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Senior Manager/Associate Director, Quality Systems

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COMPANY OVERVIEW:

Agios Pharmaceuticals is focused on discovering and developing novel drugs to treat cancer and rare genetic metabolic diseases, through scientific leadership in the field of cellular metabolism. In addition to an active research and discovery pipeline across both therapeutics areas, Agios has multiple first-in-class lead product candidates in cancer metabolism and rare genetic metabolic diseases in clinical and/or preclinical development. All Agios programs focus on genetically identified patient populations, leveraging our knowledge of metabolism, biology and genomics.

POSITION OVERVIEW:

We are currently seeking a Sr. Manager or Associate Director, Quality Systems. This position will support the organization by establishing and continuously improving Quality Management Systems (QMS) aligned with industry standards and in accordance with the relevant product’s lifecycle.

RESPONSIBILITIES:

  • Develop the QMS to support early-stage clinical, late-stage clinical and future commercial operations.
  • Supporting internal quality systems, vendor management, audits and inspections, change control, deviations, investigations, corrective/preventative actions, risk assessments, computer systems validation and other GXP systems
  • Provide oversight for the GXP document control and training functions
  • Facilitate quality system improvement activities
  • Working with appropriate functional areas to ensure that the quality systems are effectively implemented and maintained in compliance with relevant standards and regulations.
  • Understanding global regulatory agency policies and guidance as they pertain to Quality issues including 21 CFR Part 11 compliance
  • Evaluate and implementing electronic systems to support management of quality systems
  • Conduct/support internal and external audits as appropriate
  • Business owner of enterprise electronic document management systems (eDMS)

REQUIREMENTS:

  • BA or BS degree (preferably a scientific discipline) plus at least 7+ years of pharmaceutical experience in Quality Management Systems
  • Demonstrated expertise and hands-on experience with quality systems regulations and guidelines including working in a cGMP environment.  GLP and GCP experience a plus
  • Experience providing leadership and oversight of implementation of 21 CFR Part 11 compliant Quality Management Systems
  • Experience in the implementation and management of 21 CFR Part 11 compliant applications as business owner and super user
  • Exercises judgment within broadly defined practices and policies in determining solutions and actions
  • Ability to develop clear, concise, and timely oral and written reports
  • Strong written and verbal communication skills and interpersonal skills to effectively translate ideas, concepts and information

Demonstrated project management


Scientist, Process Chemistry

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COMPANY OVERVIEW:

Agios Pharmaceuticals is focused on discovering and developing novel drugs to treat cancer and rare genetic metabolic diseases, through scientific leadership in the field of cellular metabolism. In addition to an active research and discovery pipeline across both therapeutics areas, Agios has multiple first-in-class lead product candidates in cancer metabolism and rare genetic metabolic diseases in clinical and/or preclinical development. All Agios programs focus on genetically identified patient populations, leveraging our knowledge of metabolism, biology and genomics.

POSITION OVERVIEW:

The Agios Pharmaceuticals CMC department is building a new generation of pharmaceutical development capabilities to deliver transformative precision medicine with quality and speed. We are seeking a motivated process chemist to enable drug substance process research and development both internally as well as externally.  The successful candidate needs to demonstrate a proven track record of being able to not only independently design his or her own experiments, but also help successfully design and manage experiments being conducted at external CROs and CMOs.   The effective candidate must have practical experience with modern Design of Experiment techniques and statistical analysis.  The candidate’s efforts will culminate in the support of external small molecule cGMP manufacturing to supply programs from Phase I through NDA. The candidate will be responsible for project planning, execution and taking their results back to internal project team as a representative of the process chemistry function.  Most importantly, the candidate will be evaluated by their ability to concisely explain their work to a cross-functional team through clear presentations and address concerns before they become issues.

RESPONSIBILITIES:

  • Help setup a new internal research lab utilizing FBRM, PVM, PLM, EasyMax and HPLC systems
  • Guide CROs/CMOs through process development activities via designing experiments, critical evaluation of the results, and providing constructive feedback
  • Use the internal lab to augment external development activities 
  • If qualified, will serve as the technical lead on a CMC sub-team

 

REQUIREMENTS:

  • PhD in organic chemistry with 2-5 years of process chemistry experience or MS degree with 8+ years of experience 
  • Excellent scientific knowledge in organic chemistry and process chemistry
  • A proven track record of scaling-up and delivering Drug Substances in the appropriate physical form
  • Ability to navigate and be successful in a fast-paced, highly-matrixed work environment
  • A desire to be part of a highly innovative company aimed at helping patients with serious diseases
  • Effective verbal and written communication skills

 

PREFERRED QUALIFICATIONS:

  • Experience managing CROs and CMOs.
  • Experience drafting and reviewing the required regulatory documentation pertaining to the development and preparation of drug substances in support of clinical trials
  • Process validation experience is a plus

Scientist/Senior Scientist - Cancer Cell Biology

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COMPANY OVERVIEW:

Agios Pharmaceuticals is focused on discovering and developing novel drugs to treat cancer and rare genetic metabolic diseases, through scientific leadership in the field of cellular metabolism. In addition to an active research and discovery pipeline across both therapeutics areas, Agios has multiple first-in-class lead product candidates in cancer metabolism and rare genetic metabolic diseases in clinical and/or preclinical development. All Agios programs focus on genetically identified patient populations, leveraging our knowledge of metabolism, biology and genomics.

POSITION OVERVIEW:

The Research team at Agios is looking for a highly motivated, autonomous, and collaborative Scientist who can spearhead the development and integration of a new scientific screening platform within the research organization.  This individual must be able to drive compelling results while thriving in a scientifically rigorous environment.

In this role, the successful candidate will design and conduct cell and molecular biology studies focused on the identification and validation of new drug targets in the rapidly emerging field of cancer metabolism. S/he will interact and collaborate cross-functionally with scientists in other departments, including biologists, biochemists, chemists, and pharmacologists. Significant project ownership will allow for acquisition of new skills and for learning opportunities of additional facets of the drug discovery process as the project matures and advances.

Strong experience with shRNA and lentiviruses in academia or industry required.  Experience in cell-based target ID/validation or various screening platforms would be a plus.   Experience with CRISPR gene editing technology not required, but preferred.

RESPONSIBILITIES:

  • Develop and characterize cell-based models and assays to be used in target validation studies and/or medium-throughput screening campaigns
  • Use of CRISPR and shRNA lentiviral libraries in cell-based screening campaigns
  • Lead the development and integration of a CRISPR gene editing platform into Agios’ target ID/validation research efforts
  • Design, execute and analyze knockout/knockin/knockdown and functional assays to establish functional role of targets in cancer cells
  • Maintain good written records of laboratory procedures, results, and conclusions
  • Perform and report interim analysis of accumulated data to monitor work progress

Critical Success factors (key qualities and abilities for successful job performance):

  • Strong experimental design and data analysis skills
  • Effective multi-tasking skills and ability to operate autonomously
  • Creativity in problem solving and intellectual rigor in scientific approach
  • Ability to thrive within a fast-paced, highly collaborative environment
  • Excellent organizational and communication skills

REQUIREMENTS:

  • PhD with 2-6 years of industry or 4-8 years of academic experience
  • Experience in cell biology techniques including mammalian cell culture and in retroviral and/or lentiviral-based knockdown and overexpression
  • Experience in molecular biology (gel electrophoresis, Western blotting, qPCR, etc.)

 

Senior Bioinformatics Engineer

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Job ID: 26954
Date Posted: 08/11/2015
Location: Center for Life Sciences
Job Family: Bioinformatics
Full/Part Time: Full-Time
Regular/Temporary: Regular
About Dana-Farber

Located in Boston, Dana-Farber Cancer Institute brings together world renowned clinicians, innovative researchers and dedicated professionals, allies in the common mission of conquering cancer, HIV/AIDS and related diseases. Combining extremely talented people with the best technologies in a genuinely positive environment, we provide compassionate and comprehensive care to patients of all ages; we conduct research that advances treatment; we educate tomorrow’s physician/researchers; we reach out to underserved members of our community; and we work with amazing partners, including other Harvard Medical School-affiliated hospitals.


Overview

The Dana-Farber Cancer Institute seeks Senior Bioinformatics Engineer
to lead the development of multiple open source data mining and analytics
platforms for precision (or "personalized") cancer medicine.


If you:

  • dream of big data
  • enjoy building big, complex software systems
  • thrive working within a creative team of scientists and engineers
  • want to contribute to open source,
  • want to use your skills to make a positive impact on cancer care, and
  • want to take a leadership role at the ground floor of multiple new initiatives.

… we want to talk with you.


The Senior Bioinformatics Engineers an exceptional candidate who has
both deep bioinformatics experience and extensive software architecture experience.
We operate at the crossroads of cancer genomics, software, and data science and are
looking for that rare individual who has experience and passion for all three.
Our platforms are focused on mining of cancer genomic data sets, understanding
resistance to targeted therapy, matching genomic profiles to clinical trials, and
identifying exceptional responders to targeted therapy. Technical and scientific
challenges for the platform include data mining and visualization of large-scale
cancer genomic data sets, extracting information from natural language text and building
web-based data analytics platforms.


Required skills:

  • Bachelor's degree, Masters Degree or Ph.D. in Computer Science,
  • Bioinformatics, Computational Biology or a related field.
  • 5+ years of bioinformatics software engineering experience, preferably in the cancer genomics space.
  • Expert knowledge of Java and Spring.
  • Strong interest in contributing to biological research with clinical applications.
  • Experience in modern software development technologies, including distributed versioning systems, continuous integration, and Agile programming practices.
  • Data science expertise, including statistical analysis and data mining.

Desirable skills: Any of the following would be significant plusses: NoSQL database
experience, especially MongoDB. Cloud computing, e.g. Amazon, Google Compute, or
Digital Ocean. Any cloud devop framework experience, such as Chef, Puppet or
Ansible. Natural language processing and/or handling of cancer genomics data sets,
especially those generated by The Cancer Genome Atlas (TCGA) project. User
interaction design and data visualization. Experienced knowledge of Javascript and any
modern Javascript library, such as JQuery, Angular or D3.

For additional background regarding the Knowledge Systems Group at DFCI, please see: http://bcb.dfci.harvard.edu/knowledge-systems/



Schedule

Standard business hours.

Monday - Friday, 8:30-5:00.

 

For consideration, please submit a resume and cover letter.



How to Apply

Please apply directly online at http://www.dana-farber.org/Careers/Careers-at-Dana-Farber.aspx. Click Search Job Openings and use the Job ID number to quickly locate the appropriate job listing. Once you have located the desired job, click on the checkbox in the 'Select' column, and then click the 'Apply Now' button, located at the bottom of the screen.

DFCI Employees please apply directly through PeopleSoft Self Service. Sign on to PeopleSoft and navigate to Main Menu > DFCI Careers.



Equal Employment Opportunity

Dana-Farber Cancer Institute is an equal opportunity employer and affirms the right of every qualified applicant to receive consideration for employment without regard to race, color, religion, sex, gender identity or expression, national origin, sexual orientation, genetic information, disability, age, ancestry, military service, protected veteran status, or other groups as protected by law.




Apply Here

PI92122929

Bioinformatics Analyst II

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Bioinformatics Analyst

PROFILE is a joint partnership between DFCI, Brigham and Women’s Hospital (BWH), and Boston Children’s Hospital. PROFILE employs state-of-the art genomics technology to generate a detailed report of medically actionable genetic alterations in a CLIA-certified and real-time process to facilitate rapid clinical application. These cancer genomic profiles are being used to guide patient treatment and/or stratification for clinical trials of novel anticancer agents.

Our growing Clinical Bioinformatics team is an integral part of CCGD and Profile, providing detailed analysis of genomic data. We develop novel approaches for the analysis of `omics data in a research context and translate those developments into clinical applications. Our team members have a wide variety of skills from data analysis, software engineering, and computational biology. We are looking to expand our team with another Bioinformatics Analyst.

Role and Responsibilities:

The Bioinformatics Analyst will help develop, maintain, and refine the bioinformatics capabilities for genome research in Cancer. More specifically, he/she will work closely with CCGD scientists in the analysis and interpretation of next generation sequencing data produced for cancer-related research projects. The Bioinformatics Analyst will provide customized analysis of research projects tailored to the investigators experimental questions and assist in presenting these results in a clear and concise manner.

Additional duties may include, but are not limited to:

  • Identify opportunities and develop innovative solutions for the analysis, integration, and representation of data from multiple NGS endpoints (DNAseq, RNAseq, etc).
  • Evaluation of external and internally developed tools for analyzing NGS data
  • Work closely with CCGD scientists in the design and analysis of internal research projects
  • Provide direct technical and scientific support for CCGD investigators and staff

Requirements

  • Bachelor's degree in bioinformatics, computer science, statistics, and/or the life sciences and 1+ years relevant experience. Previous experience in molecular biology, cancer genomics, or a related field is required.
  • Experience in Java or Python is required
  • Working knowledge of OOD principles is preferred.
  • Experience performing statistical analysis on large data sets, including proficiency in R.
  • Excellent communication and effective problem-solving skills; and ability to interact with multidisciplinary staff in a fast-paced environment. The successful candidate should be able to work independently, prioritize and manage a variety of tasks, and shift priorities rapidly.



Apply Here

PI92123247

Clinical Trial Manager

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Title:  Clinical Trial  Manager

Job Description

The Clinical Trial Manager in collaboration with the Clinical Project Manager, contributes to the operational execution of clinical studies to ensure delivery on time, within budget, and of high quality in compliance with ICH/GCP, Regulatory Authorities’ regulations/guidelines, and applicable SOPs. The CTMs overall responsibility is managing the daily study activities to ensure study team members understand the project deliverables and are adhering to timelines and budget. The CTM is fully accountable for the performance of the monitoring team in all aspects of the delivery such as patient recruitment, quality of the clinical data and compliance with SOPs and GCP.

Role Purpose

  • Key  support role to the Project Manager; manages components of clinical trials and,  with minimal direction and oversight, ensures that they are executed to  specified quality standards
  • In  addition to responsibilities related to quality control, provides project  management support on budget and timelines, vendor oversight and site  management
  • Applies  knowledge of Promedior Clinical Operations, the scientific/medical objectives  of the clinical trials and best practices to assess and evaluate specific  components of clinical studies against time, budget and quality parameters
  • Provides  GCP expertise and brings to bear best practices in areas of oversight,  including: monitoring, TMF content, clinical trial supply, and sample collection

Role Accountabilities

  • Contributes  to TMF QC plan development and performs QC of Trial Master Files; creates,  maintains, and closes out TMFs
  • Thoroughly  understands clinical trial protocols and site specifications and manages the  oversight of the data delivery process in clinical trials ensuring consistency  with protocols, including participation in data review/ reconciliation efforts
  • Manages  elements of the quality plan (e.g., inspection readiness, compliance);  diligently follows Promedior Clinical Operations SOPs; identifies gaps, and  works with other senior Clinical Operations staff or independently to eliminate  those gaps
  • Ensures  patient enrollment activities are within protocol guidelines
  • Manages  aspects of the relationship with CROs and/or trial sites; works with CPM or  other Clinical Operations senior staff to resolve issues or problems with the  sites
  • Supports  the PM in the set-up, conduct, and close out of TMF activities - e.g. Central  Lab and ancillary vendors
  • Conducts  oversight of sample definition, collection, and analysis at the study level and  ensures the link back to the program level sample (biomarker, PD) strategy
  • Provides  study level information to enable accurate and efficient supply of clinical  product to the sites and identifies potential risks/challenges associated with  doing so
  • With  minimal oversight from CPM, oversees vendor site monitoring and monitor  performance including, monitoring plan creation, oversight of activities at the  study level, and ensuring adherence to plan and quality metrics; works with  Project Manager with larger vendors/more complex studies
  • Actively  participates in the development of department initiatives, may act as lead on  the development/definition of certain SOPs and processes under the leadership  of more senior Clinical Operations staff; provides suggestions on department  initiatives and goals that will support and enhance the vision and mission of  Clinical Operations
  • Reviews  and provides input to clinical protocols for feasibility of clinical trials  delivery; looks for short and long-term potential obstacles or opportunities  for accelerating delivery of a clinical study
  • Drafts  and manages clinical trial project timelines for elements on a day to day  basis, proactively alerting PM and/or senior Clinical Operations staff to risks  / challenges
  • Ensures  accurate and comprehensive completion of documents needed by Regulatory Affairs  or delegate; makes sure that completed documents are handed over to RA within  the requested; timeframes and ahead of submission deadlines
  • With  minimal guidance and direction from the Project Manager and/or Clinical  Operations management, interfaces with other Promedior functions to coordinate  relevant and timely exchange of information / materials to support clinical  trials delivery within the drug development process
  • Ensures  patient enrollment activities are conducted in a timely manner
  • Provides  study level information to ensure timely database lock can occur

Knowledge & Skills

  • Demonstrates  advanced knowledge of and appropriate experience of relevant software packages  (e.g. Microsoft Project, Word, Excel) and Promedior systems and programs.  
  • Demonstrates  thorough knowledge and understanding of key regulatory authorities, ICH  Guidelines, and GCPs governing the conduct of routine clinical trials. 
  • Learns,  interprets, and explains protocol requirements to others. 
  • Manages  components of clinical trials independently with limited general guidance from  senior staff.
  • Demonstrates  deep understanding of interdependencies of data, technology, vendor systems and  metrics and differences across vendor abilities and requirements.
  • Strong  verbal, written and presentation skills.

Clinical Project Manager

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Title:  Clinical Project  Manager

Job Description

The Clinical Project Manager provides strategic and operational leadership of clinical research studies to ensure delivery on time, within budget, and of high quality in compliance with ICH/GCP, Regulatory Authorities’ regulations/guidelines, and applicable SOPs. They are the primary operational contact for the study and lead the cross-functional global team for execution of the study. Responsibilities may include operational direction of one or more cross-functional study team(s) and/or performance and quality oversight of one or more Contract Research Organization (CRO) teams. They should have the command of the projects, the ability to zoom in and out as the situation demands. The Clinical Project Manager should have critical thinking skills for problem solving and have the lateral and strategic thinking capacity to drive the study(ies) and understand implications of decisions that affect study outcomes and timelines.

Role Purpose:

  • Leads  several clinical studies  under a  distinct program  and is seen as the standard  for project management at Promedior by demonstrating a high level of knowledge  of clinical operations’ methodologies, organizational, project management and  leadership capabilities as well as increased strategic insight, decisiveness  and strong judgment
  • Works  to ensure that the standardized approach to project management established by  Clinical Operations is adhered to
  • Manages  clinical trials projects through leadership of and delegation to a cross-functional  study execution team, working under the guidance and direction of a Program  Lead. May be required from time to time to serve as a coach and mentor to  Clinical Trial Managers and junior staff
  • Ensures  successful clinical trial planning, execution and delivery – within specified  quality, time and cost parameters
  • As  a result of a strong understanding of methodologies and approaches, ensures  alignment of clinical project goals with Clinical Operations program objectives

Role Accountabilities

  • Develops  a quality control plan for trial master files and then ensures those TMFs are  created, maintained, monitored, and closed out on a timely basis
  • Actively  participates in the development of department initiatives, including acting as  lead on the development/definition of certain SOPs and processes; makes  recommendations on how best to approach, manage and engage others on department  initiatives
  • Ensures  site monitoring reports are accurate and thorough and that metrics are being  adhered to
  • Ensures  that an overarching trial cross-functional quality plan is in place and adhered  to
  • Develops  project management skills in self to increase consistency and drive Clinical  Operations performance
  • Responsible  for managing creation, maintenance and close out of TMF activities
  • Develops  and seeks ways to improve project management processes and SOPs
  • Oversees  and manages vendors (CRO) to ensure that Promedior's clinical trials are  getting the necessary resources and attention the vendor has committed to  ensure trial deliverables and performance goals are met. 
  • Develops  project management skills in self and others to increase consistency and drive  Clinical Operations performance; mentors CPM, and CTM staff as appropriate
  • Manages  ancillary vendors, including IVRS, central lab imaging vendor, central ECG,  central pathology selection, set-up, conduct, and close-out
  • Oversees  the development of and adherence to clinical trial project timelines and  ensures senior Clinical Development staff informed of and understand risks /  challenges, which includes putting risk mitigation plans in place, monitoring  risk metrics, and communicating those risks
  • Coordinates  the relevant and timely exchange of information / materials (e.g., patient  enrollment, site selection, and data collection) with other Promedior functions  to support clinical trials delivery within the drug development process
  • Ensures  that all clinical data, including third party data, is managed and completed in  a timely manner in order to enable Data Management to lock the database on  appointed dates
  • Ensures  that external partnerships (e.g. CRO) are effectively supporting clinical  trials, within contracted terms including budget;
  • Oversees  the administration of invoice reconciliation, scoping, and change orders, for  clinical trial operations
  • Adheres  to clinical trial budgeting process and provides input on process optimization
  • Leads  matrix, multi-disciplinary, cross-functional study execution teams from  start-up through close to ensure both internal and external deliverables are on  time and on budget
  • Has  both an internal and external perspective on clinical trial management; ensures  that clinical trials are operationally feasible while understanding the  external landscape, including a focus on KOL activity and the competitive  landscape
  • Leads  cross functional team to ensure timely activation of clinical trials; including  risk management, problem-solving;
  • Proactively  identifies, negotiates and brokers solutions to individual clinical study  issues
  • Delegates  and oversees the management of certain aspects of project management to CTM  staff to ensure clinical studies at a project level are executed within  specified time, quality and cost parameters
  • Proactively  identifies, negotiates and brokers solutions to cross-study issues and  identifies connections with other studies

Knowledge & Skills

  • Demonstrates  ability to provide input into clinical protocol development.
  • Demonstrates  extensive experience and expertise in managing high-volume/complex clinical  studies. 
  • Demonstrates  thorough knowledge and understanding of key regulatory authorities, ICH  Guidelines, and GCPs governing the conduct of routine clinical trials. 
  • Proactively  and independently manages vendors, including identification and mitigation of  risk.
  • As  a result of being member and project manager of clinical study execution team,  develops detailed understanding of different departments and functions within Promedior  and interdependencies of the functions.
  • Very  strong verbal, written and presentation skills are required.
  • Experience  in leading of a matrixed cross-functional team.

Medical Director

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Title:  Medical Director

Reports to:   Chief Medical Officer

Education:  Board certification in Internal Medicine, and preferably  additional Board Certification in Pulmonary Medicine

Job Description

This  role represents a unique opportunity for a physician experienced in clinical  trial design and conduct to expand his or her experience across all medical  aspects of drug development, including clinical development, medical affairs,  and pharmacovigilance.  This physician  will serve as the Promedior Medical Monitor for a Phase 2 Study of PRM-151 in  Idiopathic Pulmonary Fibrosis, working closely with the Chief Medical Officer,  Contract Research Organization (CRO),   and CRO Medical Monitor to ensure optimal enrollment and conduct of the  clinical trial, will participate in or lead all advisory boards and  interactions with regulatory authorities  regarding the study and future development in IPF, and will have primary  medical responsibility for data analysis, clinical study report and  publications.  He or she will be the  primary Promedior liaison with IPF clinical trial investigators and key opinion  leaders and will oversee a team of contract Medical Science Liaisons in the US  and Europe.  This physician will also be  responsible for overseeing all pharmacovigilance activities for PRM-151 in all  indications, including oversight of the pharmacovigilance CRO and leadership of  the Promedior Executive Safety Committee. 

Requirements:

  • Experience in clinical trial design and conduct in pulmonary  diseases, preferably Idiopathic Pulmonary Fibrosis
  • Experience in data analysis and manuscript writing
  • Outstanding interpersonal and presentation skills
  • 3-5 years industry experience preferred but not required

Senior QA Specialist (15-87)

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  • Review of batch records and supporting documentation, testing data, and packaging/labeling from Contract Manufacturing Organizations (CMO) and Contract Testing Laboratories to support commercial activities.
  • Disposition Product (drug substance, drug product, package/labeling) supporting commercial product.
  • Track/maintain applicable logs related to lot disposition and CMO deviations/investigation/CAPAs
  • Review and approve CMO Master Batch Records.
  • Represent QA in CMOs meetings as applicable to ensure resolution of batch record review comments or QA related questions.
  • Assisting in Investigation and deviation activities, and CAPAs, and providing general quality assurance support for the overall Quality System at Sarepta, and updating internal electronic system.
  • Assist QA Manager with the day to day oversight of CMOs.
  • Participate and assist with regulatory inspections as needed.
  • Other duties as assigned.

The candidate will have 10+ experience with general Quality Systems in a regulated environment, with a focus on commercial Product Disposition, deviation/investigation writing and review. Experience with interaction of CMOs and other groups across Sarepta.

 

Systems Support Consultant R &D

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The R &D Systems Support Consultant will provide business and systems support for FORUM’s growing portfolio of clinical systems, including clinical data management and analytics, pharmacovigilance tracking and reporting, and clinical document management and regulatory filing. Experience with Clinical systems in a regulated mid-size to large pharmaceutical manufacturing environment is required.

                                                                                                                                                                                   Job Description                                                                                                                           The R &D Systems Support Specialist will provide business and systems support for FORUM’s growing portfolio of clinical systems, including clinical data management and analytics, pharmacovigilance tracking and reporting, and clinical document management and regulatory filing. Experience with Clinical systems in a regulated mid-size to large pharmaceutical manufacturing environment is required.
This position reports to the Director of Information Systems Management, and requires excellent project management and communication skills
Primary Position Responsibilities/Tasks:

  • Maintain alignment between IT and business stakeholders in clinical operations, in regards to systems necessary for business operations, including new implementations, ongoing support, training, or system upgrades or modifications.
  • Provide leadership, management, mentoring, and direction where necessary to support Research and Development operations and systems.
  • Comfortable with a hands-on management and business liaison environment.
  • Experience with business needs and the evolving landscape of available commercial options to support Research and Development activities:
  • Compliant Document Repositories for Quality Assurance, Regulatory Affairs (eCTD), and Clinical Operations (eTMF) from Veeva Systems or equivalent.
  • Audit management using Sparta Systems’ TrackWise or equivalent.
  • Multi-user document review tools including PleaseTech’s PleaseReview or equivalent.
  • Stability Assay management from ScienTek or equivalent.
  • Pharmacovigilance systems such as Argus or equivalent.
  • System and Database management tools such as Dell’s TOAD and equivalents.
  • GxP Processes and their validation requirements for installation, operation, and performance qualification (IQ/OQ/PQ).
  • Responsible for vendor relationship management across all clinical systems used by the business.

Minimum Qualifications

  1. Eight (8) years’ experience performing similar duties with a demonstrated track record of success in the pharmaceutical industry

  2. Three (3) years’ managing Sr. Analysts and Contractors supporting discovery informatics and regulated GxP systems from the perspectives of day to day support, new implementations or upgrades, and a rapidly growing company.

  3. Master’s degree in Information Systems, Computer Science, or related technical discipline

  4. Experience using or administering SharePoint 2013 for project team collaboration

  5. Excellent written and verbal communication skills

  6. Proficient in all Microsoft Office products – Outlook, Word, Excel, Project, Visio, etc.

  7. Strong project planning, driving, tracking, and reporting capabilities

  8. Excellent verbal and written communication skills.

Preferred Qualifications

  1. Direct experience in supporting IND and NDA regulatory filing processes

  2. Direct experience in supporting FDA CFR Part 11 inspections and audits.

This is an exciting information technology opportunity to join a small team of dedicated professionals in a growing and dynamic company. Will provide business and systems support for FORUM’s growing state-of-the-art on-premise and cloud-based portfolio of clinical development systems. This position will provide the primary direction and management for new and expanded systems to support clinical data management and analytics, pharmacovigilance tracking, reporting, and signal detection, as well as clinical document management and regulatory filings and reporting. The successful candidate will take their current 8+ years’ experience with clinical systems, in a regulated mid-size to large pharmaceutical manufacturing environment, to the next level. This position reports to the Director of Information Systems Management, and requires excellent project management and communication skills, as well as the ability and desire to excel, to contribute, and to grow.

                

                

                

                

                

                    

 

HR Associate

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Key Responsibilities:

• Manage special projects related to business needs – examples; employee engagement survey roll-out and process, performance management schedule, salary planning and other types of work

•Conduct market research on HR trends and stay on top of best practices

•Generate and present content for HR presentations, training and reports

•Assist HR team with day to day tasks

 

Requirements/Qualifications:

•Bachelor’s or Master’s degree in Human Resources or related field required

•Superior communication skills and the ability to convey HR processes and programs to wide variety of audiences

•Excellent attention to detail and organization skills

•Assertive, self-starter, and independent quick thinker

•Proven ability to build successful and effective relationships with individuals at all levels

•Sound judgment, high integrity, and ability to maintain strict confidentiality

•Advanced computer skills in Microsoft Excel, Word, Power Point – computer savviness a must

•Strong time management and prioritization skills

•Ability to deliver effective results and adhere to deadlines

•Ability to anticipate activities and take proactive action with limited direction

HR Associate

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Key Responsibilities:

• Manage special projects related to business needs – examples; employee engagement survey roll-out and process, performance management schedule, salary planning and other types of work

•Conduct market research on HR trends and stay on top of best practices

•Generate and present content for HR presentations, training and reports

•Assist HR team with day to day tasks

 

Requirements/Qualifications:

•Bachelor’s or Master’s degree in Human Resources or related field required

•Superior communication skills and the ability to convey HR processes and programs to wide variety of audiences

•Excellent attention to detail and organization skills

•Assertive, self-starter, and independent quick thinker

•Proven ability to build successful and effective relationships with individuals at all levels

•Sound judgment, high integrity, and ability to maintain strict confidentiality

•Advanced computer skills in Microsoft Excel, Word, Power Point – computer savviness a must

•Strong time management and prioritization skills

•Ability to deliver effective results and adhere to deadlines

•Ability to anticipate activities and take proactive action with limited direction

Research Associate-Chemistry

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Are you able to think critically and creatively as part of a talented and fast-paced research team and play a key role in the companies growth? My biopharmaceutical client is looking for an exceptional Research Associate to contribute to the company’s efforts in building a high throughput platform.
If this  sounds like an opportunity for you, apply today!
Key Qualifications

  • Bachelor’s or Master’s degree in organic, polymer, or food chemistry 
  • Experience with up to date synthetic chemistry techniques (carbohydrate synthesis and analysis a plus)
  • Experience with modern analytical and purification methods, including HPLC, mass spectrometry, and NMR spectroscope
  • Excellent collaboration, communication and interpersonal 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™

Medical Device Complaints Processing & Remediation

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NovusLife is a rapidly growing consulting firm focused on providing expertise to companies working in rare disease and orphan indications.


Our client needs multiple contractors/consultants experienced with quality and regulatory compliance, complaints databases, product safety, complaints backlogs, competent authority reports as they prepare to implement an updated complaint handling system. This is an on-site, full-time (40 hrs/wk) contract starting IMMEDIATELY through April 2016.

Eligible candidates with a degree in Nursing (BSN/RN) must be LOCAL to either Miami FL and metro-west area of Boston.
Candidates must have experience as clinicians, quality & compliance, Class II, III medical device experience.
RN and cardiac medical device experience is a plus.

Job Type: 6-mo Contract

Local candidates only:

  • Boston's Metro-West OR Miami FL

Required experience:

  • Nurse, clinician: 1 year

Required education:

  • BSN/RN

BS/MS level Oncology Scientist

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Novartis Institutes for Biomedical Research (NIBR) is seeking a experienced BS/MS level Oncology Scientist to join our Oncology team in Cambridge, MA.

The successful candidate in this position will be playing a key role in evaluating new cancer drug candidates in pre-clinical and clinical development. Previous experience with oncology translational research projects would be beneficial.

Major responsibilities will include: 
• Evaluation and characterization of cellular and pharmacological responses to new drug candidates in a wide variety of cancer cell lines, which will be utilized, in combination with cancer genetics information, to aid our patient stratification efforts. Application of various genetic and chemical tools to dissect cancer and signal transduction pathways in different cancer models to help elucidate drug mechanisms of action as well as mechanisms that predict sensitivity and/or resistance. 
• Taking an active part in designing and developing new biological and chemical assays/screens to accelerate the current drug and biomarker discovery effort.
• Evaluation of drug combinations based on responder hypotheses
• Proficiency in gene expression assays and analysis

Major activities:
• Articulates key scientific questions, hypothesis generation, and project timeline planning
• Provide data analysis and propose designs for next experiments to supervisor
• Independently research and implement new lab techniques based on literature
• Independently write method and data summary reports
• Maintain lab notebook with highest standards of data quality
• Present results to supervisor, lab, and project teams
• Demonstrate command of cancer biology and ability to apply knowledge in discipline to complete work assignments  

ADDITIONAL REQUIREMENTS

• BS or MS (USA) in scientific discipline such as Biology, Biochemistry or Pharmacology with 2-5 years of experience in drug discovery or other related laboratory research
• • Must possess excellent oral and written communication and organizational skills, critical problem-solving abilities, and a commitment to science.
• Strong interpersonal skills.
• Familiarity with data analysis software (Microsoft Excel at minimum) and basic bioinformatics concepts are required.
• The ideal candidate will have experience in mammalian cell culture, cell biology and molecular biology. Familiarity with techniques such as cloning, western blotting, compound efficacy profiling, viral based gene delivery, Real-time qPCR, RNAi, or CRISPR technologies are highly desired. 
• Must be able to work independently, learn and become proficient in new techniques rapidly while also being an integral part of a highly dynamic team


BS/MS Research Associate – Musculoskeletal Diseases

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We are looking for a highly motivated and experienced research associate to join our Musculoskeletal Diseases department at Novartis Institute for Biomedical Research. 

This individual will assume a multidisciplinary role within the in vivo and cell pharmacology teams and contribute to several research projects focused on the development of new therapies for musculoskeletal disorders.
The candidate should have a B.S. or M.S. degree or equivalent in biology, pharmacology, or a similar discipline with at least three years of industrial or academic research experience. 

Expertise in animal handling, dosing, blood collection and dissections as well as the ability to multi-task in a fast-paced drug discovery environment is required. The candidate must be interested in expanding their skillset to include ex vivo, cellular and molecular biology techniques. Experience with biochemical assays and muscle research is preferred. 

The candidate must be self-motivated and team-oriented with excellent communication and organizational skills.  

ADDITIONAL REQUIREMENTS

• B.S. / M.S. degree in biology, pharmacology or similar discipline + 3 years research experience.
• Experience working with rodents (handling/restraint, dosing: PO, SC, IP, IV, etc., blood collection and tissue dissection)
• Good interpersonal and communication skills and the ability to work efficiently as a team and independently.
• Ability and willingness to perform studies that may require the use of hazardous materials and occasional time commitment on weekends.
• Motivation to learn and develop new techniques both in vivo and in vitro.
• Ability to multi-task complicated experiments.
• Meticulous record keeping and attention to details.
• Experience using Microsoft Office (Word, Excel and Powerpoint).

Clinical Trial Manager

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Clinical Trial Manager

About Acceleron:

Acceleron is a clinical stage biopharmaceutical company focused on the discovery, development and commercialization of novel therapeutic candidates that regulate cellular growth and repair.  The company is a leader in understanding the biology of the Transforming Growth Factor-Beta (TGF-β) protein superfamily, a large and diverse group of molecules that are key regulators in the growth and repair of tissues throughout the human body, and in targeting these pathways to develop important new medicines. Acceleron has built a highly productive R&D platform that has generated innovative clinical and preclinical protein therapeutic candidates with novel mechanisms of action.  These protein therapeutic candidates have the potential to significantly improve clinical outcomes for patients with cancer and rare diseases.

Position Overview:

This position is responsible for overall clinical study management.  The successful candidate will be a reliable team player that has the ability to work well with many different functional areas including regulatory affairs, program management, medical research, data management and drug supply.

Job Responsibilities:

Team oriented individual who is able to:

  • Work efficiently both independently and with a team
  • Manage the supervision of contracted clinical research organizations, clinical laboratory vendors, and other outsourced work
  • Lead both an internal and external/CRO study management team, to ensure the successful conduct of clinical trials in accordance with State and Federal regulations, GCP regulations, ICH guidelines, and internal SOPs
  • Author and review as needed clinical study documents (Informed Consent Forms, Clinical Study Plans, Case Report Forms, Statistical Analysis Plan, etc.).  Review and contribute as needed to Investigator’s Brochure and other supportive regulatory documents
  • Drive IRB/ethics committee and regulatory submissions as needed to support study timelines
  • Effectively evaluate qualified study sites, perform site initiation, plan and present at investigator meetings/advisory boards, and implement study start up activities including development of documents related to conduct of the study (e.g., investigator binder, pharmacy binder, regulatory binder development, etc.) in collaboration with the clinical study team
  • Manage and review study budgets and investigator grants
  • Oversee interim study conduct including management of operations/medical questions from CRO and sites, planning and facilitation of interim safety meetings, tracking subject recruitment, laboratory samples, and study drug supply, review of monitoring reports, and ensure proper documentation is filed to meet GCP requirements
  • Assess study drug requirements and shipment logistics; contribute to labeling strategy
  • Responsible for study close-out and ensuring study timelines are met

Required Experience

  • Bachelor’s Degree required, relevant scientific or health-care related discipline highly preferred
  • Minimum of 2 years of clinical trial management experience including protocol development, selection and management of CROs and contract vendors, timeline management, and budget management. Prior experience working in the biopharmaceutical industry is required
  • Demonstrated proficiency in management of multi-center international clinical trials (from initiation to closure)
  • Experience managing outsourced work
  • Excellent interpersonal, communication (written and verbal), time management, presentation and organizational skills
  • Ability and willingness to travel 5-10% of the time (international and domestic)

*Recruiters - please do not send unsolicited resumes to this posting.

FOR IMMEDIATE CONSIDERATION PLEASE VISIT OUR WEBSITE AT:

www.acceleronpharma.com

Senior Research Associate/Scientist: Molecular and Cell Biology

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Senior Research Associate/Scientist: Molecular and Cell Biology

About Acceleron:

Acceleron is a clinical stage biopharmaceutical company focused on the discovery, development and commercialization of novel therapeutic candidates that regulate cellular growth and repair.  The company is a leader in understanding the biology of the Transforming Growth Factor-Beta (TGF-β) protein superfamily, a large and diverse group of molecules that are key regulators in the growth and repair of tissues throughout the human body, and in targeting these pathways to develop important new medicines. Acceleron has built a highly productive R&D platform that has generated innovative clinical and preclinical protein therapeutic candidates with novel mechanisms of action.  These protein therapeutic candidates have the potential to significantly improve clinical outcomes for patients with cancer and rare diseases.

Position overview:

We are seeking a highly motivated and skilled individual with expertise in molecular biology techniques, as well as in-depth experience with mammalian cell culture and cell-based assays, to work in a collaborative and energetic environment.  As part of the Molecular and Cell Biology group, the candidate will be responsible for the construction and in vitro evaluation of various discovery molecules.   This includes testing the functional activity of these molecules in biochemical/cellular assay formats such as ELISAs, reporter gene assays, and flow cytometry, or to perform assay development as needed.  The individual will also be responsible for the evaluation, interpretation and communication of all results associated with activities and project goals.  This position will provide the candidate with the opportunity to make visible contributions to the success of our research programs. 

Basic Qualifications:

  • PhD in Biology, Molecular Biology, Biochemistry or related discipline with 0-2 years of experience in molecular and cell biology, or BS/MS with 5-10 years of full time working experience, with a preference for gene cloning and cell based assay activities within the past two years. The level will be commensurate with experience
  • Strong background in plasmid construction and mutagenesis and expression of fusion molecules; experience in antibody cloning and expression is desirable
  • Demonstrated proficiency in aseptic cell culture techniques and the performance of mammalian cell-based assays
  • Working experience with SDS-PAGE, Western blot, RT-pcr, and transient/stable transfection in mammalian cells
  • Experienced in the design, implementation and troubleshooting of assays, along with data interpretation
  • Display initiative for assay development and implementation
  • Experience with Vector NTI is desirable
  • Highly analytical mind, attention to details, and organizational skills are critical
  • Strong communication, interpersonal and teamwork skills are essential

*Recruiters - please do not send unsolicited resumes to this posting.

FOR IMMEDIATE CONSIDERATION PLEASE VISIT OUR WEBSITE AT:

www.acceleronpharma.com

Senior Scientist, Biology/ Immunology

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Senior Scientist, Biology/ Immunology   

GlaxoSmithKline’s Tempero Discovery Performance Unit (DPU) within the Immuno-Inflammation Therapeutic Area is located in the heart of Technology Square in Cambridge, MA, less than a mile from downtown Boston.

We are seeking a highly motivated and experienced senior scientist to join our drug discovery team and play an important role in our efforts to develop novel therapeutics for the treatment of inflammatory and autoimmune diseases. This individual will have the opportunity to make significant and high impact contributions in a dynamic small group setting on drug discovery programs in the area of Th17 modulation.

Basic qualifications:

  • Master’s degree with 1+ year of drug discovery experience or Bachelor’s degree with 4+ years of drug discovery experience in cell biology, immunology, molecular biology, pharmacology or a related discipline
  • Broad and deep knowledge of cell and molecular immunology
  • Strong understanding of the immune system
  • Ability to design, execute and analyze in vitro experiments
  • Techniques and skill set include:  qPCR, microarray, flow cytometry, tissue culture (primary cells and cell lines), ELISA, MSD
  • Excellent written and oral communication skills
  • Ability to work effectively in a multidisciplinary matrix environment.
  • Team spirit and excellent interpersonal skills
  • Self‐motivated AND meticulous, with focus on critical AND innovative thinking

Preferred qualifications:

  • Experience with cell assay development and biomarker discovery
  • Learning agility and a strong desire to continuously improve and develop

Details:

We are looking for the individual with a strong background in immunology to play an important role in our efforts to translate recent advances in the understanding of Th17 biology relative to the new medicines we are developing for the treatment of inflammatory and autoimmune diseases. We are interested in discovering how our targets affect effector cell responses as well as the innate and adaptive arms of the immune system.  This position will be responsible for conducting in-vitro studies to investigate the mechanisms of action and potential clinical utilities of novel drug candidates. The successful candidate will possess a deep understanding of the immune system and will work both independently and within a team to design, execute, and analyze experiments.  Other responsibilities will include working closely with other scientists within a drug discovery team and coordinating studies across several functional groups.  

Key responsibilities include:          

  • Work in partnership with cross-functional teams to investigate the biology of novel drug targets and execute experiments to test the impact of newly developed lead candidates on the immune response
  • Analyze, interpret, and report experimental results in a small group setting
  • Maintain detailed records of experiments in electronic lab notebooks in accordance with company policy
  • Share in responsibilities to support general lab functions

 Please reference that you are applying for the requisition numbers:  WD41490 or WD43285. 

Note:  Position WD43285 would require more experience with high-throughput screening assays.

 

Scientist III (ID: 382)

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About ImmunoGen, Inc.

ImmunoGen, Inc. develops targeted anticancer therapeutics. The Company’s ADC technology uses tumor-targeting antibodies to deliver an ImmunoGen cell-killing agent specifically to cancer cells. The Company utilizes its ADC technology with its antibodies to create ImmunoGen product candidates and also out-licenses limited rights to use its technology to other companies. Roche's Kadcyla® is the first marketed product with ImmunoGen's ADC technology. More information about the Company can be found at www.immunogen.com.

Kadcyla® is a registered trademark of Genentech, a member of the Roche Group.

The Opportunity

ImmunoGen, Inc. Process Science and Engineering Group is seeking a highly motivated Scientist I/II, who will work with minimum supervision on process development for antibody downstream purification and antibody drug conjugate. The successful candidate will initially work on development of antibody downstream process and later on antibody drug conjugate (ADC) process for early and late stage manufacturing. The candidate will be able to work independently for process development, process transfer, troubleshoot and process validation.

  • In depth knowledge of protein downstream purification, process robustness, process scale up and process cost- effectiveness
  • Good understanding of protein chemistry, specifically chemical modification of proteins and how this would apply to conjugate processes
  • Hands on experience on protein purification techniques, such as chromatography, ultrafiltration, diafiltration, viral nano filtration
  • Hands on experience on analytical techniques, such as HPLC, UPLC, CE-SDS (Gel chip)
  • Able to use DoE and other approaches for process development
  • Able to learn new techniques and apply them to process development
  • Good communication skills including good writing skills, such as technique report, regulatory document and support document (e.g. change controls)
  • Must be a good team player, capable of interaction with different functional groups within the company and outside CMO
  • This job will need occasional travel (domestic and international) up to 10%.

Who You Are

  • The candidate must have a PhD in Biochemistry or Chemistry, with three plus years of experience ideally in process development or equivalent experience with a degree in Chemical Engineering
  • Pivotal/commercial process development experience is preferred.
  • Management experience a plus

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.

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