Join bluebird bio’s enthusiastic and collaborative team by contributing to the overall success of our novel gene therapy approach.  We are seeking a highly motivated individual with strong technical skills in Information Technology Operations responsible for technical management of IT server, network and storage infrastructure; including on-premises, IaaS, Cloud environments. You will provide technical management and support for our IT infrastructure and will work closely with managed service provider(s) and contractors or consultants.

About the Role:

• In conjunction with IT infrastructure vendors, manage the day to day management, monitoring, maintenance, upgrade and support of all Data Center Operations including servers (physical/virtual), storage (NAS/SAN), Network, Security and telephony infrastructure
• Maintain, enhance and test all aspects of bluebird bio’s data protection environment, including backup/recovery, business continuity and disaster recovery
• Work with the IT Operations Senior Management team to design, develop and implement new IT infrastructure platforms and strategies; including on premises, Cloud, SaaS and hosted environments
• Maintain a high level of infrastructure uptime in a fast paced, regulated environment
• Partner with IT and business units on key infrastructure projects, providing assessments and implementation services for key new applications and systems

About You:

• Bachelor’s degree or equivalent experience and a minimum of 6-8 years of IT Operations experience, 3-5 years of hands on technical experience within IT, preferably in a regulated environment/public company
• Experience maintaining a Windows corporate network environment
• Experience in data center operations, including physical and virtual servers, networking concepts and storage architectures
• Must have the ability to work autonomously on various problems and be willing and able to take on new responsibilities as needed.
• Ability to manage multiple projects, activities and tasks simultaneously
• Experience with supporting a multi-site IT infrastructure supporting a 300+ end user environment
• Experience in vendor management, computer operations, network  management, technical management and end user support
• Experience with SaaS and hosted solutions including Office 365, Identity Management. and Mobile Device Management, and Okta single sign in
• Cloud/IaaS (AWS or Azure) and VMWare vSphere experience preferred
• Ability to work on an “on call” schedule, lift 50 pounds, and limited travel
• Experience operating in an environment with one or more of the following processes: IT incident/service request management, IT release and deployment, IT change management, IT configuration management
• Excellent communication, customer relations and problem-solving skills a must.
• Experience in biotech, pharma or life sciences preferred
• 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.
• Be ready to embrace the principles of the bluebird bio culture:  b colorful, b cooperative, and b yourself

Acorda Therapeutics is a world leading biotechnology company focused on developing therapies that improve lives of people with neurological disorders. Acorda has a cGMP manufacturing facility in Chelsea, MA. The lead product in this facility is for the treatment of Parkinson’s disease.

The Manufacturing Technician assists in the performance of routine operations for the GMP production of pharmaceutical products. This individual operates in accordance with environmental, health, safety, and cGMP guidelines. The Manufacturing Technician executes production activities under direct supervision for spray drying, capsule filling, and blister packaging operations.

This is a second shift position.  The hours are 3 - 11:30, Monday through Friday. 

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

• Performs Clean-In-Place, Clean-Out-of-Place, and equipment sterilization as required.
• Operates and monitors manufacturing equipment for the production of clinical and commercial pharmaceutical products.
• Assists in the execution of routine and complex production processes.
• Performs final packaging and inspection of pharmaceutical products.
• Receives and distributes supplies in the manufacturing area.

Education and/or Experience:
A High School diploma or equivalent is required.

Prior experience in a manufacturing environment preferred, preferably the pharmaceutical or biotechnology industry.

Qualifications: Critical understanding of the importance of documentation and data traceability. Familiarity with executing Standard Operating Procedures in a manufacturing or assembling environment preferred. Working knowledge of Good Documentation and Good Manufacturing Practices preferred.

Computer Skills: Must be proficient in MS Office Word and Outlook.

Certificates, Licenses, Registrations: None required.

Other Skills and Abilities:

Demonstrates attention to detail.

Excellent written and verbal communication skills.   Ability to communicate in English.

Excellent organizational skills.

Must be able to work well independently and in a team environment.

Ability to multi-task and adjust priorities as necessary.

Must demonstrate appropriate safety consciousness.

Physical Demands: The physical demands here are representative of those that must be met by an employee to successfully perform the essential functions of this job.
Must have the ability to lift up to 50 pounds. Requires physical activity such as standing for long periods of time, walking, and working with hands. This position requires minimum travel. Average travel for this position is less than 5% with some variation based upon the demands of the business imperative.

Work Environment: The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job.
Must be able to work in a controlled or clean room environment requiring special gowning. Must have the ability to work safely and conscientiously in a manufacturing environment. Some weekends or holidays may be required. May require adjustment to a shift schedule as manufacturing objectives change.
*To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed above are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

Please visit our website to learn more about Acorda Therapeutics.   www.acorda.com  If interested and qualified, please submit your resume on line.  You may also email your resume to mricher@acorda.com

Join bluebird bio’s enthusiastic and collaborative team by contributing to the overall success of our novel gene therapy approach. Working together with the Director of Translational Bioassays, the Research Coordinator will oversee the analysis and management of outsourced (CRO) clinical trial samples. This individual will collaborate with Clinical Operations to ensure that samples from clinical trial sites are collected as described in the study laboratory manual and shipped under appropriate conditions.  You will be responsible for tracking and monitoring sample analysis at the CRO to ensure good quality data is delivered in a timely manner.  Will work with Finance to review and approve invoices and conduct monthly accruals. Will work independently and with clinical sites, labs and internal stake holders to resolve issues as they arise.

About the role:

• Oversee or contribute to the transfer, implementation and application of bluebird assays to CROs for new or existing programs
• Assist Director with negotiating budgets with CROs
• Work with Clinical Operations to develop and design new Laboratory Manuals and requisition forms for new clinical studies.
• Assist with completing and maintaining study data collection forms and source documents
• Continually monitoring commitments and deadlines to track shipment of samples from clinical sites to testing laboratories
• Work with testing lab and Clinical Research Associates (CRAs) to resolve sample discrepancy issues in a timely manner
• Maintain internal spreadsheets to track sample delivery at CROs.
• Receive and archive clinical sample analysis reports as well as study related documents from the testing laboratory

• Assist team with financial and/or administrative duties including tracking budgets, review and approval of invoices against completed work, and performing monthly/quarterly accruals
• Identifying problems and effectively communicating issues to ensure timely resolution
• Perform any other duties necessary to support departmental and company goals, as needed.
• Maintains strictest confidentiality

About you:

• BS degree in a scientific discipline, required
• 3-5 years’ experience as a preclinical or clinical research coordinator, grant administrative assistant, or compound management coordinator in academia or pharmaceutical industry
• Strong organizational and time management skills. Ability to work on multiple projects in parallel is essential.[LY1] 
• Excellent Excel skills
• Exceptional record keeping and communication skills
• Ability to work independently and in cooperation with others
• Ability to execute and follow through to completion and documentation.
• 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.
• Be ready to embrace the principles of the bluebird bio culture:  b colorful, b cooperative, and b yourself

 [LY1]Can these 2 bullets be combined?

Join bluebird bio’s enthusiastic and collaborative team by contributing to the overall success of our novel gene therapy approach. Working together with the Director of Translational Bioassays, the Research Coordinator will oversee the analysis and management of outsourced (CRO) clinical trial samples. This individual will collaborate with Clinical Operations to ensure that samples from clinical trial sites are collected as described in the study laboratory manual and shipped under appropriate conditions.  You will be responsible for tracking and monitoring sample analysis at the CRO to ensure good quality data is delivered in a timely manner.  Will work with Finance to review and approve invoices and conduct monthly accruals. Will work independently and with clinical sites, labs and internal stake holders to resolve issues as they arise.

About the role:

• Oversee or contribute to the transfer, implementation and application of bluebird assays to CROs for new or existing programs
• Assist Director with negotiating budgets with CROs
• Work with Clinical Operations to develop and design new Laboratory Manuals and requisition forms for new clinical studies.
• Assist with completing and maintaining study data collection forms and source documents
• Continually monitoring commitments and deadlines to track shipment of samples from clinical sites to testing laboratories
• Work with testing lab and Clinical Research Associates (CRAs) to resolve sample discrepancy issues in a timely manner
• Maintain internal spreadsheets to track sample delivery at CROs.
• Receive and archive clinical sample analysis reports as well as study related documents from the testing laboratory

• Assist team with financial and/or administrative duties including tracking budgets, review and approval of invoices against completed work, and performing monthly/quarterly accruals
• Identifying problems and effectively communicating issues to ensure timely resolution
• Perform any other duties necessary to support departmental and company goals, as needed.
• Maintains strictest confidentiality

About you:

• BS degree in a scientific discipline, required
• 3-5 years’ experience as a preclinical or clinical research coordinator, grant administrative assistant, or compound management coordinator in academia or pharmaceutical industry
• Strong time management skills and the ability to work on multiple projects in parallel is essential.
  
• Excellent Excel skills
• Exceptional record keeping and communication skills
• Ability to work independently and in cooperation with others
• Ability to execute and follow through to completion and documentation.
• 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.
• Be ready to embrace the principles of the bluebird bio culture:  b colorful, b cooperative, and b yourself

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

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

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

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

Education and/or Experience:

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

 Qualifications:

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

Other Skills and Abilities:

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

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

No agencies please!

Lonza Portsmouth, has significant expertise in the field of mammalian cell culture and cGMP custom manufacturing and is active in the large-scale production of biopharmaceuticals. Portsmouth is a custom manufacturer of therapeutic monoclonal antibodies and recombinant proteins using mammalian cell culture for mammalian biopharmaceutical. The facility has been in cGMP manufacture since 1996 and is dedicated to meeting the needs of our customers. The setup and performance of projects teams with experts from Lonza and our customers working together is unmatched in the industry.  We currently have a position open on our QA team.

Quality Specialist-Risk Management, Level 3-Portsmouth, NH

Quality Risk Management:  To provide site support in quality risk management with training on risk principles and tools, risk assessment facilitation, management of quality and site significant risks and assist with the development of the Quality Risk Management program at the site.

Responsibilities:

• Facilitate or assist with risk assessment facilitation
• Represent quality risk management on cross functional teams
• Manage inventory of risk assessments
• Assist with integration of quality risk management process into site operations
• Monitor mitigation activities; update and contribute to the management and oversight of Site Risk Register
• Create training material on risk tools to educate users on applicability and use of tools
• Train risk leads on quality risk management principles and tools used for risk assessing
• Assist with development and maintenance of metrics or key performance indicators for determination of system effectiveness
• Assist with development and refinement of the Quality Risk Management program
• Draft new and review and edit existing SOPs for accuracy and compliance with internal procedure/policy and applicable regulations.
• Assist with projects as assigned by Management.

TrackWise:  To provide site wide administrative support for the TrackWise quality system.  This is accomplished through providing access to the tool, maintenance of user accounts (setting up new hire, management of permission changes and departing employees); troubleshooting (user related problems) and train/assist users on the use of the system or certain applications.

Additional responsibilities include:

• Perform annual critical TrackWise System permissions review
• Perform quarterly TrackWise Quality Systems Access Audits
• Support the site during periods where the TrackWise System is not available to ensure no/minimal impact to the business regarding documenting quality activities (e.g. planned system maintenance)

ALL LONZA BIOLOGICS EMPLOYEES HAVE THE FOLLOWING RESPONSIBILITIES:

-          Quality should be the responsibility of all persons involved in Manufacturing.  Adherence to cGMPs is required at all times during the manufacture of APIs.

-          All personnel are responsible for notifying responsible management in a timely manner of regulatory inspections, serious GMP deficiencies, product defects and related actions (e.g. quality related complaints, recalls, regulatory actions, etc).

-          All personnel should practice good sanitation and health habits.

-          Personnel suffering from an infection disease or having open lesions on the exposed surface of the body should not engage in activities that could result in compromising the quality of APIs.

Qualifications:

• BS/BA Degree preferred; Preferred but not required
• 2+ years related experience in a pharmaceutical, biotechnology and/or biomedical industry, preferably with risk management experience
• 2+ years experience working in or adminstration of TrackWise or similar quality software application

• 2+ years experience working in a GMP or regulated environment
• 2+ years prior experience in QA or Quality Systems (specifically with Quality Risk Management exposure) - preferred

SPECIFIC SKILLS REQUIRED (USE ADDITIONAL SHEET IF NECESSARY)

• Experience in leading, coordinating and execution of risk assessments
• Ability to work in a fast paced environment, both independently and as part of a team
• Ability to organize work schedule and to communicate effectively and interact with others
• Ability to set priorities and work under occasional stressful situations
• Strong interpersonal skills, freely develops networks, builds consensus, prioritizes effectively, and develops alliances across an organization
• Highly motivated self-starter with multi-tasking abilities
• Strong sense of ownership and accountability for quality output

Knowledge:

Six Sigma tools (e.g. Failure Modes and Effects Analysis)

cGMPs and applicable regulations (e.g. specific to Quality Risk Management)

Proficient in computer programs: Word, Excel

Skills:

Excellent communication and presentation skills

Ability to independently work on routine departmental activities and requirements at job level

Ability to prioritize and schedule work

Ability to work with differing points of view

Ability to troubleshoot, solve problems and make sound compliance decisions

An Equal Opportunity Employer

      M/F/Disability/Veterans

Please take virtual tour of the Portsmouth, NH site. Click here http://lonzavirtualtours.com/

Quanterix is an exciting early-stage commercial company currently developing a transformational platform that combines proprietary single-molecule sensitivity, multiplexing and full automation with its revolutionary Single Molecule Array (Simoa) technology.  Located in Lexington, MA, the company has launched an instrument for the life sciences research industry.   With unprecedented sensitivity, precision, multiplex capabilities, and full automation, Simoa offers significant benefits for both research and clinical testing applications.   Quanterix is looking to hire an experienced Senior Quality Assurance Specialist to join our growing team.  

This Senior Quality Assurance Specialist will be responsible for routine management and coordination of cGMP and ISO compliant systems and provide leadership for quality compliance activities and initiatives.

 Key Responsibilities:

• Perform product releases and associated batch record reviews
• Perform quality review of validation protocols and reports
• Active participant in audits performed by customers and regulatory agencies
• Manage Internal Audit Program
• Provide QA support of investigations, including nonconformance, CAPA, root cause analysis, complaints, out-of-specification and environmental excursion
• Maintain company compliance with national and international Quality System regulations for medical devices by evaluating current procedures and practices
• Participate in project teams and perform other related duties as assigned.

 Qualifications:

The ideal candidate will have:

• Bachelor’s degree in the life sciences
• 5 to 8 years of experience in the medical device and/or pharmaceutical industries working in a Quality Assurance/Quality Compliance role
• Keen attention to detail skills

 Desired Experience, Knowledge, and Skills:

• Experience being the Quality Assurance project team representative on projects with tight timelines
• Demonstrated experience writing, reviewing and approving quality policies and standard operating procedures
• Ability to document, understand and resolve complex technical issues
• Ability to handle multiple priorities and meet established deadlines
• Excellent interpersonal and written/verbal communication skills

About Quanterix

Quanterix Corporation is a privately held, dynamic and growing company located in Lexington, Massachusetts. We are building a team of best-in-class scientists, engineers and business professionals that thrive in a collaborative high-energy entrepreneurial environment. We believe that the commercialization of an enabling technology with the potential to revolutionize life science research and clinical diagnostics will require the very best people working together and exchanging ideas while sharing a commitment to innovation.  Our science and technology has been featured on CBS news, Good Morning America, The Boston Globe and several other prominent news sources.  For more information, visit us at www.quanterix.com

Primary Role:
The Zone Director (ZD) for HAE is responsible for the implementation of the strategic initiatives developed in partnership with the leadership team for the promotion of the drug. The ZD will develop deep understanding of the business situation within their geographic responsibility. They will manage and develop a top preforming sales team. They will:

Drive results
* Work with salesforce to prioritize key accounts
* Monitor and report on short-term and long-term goals of zone
* Allocate resources and secure additional resources as necessary to support salesforce activities
* Maintain an in-depth understanding of the market by reviewing and analyzing market data and use this market/industry know-how to drive success

Translate and implement strategy
* Assist US Head of Sales and home office personnel in developing an effective strategy
* Translate strategy into actions and objectives for salesforce and take an active role in communicating and reinforcing strategic vision to salesforce
* Hold regular meetings to help salesforce better understand strategies and objectives and implement sales tactics

Partner internally and externally to the business
* Serve as a liaison between the field and US Head of Sales; prioritize and communicate relevant issues and ideas
* Work collaboratively with home office (e.g. training, marketing, reimbursement) to effectively develop the most effective plans, processes and programs for the product
* Advocate Shire and the product to KOLs, physicians, and patients

Develop and lead effective sales force
* Problem-solve with salesforce to identify ways to add value/help influence customers
* Motivate salesforce to maintain passion for the mission and value of the product's capabilities
* Build team and company commitment within area
* Monitor performance, recognize top performance and address performance issues
* Provide continuous performance feedback, coaching, development and mentoring of salesforce

Responsibilities:
60%:
Responsible for meeting and exceeding sales objectives. This includes, but is not limited to effective hiring of top talent, effective implementation of the fundamentals of selling and implementation of the marketing plan.

20%:
Responsible for coordinating with broader commercial team (Marketing/Reimbursement/Patient Services) for the design and implementation of the U.S. business plans

20%:
Effectively assesses the development needs and initiates activity that will further develop salesforce members.

Education & Experience Requirements:
* Minimum of a Bachelor's degree in business or science related field is required.
* Minimum of 5 years of experience as a sales representative, within substantial orphan and/or hospital therapy sales success preferred.
* Previous experience as a first line manager

Other Job Requirements:
* Must live in zone
* Travel required 50%

About Shire:
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 employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by applicable law. US Applicants who require accommodation in the job application process may contact 484-595-8400.

Please apply at: Application URL:http://www.aplitrak.com/?adid=bHZhaWwuOTk4NjQuMzE2N0BzaGlyZS5hcGxpdHJhay5jb20

Primary Role:
The Regional Business Manager (RBM) is responsible for the implementation of the strategic initiatives developed by the leadership team. The RBM will develop strong working relationships with all physicians within their geographic responsibility who treat patients appropriate for the Shire Rare Disease portfolio of products. This entails the promotion of the drug within approved labeling, to all targeted physicians and patient candidates. The RBM's primary objective is to identify providers managing patients with Hereditary Angioedema to educate those providers regarding the benefits of using our therapies with appropriate patients. Further, once an appropriate patient is identified by the provider, assist the clinical staff with the steps necessary to get the patient on drug. This may include areas such as reimbursement, proper testing, and site of care determination.

Responsibilities:
This position will be responsible for all business related activities within their geographic responsibility, including achievement of sales goals, business planning, and expense control. The RBMs primarily call on Allergy/Immunology specialists and with some interaction with other specialists and targeted healthcare facilities.

Education & Experience Requirements:
* Minimum of a Bachelor's degree in business or science related field is required.
* Minimum of 8 or more years selling specialty biologics, preferably infused products
* Candidates must demonstrate a consistent track record of success (Top 20% performance). President's Club or other top tier awards preferred.
* Biotech, biologics, and specialty pharmacy experience helpful. Complex sales model experience is a requirement. Rare disease experience is a plus.
* Must demonstrate strategic territory management success.

Other Job Requirements:
Extensive travel required and varies by territory.

About Shire:
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 employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by applicable law. US Applicants who require accommodation in the job application process may contact 484-595-8400.

Please apply at: Application URL:http://www.aplitrak.com/?adid=bHZhaWwuMjA5NDMuMzE2N0BzaGlyZS5hcGxpdHJhay5jb20

Org Marketing Statement
A career at Pfizer offers opportunity, ownership and impact.

All over the world, Pfizer colleagues work together to positively impact health for everyone, everywhere.Our colleagues have the opportunity to grow and develop a career that offers both individual and company success;be part of an ownership culture that values diversity and where all colleagues are energized and engaged;and the ability to impact the health and lives of millions of people. Pfizer, a global leader in the biopharmaceutical industry,is continuously seeking top talent who are inspired by our purpose to innovate to bring therapies to patients that significantly improve their lives.

Role Description
The Process Technician will be responsible for the execution of Purification, Buffer preparation and glasswash activities in a multi-product, multi-line cGMP facility capable of manufacturing commercial, clinical and development drug substance. Successful candidates will be flexible and adaptable, willing to work in a fast-paced, dynamic environment.

Responsibilities
* Set-up and execution of cGMP unit operations with a focus on Purification (Chromotography, flow through filtration, tangential flow filtration) and solution formulation. Includes cleaning and sanitization of the facility and equipment (CIP, SIP, COP, autoclaving, depyrogenation, etc).
* Accurately follow oral, written and electronic instructions in the production area and document daily operations in GMP batch records and logs.
* Operate manual and automated equipment. Individuals will be expected to learn and work with enterprise system such as LabWare LIMS and SAP.
* Support implementation of new technology for process execution and/or analysis. May be responsible for authoring and revising cGMP documents including batch records and SOPs.
* Responsible for data entry and real time process monitoring.
* Assist in inventory tracking, maintenance scheduling, and troubleshooting of mechanical equipment.

Qualifications
* Associates Degree with 2+ years of experience, or an equivalent combination of education and experience is required.
* Experience working in a federally regulated environment is strongly preferred.
* Familiarity and experience with biotech cell culture, protein purification and/or support operations (such as solution preparation and/or operation of autoclave/depyrogenation ovens) preferred.
* Previous experience with manufacturing-scale purification (chromatography, UF/DF, VRF, FF) a plus

PHYSICAL/MENTAL REQUIREMENTS:
* Daily routine may require moving heavy equipment, standing for long periods of time, and/or walking throughout the suite including up and down stairs.
* Must be able to lift ~50 pounds.

EEO & Employment Eligibility
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 work authorization and employment eligibility verification requirements of the Immigration and Nationality Act and IRCA. Pfizer is an E-Verify employer.

Please apply at: Application URL:http://www.aplitrak.com/?adid=SmltLlRhdm9saWVyaS4wNDgwMi4zMTY3QHBmaXplci5hcGxpdHJhay5jb20

Join bluebird bio’s enthusiastic and collaborative team by contributing to the overall success of our novel gene therapy approach.  The focus of this position is to provide support for the development of the stem cell transduction and manufacturing processes. We are looking for a motivated associate scientist with the experience and drive to take ownership important process development projects.

About the role:

• All aspects of mammalian cell culture, including media and buffer preparation, culture initiation, propagation, and cryopreservation of cells, including primary human cells from commercial and/or patient sources 

• Perform complex technical work related to stem cell biology, viral gene transfer, and molecular biology, including tissue culture, flow cytometry and RT-PCR

• Transduction of CD34+ cells with lentiviral vectors

• Preparation of cells to meet the demands of multiple concurrent projects that require working evenings and occasional weekends

• Performance of general laboratory tasks, including maintenance of equipment

• Maintain accurate and reliable record keeping including database management, batch records, notebooks, and all other pertinent documentation

About you:

• BS or MS cell biology, immunology or related discipline with at least 2 years' experience in the biotechnology or pharmaceutical industry

• Willingness to work with lentiviral vector and human biological samples (viral vector biology experience a plus)
• Ability to take ownership of projects and results

• Independently motivated, detail oriented and good problem solving ability

• Excellent organizational skills, sufficient to multi-task in a fast-paced environment with changing priorities

• Strong verbal and written skills; ability to provide focus and clarity; able to handle confidential information and material appropriately

• Experience working with blood products

• Well versed in a variety of cell based methods with a strong understanding of tissue culture, cell biology, immunoassays, and general laboratory techniques.

• Working knowledge of various computer software, hardware, and standard office sufficient to record scientific data and results, and prepare reports.

• Ability to work in a team environment, meet deadlines, and prioritize and balance work from multiple individuals

• Ability to work effectively in a collaborative team environment where results are achieved through influence and the incorporation of multiple points of view

• Be ready to embrace the principles of the bluebird bio culture: b colorful, b cooperative, and b yourself

Join bluebird bio’s enthusiastic and collaborative Quality Assurance Validation (QAV) team to contribute to the overall success of our novel gene therapy.  This position will support the organization through the establishment of bluebird bio validation/qualification programs across disciplines and ensure alignment with industry standards in accordance with the relevant product’s lifecycle. In this position you will be responsible for guidance and technical review of protocols and reports related to equipment, test methods, computer systems, technology transfers, process validation, and shipping validation activities. These activities will encompass IND-enabling, pre-clinical, clinical and commercial projects.  The successful individual will own, lead or support multidisciplinary, multi-site, complex projects.

About the role:

• Provide support and guidance for the development, execution, data analysis and reporting of clinical and commercial protocols as necessary.
• Provide expertise to technical teams in the implementation of strategies for characterization and validation studies.
• Ability to exercise judgment within and outside of defined procedures and practices to determine appropriate action.
• Ability to multitask and prioritize independently in a high paced environment.
• Complete understanding of industry practices for product lifecycle.
• Thorough knowledge and understanding of FDA and foreign requirements and expectations.
• Ensures existing practices comply with industry standards.
• Responsible for the alignment of the bluebird QAV strategy and content with internal and external clients.
• Support the development, review and reporting of bluebird bio driven audit program consisting of internal clients or external CMO’s.
• Author risk assessments and validation documentation in close collaboration with internal and external interfaces as necessary.
• Provide QA support and implementation expertise for the introduction of new computer systems following industry regulatory guidance and best practices.
• Provide QA and Validation support/expertise to CMC and Tech Transfer teams.
• Provide subject matter expertise to scalable development of bluebird bio internal QC lab along with assay/method development.
• QA Approval of change controls and validation documents e.g. Risk Assessment, Protocol, Report, and User Requirements.
• Review of deviations and investigations with respect to equipment and validated processes.
• Represent the Quality Assurance Validation group in project teams, audits and inspections.
• Responsible for supporting the development of process validation requirements for new product introductions through commercial scale.
• Support the development of solutions to problems of varying complexity which require a high degree of ingenuity, creativity, and innovativeness.
• Contributes to the development of organizational objectives and principles.
• Supports the development of long-range goals and objectives
• Exercises considerable latitude in determining objectives and approaches to critical assignments.
• Acts as primary contact in absence of management.
• Participates in the selection of contract support as necessary.
• Provide management support and training to internal contractors.

About you:

• Wide range of expertise or working knowledge across all validation disciplines including process validation, shipping and cold chain storage, computer systems, method validation, facility utility systems and equipment (FUSE) along with cleaning validation.
• Bachelors’ and/or Masters’ degree in Engineering, Biochemistry or related field required. Technical understanding of biopharmaceutical production.
• A minimum of eight (8) years of experience in the industry, ideally all clinical phases through commercial drug product.
• Knowledge of cGMP guidelines, ICH Q7, Q8, Q9, Q10 and other international regulatory requirements relevant for process, cleaning and equipment validation.
• Leadership skills to lead cross functional teams to ensure project success.
• Excellent written and verbal communication skills including the ability to communicate and negotiate across the organization.
• Microsoft Office, including Word, Excel, PowerPoint, Outlook, MS Project.
• Ability to travel approximately 25%
• Experience within a multi-product facility and/or Contract Manufacturing Business is a plus
• Validation experience using risk based approach (FMEA, PHA, etc).
• Project management experience.
• Strong analytical ability.
• Experience with Validation of Processes; experience with protocol development and execution; experience with presenting documents during inspections (regulatory agencies).
• Experience with computer system validation and FDA Part 11 requirements.
• Demonstrates initiative; ability to undertake additional responsibilities and respond to situation as they arise with little or no supervision.
• Ability to make independent sound decisions and independently manage priorities in alignment with department and site drivers.
• Be ready to embrace the principles of the bluebird bio culture:       b colorful, b cooperative, and b yourself

Join bluebird bio’s enthusiastic and collaborative team and contribute to the overall success of our novel gene therapy approach. We seek an experienced QC Associate Scientist to support pre-clinical, IND enabling activities and late stage clinical trials. This role interfaces with internal stakeholders as well as contract testing and contract manufacturing organizations to: develop, transfer and validate test methods; review release and stability data; and support process characterization activities. The position requires a strong technical background in cell biology and/or molecular biology and an in-depth knowledge of cGMP/ICH/FDA/EU regulations.

About the role:

• Collaborates internally and externally to transfer, qualify/validate and troubleshoot test methods

• Drafts phase-appropriate qualification/validation protocols and reports

• Reviews release and stability data for starting materials and drug product

• Utilizes statistical software to identify and investigate potential data trends

• Participates in cross-functional laboratory investigations

• Works with QC management and external vendors to generate, review and approve Quality documentation, including: SOPs, test methods, change controls, deviations, CAPAs, OOS/OOT and Certificates of Analysis

• Compiles and verifies data in the CMC sections of regulatory filings

  About you: 

• Bachelor’s degree in a scientific discipline, 2-5 years of related experience in QC GMP environment
• Strong knowledge of cGMP/ICH/FDA/EU regulations
• Strong technical knowledge. Experience with cell culture, flow cytometry, and qPCR preferred
• Superb communications—both written and oral skills and “do-what-it-takes” attitude
• 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
• Excellent communication skills and ability to influence across multiple functions
• Be ready to embrace the principles of the bluebird bio culture:  b colorful, b cooperative, and b yourself

Scientist I, Emerging Technology in Gene and Cell Therapies

Clinical-stage, fast-growing gene therapy company

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

Join bluebird bio’s enthusiastic and collaborative Horizon team and contribute to the overall success of our novel gene and cell therapy approaches.  This new Scientist will join our exploratory group to develop and validate a variety of emerging technologies for novel cellular therapeutics using gene addition and gene editing approaches.

About the role:

• Dynamic bench position working in wide array of technology development and technology transfer for cell therapy, including; gene delivery techniques, optimization of nuclease-mediated gene editing, novel cell-based immunotherapies, and emerging areas/techniques.
• Perform various cell-based and molecular assays to assess the characteristics of cells genetically modified via viral transduction and nuclease-induced gene editing.
• Exercise independent judgment in development of new methods, techniques and protocols.
• Prepare all technical reports needed in support of an exploratory project moving to process development.

About you:

• Ph.D. in molecular biology, cell biology, immunology, virology or related discipline.
• Experience in adoptive T cell immunotherapies.
• Expertise in mammalian cell culture, including primary T cells.
• Expertise in cell based immunology assays, including ELISA/Luminex/or MSD cytokine analysis, cytotoxicity, cell tracing, co-culture assays, etc.
• Experience with cell transfection/transduction platforms including electroporation and retro/lentivirus.
• Experience in flow cytometry analysis/sorting, including multi-parameter antibody stains.
• Expertise in molecular biology techniques such as PCR/qPCR, gDNA/RNA isolation, cloning (Gibson and conventional).
• Experience with gene editing protocols, such as indel analysis and/or homology directed repair.
• Excellent computer, data analysis, and presentation skills with experience in Microsoft Excel, Flow cytometry analysis software, DNA plasmid management software (Vector NTI, Geneious, etc), Graphpad Prism, and Power Point.
• Should be highly and independently motivated, flexible, and have excellent organizational and communication skills.
• Ability to multi-task and prioritize in an extremely fast-paced environment with changing priorities.
• Must be able to work both independently and as part of a multi-disciplinary team.
• Willingness to learn and perform a wide variety of assays that may vary day-to-day.
• “Do-what-it-takes” attitude and ability to think outside of the box.
• Be ready to embrace the principles of the bluebird bio culture:  b colorful, b cooperative, and b yourself.

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

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

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

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

Join bluebird bio’s enthusiastic and collaborative team by contributing to the overall success of our novel gene therapy approach. Under the guidance of the Senior Director, Global Pricing, Reimbursement, & Market Access, this position will lead all aspects of Health Economics. Be a critical part of a team tasked with helping to shape the market access landscape for gene therapy.  Conceive of and execute innovative Pricing Market Access and Health Economics initiatives to support bluebird bio’s gene therapy and evolving oncology portfolio.  Contribute to the creation of market access strategies worthy of bluebird bio’s innovative therapies and the patients they are meant to serve.

About the role:

• Develop and prioritize evidentiary requirements for Health Technology Assessment (HTA) and Market Access decision makers.  Partner with cross functional business partners (e.g. Medical Affairs) to prepare and execute evidence generation plans
• Lead the development of economic models with sufficient evidentiary support to withstand critique of HTA bodies and other key access decision makers
• Engage with key European HTA bodies to understand their value drivers and then map them back to economic modeling and evidence collection efforts for bluebird bio products
• Become a health economics thought leader for curative therapy including health services presentations at key society meetings (e.g. ASH) and Pricing, Market Access forums (e.g. ISPOR)
• Provide input in to the development of target product profiles (TPPs) clinical studies, registries, etc to ensure payer requirements are captured
• Partner with internal business partners to ensure market access requirements are considered in the development of studies to fulfill post-marketing commitments and in the design of patient registries
• Highlight evidentiary requirements of HTA bodies and make recommendations to cross functional business partners about the need for registries, databases, etc. to fill evidentiary gaps
• Partner with Patient Advocacy to understand the patient journey and translate it in to economic models and evidence generation plans
• Evaluate existing patient reported outcomes (PRO) instruments from a Health Economics perspective and make recommendations to relevant business partners for inclusion study planning
• Seek opportunities to educate the bluebird bio organization on best practices in areas including but not limited to HE research, HTA assessments, and economic modeling
• Partner with the Sr. Director, Global Pricing, Reimbursement, and Market Access to inform the payer requirements for bluebird bio’s evolving oncology portfolio
• Support the evaluation and modeling of outcomes-based pricing and contracting initiatives
• Create and maintain relationships with experts in the field

About you:

• Advanced degree (PhD or PharmD preferred) with at least 8 years of industry experience with pipeline and marketed products, launch experience strongly preferred
• Strong methodological, quantitative, and analytical skills
• Self-starter with a demonstrated ability to operate independently
• Ability to translate insights in to a prioritized action plan a prioritized research agenda
• Strong project management skills
• Deep understanding of the drug development process and regulatory environment
• Experience with selection and inclusion of appropriate PRO instruments in to clinical trials
• Demonstrated understanding of the US and European Healthcare systems and payer policy
• Ability to clearly communicate highly technical issues to non-technical experts
• Demonstrated ability to thrive in sometimes uncertain environments
• Domestic and international travel required, expected to be about 25%
• Be ready to embrace the principles of the bluebird bio culture:  b colorful, b cooperative, and b yourself

Country Medical Leads in

France, Germany, Italy, United Kingdom

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

Join bluebird bio’s enthusiastic and collaborative team by contributing to the overall success of our novel gene therapy approach. Within Medical Affairs, you will function as a medical/scientific connection between bluebird bio and key external stakeholders to further medical/scientific exchange.  This Field Medical Manager will execute the medical strategy for bluebird bio’s gene therapy programs in hemoglobinopathies and adrenoleukodystrophy (ALD) relevant to local geography. This person will play a central role in medical contribution to brand planning and local medical strategies.

About the role:

• Builds relationships with key external stakeholders including, but not limited to, healthcare professionals at key institutions, patient advocacy groups, and regulators by providing disease state education and communicating the clinical value of the bluebird bio therapeutic platform; provides high-quality medical expertise as a trusted medical/scientific partner;
• Contribute to company success through external medical education and medical/scientific information exchange and support, using their medical/scientific expertise to gather medical insights, and support research/data generation initiatives;
• Represents  bluebird bio and its therapeutic platform at global and regional scientific congresses and meetings;
• Identifies qualified collaborators to participate in company-sponsored activities (e.g. speaker, investigator, consultant); 
• Works cross-functionally with colleagues in the field across Sales, Marketing, Medical, etc. to establish ongoing collaborative internal relationships and develop region-specific strategic & tactical plans;

About you:

• Doctorate degree (PharmD, MD, DO, PhD) with at least 3 years of relevant  experience required; experience in rare disease preferred;
• Ability to understand and effectively communicate scientific and medical information to both internal and external stakeholders;
• Excellent written and oral communication skills. Ability to anticipate and adapt to change; strong interpersonal skills commensurate with the need to work closely with partners, investigators, contractors, consultants, and team members across functions;
• Ability to work independently, yet engage in collaborative decision making, to complete tasks in a timely fashion, and function in a rapid-paced environment;
• Ability to communicate well with health care professionals. Ability to establish strong relationships with peer groups, professional organizations, and other outside parties;
• Availability for overnight travel;
• Readiness  to embrace the principles of the bluebird bio culture:  b colorful, b cooperative, and b yourself

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

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

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.

Position Summary:

This position manages the training function at the site.

Responsibilities:

·Create and maintain the site training plan.

·Design, development, source, and delivery of site training program content, instructional tools, and hands on exercises, including computer-based training.  

·Provide key performance indicators to site leadership team.  Collect and provide trending data for training.

·Create and Maintain training history for site. 

·Interact with project teams and cross-functional groups on training needs.

·Set the direction for the preparation and means of delivery for regular training.

·Develop criteria for evaluating effectiveness of training activities. Ensure that training effectiveness assessments are timely and visible to the site.

·Develop and maintain procedures that govern the training function. Ensure programs and training procedures are current with industry standards.

·Work with the site management to evaluate training needs, and participate in the development and delivery of training materials.  Lead the development of tests, participant materials and visual aids as required.

·Participate in the delivery of new hire training and identify needs/solutions for ongoing training

·Manage course evaluations and other training effectiveness tools (instructor feedback, in class evaluations, exams, etc.).

·Manage the maintenance of personnel training files.

·In partnership with functional areas, develop training materials, and knowledge assessments, for area SOPs  

·Develop, maintain, and continuously improve site training program, including conducting effectiveness checks to ensure program applicability.

BASIC QUALIFICATIONS:

·Bachelor's degree or equivalent

·8 or more years of training experience in a pharmaceutical, medical device, or biotech environment.

·Previous supervisory/management experience.

·Excellent verbal and written communication skills.

·Highly versed in regulatory expectations, training and assessment techniques, and key site performance indicators in the continuous management and improvement of the site training function.

All qualified applicants will receive consideration for employment without regard to their race, color, religion, sex, national origin, sexual orientation, gender identity, or protected veteran status and will receive consideration for employment and will not be discriminated against on the basis of disability. Vericel Corporation is an Equal Opportunity Employer.

We are looking for an IT professional to take ownership of several internal tech support needs and grow with the company.

Job Overview:

Maintain internal network and computing environment. Troubleshooting / help desk support for staff. New user set up and training, upgrade installations and rollout of new software for all staff. monitoring and maintaining of network performance.

Job Requirements:

• Multiple years of experience as IT support/tech, Network Ops support/tech
• Experience with Apple OS & Mac environments. Courtagen employees have Apple hardware so experience with OS is required.

Job Duties include:

• Setup and maintain employee’s workstations / end user support / help desk support for remote users
• End user support will include working with Good Apps for Work and the job will require admin duties with Google Apps for Work. Some experience with Google Apps admin would be good.
• Work with critical IT and software vendors for software support contracts and roll out of updates
• Work with Courtagen’s outsource IT partner for Network Ops and Infrastructure support issues and manage all support tickets and resolutions
• Work with outsource IT partner to perform periodic network testing and quality control
• Support WIFI network and local area network and infrastructure as needed
• Help keeping all users compliant by making sure all systems are up to date (Google Apps, SOPHOS, Password compliance, etc.)
• Update job knowledge by participating in educational opportunities
• Take ownership of end user support and management and explore opportunities to add value to the job and expand the role

Other Desired Skills

• Google Apps for Work Admin tools
• Experience with HIPAA security & encryption
• Network Performance & Design Implementation
• Experience with NetSuite or other ERP / CRM systems
• Experience with Amazon Web Services admin tools
• AWS certification
• VMWare certification

VL37, Inc. is an early-stage startup in Cambridge, Massachusetts developing an entirely new class of immune-stimulating therapeutics. VL37 was founded by VentureLabs, a unit of Flagship Ventures that has launched over 36 breakthrough companies including Seres Therapeutics, Symbiota, Pronutria, and Moderna Therapeutics.

RESPONSIBILITIES:

The successful candidate will play a key role in building and advancing VL37’s first-in-class platform for immune stimulation and rejuvenation and have the opportunity to engage broadly across all aspects of the company’s early development, including hiring as well as growth of the intellectual property estate. The successful candidate will engage in high-level development of research programs and enjoy significant potential for advancement and expansion of responsibility.

QUALIFICATIONS:

• PhD or MD/PhD in immunology or a related field
• 1-3 years of relevant post-doctoral or industry research preferred
• Enthusiasm for multitasking in a fast-paced environment
• Knowledge and research experience in immunology and/or tumor biology
• Demonstrated experience working with murine cancer models and processing murine tumors and other tissues
• Demonstrated experience working with T-cells and other immune cells ex vivo and in vitro
• Demonstrated mastery of flow cytometry, flow-based assay development, and cell sorting 
• Ability to train and supervise junior staff in a laboratory based environment
• Ability to work in concert with a small team as well as independently
• Outstanding written and verbal communication
• Strong motivation and passion for cutting-edge immunology

Compensation

A competitive overall compensation package including: competitive base salary, bonus potential and stock options.

Join bluebird bio’s enthusiastic and collaborative team by contributing to the overall success of our novel gene therapy approach.  Reporting to the Associate Director of Clinical Operations, the successful candidate will be responsible for overseeing clinical operations/clinical trial management for a novel gene therapy based approach to the treatment of various oncologic diseases.  Responsibilities include oncology clinical study planning and execution, maintaining timelines and budget, vendor management, relationship management between clinical sites and vendors, and identification of project risks and contingency planning. Externally manage CROs, study managers, field clinical monitors, and investigator site staff.  Ensures trial(s) are managed to the highest quality to ensure safety and effectiveness of bluebird bio’s products. 

About the role:

• Represent the clinical operations function on the clinical trial team.
• Manage day to day operations of clinical early phase studies; accountable for trial timelines and execution and accuracy of information in trial databases and tracking systems.
• Manage and provide day-to-day oversight of full service CRO, third-party-vendors including set-up, logistics, documentation, and clinical supplies needed for clinical trial(s)
• Forecast trial resource needs (external costs); accountable for the trial level clinical operations budget, management and tracking of trial budget in conjunction with CRO and contract manager. Contribute to developing SOWs, site budgets, CTAs, etc.
• Communicate study status, issues, and mitigations to relevant cross-functional stakeholders. Engage the input of line functions as appropriate. Lead trial level interactions with external functions (clinical sites, CROs, third party vendors) and relevant internal functions including Pharmacovigilance, Cell Procurement, CMC, QC/QA, and Supply Chain.
• Collaborate with Clinical Development, Data Management/Biostatistics, Pharmacovigilance, and other functions to ensure robust plans for trial level data review including trend evaluation.
• Oversee one or more concurrent clinical studies, ensuring the following activities are tracking toward goal:
  • Lead and coordinate study management meetings
  • Manage trial budget and MS Project timeline
  • Train team members, including vendors, as needed
  • Participate in contracts and budgets negotiations with clinical sites and vendors 
  • Develop critical study documents including informed consent forms, study conduct documents such as study manuals, study tools, etc.; participate in development of protocols, investigator brochures, including updates and amendments
  • Drive traceability procedures for investigational product and cross functionally coordinate subject treatment planning
  • Provide oversight of individual clinical trials to ensure that safety concerns and/or adverse events are identified and appropriate responses to such concerns are developed and executed
  • Perform research site activities, such as site qualification visits, site initiation visits, trainings and motivational visits, as needed
  • Review and approve corrective action plans at individual sites and across study, may participate in internal/external study related audits
• Contribute to the implementation of best practices and standards for trial management, including sharing lessons learned.

About you:

• BS/BA/RN Degree in science or a health related field; advanced degree is preferred
• ≥ 4 years technical, operational and managerial experience in planning, executing, reporting and publishing clinical studies in a biotech/pharmaceutical company or contract research organisation
• Phase I/II Oncology trial management, or closely relevant experience required and oncology monitoring experience preferred.  Preference for FIH and early development experience.
• Must be comfortable working independently and leading a clinical operations team, managing interactions with and between internal and external team members
• Experience with trial and site startup
• Familiarity with clinical data review and data management processes; Hands-on experience in data cleaning and analysis (including data visualization) recommended
• Must be able to travel up to 25%
• Strong verbal and written communication skills
• Excellent interpersonal and organizational skills
• Ability to deal with competing priorities, strong reasoning, detail oriented and problem solving ability is essential
• Ability to work on teams and with multiple projects, and works well under general direction with tight timelines
• Excellent knowledge of GCP, ICH and FDA regulations
• “Do-what-it-takes” approach to problem solving.
• Be ready to embrace the principles of the bluebird bio culture:  b colorful, b cooperative, and b yourself