Foundation Medicine is dedicated to helping bring personalized cancer medicine into routine clinical practice. Harnessing advanced technology, Foundation Medicine is developing clinical laboratory tests that will broadly capture the most relevant tumor genomic and other molecular information, and connect it with relevant scientific and medical knowledge to help oncologists determine the right treatment for each patient.

The Bioinformatics Scientist will be responsible for development of clinical diagnostic assays and biomarker signatures for pharmaceutical partners through research, implementation, and validation of advanced computational methods. The successful candidate will possess strong analytical skills, solid programming experience, a high level of professional maturity, and ability to consistently meet deadlines under pressure.

• Development, analysis and testing of advanced computational methods to enhance FM's clinical diagnostic platform with an emphasis on rigorously validated results and robust procedures to bring methods to the operational level.
• Delivery of novel biomarker signatures based on NGS to pharmaceutical partners and academic collaborators, with an emphasis on accuracy and timeliness.
• Development and validation of clinical diagnostic assays for pharmaceutical partners based on massively parallel sequencing (NGS) data.
• Assume responsibility for developing annotated genomic profiles of somatic aberrations based on NGS, in the context of studies of cancer-patient samples.
• Collaborate with other technical teams in specifying requirements for tools to enhance workflow efficiency and robustness
• Assist with drafting and completing manuscripts for publication; manage data analysis and interpretation of study results throughout manuscript publication process from draft through submission and acceptance.

• Either PhD or MS in Bioinformatics, Computer Science, or a related field with a significant quantitative base.
• For MS, requires 3+ years' experience in the biopharmaceutical/diagnostics industry or similar academia research
• Possess extensive scientific understanding of cancer genetics and genomics and show a strong capacity for independent thinking
• Track record of achievement in developing computational biology methods, preferably Python
• Highly desirable experience in software engineering, writing production level code with rigorous testing
• Confident, proactive individual capable of taking the initiative and driving to results.
• Strong organizational skills in order to maintain a high level of productivity innovation, and setting priorities in order to complete assignments in a timely manner

Desired Skills and Experience:

• Working knowledge of cancer genetics and experience with Next-Generation Sequencing (NGS)
• Experience with bioinformatics tools and databases (NCBI, UCSC Genome Browser, IGV)
• Familiar with UNIX environment and use of clusters to parallelize the execution of computational methods
• Experience working within a CLIA certified clinical diagnostics laboratory

Apply Here

PI92729838

The successful Application Developer candidate will be an engineer or developer with a strong foundation in programming and application development. The candidate will be tasked with assisting in the development of applications, infrastructure, and interfaces in support of Clinical Operations.

• Development of applications to assist Clinical Lab sample processing, tracking and reporting
• Identify opportunities for process streamlining and scaling
• Translate End User requirements (Research and Development, Clinical Operations) into formal technical specifications, developer tier troubleshooting, patching and support of new and existing lab applications
• Conform to CAP and CLIA Guidelines
• Process and application support for non-standard special projects run through the Clinical Laboratory
• Create documentation for the validation and adoption of applications introduced into the Clinical Laboratory

• 3 years of experience in a programming language (ex: Python or Java or C# or Javascript, Perl, etc.)
• Proficiency in SQL
• 2 years of experience in a laboratory setting
• Experience in a high throughput Laboratory environment

Desired Skills and Experience:

• Familiarity with basic Molecular Biology techniques (PCR, Nucleic Acid Purification)
• Familiarity with Liquid Handling Platforms (Agilent VWorks, Beckman Biomek, Hamilton, etc.)
• Experience with next generation sequencing (NGS) protocols
• Experience working in a regulated environment (GxP, HIPAA, CLIA, CAP, FDA)

Education or Experience:

• B.S. in Computer Science or related field. Software focused engineers with experience in a laboratory setting and Life Scientists with sufficient programming experience also encouraged to apply.

Apply Here

PI92729855

Foundation Medicine is dedicated to helping bring personalized cancer medicine into routine clinical practice. Harnessing advanced technology, Foundation Medicine is developing clinical laboratory tests that will broadly capture the most relevant tumor genomic and other molecular information, and connect it with relevant scientific and medical knowledge to help oncologists determine the right treatment for each patient.

The Scientist will be responsible for leading data mining and analysis to support designing clinical diagnostic assay validation plans and protocols, performing statistical analyses and writing study reports for novel biomarker development and companion diagnostic programs. The successful candidate will possess strong analytical skills, solid scientific background, a high level of professional maturity, and ability to consistently meet deadlines under pressure.

• Implement data mining strategies to enable genomic discovery and comprehensive genomic profiling analysis
• Lead designing and analyzing analytical validation studies for novel NGS-based companion diagnostics assays for cancer
• Contribute in drafting study protocols and final reports, soliciting feedback, communicating study results within Foundation Medicine and to external stakeholders
• Collaborate with laboratory scientists and technologists and regulatory affairs team on study design, planning, data preparation, programming, analysis and presentation of results

• Ph.D. or M.S. (with more extensive work experience) in Bioinformatics, Statistics or a related field with a significant quantitative base
• For M.S., requires 3+ years' experience in the biopharmaceutical/diagnostics industry
• Possess extensive scientific understanding of cancer genetics and genomics, have technical proficiency and creativity, and show a strong capacity for independent thinking
• Strong programming and computing skills; Fluency in one or several scripting language (Python, Perl) and/or programming language (R, SAS) is required
• Excellent communication, presentations and writing skills, and the ability to explain complex technical details in clear language

Desired Skills and Experience:

• Knowledge and experience with Next-Generation Sequencing (NGS) is preferred
• Experience with bioinformatics tools and databases (NCBI, UCSC Genome Browser, IGV) desirable
• A high level of professional maturity, including an ability to consistently meet tight deadlines under pressure and command attention and respect in a client-facing setting
• Exquisite attention to detail and an obsession with quality
• Capability of highly-independent work as well as being a team player and role model
• Entrepreneurial attitude and skills including a willingness to take risks
• High energy level, a driving sense of urgency and a seasoned “make it happen/can do” orientation

Apply Here

PI92729853

Foundation Medicine (FMI) has developed a companion diagnostics business utilizing its Molecular Information Platform that enables biopharma partners to accelerate their drug development process and expand opportunities for their new medicines. FMI has an outstanding opportunity for a Director, Business Development (CDx) to partner with FMI leadership teams to develop and implement strategies for the expansion of the companion diagnostics business. The Director will be responsible for development and execution of comprehensive account management and project plans for pharma and biotech customers to utilize FMI''''s portfolio of pharma solutions, and specifically to advance the goals of the Companion Diagnostics business line. The role is both inward and outward facing as the individual will be the key point of contact for all matters relating to these CDx partnerships. The individual is expected to collaborate with internal stakeholders including BD peers, Strategic Alliances team, R&D, Regulatory and Finance to forecast and manage timelines, resource plans, critical path activities, and risks. As a member of the Business Development team, the Director will also have opportunities to contribute to other activities and projects across the team.

• Deliver on quarterly/annual strategic objectives and revenue goals for CDx business line, and contribute to the overall Pharma team goals and success;
• Interact closely with Strategic Alliances team to manage day-to-day operational and tactical aspects of pharma/biotech relationships. Key point of contact for all customer interactions post contract signing;
• Builds relationships with senior-level R&D executives at partner organizations that enable identification and execution of additional value-creating opportunities, both specific to CDx as well as to the broader pharma solutions portfolio;
• Drives progress against defined partner strategies; proactively raises issues and proposes solutions.
• Contribute to the overall development of the pharma solutions portfolio and support, as appropriate, strategic transactions outside the direct Pharma business.

• Advanced degree in a scientific discipline required, with an MBA or comparable experience.
• 6-8+ years of experience in the oncology biopharmaceutical or diagnostic industry or a comparable position in clinical operations, or regulatory affairs in an academic cancer center.
• Experience in Companion Diagnostics (CDx) preferred. Strong understanding of the regulatory and operational considerations in executing biomarker and companion diagnostic strategies in clinical development is preferred.
• Experience leading multi-disciplinary development teams in the execution of operational plans; ideally across multiple functional areas and various development phases.
• Demonstrated success in building and maintaining senior-level relationships at customer organizations.
• Confident, ambitious, proactive individual capable of taking the initiative and driving to results.

Apply Here

PI92729880

Foundation Medicine is dedicated to helping bring personalized cancer medicine into routine clinical practice. Harnessing advanced technology, Foundation Medicine is developing clinical laboratory tests that will broadly capture the most relevant tumor genomic and other molecular information in a single test, and connect it with relevant scientific and medical knowledge to help oncologists determine the right treatment for each patient.

The Clinical Reporting Coordinator will perform critical administrative tasks related to information management and tracking of metrics for Foundation Medicine's medical reporting process. Working closely with scientists andsupport staff on the biomedical informatics team, the emphasis for this position is on the organization, development, and support of robust and flexible tools for information management.

• Assist with tracking the progress of ongoing projects and with other aspects of project management.
• Assist with the organization of information and maintenance of information management tools.
• Gather, track, and perform basic analysis of metrics related to the reporting workflow.
• Responsible for tracking compliance paperwork for the team.
• Assist with the development and formatting of documentation related to ongoing projects.
• Assist with the development and maintenance of an efficient administrative infrastructure for the biomedical informatics team.
• Must be able to collaborate with other departments and colleagues for problem solving
• Coordinate communication within and between FMI departments to regarding report status and tracking
• Follow all local, business unit and corporate safety policies and assure compliance with CLIA certification
• Additional administrative tasks as needed.
• Must be able to perform assignments with minimal supervision

• Advanced experience with Microsoft Word, Outlook, and Excel.
• Familiarity with basic data analytics and tools for summarizing data in Excel
• Experience with PowerPoint and/or Visio a plus.
• Superior verbal and written communication skills
• Strong organizational and analytical skills
• Ability to work to deadlines
• Ability to manage and prioritize multiple tasks with careful attention to detail
• Ability to collaborate with colleagues across departments and to integrate diverse perspectives and priorities when developing processes.
• Creativity and problem solving skills a must.
• Must be meticulous and thorough; attention to detail is a must.
• Bachelor's degree and minimum 2 years work experience required.

Apply Here

PI92729871

Position Responsibilities:

The Quality Assurance (QA) GCP Associate Director of Vendor Management is responsible for strategic quality planning and quality management for overseeing global vendors contracted to support Vertex’s clinical development activities.

General Responsibilities And Required Skills:

•  Provide Quality Assurance leadership to clinical teams with the analysis quality information regarding global vendors, audit program results, quality issues and investigations.

•  Review with Clinical Teams all development program risks and mitigation strategies.

•  Ensure that clinical development activities conducted by vendors supporting Vertex pharmaceuticals GCP activities worldwide are conducted in compliance with Good Clinical Practice (GCP) regulations, and the International Conference on Harmonization (ICH) and Vertex Policies and Procedures, as applicable. 

•  Identify and escalate key risks to development programs.

•  Manage global Regulatory Readiness activities for assigned vendors. Provide on-site inspection support as needed. Leis with vendors when appropriate to ensure global coverage to inspection readiness needs for outsourced activates and collaborations.

•  Develop, implement, and update standard operating practices for Quality Assurance activities that support the QA GCP Vendor Program.

•  Collaborate with QA GCP leadership team to ensure that key goals and priorities are appropriately aligned.

•  Monitor compliance issues and investigations across vendors for assigned studies. Elevate serious and/or systemic problems with appropriate recommendations/solutions to senior management for immediate and long-term resolution.

•  Collaborate with QA GCP Associate Director of Compliance to ensure audit reports and corrective actions are developed and completed within timelines mandated in internal procedures.

•  Provide appropriate risk analysis for key stakeholders to make critical decisions.

•  Act as key point of contact for QA to QA relationships with GCP Vendors, develop and conform to quality agreements, and facilitation of Quality Management Working Group accountabilities.

Position Qualifications:

• M.S. in a scientific, nursing or allied health field and 5+ years of relevant GCP work experience, or

• B.S. in a scientific, nursing or allied health field and 8+ years of relevant GCP work experience, or relevant comparable background.

• 3+ years’ experience serving in a Quality Management role.

• Proficiency in using Microsoft Office applications required (MS Word, MS Excel, MS PowerPoint)

• Approximately 40 % required travel will be required.

• In-depth knowledge of the applicable GxP regulations and ICH Guidelines.

• Demonstrates advanced knowledge in the conduct and reporting of audits and the translation of findings into corrective actions plans that mitigate risks to the company, to safety and data integrity.

• Demonstrates proficiency in negotiation and conflict resolution.

• Possesses the necessary science education and knowledge to manage quality assurance oversight for clinical trials and to assure the ethical treatment of subjects. Understands medical terminology and is familiar with standards of care and disease states.

• Must communicate professionally, clearly, concisely and consistently to external and internal customers, both verbally and in writing. Must demonstrate professional presentation skills and deliver informative and balanced presentations and, when applicable, facilitate resolution of differing opinions.

• Must demonstrate proficiency in managing complex projects, delivering all expected deliverables in a timely manner, and proactively communicating changes in pre-established goals and deadlines.

• Must be able to prioritize work effectively to meet timelines.

Our client, a dynamic biotechnology company in Cambridge, MA with a passion for developing new drugs in areas of high unmet need is seeking to add a Director of GMP Quality Assurance to their team. If you are an individual who exhibits leadership qualities and has had past experience with early stage clinical development, this is a great opportunity for you!

In this role, you will have an opportunity to create and implement quality standards and systems across the supply chain, so past experience with implementation of quality systems will ensure success in this role. This crucial hire will manage external resources, and coach the CMC team on all quality issues prior to final product release. The ideal individual for this role while have past experience in batch record and validation, and have a wide range of QA knowledge with some commercial experience preferred. This is a not to be missed opportunity!

Requirements:

• At least an MS in a related field of study
• 2-4 years’ experience in direct oversight of QA
• Exposure to early stage clinical development
• Experience in Biologics QA
• Commercial experience preferred
• Some travel required

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™

Who We Are ImmunoGen is a clinical-stage biotechnology company that develops targeted anticancer therapeutics with its proprietary antibody-drug conjugate (ADC) technology. The Company's lead product candidate, mirvetuximab soravtansine, is a potential treatment for folate receptor α-positive ovarian cancers and other solid tumors. Leading healthcare companies have licensed rights to use ImmunoGen's technology to develop novel anticancer therapies, and Roche's marketed product, Kadcyla, utilizes ImmunoGen's ADC technology. More information about the Company can be found at www.immunogen.com.  

The Opportunity  

The Analytical Associate I's duties and responsibilities include but are not limited to the following:

• Perform routine high throughput testing as needed to support cell line     development and upstream process development. The assays include size variants by CE-SDS  (gel-chip) and SEC, charge variants by CZE (gel chip), and carbohydrate profiles by gel chip and UPLC.

• Prepare memos, reports and presentations/data summaries with direct supervision

• Work with senior members in the group to perform more complex analytical methods.  

Who You Are

Qualified candidate will possess biochemistry, analytical chemistry, chemical engineering, or bioengineering background. The candidate having one or more experience in the following will be strongly considered: capillary-electrophoresis, small scale protein purification, liquid chromatography, or robotic liquid handler platform.

They will possess good written and oral communication skills and be able to work within a multifunctional team.

Educational Requirements:  a BS degree with 0-3 years relevant experience or a MS degree with 0-1 year relevant experience.  

ImmunoGen, Inc. is an equal opportunity employer & prohibits unlawful discrimination based on race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, disability, marital and veteran status.

ImmunoGen, Inc. does not accept non-solicited resumes or candidate submittals from search/recruiting agencies not already on ImmunoGen, Inc.’s approved agency list. Unsolicited resumes or candidate information submitted to ImmunoGen, Inc. by search/recruiting agencies not already on ImmunoGen, Inc. approved agency list shall become the property of ImmunoGen, Inc. and if the candidate is subsequently hired by ImmunoGen, Inc., ImmunoGen, Inc. shall not owe any fee to the submitting agency.

Who We Are

ImmunoGen is a clinical-stage biotechnology company that develops targeted anticancer therapeutics with its proprietary antibody-drug conjugate (ADC) technology. The Company's lead product candidate, mirvetuximab soravtansine, is a potential treatment for folate receptor α-positive ovarian cancers and other solid tumors. Leading healthcare companies have licensed rights to use ImmunoGen's technology to develop novel anticancer therapies, and Roche's marketed product, Kadcyla, utilizes ImmunoGen's ADC technology. More information about the Company can be found at www.immunogen.com.

The Opportunity

The Analytical Associate II/III will work on a wider variety of moderately complex tasks with minimal supervision and may train new associates in those techniques. They will  participate in interdisciplinary meetings (internal or external).  They may present summaries of their work at conferences and seminars.

Duties and responsibilities include but are not limited to the following:

• Perform routine high throughput analytical testing as needed to support cell line development. Analyze size variants by CE-SDS (gel chip) and SEC, charge variants by CZE (gel chip), carbohydrate profiles by gel chip and UPLC.
• Prepare memos, reports and presentations/data summaries with direct supervision
• Train less experienced members of the group to perform more complex analytical methods, assist training in department policies and procedures.  

Who You Are

The Analytical Associate II/III  in APS will possess analytical skills in one or more of the following areas: high-throughput analytical platforms such as the Octet, GXII LabCHIP, or Capillary-Electrophoresis based separation systems, small scale protein purification, liquid chromatography, or robotic liquid handler. They will possess good written and oral communication skills.  Educational requirements are either a BS degree with 2-6 years relevant experience or a MS degree with 1-4 years relevant experience.

ImmunoGen, Inc. is an equal opportunity employer & prohibits unlawful discrimination based on race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, disability, marital and veteran status.

ImmunoGen, Inc. does not accept non-solicited resumes or candidate submittals from search/recruiting agencies not already on ImmunoGen, Inc.’s approved agency list. Unsolicited resumes or candidate information submitted to ImmunoGen, Inc. by search/recruiting agencies not already on ImmunoGen, Inc. approved agency list shall become the property of ImmunoGen, Inc. and if the candidate is subsequently hired by ImmunoGen, Inc., ImmunoGen, Inc. shall not owe any fee to the submitting agency.

Our client, a Boston area Biotech company focused on the development of life changing medications & therapies, is seeking to add a Regulatory QC Document Specialist to their team. This individual will handle quality control reviews of regulatory documentation, ensuring consistency and compliance with all regulatory guidelines. The perfect individual for this role will possess strong organizational and attention to detail as they will handle editing, formatting and checking clinical assay-relation documentation.
If you possess knowledge of Regulatory policies, procedures, industry standards and have strong written & verbal communication skills – this is a not to be missed opportunity and we encourage you to apply and join this outstanding team!
This amazing opportunity is looking for someone who also meets the following requirements:
• BS in related or scientific discipline preferred
• At least 3 years related experience in document QC
• Knowledge of regulatory & industry standards and GXP
• Strong organizational skills & attention to detail
• Proficiency using spreadsheets and job specific software, including Adobe, Microsoft Excel, Word & Powerpoint
• Ability to manage & prioritize project and meet deadlines
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™

The Senior Manager, Project Management at Repligen will lead and manage cross functional  project teams in all elements of the design , development and launch of new products to the bioprocess market. These elements include scope definition and control, stakeholder alignment, project planning, resource and risk management, project leadership, team development and communication. Successful Project Management includes guiding project team activities to meet project and business objectives, and approval of project recommendations through governance. Project Management is responsible for management of cost and timing of Product Development programs.

Responsibilities:

Independently lead cross-functional teams in a matrix environment  in new product development and product modification programs for devices used in bioprocessing

Influence and inform others beyond own scope and level (Director and VP).

Develop and integrate product development plans (technical and business) per corporate strategic goals.  Lead prioritization exercises with teams.

Develop, manage and maintain up-to-date project timelines inclusive of all critical milestones, key interdependencies and resource constraints, applying appropriate project scheduling techniques.. Develop agendas, minutes, metrics and project communication tools for the teams and management.

Drive the development, documentation, implementation and adherence to a Product Commercialization Process.  Lead team in use of the defined project communication tools.

Proactively identify and escalate risks and issues to relevant stakeholders; lead development and delivery of tactical and achievable mitigation and contingency planning.

Drive team accountability for deliverables and ensure projects meet milestones.

Lead "lessons learned" exercises, share lessons among project leaders and other teams, integrate lessons into existing processes, tools and templates.

Qualifications

Bachelor's Degree (or higher) in an Engineering (Chemical, Materials or Mechanical) or Scientific (biochemistry) discipline is required. Master's Degree in scientific or business field is preferred.  PMP or other Project Management certification is preferred.

Demonstrated ability to manage programs related to new product development or significant product modification is required.

Minimum of 10 years of relevant experience with increasing responsibility in the Life Sciences, Medical Device and/or Bioprocess products industry is required.

Excellent oral, written, and presentation communication skills and attention to detail are required.

A proven record of leading and influencing cross-functional teams in a matrix environment to gain alignment, resolve conflicts and deliver results is required.

Familiarity with standard Project Management tools and templates (MS Project) is required.

Business and Financial acumen is required.

Process Excellence or Six Sigma certification is preferred.

Who We Are

ImmunoGen is a clinical-stage biotechnology company that develops targeted anticancer therapeutics with its proprietary antibody-drug conjugate (ADC) technology. The Company's lead product candidate, mirvetuximab soravtansine, is a potential treatment for folate receptor α-positive ovarian cancers and other solid tumors. Leading healthcare companies have licensed rights to use ImmunoGen's technology to develop novel anticancer therapies, and Roche's marketed product, Kadcyla, utilizes ImmunoGen's ADC technology. More information about the Company can be found at www.immunogen.com.

The Opportunity

• Provide informatics support to biomarker discovery strategies and data analysis plan
• Provide statistical guidance on design of robust molecular/genomic profiling experiments
• Conduct and/or manage outsourcing of analysis of large phenotypic datasets with correlative molecular data for the discovery of predictive biomarkers
• Process and analyze large molecular datasets such as mRNA expression data, genomic sequence data, and proteomics data for clinical or translational research purposes;
• Work collaboratively and cross-functionally to maintain an understanding of a broad variety of biological questions and methods;
• Mine and manipulate publicly accessible, genomicand proteomic databases;
• Compile molecular data for use in activities such as target validation and molecular epidemiology studies;
• Implement bioinformatics algorithms for data mining and data modeling; Establish databases and necessary informatics infrastructure for efficient management of –omics data    

Who You Are

• Will possess a PhD in biology, computer science or related discipline
• Broad knowledge of biology and bioinformatics tools and expertise in areas such as expression,  copy number, and mutation analysis, solid understanding of NGS
• Hands on experience in analysis of –omics data for oncology biomarker discovery projects In depth and up to date knowledge of major public data sources Database design and programming skills (e.g. R/Bioconductor and Perl)
• Strong interpersonal and communication skills    

ImmunoGen, Inc. is an equal opportunity employer & prohibits unlawful discrimination based on race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, disability, marital and veteran status.

ImmunoGen, Inc. does not accept non-solicited resumes or candidate submittals from search/recruiting agencies not already on ImmunoGen, Inc.’s approved agency list. Unsolicited resumes or candidate information submitted to ImmunoGen, Inc. by search/recruiting agencies not already on ImmunoGen, Inc. approved agency list shall become the property of ImmunoGen, Inc. and if the candidate is subsequently hired by ImmunoGen, Inc., ImmunoGen, Inc. shall not owe any fee to the submitting agency.

Who We Are

ImmunoGen is a clinical-stage biotechnology company that develops targeted anticancer therapeutics with its proprietary antibody-drug conjugate (ADC) technology. The Company's lead product candidate, mirvetuximab soravtansine, is a potential treatment for folate receptor α-positive ovarian cancers and other solid tumors.  Leading healthcare companies have licensed rights to use ImmunoGen's technology to develop novel anticancer therapies, and Roche's marketed product, Kadcyla, utilizes ImmunoGen's ADC technology. More information about the Company can be found at www.immunogen.com.

The Opportunity

• Work across all programs partnering primarily with colleagues in Clinical Development, Clinical Operations, to ensure robust clinical sample management that is in compliance with protocols, regulatory guidance and project timelines;
• Work closely with the preclinical and clinical teams on the logistics of incorporating specific biomarker or other relevant assays into protocols;
• Manage various aspects of outsourcing process with respect to translational medicine needs, including creation of RFPs and contract execution
• Assist in the management of technical and logistical aspects of studies performed at external vendors and CROs that are associated with translational medicine objectives;
• Assist in the management and analysis of data related to translational research/biomarker objectives as needed;
• Assist in the authoring of relevant translational medicine sections in clinical protocols and study lab manuals, as well as all relevant regulatory documents;
• Oversight of Translational Medicine budget

Who You Are

• The qualified candidate will possess a BA/BS degree in life sciences, with 5+ years of relevant experience in industry (biotech/pharma/CRO)
• Knowledge of molecular, cell biology, IHC and/or flow cytometry techniques are highly desired
• Must be able to work in cross-functional, collaborative team environment Ability to multi-task, work independently
• Strong attention to detail
• Strong interpersonal and communication skills    

ImmunoGen, Inc. is an equal opportunity employer & prohibits unlawful discrimination based on race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, disability, marital and veteran status.

ImmunoGen, Inc. does not accept non-solicited resumes or candidate submittals from search/recruiting agencies not already on ImmunoGen, Inc.’s approved agency list. Unsolicited resumes or candidate information submitted to ImmunoGen, Inc. by search/recruiting agencies not already on ImmunoGen, Inc. approved agency list shall become the property of ImmunoGen, Inc. and if the candidate is subsequently hired by ImmunoGen, Inc., ImmunoGen, Inc. shall not owe any fee to the submitting agency.

Quad Technologies is a fast-growing life sciences company focused on transforming cell separation and cell therapy workflows though our disruptive QuickGel™ technology. Our commitment is to providing best in class methodology and support to researchers and clinicians working on translational medicine and cell therapy applications. Our goal is to help deliver breakthrough therapies by improving cell purity and cell health for translational medicine applications by providing cell biologists with simple, cell-friendly capture and release technologies for cell isolation.

This Process Development Scientist position will support research and development efforts around our breakthrough cell isolation technology, and will contribute significantly to the development of new technologies, products and applications for cell separation and bio-manufacturing. You’ll join a strong and fun team working in an exciting area of research, with great opportunities to develop your technical and intellectual skill sets in a highly dynamic and interactive environment.

We are looking for candidates experienced at independently developing and performing cell-based assays with an immunological focus. Previous experience with activation and analysis of T lymphocytes is highly desirable. Experience with flow cytometry and cell separation technologies is strongly preferred, as is practical knowledge of protein conjugation and immunodetection. The role will require you to take independent ownership of development projects, share in lab management responsibilities, and arrange activities to accomplish objectives with short deadlines. Good teamwork and communication skills are key.

Essential Job Functions:

• Design and perform product development and optimization experiments.  Troubleshoot experimental failures.  . 
• Prepare and provide written and verbal technical reports, project summaries and updates.
• Help develop, establish, and document appropriate quality control, manufacturing, and other protocols.            
• Maintain laboratory records and notebooks.  Ensure all work complies with established process and procedures.  
• Complete other related duties as assigned.

Job Specifications:

• Minimum of BS or MS in Biological Sciences or related discipline with 2 years hands-on cell biology research experience.
• Demonstrated expertise with mammalian cell culture; flow cytometry and T cell experience strongly preferred.
• Ability to perform multiple tasks and prioritize workload to ensure timely completion of projects.
• Demonstrated attention to detail and excellent planning and experimental design skills.
• Excellent written and verbal communication.
• Comfortable working in a fast-paced startup environment.

If you share our goals and values, and want to make your mark at a rapidly growing company, join us and help enable advanced discoveries.

Contact:  aball@quadtechnologies.com

Position Responsibilities:

The Senior Quality Manager of Clinical Quality Assurance (CQA) is an independent contributor who reports to the CQA Associate Director, Quality Oversight of Clinical Programs.  This individual is responsible for performing quality assurance activities to ensure that Vertex clinical trials are conducted in accordance with Good Clinical Practice (GCP) guidelines, applicable regulations and Vertex policies and procedures.  In addition, this position is responsible for adhering to the Vertex’s quality standards as set forth in the Quality Management System (QMs). The Senior Quality Manager is also responsible for accurately identifying and communicating compliance risks and overseeing action plans to mitigate risks.

Key Responsibilities:

· Maintains a contemporary knowledge of current industry trends, standards and methodologies as it relates to Good Clinical Practice (GCP)

· Adheres to the Clinical QA department goals and ensures linkage to individual goals

· Fosters Vertex Core Values when collaborating with cross functional teams

· Provides GCP compliance interpretation, consultation, training, and other supportive services necessary to maintain and/or improve the quality of Vertex research to ensure the protection of subjects’ safety, rights, and well-being as well as the integrity and credibility of data generated

· Provides guidance and support to internal department in the form of SOP reviews and/or ad-hoc requests

· Establishes/maintains effective cross functional team communications to advance quality activities of Vertex while remaining independent and autonomous.

· Serves as a CQA Compound Lead for clinical programs as assigned

· Responsible for developing strategic audit plans for the development of assigned compounds and ensuring that audits are conducted in accordance with the plan according to the audit process as per  and Vertex’s standards operating procedures  (SOPs) and processes, inclusive of driving CAPAs to closure as necessary.

· Manages and/or leads domestic and international audits for Clinical Investigators, Trial Master Files (TMF) and/or GCP Document Audits to ensure compliance to the Code of Federal Regulations, the International Conference of Harmonization (ICH), applicable regulations and laws and Vertex SOPs.

· Participates as a co-auditor for investigations into scientific misconduct and/or serious breach of GCP, analyzes investigational findings to identify root cause.

· Oversees appropriate Corrective Actions and Preventive Actions (CAPAs).

· Assures reporting of potential or confirmed violations, as appropriate, in accordance with Vertex SOPs and processes.

· As assigned, reviews and approves audit reports for content, format, regulatory risks, and compliance with applicable standards. Promotes consistency of audit report writing.

· Identifies and escalates critical quality issues appropriately to CQA Associate Director for Quality Oversight of Clinical Programs

· Obtains audit responses from Vertex functional areas and evaluates proposed CAPAs for adequacy if implemented successfully in accordance with Vertex SOPs.

· Ensures adequate and timely closure of CAPAs with supporting documented evidence in accordance with Vertex SOPs and processes.

Position Qualifications:

Preferred Education, Knowledge, Skills & Experience:

· Master Degree in a scientific or allied health field with 4 + years or relevant GCP QA experience or

· B.S. in a scientific or allied health field and 9+ years of relevant GCP QA work experience, or relevant comparable background and 5 + years of relevant GCP QA experience.

· In depth knowledge of FDA regulations, EU Regulations and Directives, MHRA Statutory Instruments and ICH GCP guidelines.

· This position may require up to 30% travel.

· Understands the Clinical Development Phases of Drug Development. ·  Experience with clinical trials involving drugs, biologics, devices and drug/ device combinations.

· Communicates professionally, clearly, concisely and consistently both verbally and in writing to internal and external customers.

· Must be able to organize and prioritize work effectively to meet timelines with quality deliverables.

· Must be able to adapt to other personalities in a respectful manner that is conducive to goal achievement and team building.

· Possess the necessary scientific education and knowledge to manage quality oversight for clinical trials, understands medical terminology, standards of care and disease states to assure the ethical treatment of subjects.

· Understands the medical/therapeutic impact of investigational products.

· Demonstrates proficiency in negotiating skills and conflict resolution.

· Demonstrates advanced skills in the conduct of audits and the translation of findings into CAPAs that mitigate risks.

· Demonstrates proficiency in managing complex projects, delivering all expected deliverables in a timely manner, and proactively communicating changes in pre-established goals and deadlines.

· Proficiency in using Microsoft Office applications is an asset (MS Word, MS Excel, MS Powerpoint).

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 the lead in all epidemiology and real-world evidence activities. The Director, Medical Affairs will execute the real-world evidence strategy focusing on clinical studies and registries in line with expectations from global regulatory agencies. This position will support the collection of long-term outcomes for patients with the rare diseases bluebird bio intends to treat with its product candidates, thereby contributing to the successful development and commercialization of new and innovative therapies.

About the Role:

• Responsible for being the expert in the epidemiology of the diseases treated with bluebird bio product candidates, including an understanding of global patient mapping, varying disease severity, varying treatment standards, quality of care, etc.
• Lead the design, management, and analysis of registries pre- and post-approval.  Lead real-world evidence studies using data sources such as insurance claims, survey data, chart-reviews, and existing registries. Contribute to clinical trials in the area of patient reported outcomes, resource utilization, and cost-effectiveness.
• Develop and implement the long-term real-world evidence strategic plan for each bluebird bio product candidate, including studies on burden of illness, real-world clinical outcomes, epidemiology, quality of care, and unmet need.
• Provide methodological analytical expertise and strategic leadership regarding the gathering, analysis, and utilization of real-world data. Provide expert advice on available real-world data sources to answer specific research questions.
• Support regulatory, market access/pricing, and pharmacovigilance activities throughout the lifecycle of bluebird bio product candidates.
• Support market access and commercial in communication of health economic and outcomes research data to appropriate audiences.

About You:

• Advanced degree in epidemiology, public health, health economics, pharmaceutical sciences, life sciences, or related discipline (PharmD, PhD, MD, MPH)as well as a minimum of five years industry experience is required.
• Experience with conducting registry studies as well as the role and importance of epidemiology and real-world evidence generation in the multi-disciplinary drug development and commercialization environment and process (involving multiple stakeholders) is required.
• In addition to demonstrating a track record of designing and implementing retrospective and/or prospective observational research, demonstrated expertise in at least one area of outcomes research (such as, but not limited to, patient-reported outcomes/health-related quality of life assessment, clinical-economic modeling and analysis, literature synthesis/meta-analysis) is highly desirable.
• Ability to communicate highly technical scientific information/evidence to multiple internal and external audiences (both lay and experienced, including senior leadership), with strong written and verbal presentation skills.
• Experience in conducting outcomes research in different geographic regions is desirable.
• Demonstrated experience in conducting or interpreting statistical analysis is useful.
• Knowledge and experience in rare disease is a plus.

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

We are seeking an Associate Scientist / Scientist who will support our efforts to identify new drug targets and transition early exploratory projects to portfolio targets. The successful candidate will work in a newly formed exploratory biology laboratory at the AstraZeneca/BioHub Gatehouse Park site in Waltham, MA and will provide expertise in cell- and molecular biology and screening approaches.

Duties and Responsibilities

•  Perform in vitro and in vivo experiments to support the development of assays for phenotypic screens, to enable target identification and validation, and to evaluate the mode of action and efficacy of novel drug candidates.
• Design, execute and analyze laboratory experiments in collaboration with scientists from internal and external partner groups.
• Prepare and maintain primary neuronal/glial cultures, mammalian cell lines and iPS-cells.
• Conduct cell-based and biochemistry assays (including microimaging studies and high content analysis) in low and medium throughput
• Generate molecular-biology reagents (including gene-editing tools) to support mechanism of action studies.
• Provide general lab administrative support and guidance to junior scientists, graduate students and interns.

Requirements

• Minimally Bachelors and/or Masters Degree in Biology, Biochemistry, Neuroscience or related field
• Minimum 5 years (Masters) / 7 years (Bachelors) of hands-on experience working in a research laboratory
• Experience in Neuroscience and of drug discovery is preferred
• Expertise in a wide variety of techniques in cell biology, molecular biology and biochemistry is required
• Expertise in development of phenotypic screens, microimaging and high content imaging approaches is highly desirable.
• Experience in the preparation and maintenance of primary neuronal/glial cultures essential. Experience with iPS cell (maintenance, differentiation) would be a plus but not essential.
• Experience of basic in vivo experiments (dosing, tissue collection) is desirable.
• Creative thinker with excellent troubleshooting skills and in depth knowledge of cell-culture technologies and experimental methodology.
• Pro-active and self-motivated person who enjoys working in a dynamic environment in a diverse team setting.

~bsp

Equal Opportunity Employer Minorities/Women/Protected Veterans/Disabled/Sexual Orientation/Gender Identity               

Primary Duties :
The Manager of CMC Regulatory Affairs (Change control lead) will direct and manage change controls for the CMC regulatory affairs group for all biological and/or small molecule products. This will include formulating and implementing CMC regulatory strategies with the global regulatory leads and international regulatory for maintaining the compliance status and drug supply status of protein therapies and small molecules.

Primary role includes:
* Provide collaborative support for execution of global change control strategies to US and other regions (EU & International)
* Provide support to other HA interactions as required

Responsibilities:
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. Please note the percentage of time spent on each job duty is an estimate for normal operating conditions.
* Represent CMC regulatory affairs as the change control coordinator for CMC regulatory and key contact (30%)
* Collaborate and communicate with global CMC leads, EU and international regulatory colleagues to provide consistent, clear and timely assessments into the change control management system (50%)
* Provide CMC regulatory input and guidance at change control meetings and provide strategy for the continuous improvement of change control assessments (20%)

Education & Experience Requirements:
* BA/ B.S / M.S in biochemistry, biology, engineering or related pharmaceutical field
* 6-8 years of drug development experience previous experience in regulatory and/or quality preferred
* Demonstrated leadership and strong communication skills

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=amRpZXR6LjA4NDIyLjMxNjdAc2hpcmUuYXBsaXRyYWsuY29t

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
Provide engineering and technical support related to the operation, maintenance, design, installation, startup/commissioning, testing, and qualification of production & Infrastructure equipment and systems within a biopharmaceutical manufacturing facility in Andover, Massachusetts. These systems may include production equipment such as bioreactors, fermentors, centrifuges, ultrafiltration skids, chromatography skids, Clean - In - Place (CIP) skids, and other support equipment such as WFI, Clean Steam, Process Gases, HVAC and Core Building Utility Systems. Particular focus for initial assignment to be capital project engineering for a new facility with evolution to facility operational support as described below. Specific accountability to ensure the quality of and compliance with Pfizer specifications during design, construction, commissioning and qualification during project life cycle phases.

Responsibilities
* Support the operation and troubleshooting of manufacturing equipment and control systems used in the manufacture of biopharmaceuticals
* Support reliability engineering for production and support equipment
* Provide on the floor operational support as needed
* Support the design and qualification of improvements, changes, or upgrades to this equipment as needed
* Support the development of design and startup documents such as commissioning plans, User Requirement Specification (URS), Functional Requirement Specification (FRS), Configuration Specification (CS)
* Support the development of validation and qualification documents
* Provide the execution of commissioning and qualification activities
* Support the maintenance department as needed
* Provide equipment maintenance history review
* Support all investigations and audits as needed
* Support process and component improvement projects as needed
* Provide off-shift and on call support when necessary

Qualifications
* Candidate should have a BS/MS in engineering or relevant discipline. Chemical or Mechanical preferred.
* Candidates should have a 0-3 years of biopharmaceutical industry experience
* Candidate must be able to work across functional areas such as operations, maintenance, quality and regulatory.
* Good communication skills, verbal and written, are required.
* Knowledge of working with computers and associated applications such as MS Word, Excel, Powerpoint are recommended.
* Knowledge of database applications and AutoCAD are a preferred
* Technical writing and document review

NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS
* Minimal travel for equipment support
* Ability to work off shift (Nights and Weekends) as needed

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=SmltLlRhdm9saWVyaS44ODExMi4zMTY3QHBmaXplci5hcGxpdHJhay5jb20

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
Pfizer, a global leader in the biopharmaceutical industry, is continuously seeking top talent who are inspired by our purpose to develop innovative therapies that significantly improve the lives of patients. A career at Pfizer offers opportunity for both individual and company success, and to be part of an ownership culture that values diversity and contributes to positively impacting the health and lives of millions of people.
The non-physician Clinician is responsible for working collaboratively with the clinical leader and members of the development team to develop clinical plans for one or more compounds from lead development to Phase 1-2 clinical trials. The incumbent will actively participate in writing clinical protocols.

Responsibilities
* Assist in formulating clinical development plans.
* Assist in writing protocols, amendments and conducting data review, analyses and interpretation.
* Conduct regular reviews of subject safety data and perform reviews of cumulative safety data in collaboration with the safety risk lead.
* In conjunction with the clinical lead, prepare strategy presentations, present and discuss data at relevant team, governance, and external consultant, meetings.
* Author clinical sections of regulatory documents (IB, Annual Reports, IND sections).
* Routinely collaborate with discovery scientists, clinical pharmacology, safety sciences, statistics, regulatory, development operations and other members of the extended project team(s).

Qualifications
* Graduate degree in the life sciences and breadth of knowledge and experience in clinical research in an industry or academic setting.
* Familiarity with related disciplines (e.g. biostatistics, regulatory, pre-clinical pharmacology, pharmaceutical sciences).
* Demonstrated writing skills (regulatory documents, publications, etc.).
* Proven scientific writing skills and good communication skills.
* Previous experience working in a similar role.

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=TWVnYW4uSGFycmlnYW4uNzkxODcuMzE2N0BwZml6ZXIuYXBsaXRyYWsuY29t