than a job. Our goal to discover, develop, and commercialize novel therapeutic products takes a special type of person. If you're passionate about your work, motivated by a challenge, and deeply committed to what you do, you'll find like-minded individuals here at Dyax. Our environment cultivates innovation--empowering those who want to make a contribution, pursue new ideas and expand their minds along the way. Dyax provides a culture that lives its values of Respect, Teamwork, Integrity and Commitment, making it a great place to develop professionally.

This Commercial Analyst will be a member of the Commercial Analytics Team within Commercial.  This individual will be responsible for data configurations/reports of KALBITOR performance and sales operations.  Data from KALBITOR Access will provide a majority of this data.  TheCommercial Analyst will participate in a wide range of projects involving daily/weekly/monthly planning for the product performance data. 

Primary responsibilities include:

• Process and analyze data from data portals (USB, ASD &SFDC) provide sales operations Sr. Manager with timely and accurate insight into data dynamics, produce regular data reports and weekly updates.

• CRM data management e.g. Physician Profile management, field communication and coordination.

• Work with integrated data team to identify data flow processes and challenges, determine appropriate solutions and/or work- arounds.

KALBITOR HUB
Homecare Partner

• Assist in the development of Marketing programs reporting tool
  • Work with marketing team to determine measureable data elements to report ROI of programs
  • Provide ongoing support of the marketing score card

•  Frequently support and conduct ad-hoc Market research project support.

Qualifications:

• Strong computer skills
• Meticulous regarding accuracy
• Able to work and deliver on deadlines and manage multiple projects
• Team oriented

Education:

• BS in business or tech discipline
• 3-5 years prior experience in data retrieval, tracking and analysis

Submitting a resume online at a job site could cause valuable screening information to be missed.

Please apply directly at:
http://hostedjobs.openhire.com/epostings/submit.cfm?fuseaction=app.dspjob&jobid=216440&company_id=15896&jobboardid=306

We are an Equal Opportunity Employer

The Quality Assurance Manager is responsible for the programs, processes and activities within an operational cGMP Quality System. The Manager leads a team which ensures organizational compliance with all regulatory requirements. This position works in a team based environment with Manufacturing, Packaging, Materials, Engineering and R&D to ensure all quality, production, and development goals are met.

A complete job description can be found on the Careers page of our website at www.anikatherapeutics.com.

Qualified candidates will have the following level of education and experience:

• Bachelor's degree in the life sciences or related engineering field
• A minimum of 7 years within Quality Assurance with a demonstrated knowledge of cGMP/QSR
• Experience working in a high volume commercial manufacturing operation is preferred
• Demonstrated knowledge of regulatory requirements under FDA, ISO 13485:2003, MDD is required
• Previous supervisory experience of 3 years is required
• Excellent verbal and written communication skills
• Project management experience is preferred

A comprehensive compensation and benefits package is available. For consideration, please complete the on-line application process on the Careers page of the website at www.anikatherapeutics.com .

Our client is a leading biopharmaceutical company in the Boston area. They have an active need for a Manager of Compliance with previous biopharma experience, although a background in medical devices would also be considered. This is a senior role (8-10 years of experience) with a small group of direct reports. This is a full-time, permanent role with benefits.
Responsibilities may include but not be limited to:

Maintenance of quality systems and policies
Lead quality contact during audits and support of audits by external agencies
Oversight of complaints
Support CAPA program, including review and approval of plans and implementations
Review non-lot related deviations and change controls
Management of product risk profiles
Quality oversight of facility shutdowns, sanitization, walk-throughs, etc.
Track and report internal compliance metrics
Ensure all documentation and operations meet established requirements
Manage small staff in all areas mentioned above

Qualified candidates will have:

BS/BA in a scientific discipline with 8-10+ years of industry experience in quality or operations
3 years in a managerial/supervisory capacity
Experience with CAPA and complaint management
Thorough knowledge of applicable regulations and standards

Top BioPharma client seeking technical cold-chain logistics expert to support the development of shipping systems, develop design specifications in accordance with regulatory requirements, work cross functionally to ensure that logistics solutions are designed, developed, qualified and meet product requirements. Will also investigate and analyze the impact of new shipping systems to assess technical performance, operational efficiencies, sustainability and time to implementation. Scope includes package development for all the company's clinical trials worldwide and global commercial package development.

Other Responsibilities:

Manage packaging material selection, testing and qualification

Author technical documentation including protocols, reports, SOPs, DOEs, and item specifications

Provide technical oversight and coordination for new packaging equipment and processes

Provide technical support and perform investigations related to packaging

Participate in packaging cold-chain qualification activities

Requirements:

BS in Engineering.

3+ yrs of Cold-Chain and 5+ years of project management experience.

Experience with computational heat transfer thermal modeling, GDP and GMP requirements for storage and transport of pharmaceutical products.

Working knowledge of the design/testing of active and passive shipping systems.

Knowledge of ISTA & ASTM testing programs, freight transportation carrier selection, transportation regulations (domestic and global).

Experience in cold chain shipping, validated shipping containers/systems, and import/export processes/ documentation.

Manager of Regulatory Affairs

 Participate in development and implementation of regulatory strategy for specific programs. Utilize sophisticated understanding of international regulatory affairs and government. Working in a team environment, responsible for planning and coordinating all aspects of regulatory submissions necessary to support clinical trials, product registration and maintenance. Represent the department on multidisciplinary product development teams. Work with and report to Associate Director of Regulatory Affairs to implement the regulatory strategy to move products through late-stage development, regulatory approval and post-marketing regulatory activities. Evaluate and communicate regulatory requirements for submissions and programs to ensure that all regulatory activities are in compliance with applicable regulations and guidelines. Remain abreast of changes and meaningful trends in the regulatory environment in the US and pertinent international jurisdictions. Participate on project teams or sub-teams for the planning of activities needed to meet program objectives, including preparing and managing timelines for all regulatory submissions such as international CTx, IND amendments, NDAs, post approval supplements, annual reports, and briefing books. Serve as primary liaison with regulatory authorities and participates in meetings with regulatory agencies. Write Agency correspondence, meeting minutes, and introductory sections of regulatory submissions. Review documentation associated with regulatory submissions. Work with Regulatory Operations to develop submissions in electronic format. Collaborate with regulatory team and cross-functional teams to promote an environment of knowledge sharing and team effectiveness.

 Requirements include a Bachelor’s degree or equivalent in Political Science, Chemistry, Biology or a health-related field and five years of work experience in the job offered or related field of regulatory affairs in the pharmaceutical/biotech industry.

Special Requirements:

Experience must include interpretation of regulations and guidelines related to drug development and lifecycle management of approved products. Must have prior experience with US and ex-US submissions.

Work Site Location: Cambridge, MA

If interested, email resume to careers@ironwoodpharma.com, reference job code AHMRA, or, if necessary, send by mail to HR Staffing, Ironwood Pharmaceuticals, Inc., 301 Binney Street, Cambridge, MA 02142.

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. In this new role, the successful candidate will create the vision, build and lead our new initiative in creating novel cellular immunotherapy products at bluebird bio. The scope of this initiative will encompass cellular immunology and tumor biology to enable a pipeline of novel immunotherapy products. Our goal is engineering cells of the hematopoietic system to more effectively treat malignant and autoimmune disease. The position demands an experienced scientific leader who can make informed risk/benefit decisions as to target identification and preclinical candidate development. In addition, the candidate will provide a sophisticated level of coordination with bluebird’s core functions by leading a multi-disciplinary cellular immunotherapy project team.  The candidate will have direct responsibility to recruit a team of 8 to 10 staff who are experts in T cell biology and tumor biology. 

Primary responsibilities:

• Communicate to Management and the Board of Directors a clear strategic direction and realistic operational plan, including the timeline, personnel requirements and internal and external program costs for development of product candidates from concept to IND initiation;
• Build and lead a team of 8 – 10 talented scientists to identify therapeutic target molecules and engineer cells of the hematopoietic system with the goal of bringing these modified cells through phase I clinical development;
• Oversee the development of relevant in vitro assays to assess function, as well as vivo animal models for efficacy and safety evaluation;
• Build reputation for bluebird bio as a world-class development organization for cellular immunotherapy products;

• Identify and bring in new technology to improve the therapeutic potential of gene- modified hematopoietic cells for cellular immunotherapy.

Qualifications:

• Ph.D. in cellular or molecular immunology, or MD with training in oncology or autoimmune disorders. The ideal candidate will have at least 15 years of experience with at least 10 years of management experience and track record of innovative laboratory research;
• The candidate must be a recognized academic or industry leader in cellular/ molecular immunology and have substantial experience with development of biological, vaccine or gene/cell therapy products;
• If from industry, at least 15 years’ experience in biotechnology/biopharmaceutical discovery and drug development with a track record of successfully moving first-in- class compounds from discovery through phase II.
• If from an academic environment, Associate Professor or equivalent level with strong track record of publication in top-tier journals and demonstrated success in obtaining grant funding through NIH and private foundations. In addition, the ideal candidate demonstrates a track record for running a laboratory at a major academic institution supervising multiple postdocs and graduate students
• The candidate will be recognized as an emerging thought leader evidenced by a strong track record of publication and invited presentations
• Experience developing and managing operational budgets
• Track record of leading developing high performance individuals/teams that have/ has gone on to become leaders in industry/academic research
• Excellent written and verbal communication skills
• Ability to work effectively in a collaborative team environment where results are achieved through influence and the incorporation of multiple points of view
• Independently motivated, detail oriented and good problem solving ability
• Excellent organizational skills, sufficient to multi-task in an extremely fast-paced environment with changing priorities

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.