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Career postings for the Massachusetts Biotechnology Council

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    The Director will partner with late-stage product development teams in order to ensure the robustness of analytical methodology in a commercial setting and will take a leadership role in its implementation at contract manufacturing facilities. The Director is expected to lead continuous improvement opportunities throughout method life-cycle and have a solid understanding of the regulatory and business impact of making changes to existing analytical technology in order to help define the appropriate regulatory and validation strategies to support post-approval changes. The Director will lead high-impact cross-functional initiatives, the resolution of complex analytical / manufacturing issues and provide strategic input to the commercialization of new products and the direction of the Technical Operations - Analytical group. In order to assure success in this role, the candidate must be an excellent collaborator with proven experience in a cGMP pharmaceutical environment while bringing creativity and energy to all teams in order to promote positive, collaborative, and effective relationships with internal stakeholders and key external suppliers.

    Key Responsibilities:

    • Represent Technical Operations in cross-functional CMC
    subteams to influence late stage product development, regulatory submissions and minimize commercialization risks while building strong relationships with key stakeholders.
    • Partner with Pharmaceutical Development, Supply Chain, Quality
    and Regulatory on activities to define technical transfer strategies which
    enable process validation and commercial manufacturing of Vertex products at new suppliers and new manufacturing sites. 
    • Design/conduct complex troubleshooting activities associated with ongoing commercial manufacturing.
    • Participate in shaping the strategic direction of the Technical Operations-Analytical group
    • Mentor and develop junior staff within Technical Operations – Analytical 

    Minimum Qualifications:

    BS/MS and 12+ years or PhD with 8+ years of relevant work experience

    • Proficient in standard analytical technology (chromatography, spectroscopy, compendial methods, etc.)
    • Proficient in at least one other area of pharmaceutical development (e.g. solid state analysis, dissolution IVIVC, physical characterization, trace analysis)
    • Experience with both drug substance and drug product (especially oral solid dosage forms) development
    • Advanced knowledge of cGMP’s (e.g. Quality Control) and associated CMC regulatory considerations in a pharmaceutical setting
    • Must be a committed team player and collaborator

     Preferred Qualifications:

    • PhD in Analytical Chemistry
    • Experience in applying QbD concepts, methodology and implementation to analytical technology and manufacturing processes
    • Strong knowledge of DoE and statistics
    • Experience with any or all of the following is a definite plus: cleaning validation, microbial testing, heavy metals testing, experience with regulatory submissions in Emerging Markets, post-approval change management

     


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

    Job Summary:
    The Global Quality group is seeking a team member within QA Operations located in Cambridge MA to fulfill a strategic and leadership role necessary to support long term initiatives, GMP vendor relationship management and GMP quality process improvements.  The ideal candidate will have excellent collaborative skills and coordinate proactively and effectively with internal ARIAD team members and with Vendors.

     

    Duties and Responsibilities:

    • Provide primary quality oversight and point of contact for outsourced drug substance and drug product manufacturing, testing and distribution for one or more ARIAD products.
    • Collaborate cross-functionally internally with ARIAD departments including ARIAD Europe and externally with GMP Vendors on project initiatives and programs necessary to ensure all phases of the product lifecycle are met . 
    • Lead efforts for Vendor quality contract generation, monitoring and maintenance.
    • Ensure inspection readiness within ARIAD and at Vendors and support regulatory inspections
    • Maintain the Vendor Management Program including development of the Vendor risk assessments, contributing to the development of audit plans and leading external audits of GMP vendors
    • Define and monitor Vendor standard quality KPI and quality indicators necessary for assessment, review and with recommendation of actions of improvements
    • Provide GMP quality expertise, advice and/or assistance across the organization as required
    • Support the requirements of the ARIAD QMS
    • Perform responsibilities in compliance with written procedures and policies.
    • Lead continuous Quality improvement initiatives
    • Maintain a work environment that fosters collaboration, respect, open communication and teamwork
    • Fills in for the Director of QA Operations as required
    • Other duties as assigned by manager
    • May travel up to 20% of time

     

    Qualifications:

    • Bachelor degree in life sciences, chemistry or equivalent
    • 10-15 years’ experience combining quality assurance and technical/validation responsibilities in a Pharmaceutical/Biotech setting including drug substance and drug product manufacturing and distribution.
    • Thorough knowledge of cGMP and global regulatory requirements
    • Experience working effectively with domestic and/or international contract manufacturers and suppliers in a virtual setting
    • Experience in development and validation of small molecule manufacturing processes
    • International experience within global Quality Units.
    • Auditing of outsourced manufacturing and testing activities (Certified Quality Auditor)
    • Strategic thinker with ability to assess and communicate risks to diverse cross functional team.
    • Proven ability to establish collaborative working relationships with internal and external stakeholders
    • Ability to effectively prioritize and manage multiple projects and tasks

     

    ARIAD Pharmaceuticals, Inc. provides equal employment and affirmative action opportunities to applicants and employees without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability.

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

    Click here to apply:
    http://ariad-openhire.silkroad.com/epostings/submit.cfm?fuseaction=app.dspjob&jobid=612&company_id=16419&jobboardid=306

    ARIAD is an equal opportunity employer. The Company's policy is to afford equal employment opportunities to qualified individuals without regard to race, color, religion, national origin, ancestry, citizenship, marital status, veteran status, physical or mental disability, sex, sexual orientation or age and to comply with applicable laws and regulations. All employment decisions will be consistent with the principle of equal employment opportunity.


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  • 01/20/16--22:09: Biostatistics Team Lead
  • Primary Role:
    Responsible for management and leadership of biostatistics-related activities within therapeutic area through direct product responsibility or through subordinates. Contributes to product development strategy including creation of development scenarios for business planning purposes and serves as a statistical expert in registration and communication activities. Represents Shire for statistical issues in communications with regulatory authorities. Reviews and approves regulatory documents such as protocols and Clinical Study Reports, as well as summary documents. Supports due diligence activities. Prepares resources estimates and manages staff (internal and CRO) to ensure project milestones are achieved.

    Education & Experience Requirements:
    * M.S. in Biostatistics or closely related field is required.
    * Ph.D. in Biostatistics or closely related field is strongly preferred.
    * Generally has 10+ years of relevant pharmaceutical experience with 5+ years of supervisory experience.

    Key Skills, Abilities, and Competencies:
    * Strong background and working knowledge of statistical methods that apply to all phases of clinical trials and other study designs. Must have a working knowledge of statistical analysis plans including the report outline, mockup tables, graphs and data listing shells and appendices.
    * Must have a working knowledge of all appropriate relevant regulatory guidance documents (e.g. ICH, FDA and EMEA).
    * Direct regulatory filing experience is required.
    * Some people management experience strongly preferred.
    * Proficiency in SAS is strongly preferred.
    * Ability to help others understand the broader business and organizational context (inspiring and motivating others)
    * Demonstrated ability to deliver excellence by integrating planning efforts across departments or organizational boundaries to ensure organizational effectiveness (delivering excellence)
    * Demonstrates a customer focus by partnering with customers as a trusted consultant and serves as an integral part of customer's decision-making process (serving customers)
    * Demonstrated ability to reinforce a culture in which partnering is a norm (global and cross-boundary communication)
    * Demonstrated ability to accept responsibility for individual and team performance (accountability & ownership)
    * Demonstrated ability to evaluate the business impact of decisions and remains committed to following through on agreed upon decisions yet remains flexible should priorities change (judgment and decision making)

    Other Job Requirements: Some domestic and international travel required.

    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.

    Application URL:http://www.aplitrak.com/?adid=YXN0YW5pdHMuMjMxNzEuMzE2N0BzaGlyZS5hcGxpdHJhay5jb20


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    Primary Role:
    * Serve as the field-based extension of the Therapeutic Area Medical Strategy Group
    * Systematically identify the scientific exchange needs of Key Opinion Leaders (KOLs), investigators and other stakeholders in patient care, establishing strong professional relationships, providing credible scientific expertise and serving as a liaison to Shire Global Medical, Global Clinical and external partners
    * Ensure compliant communication and education of Shire's marketed and emerging product portfolio to meet the educational and professional needs of Shire's key customers
    * Responds effectively to requests for scientific exchange
    * Support design and implementation of scientific programs with external experts and Global Medical Affairs

    Responsibilities:
    60%: KOL Relationship Management:
    * Through appropriate scientific exchange, builds and maintains professional relationship with external stakeholders to expand Shire's research, advisory and educational partnership opportunities
    * Ensures high standard of professionalism to develop and maintain "peer-to-peer" scientific relationships with key thought leaders in healthcare, academia, payer, and government organizations per strategic territory plans and as requested by KOLs, including the management of strategic scientific partnerships and scientific exchange
    * Provide scientific liaison support to Investigators currently involved in Shire's interventional or observational studies and investigator sponsored trials
    * Serve as a liaison between HCPs and Shire medical affairs
    * Facilitate 1:1 and group scientific interactions with healthcare professionals
    * Participate in KOL planning

    30%: Effective and Compliant Dissemination of Data
    * Respond within defined timeline and quality standards to unsolicited inquires from HCPs and other stakeholders received by Global Medical Affairs and referred to GMA by other Shire functions
    * Support development of appropriate responses to unique inquiries as required, such as the presentation of scientific evidence and medical education
    * Presents clinical and disease state information to a variety of audiences, including KOLs, Medical advisors, formulary/decision makers and other HCPs
    * Ensures appropriate scientific exchange with HCPs by fostering fair and balanced medical and scientific communications that are not misleading

    5%: Contribute to Shire's Strategic Medical Strategy
    * Provide scientific input and participate into local medical and cross-functional initiatives
    * Provide field-based medical support to Shire's clinical research programs, registries, and facilitation of ISTs
    * Communicates key medical insights from KOLs/HCPs to inform refinement of medical strategy
    * Gains customer insights, opinions and feedback and engages with internal colleagues to connect business opportunities with internal resources
    * Under the guidance of MSL Team Lead or Region Lead, provides scientific support for company-sponsored meetings

    5%: Maintaining personal expertise in relevant disease areas and MSL best practices
    * Maintain knowledge base and scientific expertise on all assigned Shire disease areas and
    products
    * Develop and update knowledge of applicable pharmaceutical guidelines and regulations,
    including, but not limited to, ICH, GCP, PhRMA, DOJ, OIG, R&D code of Ethical Practices
    and company policies

    Education & Experience Requirements:
    * An advanced degree in life sciences (MD, PharmD or PhD or equivalent) is required
    * Has an established track record of effective and influential oral presentations within the healthcare profession
    * Demonstrative therapeutic research or substantive patient care experience is required (3 years minimum)
    * Demonstration of expertise in key skills and competencies
    * Medical Affairs or Medical Science Liaison experience required

    Other Job Requirements:
    * Frequent travel is required. Availability to travel approximately 40-70% of time
    * Availability to attend meetings on holidays and weekends
    * Clean and valid driver's license

    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.

    Application URL:http://www.aplitrak.com/?adid=amRpZXR6Ljc3NDM0LjMxNjdAc2hpcmUuYXBsaXRyYWsuY29t


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    Primary Role
    * Serve as the field-based extension of the Therapeutic Area Medical Strategy Group
    * Systematically identify the scientific exchange needs of Key Opinion Leaders (KOLs), investigators and other stakeholders in patient care, establishing strong professional relationships, providing credible scientific expertise and serving as a liaison to Shire Global Medical, Global Clinical and external partners
    * Ensure compliant communication and education of Shire's marketed and emerging product portfolio to meet the educational and professional needs of Shire's key customers
    * Responds effectively to requests for scientific exchange
    * Support design and implementation of scientific programs with external experts and Global Medical Affairs
    * Support local team disease area and product knowledge through scientific training
    * Maintain personal expertise in relevant disease areas and MSL best practices

    Responsibilities
    55% KOL Relationship Management:
    * Through appropriate scientific exchange, builds and maintains professional relationship with external stakeholders to expand Shire's research, advisory and educational partnership opportunities
    * Ensures high standard of professionalism to develop and maintain "peer-to-peer" scientific relationships with key thought leaders in healthcare, academia, payer, and government organizations per strategic territory plans and as requested by KOLs, including the management of strategic scientific partnerships and scientific exchange
    * Provide scientific liaison support to Investigators currently involved in Shire's interventional or observational studies and investigator sponsored trials
    * Serve as a liaison between HCPs and Shire medical affairs
    * Facilitate 1:1 and group scientific interactions with healthcare professionals
    * Participate in KOL planning
    * Maintain KOL plans and update medical customer relationship management system in a timely, accurate and compliant manner
    * Maintain awareness of and access to internal and external information sources available to support high-quality scientific exchange, and coordinate high-quality interactions between these resources and external customers

    25% Effective and Compliant Dissemination of Data
    * Respond within defined timeline and quality standards to unsolicited inquires from HCPs and other stakeholders received by Global Medical Affairs and referred to GMA by other Shire functions
    * Support development of appropriate responses to unique inquiries as required, such as the presentation of scientific evidence and medical education
    * Presents clinical and disease state information to a variety of audiences, including KOLs, Medical advisors, formulary/decision makers and other HCPs
    * Ensures appropriate scientific exchange with HCPs by fostering fair and balanced medical and scientific communications that are not misleading
    * Serves as scientific resource at key medical, scientific, and patient advocacy conferences as assigned
    * Conducts therapeutic training for Sales and Medical colleagues upon request

    20% Contribute to Shire's Strategic Medical Strategy
    * Provide scientific input and participate into local medical and cross-functional initiatives
    * Provide field-based medical support to Shire's clinical research programs, registries, and facilitation of ISTs
    * Communicates key medical insights from KOLs/HCPs to inform refinement of medical strategy
    * Gains customer insights, opinions and feedback and engages with internal colleagues to connect business opportunities with internal resources
    * Under the guidance of [MSL Team Lead or Region Lead], provides scientific support for company-sponsored meetings
    * Participates on internal project teams as directed by Management

    Education & Experience Requirements
    * An advanced degree in life sciences (MD, PharmD or PhD or equivalent) is required
    * Has an established track record of effective and influential oral presentations within the healthcare profession
    * Demonstrative therapeutic research or substantive patient care experience is required (3 years minimum)
    * Require minimum 24 months of experience as a field MSL
    * Demonstration of expertise in key skills and competencies

    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.

    Application URL:http://www.aplitrak.com/?adid=amRpZXR6LjQ4MDc3LjMxNjdAc2hpcmUuYXBsaXRyYWsuY29t


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    Primary Role:
    The Senior Director, US Advertising and Promotion (A&P), is accountable for the Shire GI/IM/HAE & OPTH and other Business Unit products as directed with regard the CMLR process. This process defines the review of promotional and other materials through CMLR as directed and as per policy. The role is jointly responsible for the development, implementation and integration of the Shire US CMLR Standards (USCS) within the remit of the business units in conjunction with the NS/LSD A&P group Lead.

    This role is responsible and accountable for decision-making, direction, and oversight of day-to- day activities of assigned products, departmental activities, and managing direct reports who review and assess US specific promotional items across all relevant BUs in order to meet internal and external customer needs. This function will continually monitors the regulatory environment, interprets new regulations, guidance documents, and enforcement activities, and evaluates the potential impact on the business.

    This role will be jointly responsible for the identification, development, integration, implementation, and improvement of the CMLR process, standards and specific requirements to ensure material is produced in a compelling, compliant and timely manner.

    This role will liaise with US and International counterparts to ensure consistency in departmental and cross-functional practices with regard to Globally-produced promotional materials.

    Responsibilities:
    60%:
    Provides expert direction regarding regulatory review of US promotional and related relevant BU materials developed specifically for the US business. Has extensive knowledge and understanding of complex medical and scientific subject matter, as well as evolving FDA policy and guidance related to advertising and promotion topics.
    In liaison with the leadership of COE, Medical Communications, Medical Affairs, Commercial, Compliance and Legal, conducts detailed evaluation of the CMLR process and standards, adequacy of clinical evidence provided to support proposed claims, and assesses consistency of proposed promotional claims with the approved prescribing information. Working with a cross-functional team, provides direction and evaluation of CMLR metrics. Assures alignment and consistency in GRA policy application within and across therapeutic areas, as well as providing the US A&P assessment during the development of the Global Regulatory Strategy Plan to ensure promotional goals can be achieved. Provides guidance and advice to pre-empt areas of potential concern, including proposed press releases and related media activities materials. Takes ownership to develop, implement and lead a US complaint process. Establishes and develops key internal relationships with therapeutic product leaders in R&D, Commercial, and Corporate to foster open communication and teamwork.

    30%: Integration of review processes, standards and criteria' of the BUs:
    1. Align the promotional review processes and standards following the One Shire structure.
    2. Lead the continued development of the USCS through cross- functional collaboration.
    3. Ensure a promotional review planning tool is implemented across all BUs and provide a communication plan to the BUs to ensure transparency of upcoming projects.
    Manage direct reports to ensure the integration of review processes and criteria is upheld and BU requirements are assessed and addressed. Provide direct report training and development to support the CMLR process and SOP.

    10%: Provides support and address unmet BU needs through discussions and the development of online collaboration tools.

    Education & Experience Requirements:
    Education Minimum Requirement: B.A. or B.S. degree Required Experience and Skills -
    * Typically the candidate would have 8 years experience in pharmaceutical/biologics regulatory, legal, scientific, medical, or marketing disciplines
    * Experience and Skills - Experience in US CMLR review and approval process of pharmaceutical/biologics promotion
    * Have FDA and OPDP experience

    Other Job Requirements: Expected travel:

    10%
    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.

    Application URL:http://www.aplitrak.com/?adid=amRpZXR6Ljg4MTk1LjMxNjdAc2hpcmUuYXBsaXRyYWsuY29t


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    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 Neuroscience and Pain Research Unit (NPRU) has an open access, in vitro pharmacology facility and a centralized cell culture service that support the entire research unit and is managed by a dedicated Technology Core Lead.

    This technology specialist will be an integral member of the Lab Operations team, which broadly supports the NPRU portfolio of programs at various stages across all the disease areas of interest. The primary goals will be to support project team efforts to develop and validate robust in vitro assays for compound screening, to establish and support automated workflows and to manage a small group to provide high-quality primary and immortalized cell cultures for all relevant research applications.

    In this position, the successful candidate will work within a large matrix environment, across a portfolio of programs, collaborating with multiple groups including discovery biology and several partner lines including medicinal chemistry and the central primary pharmacology group.

    Responsibilities
    * Serve as a technical and strategic advisor to Neurodegeneration, Neuroinflammation and Psychiatry project teams around compound screening technologies, assay development and automated workflows
    * Manage a broad array of liquid-handling and plate-based pharmacology equipment, including writing methods and training users
    * Serve as an interface to Global Operations for equipment and facilities support
    * Work closely with the Primary Pharmacology Group on assay transfers and outsourced screening efforts
    * Manage Cell Culture Core to ensure delivery of quality primary cells and immortalized cell cultures
    * Work closely with external vendors around new technologies and instrumentation

    Qualifications
    Masters in biology or neuroscience with 5+ years relevant experience in plate-based pharmacology, assay development and workflow automation.
    * Strong background in assay technologies for all major target classes (GPCRs, Enzymes, transporters, ion channels, etc.)
    * Expert level knowledge of assay development methodologies
    * Experience in moderate throughput compound screening
    ·Experience with automation of liquid handling and screening workflows
    * Cell culture expertise (primary and immortalized)
    * Broad understanding of biology, preferably with an emphasis in Neuroscience.
    * Competent in IT systems and demonstrated ability to troubleshoot systems and manage upgrades
    * The attitude of self-directed scientist; demonstrated ability to multitask, prioritize work and manage a number of projects
    * Exceptional communication skills and customer focus; ability to explain systems and train staff at all levels
    * Demonstrated ability to work effectively as a part of a team, experience as a people manager is a plus
    * Demonstrated ability to effectively deal with ambiguity and change

    Technical Skill Requirements
    * Experience programming BioMek and ECHO liquid Handling systems
    * Experience with high content screening platforms and automation
    * Experience managing equipment and troubleshooting issues before engaging technical service
    * Experience with in vitro pharmacology data analysis, Activity Base and Biobook preferred

    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.

    Application URL: http://www.aplitrak.com/?adid=amVmZnJleXN0b25lLjg5MDYyLjMxNjdAcGZpemVyLmFwbGl0cmFrLmNvbQ


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  • 01/20/16--22:45: Manager, Research Statistics
  • 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
    Statistician in a preclinical team focused on all aspects of early preclinical research and development supporting Neuroscience and Pain Research Unit.

    The Research Statistician will be an integral member of a team, which develops and uses computational and statistical approaches to validate and discover disease targets, develop assays around these targets, and derive robust biomarkers. The statistician will play a pivotal role at all stages of experiments from design through signal processing to statistical analysis and interpretation.

    In this position, the Research Statistician will work within the matrix environment collaborating across multiple groups including discovery biology, electrophysiology, imaging, genetics, computational biology, PK/PD modeling, and informatics. She/he will also interface with statisticians and clinicians whose focus is advancing compounds from lead development through Proof of Concept in the clinic.

    Responsibilities
    * Collaborate with scientists across WRD, including Neurodegeneration, Neuroinflammation and Psychiatry teams to design, analyze and present results of the experiments
    * Bring innovative statistical thinking and methods to help drive data-driven drug discovery and development employing modern methods including Bayesian techniques
    * Work with scientists to understand the biology and improve existing or derive new endpoints, utilize prior information, develop 'fit-for-purpose' statistical models
    * * Use statistical expertise to prepare both internal and external reports, presentations, manuscripts

    Qualifications
    MSc (PhD preferred) in Statistics, Biostatistics or in quantitative discipline such as Physics, Applied Mathematics, Bioengineering, Electrical Engineering coupled with high level of statistical expertise.
    * Strong background in experimental design and statistical analysis including good understanding of inference and probability, competence in contemporary linear and predictive modeling including (longitudinal) mixed models, nonlinear regression, and predictive modeling
    * Expert level knowledge of machine learning algorithms with robust feature selection and optimization
    * Working knowledge of methods of signal processing including image segmentation and/or electrophysiological data analysis
    * Genuine interest in biology, preferably Neuroscience.
    * The attitude of self-directed scientist; demonstrated ability to multitask
    * Outstanding communication skills; ability to explain modeling concepts to non-experts
    * Demonstrated ability to work effectively as a part of a team

    Technical Skill Requirements
    * Expert level knowledge of statistical programming environments such as R and/or SAS
    * Working knowledge of scientific programming in MATLAB and/or Python, along with low level languages C/C++/Fortran
    * Hands-on experience with high-performance computing, Unix environment, scripting, are preferred

    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.

    Application URL:http://www.aplitrak.com/?adid=SmFtZXMuQ3JvbmluLjY5Mzg5LjMxNjdAcGZpemVyLmFwbGl0cmFrLmNvbQ


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  • 01/20/16--22:48: Operations Team Leader
  • 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
    Focus for initial assignment to be capital project detail design and startup engineering for a new facility with evolution to facility operations team leader as described below. Specific accountability to ensure the quality of and compliance with Pfizer specifications during design, construction, commissioning, qualification and start up. Also, interface with the quality unit to create all necessary c-GMP compliant documentation for the initial operation of the facility.

    Provide process functions related to the operation, design, installation, startup/commissioning, testing, and qualification of production equipment and systems within a biopharmaceutical manufacturing facility in Andover, Massachusetts. These systems may include production equipment such as bioreactors, fermenters, centrifuges, ultrafiltration skids, chromatography skids, Clean - In - Place (CIP) skids.

    Responsibilities
    * Perform the operation and lead troubleshooting of manufacturing equipment and control systems used in the manufacture of biopharmaceuticals
    * Collaborate with the Quality Unit to create a training program for technicians
    * Lead Tech Transfer activities for new products and product changeovers
    * Support reliability engineering for production and support equipment
    * Perform on the floor commissioning and startup of operations equipment
    * Lead/Support the design and qualification of improvements, changes, or upgrades to this equipment as needed
    * Lead/Support the development of design and startup documents such as commissioning plans, User Requirement Specification (URS), Functional Requirement Specification (FRS), Configuration Specification (CS)
    * Lead/Support the development and execution of commissioning, validation and qualification documents and activities
    * Support all investigations and audits as needed
    * Initiate and execute process improvement projects as needed
    * Provide off-shift and on call support when necessary

    Qualifications
    * Candidate should have a BS/MS in Biomedical, Bio Chemical Engineering or relevant + minimum of 10 years of experience in this industry.
    * Candidate must be able to work across functional areas such as development, maintenance, quality and regulatory.
    * Good communication skills, verbal and written, are required.
    * Working knowledge of computers and associated applications such as MS Word, Excel, and PowerPoint are recommended.
    * Knowledge of database applications and distributed control systems are a plus.
    * Proficiency in the arena of Process Operations and Technology Transfer in a cGMP environment within a biopharmaceutical facility
    * Working knowledge of automated production systems with ability to manipulate and troubleshoot systems
    * Working knowledge of documents such as Piping & Instrumentation Diagrams (P&IDs), User Requirement Specifications (URS), Functional Requirement Specifications (FRS), Configuration Specifications (CS), and Qualification documents.

    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.

    Application URL:http://www.aplitrak.com/?adid=SmFtZXMuQ3JvbmluLjUxODAwLjMxNjdAcGZpemVyLmFwbGl0cmFrLmNvbQ


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  • 01/20/16--22:51: Senior Process Engineer
  • 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
    Focus for initial assignment will be capital project detail design and startup engineering for a new facility with evolution to facility operations or technology transfer as described below. Specific accountability to ensure the quality of and compliance with Pfizer specifications during design, construction, commissioning, qualification and start up. Also, interface with the quality unit to create all necessary c-GMP compliant documentation for the initial operation of the facility.

    Provide process functions related to the operation, design, installation, startup/commissioning, testing, and qualification of production equipment and systems within a biopharmaceutical manufacturing facility in Andover, Massachusetts. These systems may include production equipment such as bioreactors, fermenters, centrifuges, ultrafiltration skids, chromatography skids, Clean - In - Place (CIP) skids.

    Responsibilities
    * Perform the operation and lead troubleshooting of manufacturing equipment and control systems used in the manufacture of biopharmaceuticals
    * Collaborate with the Quality Unit to create a training program for technicians
    * Lead Tech Transfer activities for new products and product changeovers
    * Support reliability engineering for production and support equipment
    * Perform on the floor commissioning and startup of operations equipment
    * Lead/Support the design and qualification of improvements, changes, or upgrades to this equipment as needed
    * Lead/Support the development of design and startup documents such as commissioning plans, User Requirement Specification (URS), Functional Requirement Specification (FRS), Configuration Specification (CS)
    * Lead/Support the development and execution of commissioning, validation and qualification documents and activities
    * Support all investigations and audits as needed
    * Initiate and execute process improvement projects as needed
    * Provide off-shift and on call support when necessary

    Qualifications
    * Candidate should have a BS/MS in Biomedical, BioChemical Engineering or relevant discipline (ie. Biomechanical Engineering) + minimum of 5-8 years of industry experience
    * Candidate must be able to work across functional areas such as development, maintenance, quality and regulatory.
    * Good communication skills, verbal and written, are required.
    * Working knowledge of computers and associated applications such as MS Word, Excel, and PowerPoint are recommended.
    * Knowledge of database applications and distributed control systems are a plus.
    * Proficiency in the arena of Process Operations and Technology Transfer in a cGMP environment within a biopharmaceutical facility
    * Working knowledge of automated production systems with ability to manipulate and troubleshoot systems
    * Working knowledge of documents such as Piping & Instrumentation Diagrams (P&IDs), User Requirement Specifications (URS), Functional Requirement Specifications (FRS), Configuration Specifications (CS), and Qualification documents.

    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.

    Application URL:http://www.aplitrak.com/?adid=SmFtZXMuQ3JvbmluLjE4OTYxLjMxNjdAcGZpemVyLmFwbGl0cmFrLmNvbQ


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    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
    This position is responsible for providing "hands on" training in basic study support techniques in all laboratory animal species. This position identifies training gaps, develops appropriate training programs to satisfy department training needs, and coordinates the rollout of formal training programs. This position requires a clear and detailed understanding of vivarium operations and provides support to daily operations of personnel and infrastructure.

    Responsibilities
    * Provide "hands on" training in basic study support techniques (dosing, bleeding, anesthesia, etc.) in all laboratory species.
    * Contribute to the development, implementation, monitoring, and quality of department training programs.
    * Provide strategic thinking/planning/forecasting/problem-solving (for issues 1-3 years ahead).
    * Develop or identify training programs which improve staff skills and/or quality of the work performed.
    * Support Regulatory Compliance and the Institutional Animal Care and Use Committee (IACUC), and assist the IACUC Coordinator, as needed.
    * Assess training programs to ensure that they contain the appropriate level of technical content for personnel.
    * Communicate with vivarium and laboratory personnel verbally or in writing to remain familiar with current technology and to identify training gaps to ensure that current training needs are met.
    * Identify and address department training gaps as necessary and develop training modules to address these gaps, or identify outside training resources, as appropriate.
    * Assemble and manage teams to address specialized training needs, collect pertinent data, and write training modules to support these needs.
    * Work with vendors, as needed to develop and deliver Comparative Medicine (CM) -specific training programs.
    * Act as a resource for investigators on issues relating to the training requirements for the use of animals in research.
    * Interface with IACUC Coordinator, IACUC members and clinical veterinarians and assist principal investigators in all training-related matters.
    * Participate in IACUC semi-annual inspections and USDA, FDA, Corporate Audits and AAALAC inspections, as requested.
    * Write, revise and review Standard Operating Procedures using the document management system.
    * Determine training needs based on colleague feedback and regulatory requirements.
    * Coordinate development of training through a global network of CM training colleagues.
    * Contribute to operational excellence by the collation of metrics showing the efficient delivery of training to colleagues involved in animal care and research.
    * Work closely with CM management to enhance the visibility of our training program, provide guidance as needed, and ensure compliance with all animal welfare regulations.
    * Participate in the conduct of internal audits and other inspections and on occasion assist with the evaluation of third party facility inspections and audits by acting as a CM technical expert.
    * Support entry of learning events, training records, courses and curricula into P2L
    * Write, edit, submit Animal Use Protocols (AUPs) for all species at the site
    * Integrate with site to assess and predict training needs
    * Manage training colonies for all species at site including ordering, dispositioning, creating and reviewing records
    * Maintain supplies and equipment needed for training at site
    * Manage all Sign Off Sheets for site, schedule training in a timely manner
    * Review, assess and manage Subject Matter Experts and ensure that they are training in a timely manner

    Qualifications
    Educational Background:
    BS/BA in related field required; MS/MBA in related field preferred
    Licensed Veterinary Technician and/or LATG certification (or comparable experience equivalent) preferred

    Work Experience:
    * Experience coordinating and managing educational programs.
    * Extensive experience and proficiency in "hands on" training in study support procedures for small and large laboratory animal species.
    * Excellent communication skills with training/education background.
    * Documented success of developing and implementing training programs
    * Project management experience is required.
    * Experience working with global teams.
    * Working knowledge of Federal Laws, regulations, and procedures pertaining to the care and use of research animals, and the Guide for the Care and Use of Laboratory Animals.
    * Must be able to travel up to 60% of time.
    * In general, a colleague at this level will have a minimum 3-5 years of experience.

    Other Attributes Desirable:
    * Pharmaceutical or other related industry experience or experience working on research project teams.

    All colleagues should have functional knowledge of Microsoft Office, Outlook, calendar management and Internet Explorer. Colleagues should be able to use online systems such as time tracking and document management. (e.g. SharePoint, Activity Tracker) Knowledge and use of other systems based upon job function may be required: Experience with Power2Learn or similar training database.

    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.

    Application URL: http://www.aplitrak.com/?adid=SmFtZXMuQ3JvbmluLjI3MzM5LjMxNjdAcGZpemVyLmFwbGl0cmFrLmNvbQ


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  • 01/21/16--00:24: Research Associate I
  • We seek a highly motivated individual to work within the Center for the Science of Therapeutics in a project aimed at identifying new therapeutic targets in rare cancers. This position provides an exciting opportunity to work within a very collaborative, multi-disciplinary project team, as well as to connect with patients and clinicians, all with the goal of making an impact in rare cancers with no current treatment options. The primary role of this position will be independently designing and executing experiments and protocols involving molecular, cellular and biochemical techniques, as well as working closely with other project team members.

    Characteristic duties:    
    - Designs and carries out focused molecular biology and cell biology experiments independently    
    - Participates in larger experiments as part of a team     
    - Orders and maintains necessary reagents, solutions and supplies    
    - Analyzes experimental data    
    - Maintains high quality notebooks documenting experimental procedures and results    
    - Attends team meetings and communicates results    
    - Contributes to planning experiments and writing publications

    Requirements    
    - Bachelor degree or Master degree in biology, biochemistry or related field required    
    - At least two years of research lab experience that includes molecular biology techniques and cell culture is required    
    - Experience independently executing experiments and analyzing data     
    - Strong organizational and time management skills    
    - Ability to communicate effectively and work as a member of a team    
    - Strongly motivated to contribute to making a difference in the lives of patients with rare cancers.The Broad Institute will not offer visa sponsorship for this opportunity.

    EOE/Minorities/Females/Protected Veterans/Disabilities

    To apply for this position, please CLICK HERE


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    The Environmental Health and Safety Specialist will have managerial oversight for all EH&S programs at multiple bluebird facilities, including both laboratory and offices in our Cambridge and Seattle locations.  Based in our Cambridge office reporting to the Lab Manager, this position has responsibility for overseeing the implementation of all Environmental, Health and Safety policies, procedures and programs that will assure our compliance with all relevant Regulatory Agencies.  

     

    About the position:

    • Initiates and procures all required Environmental, Health and Safety Permits.
    • Maintains OSHA 300 log
    • Manages the Hazardous waste program
    • Manages MWRA wastewater program
    • Manages Ergonomic Program
    • Authors and updates all needed EH&S policies.  Including:
      • Hazardous Communication Standard
      • Laboratory Chemical Hygiene Plan
      • Lock Out / Tag Out
      • Fall Protection
      • Bio Safety / Blood Borne Pathogens Program
      • Radiation Safety
      • Emergency Response Plan
      • Fire Protection Plan
    •  Provides companywide training on all EH&S policies.
    • Chairs the General Safety Committee.
    • Chairs the Laboratory Safety Committee
    • Performs incident investigations and implements corrective action plans.

    About You

    • 10+ years’ experience in the Field of Environmental Health and Safety Management
    • BS in Environmental Science,  Biology, Chemistry or related fields preferred
    • Ability to interact and communicate effectively with individuals from multiple departments at all levels of the organization.
    • Proven ability to manage internal customer relationships with an emphasis on excellent customer service
    • Excellent management skills with a passion for growing and developing teams.
    • Proven ability to work under pressure and adapt to a rapidly changing environment
    • Strong organizational and time management skills to balance working on multiple projects in parallel.
    • 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

     


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    Our client, a biopharmaceutical company in the Boston area who holds a strong history of successful drug discovery and commercialization is seeking to add a Quality Assurance Specialist to their growing team!
    This key hire will review and approve stability protocols for commercial product and review study testing for compliance accuracy, so a strong knowledge of commercial GMP manufacturing regulations is fundamental to this role. This individual will work closely with CMO’s to resolve issues, and approve investigations so attention to detail as well as excellent communication skills is a must.
    If you possess GMP manufacturing knowledge, as well as have a proven ability to meet deadlines and hold strong leadership qualities this is a not to be missed opportunity to join an exciting & dynamic company changing lives of patients all over the world.
    This amazing opportunity is looking for someone who also meets the following requirements:
    • BS degree in a related field
    • 5 year’s work experience in the pharmaceutical industry
    • Possesses a strong knowledge of commercial GMP manufacturing regulations, laboratory data analysis
    • Excellent written and verbal communication skills
    • Experience with stability data and stability program management
    • Exposure to direct analytical laboratory skills
    About StratAcuity
    Whether you are seeking a career change or simply interested to become part of our network, you will appreciate the ethics guiding each StratAcuity team member. We build lasting relationships with exceptional scientists and take great care to protect your personal information. Upon receiving your inquiry, you may be directly contacted by a StratAcuity team member to discuss your career goals. We will not share your information with anyone without your direct prior consent.
    CHEMISTRY IS EVERYTHING™


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  • 01/21/16--00:17: Head of Process Analytics
  • Company Background

     

    Codiak Biosciences is leveraging recent advances in the biology of extracellular vesicles and their role in intercellular communication.  Codiak aims to become the world’s leading company in developing exosomes as a new therapeutic and diagnostic modality for the treatment of a wide array of diseases, including cancer. Recent discoveries have demonstrated that exosomes derived from normal cells can act as a potent and safe delivery system for multiple therapeutic payloads. These small vesicles, which leave cells and travel throughout the body, can mediate dramatic effects in animal models of disease.  The group has also shown that exosomes derived from cancer cells contain specific proteins on their surface that can be used to quickly detect and characterize cancer from a sample of patient’s blood. They can also be used to monitor the response to cancer treatment, and to detect relapses.

     

    Position Description:  Head of Process Analytics

     

    Codiak Biosciences is seeking an experienced leader of Process Analytics to establish the company’s novel exosome production platform.  Responsibilities will include building/managing the analytical and QC team, and providing scientific vision and expertise in all relevant technical areas.  In addition to bioanalytical technology, a solid background in up- and downstream processing and GMP operation is expected.  Understanding of exosome biology, isolation and characterization will be a plus.  This is a unique opportunity for a strong leader to contribute to early- and late-stage development of our novel exosome production platform.  As part of a start-up, the candidate will be uniquely exposed to the full range of company activities within and outside the company.  The candidate will also play a critical role in helping shape Codiak’s scientific and business strategy.

     

    Qualifications

     

    The candidate will have a PhD in biochemistry, biology, biochemical engineering or a similar discipline with 10+ years of experience.  The successful candidate will have the ability to work well with the growing Codiak team, to build a leading bioanalytics & QC organization, and to deliver results in a high pace environment.  An aptitude for creative problem solving and efficient experimental design will be essential.  Additional qualifications include proven leadership skills, strong track record in organizational development, large professional network, and excellent interpersonal skills.

     

    Those interested in contributing to Codiak Biosciences’ development and manufacturing are invited to email their CV and any relevant credentials to the address below to be scheduled for an interview.

     

    Email:  jobs@codiakbio.com

    Website: www.codiakbio.com


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    Compass Therapeutics is an antibody discovery and development company focused on comprehensively drugging the tumor-immune synapse with combinations of human monoclonal antibodies, multiclonals and engineered protein constructs.  Compass is industrializing antibody discovery and decentralizing biologic validation through a partnership-first mentality that leverages best-in-class technologies and top-tier academic laboratories around the world.  Novel scientific insights are validated and explored deeply inside our labs before Compass pursues the best proprietary combinations of therapeutics into human clinical trials.

    In 2015, Compass quietly closed a $120mm Series A financing to fund our ambitious plan to build a fully-integrated biopharmaceutical company from the ground up.  Our investors are among the most sophisticated venture capitalists in the industry who exemplify our philosophy of building long term economic value only by delivering therapeutics with meaningful efficacy beyond standard of care.  They include OrbiMed Advisors, F-Prime Capital (formerly Fidelity Biosciences), Borealis Ventures, Google Ventures and a handful of smaller VCs and passionate angel investors.

    Our Biomarker & Translational Immunology Group is seeking a hands-on Senior Scientist at our Cambridge, MA site.            

    Principal Responsibilities:

    • Drive scientific and technical innovation collaboratively with preclinical pharmacology team members and other teams within the Immunology Group
    • Execute comprehensive biomarker discovery strategies for experimental therapies with various immunological modes of action including cancer vaccines, immune checkpoint inhibitors, and therapies directed against tumor-initiating cells
    • Support early exploratory biomarker hypothesis testing according to biomarker development plan
    • Collaborate with external partners and participate in authorship of scientific and/or patent publications
    • Cure cancer.

    Preferred Qualifications:

    • Experience with PK/PD, in vitro T cell assays, including ELISPOT, ELISA, Luminex and flow cytometry read-outs
    • Strong background in cancer immunotherapy, human immunology or the biology of the tumor microenvironment
    • Experience with a wide range of cellular and biochemical assays, including cell isolation and culture
    • Experience with processing and analyzing primary patient samples
    • Experience with human immune cells processing
    • Good understanding of clinical drug development strategies
    • Demonstrated hands-on experience in cellular, molecular or protein-based biomarker
    • Strong understanding of the operational considerations in executing biomarker strategies in clinical development
    • Experience with review of clinical trial related documents (e.g. LSD, LES, CTP, CTP amendments)
    • Participate and thrive in an interactive, dynamic, team-oriented culture

    Basic Qualifications:

    • Ph.D. or Ph.D./M.D. in a related field with 3-7 years of experience

    Compass Therapeutics offers individually-tailored compensation packages which include competitive cash compensation, meaningful equity participation, comprehensive healthcare and adoption benefits, continuous career development, sabbatical programs, education reimbursement and many other benefits aligned with our philosophy of putting our team first.  Our labs are located at 450 Kendall Street in Cambridge, MA.


    0 0

    Company Background

     

    Codiak Biosciences is leveraging recent advances in the biology of extracellular vesicles and their role in intercellular communication.  Codiak aims to become the world’s leading company in developing exosomes as a new therapeutic and diagnostic modality for the treatment of a wide array of diseases, including cancer. Recent discoveries have demonstrated that exosomes derived from normal cells can act as a potent and safe delivery system for multiple therapeutic payloads. These small vesicles, which leave cells and travel throughout the body, can mediate dramatic effects in animal models of disease.  The group has also shown that exosomes derived from cancer cells contain specific proteins on their surface that can be used to quickly detect and characterize cancer from a sample of patient’s blood. They can also be used to monitor the response to cancer treatment, and to detect relapses.

     

    Position Description:  Head of Upstream Development & Operation

     

    Codiak Biosciences is seeking an experienced leader of Upstream Development & Operant to establish the company’s novel exosome production platform.  Responsibilities will include building and managing the upstream team, providing scientific vision and expertise in all relevant technical areas.  In addition to cell culture technology, a solid background in biochemistry, bioanalytics, downstream processing and GMP operation is expected.  Understanding of exosome biology, isolation and characterization will be a plus.  This is a unique opportunity for a strong leader to contribute to early- and late-stage development of our novel exosome production platform.  As part of a start-up, the candidate will be uniquely exposed to the full range of company activities within and outside the company.  The candidate will also play a critical role in helping shape Codiak’s scientific and business strategy.

     

    Qualifications

     

    The candidate will have a PhD in biochemistry, biochemical engineering or a similar discipline with 10+ years of experience.  The successful candidate will have the ability to work well with the growing Codiak team, to build an elite development & manufacturing organization, and to deliver results in a high pace environment.  An aptitude for creative problem solving and efficient experimental design will be essential.  Additional qualifications include proven leadership skills, strong track record of success in process and organizational development, large professional network, and excellent interpersonal skills.

     

    Those interested in contributing to Codiak Biosciences’ development and manufacturing are invited to email their CV and any relevant credentials to the address below to be scheduled for an interview.

     

    Email:  jobs@codiakbio.com

    Website: www.codiakbio.com


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    The Facilities Project Manager will manage multiple facilities related projects including both laboratory and office projects at our Cambridge and Seattle locations.  Based in our Cambridge offices, this position will report to the Sr. Director, Facilities. The ideal candidate for this position will be looked to as the Subject Matter Expert (SME) in a wide variety of technical disciplines customarily found in a cGMP laboratory and pilot scale manufacturing environment.  Join bluebird bio’s enthusiastic and collaborative team by contributing to the overall success of our novel gene therapy approach.

     

    About the position:

    • Oversees the design, construction, modification, validation, commissioning and transfer to maintenance of multiple facilities related systems such as:
      • Physical building envelope including; laboratory casework and design, process work flow optimization, cGMP architectural finish selection and environmental requirements.
      • HVAC systems including; air handlers, VAV distribution, HEPA filtration, pressure cascade and control/alarm systems.
      • Gas generation and distribution including; compressed air generation/conditioning, instrument air, carbon dioxide systems, nitrogen systems, particularly ASSE 6010 Medical Gas Standards.
      • Pure water generation and distribution systems (DI, RODI and WFI).
    • Manages various utilities and building modification projects/teams. 
    • Maintains business requirements of project teams in terms of scope, schedule and budget.
    • Assists in route cause analysis investigation of deviations and implements corrective action plans.

     

    About You

    • 10+ years’ experience in facilities engineering and project management
    • BS in construction management, engineering or related fields preferred
    • A demonstrated background in the successful design, validation and maintenance of cGMP systems is required.
    • 5 years’ experience using CAD software systems.
    • Ability to interact and communicate effectively with individuals from multiple departments at all levels of the organization.
    • Formal training in project management principals such as PMI or Phase Gate.
    • Proven ability to manage internal customer relationships with an emphasis on excellent customer service
    • Proven ability to work under pressure and adapt to a rapidly changing environment
    • Strong organizational and time management skills to balance working on multiple projects in parallel.
    • Excellent verbal, written and presentation skills
    • Possesses strong analytical skills, strategic thinking, process and detail oriented
    • 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

    0 0

    Compass Therapeutics is an antibody discovery and development company focused on comprehensively drugging the tumor-immune synapse with combinations of human monoclonal antibodies, multiclonals and engineered protein constructs.  Compass is industrializing antibody discovery and decentralizing biologic validation through a partnership-first mentality that leverages best-in-class technologies and top-tier academic laboratories around the world.  Novel scientific insights are validated and explored deeply inside our labs before Compass pursues the best proprietary combinations of therapeutics into human clinical trials.          

    In 2015, Compass quietly closed a $120mm Series A financing to fund our ambitious plan to build a fully-integrated biopharmaceutical company from the ground up.  Our investors are among the most sophisticated venture capitalists in the industry who exemplify our philosophy of building long term economic value only by delivering therapeutics with meaningful efficacy beyond standard of care.  They include OrbiMed Advisors, F-Prime Capital (formerly Fidelity Biosciences), Borealis Ventures, Google Ventures and a handful of smaller VCs and passionate angel investors.

    Our Cellular & Molecular Immunology group is seeking a hands-on Senior Associate Scientist at our Cambridge, MA site. 
            
    Principal Responsibilities:

    • Contribute to the development of therapeutic molecules through the design and execution of cell-based assays focused on investigating mechanism of action and defining PK/PD relationships
    • Maintain subject matter expertise via surveillance and implementation of current technology
    • Contribute to project teams by surveying and staying abreast of the literature and by providing input as it relates to PK/PD/Tumor-efficacy dynamics and competitive landscape, working from the bench a minimum of 80%
    • Cure cancer.

     Preferred Qualifications:

    • Experience with in vitro PK/PD cellular assays with focus on T/NK activity, including but not limited to Luminex, ELISPOT and flow cytometry read-outs
    • Experience with Ab technology and its implementation as a therapeutic
    • Creative problem solving and expertise in troubleshooting
    • Ability to work in an intense, fast-paced, multinational work environment
    • Comfortable with balancing multiple project objectives simultaneously

    Basic Qualifications:

    • M.S. or B.S. with 2+ years of relevant industry experience in immunology or immunology-related field

    Compass Therapeutics offers individually-tailored compensation packages which include competitive cash compensation, meaningful equity participation, comprehensive healthcare and adoption benefits, continuous career development, sabbatical programs, education reimbursement and many other benefits aligned with our philosophy of putting our team first.  Our labs are located at 450 Kendall Street in Cambridge, MA.


    0 0

    Compass Therapeutics is an antibody discovery and development company focused on comprehensively drugging the tumor-immune synapse with combinations of human monoclonal antibodies, multiclonals and engineered protein constructs.  Compass is industrializing antibody discovery and decentralizing biologic validation through a partnership-first mentality that leverages best-in-class technologies and top-tier academic laboratories around the world.  Novel scientific insights are validated and explored deeply inside our labs before Compass pursues the best proprietary combinations of therapeutics into human clinical trials.          

    In 2015, Compass quietly closed a $120mm Series A financing to fund our ambitious plan to build a fully-integrated biopharmaceutical company from the ground up.  Our investors are among the most sophisticated venture capitalists in the industry who exemplify our philosophy of building long term economic value only by delivering therapeutics with meaningful efficacy beyond standard of care.  They include OrbiMed Advisors, F-Prime Capital (formerly Fidelity Biosciences), Borealis Ventures, Google Ventures and a handful of smaller VCs and passionate angel investors.           

    Our Cellular & Molecular Immunology group is seeking a hands-on Scientist at our Cambridge, MA site.
            
    Principal Responsibilities:

    • Contribute to the development of therapeutic molecules through the design and execution of cell-based assays focused on investigating mechanism of action and defining PK/PD relationships
    • Maintain subject matter expertise via surveillance and implementation of current technology
    • Contribute to the project teams as biology lead by surveying and staying abreast of the literature and by providing input as it relates to PK/PD/Tumor-efficacy dynamics and competitive landscape, working from the bench a minimum of 80%
    • When appropriate, lead project team and coordinate cross-functional efforts to deliver on key project milestones
    • Technical and (when applicable) drug development mentorship of junior department members
    • Cure cancer. 

    Preferred Qualifications:

    • Experience with in vitro PK/PD cellular assays with focus on T/NK activity, including but not limited to Luminex, ELISPOT and flow cytometry read-outs
    • Experience with Ab technology and its implementation as a therapeutic
    • Creative problem solving and expertise in troubleshooting
    • Ability to work in an intense, fast-paced, multinational work environment
    • Comfortable with balancing multiple project objectives simultaneously

    Basic Qualifications:

    • Ph.D. in a relevant field with relevant scientific experience 

    Compass Therapeutics offers individually-tailored compensation packages which include competitive cash compensation, meaningful equity participation, comprehensive healthcare and adoption benefits, continuous career development, sabbatical programs, education reimbursement and many other benefits aligned with our philosophy of putting our team first.  Our labs are located at 450 Kendall Street in Cambridge, MA.


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