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Senior Administrative Assistant (247-419)

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

Overview:

The successful candidate will work independently and provide a high level of executive administrative support to the ARIAD Quality Department in a fast paced growing biotech environment.  Responsibilities will include extensive calendar management, travel coordination, expense management and project support.

Job Responsibilities:

  • Extensive and complex calendar management, coordinating meetings, conferences and events
  • Schedule Teleconferences and WebEx meetings across sites and countries
  • Responsible for making domestic and international travel arrangements for the Director and staff
  • Responsible for submitting expense reports for the Director and Managers
  • Manage department budget; estimate spending, create purchase orders, get approvals and ensure timely payments
  • Handle various correspondence which may be sensitive and confidential in nature
  • Coordinate project deliverables as assigned
  • Maintain office supplies, handle mail, follow through with various administrative tasks
  • Ensure compliance with all applicable laws, regulations and regulatory guidelines governing commercial and scientific interactions with healthcare professionals, payers, advocacy and other business partners.
  • Serve as a role model for compliant behavior that is consistent with the mission, vision and values of the ARIAD organization
  • Strong commitment to business ethics
  • Understanding of, and experience with, regulatory framework applicable to interactions with HCPs, payers, advocacy and other business partners.

 Basic Qualifications:

  • Bachelor degree in a related discipline preferred.
  • Minimum 5 years overall administrative experience; of which a minimum of 2 years’ experience supporting multiple directors or managers
  • Demonstrated superior oral and written communication skills
  • Strong organizational skills, ability to prioritize and multi-task, detail orientation
  • Advance skills in Microsoft Office including Word, Excel, and PowerPoint; (Microsoft Project and Visio experience is a plus)
  • Prior experience with budgeting and expensing software, such as Oracle and Concur, is a plus
  • Prior work experience in a regulated industry, such as Biotech, Pharmaceuticals, Aerospace is a plus
  • Possess a high level of energy, strong work ethic, resourcefulness and flexibility
  • Strong commitment to business ethics
  • Understanding of, and experience with, regulatory framework applicable to interactions with HCPs, payers, advocacy and other business partners.

 



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Click here to apply:

http://ariad-openhire.silkroad.com/epostings/submit.cfm?fuseaction=app.dspjob&jobid=247&company_id=16419&version=1&jobboardid=306

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


Director of Clinical Operations

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Zalicus is seeking a Director of Clinical Operations to provide leadership and operational oversight for its ongoing clinical trials in CNS/ Pain.   This highly visible role will be responsible for overseeing operations in all facets of its ongoing trials with CRO partners.  This individual will further serve as a key resource on matters of clinical operations in  presenting clinical trial updates to cross-functional teams as well as senior management

Responsibilities will include the following:

  • Participate in the selection of CROs, ancillary vendors and advise on CTAs
  • Oversee cGMP ICH, FDA/EMEA vendor compliance, SOP development , Investigator Alert letters as well as other guidelines      and activity conducive to trial success.
  • Contribute to protocol design development and support clinical study report preparation
  • Develop,  lead and hire team members in clinical operations; prepare and manage department budget
  • Contribute to regulatory documents and operational trial information updates
  •  Provide data interpretation and ensure CSR e-publishing preparedness
  • Responsible for the strategy, oversight and implementation of process improvement initiatives

Qualifications:

  • BA/BS in an area of applied healthcare  or science (Advanced Degree preferred). with 8 -12 years experience in  sponsor company clinical trial operations, CRO management.  
  • Previous line management in a cross functional, fast paced environment
  • Therapeutic area experience in Pain, CNS/Neurology
  • Strong working  knowledge of FDA/EMEA, cGMP & ICH      guidelines and standards
  • Experience in  conducting and overseeing complex in-hospital clinical trials  that include  experience ranging from small Phase I studies to larger trial programs

Key competencies and qualities:

  • Strong communication skills both oral and written; a keen ability to clarify complex information in a concisemanner
  • Superior delegation and prioritization skills
  • Collaborative style; an ability to influence senior management and partner with various internal departments
  • Ability to identify simple, solutions; capable of decisions in ambiguous environs;  proposing  new ideas
  • Autonomous, self-starter who anticipates well

Compound Management Associate

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Looking for an individual to be a key contributor in the Sample Management Group.  The successful candidate will be primarily responsible for processing new compounds and inventory requests.
 
Requirements:
 
Primary responsibility will be the handling of all new compound orders
Weighing solids in order to create solutions via Tecan liquid handler.
Should have a thorough knowledge of activities related to compound management.
Experience working with laboratory robotics
Ability to diagnose and triage hardware and software issues quickly
Experience with Tecan Genesis, Biomicrolab Volume Checker, Biomicrolab Tube Sorter is a plus

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

Senior Scientist Chemistry

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Our client is looking for an experienced Medicinal Chemist to Design, synthesize, and characterize novel molecules towards a wide range of novel protein targets, efficiently and independently.This position requires a PhD in organic or medicinal chemistry with a minimum of five industry experience in chemistry /drug discovery.  A demonstrated record of productivity in organic or medicinal chemistry research should be evidenced by publications and/or patents.  A broad knowledge in organic chemistry: heterocyclic chemistry, metal catalyzed reactions, multi-step synthesis; In-depth knowledge and hands-on experience with a wide range of techniques in synthesis, purification, and spectroscopic characterization of novel compounds (NMR, LC-MS, HPLC e) is required. Experience using the concepts and tools of structure-based drug design and chemical database searching is also required.

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.

StratAcuity, CHEMISTRY IS EVERYTHING.

Metabolite Scientist

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Perform the experimental set-up for metabolism studies of chemicals, including hydrolysis, photolysis, and for the aspects of metabolite/degradation product identification. Technical expertise in development of chromatographic and mass spectral methods. Oversee a given project to achieve study objectives in a timely manner within principles of GLP's and in compliance with FDA, EPA, OPPTS (OCSPP), OECD, and JMAFF guidelines. Preparation of protocols, technical summary updates, and reports. Review data and reports for accuracy and completeness.

Developing, establishing and validating analytical testing methodology used to hydrolysis, photolysis, plant metabolism and soil metabolism studies. Interpreting data and writing technical reports to document analytical methods and experimental results.

Technical skills with HPLC/RAM, LCMS/MS, GCMS and TLC analytical method development for the analysis and identification of metabolites/degradation products of chemicals for drug discovery and DMPK.

Medical Director, Rheumatology

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EMD Serono is the biopharmaceutical division of Merck KGaA, Darmstadt, Germany, a global pharmaceutical and chemical group. We strive to create value and benefit patients by transforming medical science into breakthrough solutions in our core therapeutic areas of neurodegenerative diseases, fertility and metabolic endocrinology, as well as oncology and autoimmune/inflammatory diseases as emerging areas of expertise.

PURPOSE OF THE ROLE

  • Lead the development and execution of Clinical Development Plans for assigned Rheumatology and/or Immunology investigational agents
  • Provide scientific and medical expertise to other functions within the company

KEY TASKS & RESPONSIBILITIES

Functional Tasks

  • Act as medical director of clinical development strategies with regard to current and future rheumatology development:
  • Develop (or support development of) the Clinical Development Plan for assigned product(s)
  • Provide medical/scientific input and help drive the creation of relevant clinical documents such as study protocols and reports, Investigator Brochures, submission/registration documents, publications, etc.
  • Collaboration with the safety representative with regard to safety assessments and risk management plans
  • Function as the medical responsible on assigned clinical trials
  • Supervise the review, analysis and interpretation of study data
  • Support communication of study results as assigned
  • Collaborate with Clinical Trial Management members in the selection of principal investigators and recruitment of clinical study sites

Internal Departments/Functions:

Biostatistics, Business Development, Business Unit/Marketing, Chief Medical Officer, Clinical Trial Management & Monitoring, Data Management, Drug Safety, Exploratory Medicine, Legal, Medical Information, Medical Writing, Project Management, Regulatory Affairs, R&D Quality Assurance

External Interfaces:

Health Authorities, Opinion/Thought Leaders, Clinical Investigators, Academic Institutions, Scientific and Patients' Organizations

EDUCATION

Medical Doctor (MD) specialized in the therapeutic area with experience in direct patient care

Languages

Fluency in English

PROFESSIONAL & TECHNICAL SKILLS

  • A minimum of 3 years experience in pharmaceutical product development within the pharmaceutical and/or biotech industry at an international level
  • Strong immunology or rheumatology background preferred
  • Experience in interaction with Health Authorities in US, Europe and possibly Japan and/or China
  • Ability to work with and manage people in a matrix environment

 

Medical Director, Rheumatology

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EMD Serono is the biopharmaceutical division of Merck KGaA, Darmstadt, Germany, a global pharmaceutical and chemical group. We strive to create value and benefit patients by transforming medical science into breakthrough solutions in our core therapeutic areas of neurodegenerative diseases, fertility and metabolic endocrinology, as well as oncology and autoimmune/inflammatory diseases as emerging areas of expertise.

PURPOSE OF THE ROLE

  • Lead the development and execution of Clinical Development Plans for assigned Rheumatology and/or Immunology investigational agents
  • Provide scientific and medical expertise to other functions within the company

KEY TASKS & RESPONSIBILITIES

Functional Tasks

  • Act as medical director of clinical development strategies with regard to current and future rheumatology development:
  • Develop (or support development of) the Clinical Development Plan for assigned product(s)
  • Provide medical/scientific input and help drive the creation of relevant clinical documents such as study protocols and reports, Investigator Brochures, submission/registration documents, publications, etc.
  • Collaboration with the safety representative with regard to safety assessments and risk management plans
  • Function as the medical responsible on assigned clinical trials
  • Supervise the review, analysis and interpretation of study data
  • Support communication of study results as assigned
  • Collaborate with Clinical Trial Management members in the selection of principal investigators and recruitment of clinical study sites

Internal Departments/Functions:

Biostatistics, Business Development, Business Unit/Marketing, Chief Medical Officer, Clinical Trial Management & Monitoring, Data Management, Drug Safety, Exploratory Medicine, Legal, Medical Information, Medical Writing, Project Management, Regulatory Affairs, R&D Quality Assurance

External Interfaces:

Health Authorities, Opinion/Thought Leaders, Clinical Investigators, Academic Institutions, Scientific and Patients' Organizations

EDUCATION

Medical Doctor (MD) specialized in the therapeutic area with experience in direct patient care

Languages

Fluency in English

PROFESSIONAL & TECHNICAL SKILLS

  • A minimum of 3 years experience in pharmaceutical product development within the pharmaceutical and/or biotech industry at an international level
  • Strong immunology or rheumatology background preferred
  • Experience in interaction with Health Authorities in US, Europe and possibly Japan and/or China
  • Ability to work with and manage people in a matrix environment

 

Bioanalytical Chemist/Study Director

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Bioanalytical Chemist/Study Director

 

Toxikon Corporation, originally founded in 1977, is a Contract Research and testing company with laboratories in Bedford, MA and Belgium.  Our mission continues to focus on providing quality services, competitively priced, with on-time delivery for the Pharmaceutical, Medical Device and Biotech industries.

Toxikon is seeking a Bioanalytical Chemist/Study Director with a minimum of 3-5 years of experience in the pharmaceutical industry conducting bioanalytical assays utilizing HPLC, LC/MS/MS in compliance with GLPs. Qualified individual will have a Masters or a PhD in Chemistry with a strong knowledge of method development and method validation. Expertise in various biological matrices required. Strong communication skills and experience with regulatory/agency interactions (FDA and other) desired.

Job Responsibilities:

 Hands on responsibility of managing and performing bioanalytical projects as a priority and performing support analytical services for Pharma services:

  •  Responsible for executing bianalytical testing protocol for specific projects. Supporting toxicology/pharmacology studies leading to product registration (FDA, ICH, ISO, Japanese and others). Including, dose verification, stability, characterization, PK/TK and other assays.
  •  Authoring and revising all relevant bioanalytical SOPs.
  •  Assist/manage technical site visits of the department related to assigned projects and assist QAU and Regulatory Affairs with all vendor/regulatory audits.
  •  Maintain and monitor schedule of performance, flow of information and reporting of studies. Ensure reports are timely and all special requirements are met.
  •  Interact with the daily scheduling, forecasting and needs for the laboratory/department.
  •  Assist the clients and sales staff with quotation preparation and project budgeting/pricing, wherever required.
  •  Maintain the lab accreditation and registrations, wherever applicable. Responsible for the selected studies and documentation requirements for the labs.
  •  Instrument maintenance and performance, including IQ, OQ, PQ, and IQ, PV oversight.
  •  Manage day-to-day activities of the studies and interacting with clients on technical issues.
  •  Manage work assignments of the Research Associates, including their work schedules, reporting schedules and technical performance/record keeping.
  •  Maintain conformance with Toxikon’s quality mission statement, goals and values. Enforce and maintain compliance with ISO 17025 certification through the laboratories and operations.

 

For additional information about Toxikon, please view our website at www.toxikon.com

In order to submit your resume, please reply to this posting with the position in the subject line. Please also include salary requirement in your email.

Human Resources
Toxikon Corporation
15 Wiggins Avenue
Bedford, MA 01730
Email:  hr@toxikon.com

 

Toxikon employs 160 people and offers a generous benefit program including health, dental, fsa, std, ltd, life insurance and matching 401K plan. Toxikon is an EOE.


Bioanalytical Chemist/Study Director

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Bioanalytical Chemist/Study Director

 

Toxikon Corporation, originally founded in 1977, is a Contract Research and testing company with laboratories in Bedford, MA and Belgium.  Our mission continues to focus on providing quality services, competitively priced, with on-time delivery for the Pharmaceutical, Medical Device and Biotech industries.

Toxikon is seeking a Bioanalytical Chemist/Study Director with a minimum of 3-5 years of experience in the pharmaceutical industry conducting bioanalytical assays utilizing HPLC, LC/MS/MS in compliance with GLPs. Qualified individual will have a Masters or a PhD in Chemistry with a strong knowledge of method development and method validation. Expertise in various biological matrices required. Strong communication skills and experience with regulatory/agency interactions (FDA and other) desired.

Job Responsibilities:

 Hands on responsibility of managing and performing bioanalytical projects as a priority and performing support analytical services for Pharma services:

  •  Responsible for executing bianalytical testing protocol for specific projects. Supporting toxicology/pharmacology studies leading to product registration (FDA, ICH, ISO, Japanese and others). Including, dose verification, stability, characterization, PK/TK and other assays.
  •  Authoring and revising all relevant bioanalytical SOPs.
  •  Assist/manage technical site visits of the department related to assigned projects and assist QAU and Regulatory Affairs with all vendor/regulatory audits.
  •  Maintain and monitor schedule of performance, flow of information and reporting of studies. Ensure reports are timely and all special requirements are met.
  •  Interact with the daily scheduling, forecasting and needs for the laboratory/department.
  •  Assist the clients and sales staff with quotation preparation and project budgeting/pricing, wherever required.
  •  Maintain the lab accreditation and registrations, wherever applicable. Responsible for the selected studies and documentation requirements for the labs.
  •  Instrument maintenance and performance, including IQ, OQ, PQ, and IQ, PV oversight.
  •  Manage day-to-day activities of the studies and interacting with clients on technical issues.
  •  Manage work assignments of the Research Associates, including their work schedules, reporting schedules and technical performance/record keeping.
  •  Maintain conformance with Toxikon’s quality mission statement, goals and values. Enforce and maintain compliance with ISO 17025 certification through the laboratories and operations.

 

For additional information about Toxikon, please view our website at www.toxikon.com

In order to submit your resume, please reply to this posting with the position in the subject line. Please also include salary requirement in your email.

Human Resources
Toxikon Corporation
15 Wiggins Avenue
Bedford, MA 01730
Email:  hr@toxikon.com

 

Toxikon employs 160 people and offers a generous benefit program including health, dental, fsa, std, ltd, life insurance and matching 401K plan. Toxikon is an EOE.

Sales Manager

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Sales Manager

Toxikon is seeking an experienced Sales Manager. 

 This position will be responsible for directing, and monitoring Toxikon's internal and external sales force in order to achieve annual projections and new business development.  Expectations are to expand existing accounts and focus on generation of new accounts in order to meet and/or exceed sales goals. 

 The Sales Manager will lead, manage, and support the remote and local sales staff by visiting key customers, organizing information and attending trade shows and conferences, and presenting (or arranging for others) at shows.  Will set goals and evaluate the performance of sales personnel, determine their objectives, and formulate and monitor activity plans.  Other aspects are advising sales staff of service costs and bids, closing deals and making presentations to customers and their senior management while acting as a liaison between sales personnel and study directors and/ or senior management at Toxikon. Other responsibilities include management of market focus, sales strategy, client communications, sales productivity, sales and technical training, promotion, salary, and bonus considerations.  

 The Sales Manager will be responsible for reviewing and approving costs associated with the Sales department.  Summary reports based on this data will be issued to management and related parties.  Provide reports to senior management relative to sales efforts on a monthly, quarterly, and yearly basis to include targets, growth, and future goals and costs. 

 The Sales Manager will assist in developing new sales strategies and fostering existing strategies in current markets in order to achieve sales goals.  Develop strong relationships between Toxikon and its clients by promoting positive communications between clients, the sales force, and the laboratories.

 Qualifications: This position requires a strong understanding of the testing and service industry, including regulatory agencies, as well as the ability to converse with clients on testing & service needs (for pharmaceutical and medical device companies), prior CRO and/or lab experience essential. 5-10 years of experience managing sales staff with the proven ability to generate new accounts and account revenues of $5-10 million. Must be self-motivated, with excellent communication, presentation, organizational, and mentor skills. The candidate should have a B.A., B.S in a life science, and a strong understanding of the life science industry. Position is based out of Bedford, MA with travel up to 50%.

For additional information about Toxikon, please view our website at www.toxikon.com.

Toxikon employs 160 people and offers a generous benefit program including health, dental, fsa, std, ltd, life insurance and matching 401K plan. Toxikon is an EOE.

Manufacturing Engineer (Greater Boston)

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Our client is a fast growth global medical device leader. This is a great opportunity if you are seeking to join a highly innovative and financially solid industry leader that promises excellent career growth and challenging leadership opportunities!

Responsibilities

  • Manage NPI production requirements as the manufacturing representative.
  • Participate in cross functional design reviews, validation processes and lead transition activities from Dev to Ops Engineering lead for semi-automated systems used in production.
  • Lead software and hardware improvement initiatives.
  • Provide technical support to these processes. Lead manufacturing hardware, software and system changes (ECOs) following ISO 13485 and FDA GMP standards.
  • Implement these changes together with the production technician teams.
  • Engineering lead for managing and documenting all manufacturing specifications, product configurations, BOMs, drawings, etc.
  • Devise methods to utilize and control this information for factory automation.
  • Draft work instructions as needed.
  • Support Lean manufacturing improvement and 5S activities.
  • Work closely with production teams to identify opportunities through root cause analysis.
  • Contribute to implementation strategies to increase throughput, capacity and yields.
  • Collaborate with global manufacturing teams to maintain production harmonization.
  • Occasional international travel necessary.
  • Safety, Health and Environment representative for Operations.
  • Provide manufacturing support and other duties as necessary.

Requirements:

  • 3-5 years of experience in mechanical, manufacturing, or industrial engineering roles with strong mechanical design and testing/prototyping experience.
  • Solidworks or Pro/E experience a plus. Experienced cross functional project management experience in providing structure, direction and decisions for your team.
  • Strong analytical experience using data to drive actions.
  • Exceptional verbal and written communication in English.
  • An accredited degree in mechanical, manufacturing or industrial engineering.

Preferences:

  • Experience using machine automation, CNC equipment, electronic workflow systems and software solutions to simplify tasks, manage work flow and improve performance.
  • Experience with using optical measurement systems, its calibration, setup and maintenance.
  • Experience using Lean & six sigma tools. Green or Black belt a plus
  • Experience using CAD & CAM software systems and electronic workflow control systems. 
  • Familiarity with process equipment integration and automation with database systems. 
  • Experience working in a regulated manufacturing environment adhering to relevant standards. 

Please submit resume to: careers@biomedicalsearch.com

For more information, please visit www.biomedicalsearch.com

Global Development Project Manager

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EMD Serono is the biopharmaceutical division of Merck KGaA, Darmstadt, Germany, a global pharmaceutical and chemical group. We strive to create value and benefit patients by transforming medical science into breakthrough solutions in our core therapeutic areas of neurodegenerative diseases, fertility and metabolic endocrinology, as well as oncology and autoimmune/inflammatory diseases as emerging areas of expertise.

KEY ACCOUNTABILITIES

  • Actively manage one or more late stage global drug development projects.
  • Provide the global cross-functional project team with project management and drug development expertise and coach and mentor project team members in fulfilling their tasks efficiently.
  • Ensure the compliance of the project team with applicable legal and regulatory requirements on a global level.
  • Ensure proper identification and management of project risks and their report to the respective governance body (DOC or GOC).
  • Evaluate alternative development scenarios, comprising costs, timelines, risks, and project valuation of the different options, before approval of the project strategy by the respective governance body (DOC/GOC).
  • Establish and maintain a project plan (with meaningful timelines and check points, logical links between activities, internal/external resources, and assumptions) that depicts the activities in line with the approved global development strategy and the input from the respective line functions.
  • Get this project plan (timelines, costs, internal resources, deliverables, milestones) approved by the appropriate governance body (DOC or GOC) (to set a baseline at a decision point) and ensure its regular update with new information from the various functions contributing to project delivery.
  • Track and forecast tasks, budget and project timelines and provide team with early warnings on possible variances.
  • Communicate significant variances to the respective governance body and obtain approval for necessary amendments to the project plans (as outlined in the corresponding governance rules).
  • Organize efficient information flow within the project team, which can be spread across various R&D hubs/countries and comprises representatives of various R&D functions.
  • Coordinate within the global project team the preparation and update of key project documents (TPP, TPC, IGDP, etc.).
  • Schedule project team meetings and develop meeting agendas. Lead project team meetings for routine operations, take minutes and ensure follow-up of action items from the minutes. Prepare presentations as needed.
  • Co-lead Project Team Meetings defining the strategic project direction together with the respective program lead.
  • In alignment with the program lead manage the internal (top management) and external (investors, scientific community) project reporting and communication.
  • Support the program lead in defining the program strategy, stakeholder management and overall program leadership topics.
  • Ensure seamless transition of project(s) to the LCM phase at completion of development phase.

FINANCIAL DIMENSION

  • Manage the global cross-functional project budget (overall 80-400 M€, annual budget 20-100 M€).
  • Responsible for a cost-effective approach to all development plan activities.

STRATEGIC IMPACT

  • The GDM-PROJECT MANAGER is responsible for the operational conduct of one or more drug development projects on a global level.
  • The GDM-PROJECT MANAGER leads the respective cross-functional project teams in close interaction with the respective program lead who is responsible for the strategic direction and overall program leadership.
  • The GDM-PROJECT MANAGER is the key contact on a project level both for internal partners as well as, in the case of co-development projects, for the respective counterparts in the other company.
  • The GDM-PROJECT MANAGER is a member of the core team for the drug development program and reports functionally to the respective program lead.
  • The GDM-PROJECT MANAGER oversees the respective functional sub-teams of the global cross-functional project teams and supports and directs the sub-team leads to achieve timely completion of their respective work packages.
  • The GDM-PROJECT MANAGER is responsible for the budget and overall timelines and deliverables of the respective global drug development project.
  • The GDM-PROJECT MANAGER ensures appropriate risk management and issue resolution on the project level.
  • The GDM-PROJECT MANAGER is responsible for timely reporting of the project status to the program lead and in the relevant reporting systems.
  • coudl The GDM-PROJECT MANAGER provides the project management expertise and leadership to enable efficient development of new drugs with the respective project teams and in line with global industry benchmark data for timelines, costs and quality.
  • The GDM-PROJECT MANAGER provides input into the improvement of where project management principles within GDM and Merck Serono.
  • The GDM-PROJECT MANAGER provides key learnings and best practices from the project teams into the organization to increase efficiency of drug development.

SCOPE OF PEOPLE RESPONSIBILITY

  • Managing an interdisciplinary global project team without direct reporting lines.
  • Together with program lead responsible for project objectives setting and performance review of team members (providing input into the HR performance management process for the team members).

COOPERATION

Internally:

  • All L2 functions in R&D
  • All development functions in Technical Operations
  • Global and local R&D controlling
  • Legal, Patent, Communications, etc.

Externally:

  • Partner Companies in co-development projects
  • External consultants for the respective projects

Qualifications

EDUCATION

  • Masters' degree in a scientific discipline (Ph.D. is a plus) and/or in an economic discipline with significant previous experience in the life sciences.
  • Highly developed written and verbal communications skills in English

WORK EXPERIENCE

  • 5 years experience in R&D and/or drug development in the pharmaceutical industry with ideally project management certification by a recognized project management organization (e.g. PMI, IPMA).
  • Previous working experience in cross-functional and international teams, ideally in global drug development teams.
  • Cross-functional knowledge of the Drug Development Process and Drug Development Regulations.
  • Knowledge of and /or experience in project management, spreadsheet and database management software is desirable.
  • Good understanding of finance and accounting principles in an industrial setting.
  • Experience in financial valuations of projects, decision making, and scenario thinking.

JOB-SPECIFIC COMPETENCIES & SKILLS

  • Excellent interpersonal skills in a multi-cultural environment
  • Clear leadership skills
  • Excellent project management skills
  • Strong scientific knowledge of drug development
  • Excellent problem solving and analytical skills
  • Strategic thinking skills
  • Excellent organizational skills
  • Strong communication and influence management skills
  • Facilitation skills
  • Position requires both domestic and international travel up to 20% of time.

Medical Director, US Product Surveillance

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EMD Serono is the biopharmaceutical division of Merck KGaA, Darmstadt, Germany, a global pharmaceutical and chemical group. We strive to create value and benefit patients by transforming medical science into breakthrough solutions in our core therapeutic areas of neurodegenerative diseases, fertility and metabolic endocrinology, as well as oncology and autoimmune/inflammatory diseases as emerging areas of expertise.

PURPOSE OF THE ROLE

  • To provide medical management and leadership for processing and analyzing safety reports. Responsible for the overall safety assessment, pharmacovigilance activities, risk management (IRMA, I RMETTA), label review, ad hoc reports and regulatory reporting activities for marketed products. Provide an oversight medical review of adverse event reports.
  • Provide leadership and monitor the medical staff and assist in maintaining high level adherence to the department SOP's,
  • WI's and compliance with regulatory submission requirements.

MAIN INTERFACES

INTERNALLY:

  • Senior Medical Director USPS, Associate Medical Directors and other USPS and GDS staff, call centers, Head of Medical.
  • Affairs, Regulatory Affairs, CMO, Marketing and Sales, Quality Assurance, Medical Information. CD Organization.

EXTERNALLY:

  • Co-promoter safety representative. Health care professionals. Customers (i.e., patients). Regulatory Authorities.

KEY TASKS & RESPONSI BILITIES

ACCOUNTABILITIES:

Accountable to Senior Medical Director USPS.

  • Responsible for implementing and managing functions and tools to achieve the USPS goals:
  • Provides and monitors for accurate and consistent medical assessment of adverse event reports according to USPS and company SOP's and in compliance with the regulatory requirements.
  • Monitors for seriousness, expectedness and reportability assessment of adverse events using prescribing information and conventions developed by the global medical team (MMM) to meet regulatory requirements.
  • Identifies necessary data collection for follow-up for serious and/or medically significant reports.
  • Reviews adverse events coding in MedORA, and maintain consistency with the coding convention.
  • Communicates with health professionals regard i ng safety issues.
  • Develops writi ng standard for narratives, letters, and replies.
  • Develop training modules and train USPS medical staff.
  • Processes and/or assigns CIOMS, foreign and adverse event reports in the US Clinical Trials workflow, training all USPS staff in the medical assessor and reporter roles in ARlSg.
  • Assures compliance in processing and transmitting the reports to GDS according to the department SOP's, Wl 's, and regulatory authorities regulations and guidance (i.e., FDA, EMEA, ICH,).
  • Develops written materials for the systematic investigation of adverse events including letters, data collection forms, and requests for medical information.

Provide leadership in the areas of pharmacovigilance and safety for all Company products, including:

  1. Collect, review, process, sign-off and analyze safety data
  2. Monitor data to identify safety signals, and alert management to significant trends and patterns
  3. Provide product safety knowledge
  4. Provide oversight of audits (internal and external)
  5. Provide safety summaries and reviews for risk management activities
  6. Revise SOP's and work instructions to improve the quality and efficiency of processing adverse event reports
  7. Collaborate with GDS staff to ensure a consistent global approach to safety reporting
  8. Develop periodic reports, PSUR 's, and other ad hoc reports
  • Active participation on appropriate teams, risk management, formulating action or implementation plans, and provide expertise on safety data analysis and signal detection.

Assist in staff development through:

  1. Communication of information from internal and external sources
  2. Collaboration in development of departmental training program
  3. Ad hoc "case review", planning presentation by thought leader (internal and external)
  4. Provide training on new product information/package insert revisions
  5. Liaise between USPS and Company call centers, assure a good data collection
  6. Foster a standard of excellence within the department
  7. Oversee validated safety or other database for the collection and storage of the safety data
  • Supervises and manages the medical staff
  • Recruits, hires, and trains qualified medical staff
  • Conducts performance appraisals, coach's staff and recommends compensation and awards. Ensures staff is properly trained

Qualifications

Minimum requirements:

  • Medical Degree.
  • Minimum of five years of experience in drug safety and pharmacovigilance in the pharmaceutical or biotech industry and at least one year of supervisory experience.

Preferred degree of experience

  • Demonstrated management skills.
  • Good organizational, leadership, written and verbal communication skills.
  • Demonstrated sound medical opinion and comprehensive understanding of products label and core safety index.

Professional Competence

  • Fluency in English.
  • Additional languages are a plus.
  • Detailed knowledge of FDA and global regulatory authorities (i.e., ICH, EMEA) regulations in drug safety and pharmacovigilance practices.

Skills & Abilities

  • Experience with safety database
  • Ability to retrieve, analyze and present safety data
  • Commitment to ethics and regulatory standards.
  • Convincing and effective communicator.
  • Ability to work in a fast paced environment, multi-tasking and prioritizing.

Senior Process Engineer - Biologics

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Our client is looking for an experienced Process Engineer to provide technical and troubleshooting support for manufacturing activities, support evaluation and RFP process for selection of Contract Manufacturing Organizations (CMOs) as well as support technology transfer activities in conjunction with contract manufacturers.  You will play a key role in representing the company at CMO facilities.  Additionally you will assist in troubleshooting process and equipment-related issues, facilitate communication between Company and CMO to ensure rapid and correct decision-making and agreement on procedures and activities to be carried out, support technology transfer activities, as well as review and comment on technical documents related to production, testing, facility and equipment validation status.

This position requires a MS degree with a minimum of 8 years relevant industry experience. Additional requirements include: experience with biologics manufacturing operations and familiarity with equipment; experience in biologics process development and manufacturing; experience with various upstream and downstream process technologies; a solid understanding of CMC compliance requirements and quality systems in a GMP manufacturing setting; experience with early stage biopharmaceutical process development.

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.

StratAcuity, CHEMISTRY IS EVERYTHING.

 

Clinical Lab Technologist - Histology

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Summary

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.

Foundation Medicine is seeking a talented and highly motivated Clinical Laboratory Technologist (Histology) to perform routine testing in a high complexity clinical diagnostic laboratory.

Primary Responsibilities and Essential Duties

  • Maintain, proper assay documentation including proper specimen handling, labeling and preparation of worksheets. 
  • Ensure full regulatory compliance, providing test results with the best possible quality. 
  • Maintain adequate stock and efficient use of supplies necessary for performing all procedures, and preparation of reagents as required. 
  • Apply knowledge of good laboratory practice on a daily basis. 
  • Accession clinical and research study patient samples into the Foundation Medicine LIMS.
  • Operate a microtome or cryostat to produce slides or curls from FFPE blocks.
  • Perform H&E staining with possible other histological staining methods introduced over time.
  • Perform routine Pathology including scanning of H&E stained slides with the Aperio ScanScope, measuring tissue dimensions and recording all data in the FMI LIMS.
  • Prepare and initiate samples for overnight digestion.
  • Perform QC where required.
  • Perform the assigned tests or components of the test in accordance with assay run schedule, always in compliance with written SOPs. 
  • Score, record, and provide patient assay runs to lab directors or supervisors accurately and within TAT. 
  • Participate in biohazard, chemical, and radiation safety and other continuing education programs. 
  • Perform miscellaneous duties as assigned.

Education and Required Experience

  •  Minimum BS in a Biological Science (ASCP certified Medical Technologist would be an advantage).
  • Working knowledge of histological techniques. Operation of a microtome is essential.
  • At least 2 years working with human FFPE tissue, in CLIA laboratory clinical diagnostics setting.

Sr./Scientist Bioassay & Impurity Testing

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Org Marketing Statement  

All over the world, Pfizer colleagues are working together to positively impact health for everyone, everywhere. Each position at Pfizer touches and contributes to the success of our business and our world. That's why, as one of the global leaders in the biopharmaceutical industry, Pfizer is committed to seeking out inspired new talent who share our core values and mission of making the world a healthier place.

This position is based in our Andover, MA site.

Responsibilities:  
The Scientist/Senior Scientist (R3/R4) position within the Bioassay and Impurity Testing Group is responsible for the development of SPR-based methods to assess protein-protein interactions. The methods may be used for release and stability testing, process development, and characterization for a range of biological candidates in clinical development. The successful candidate will have a thorough understanding & knowledge of the development of SPR assays, immunoassays, and experience utilizing novel technologies and approaches to study protein-protein interactions.
Experience in the following would be advantageous: impurity testing, cell-based assay development; structure-function analysis; monoclonal antibody, conjugates, and vaccine development. Prior experience in assay development and validation is highly desirable, as well as any experience working in cGMP environment. Excellent writing skills, and the ability to document and communicate results to a wide array of scientists and management will be critical. Ability to multitask while working with multiple people in a team-based environment is a requirement.

Qualifications:  
1. EDUCATIONAL BACKGROUND:
MINIMUM:
- B.S./M.S. in Biology, Microbiology, Cell Biology, Biochemistry or equivalent

2. WORK EXPERIENCE/SKILLS:
MINIMUM:
- Lab experience, SPR and/or immunoassay development

DESIRABLE:
Four (4) years industrial experience.

OTHER ATTRIBUTES DESIRABLE:
• Knowledge of cell culture and cell physiology.
• Automation and computer programming
• Background in immunology and understanding of immunotherapeutic approaches to treat disease.
• Familiarity with molecular biology (qPCR)
• Experience with oligopeptides and oligonulecotides, and assays used to test their potency.
• Familiarity with protein characterization analytical techniques.
• Knowledge of GLP/GMP practices
• Awareness of recent scientific literature.
• Application of statistical analysis for data modeling and interpretation.

To apply for this position, pleaseCLICK HERE

Postdoctoral Associate - Electrophysiology

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The successful candidate will work directly with a group in the Stanley Center for Psychiatric Research to develop and apply methods to characterize the biophysics of ion channels that harbor genetic variations associated with psychiatric disorders. The research will also involve using genome-editing techniques to modify ion channels’ genes and study the functional consequences of such genomic manipulation in different cellular contexts. The researcher will be responsible for communicating results to the scientific community through conference presentations and publications, and through the Broad Institute website. Experience with genomics desired.

CHARACTERISTIC DUTIES
• Develop and implement electrophysiological protocols and assays to understand functional genetic variation
• Interact and coordinate with collaborators as required.
• Publish scholarly reports and present at scientific conferences
• Participate within a team of scientists to foster a culture of scientific discourse and excellence
• Other related tasks as need.
• Ph.D. (0-1 years post-grad) in Neuroscience, Cell biology or related field. Proficient in electrophysiological techniques including patch clamp. Experience with tissue culture is required.
• A quantitative background, such as in ion channel kinetic modeling, is strongly desired.
• Must have outstanding personal initiative and communication skills.
• Must be able to work well on a team.
• A minimum two-year commitment

To apply for this position, please CLICK HERE

Post Doctoral Associate

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ABOUT THE BROAD:
Our research teams are working on redefining the boundaries of science and medicine with an interdisciplinary model designed to meet today’s most critical biomedical challenges. Here you will find a supportive and collaborative intellectual environment and a firm commitment to continuously invest in cutting edge technology. At the Broad we are developing the new tools that will enable scientists to begin unlocking the mysteries of genomics.

OVERALL RESPONSIBILITY
The primary role involves designing and synthesizing stereochemically-rich molecules for disrupting protein-protein interactions, with a stated commitment to developing transformative strategies for this “undruggable” therapeutic class. The successful candidate will work collaboratively within an agile team of synthetic chemists committed to tackling multiple hit and lead optimization strategies in parallel, with the shared goal of identifying suitable candidate(s) for eventual clinical proof-of-concept. This position reports directly to the Director of Medicinal Chemistry.

ESSENTIAL FUNCTIONS

• Design and synthesize high-value targets for biological testing, developing robust chemistry that yields high purity molecules.
• Evaluate and interpret SAR across multiple optimization parameters, developing strong rationale for subsequent iterations of design/synthesize/test.
• Contribute to HTS triaging efforts, including in silico analysis of hit clusters and striking proper balance of archive/wet chemistry follow-up
• Gain hands-on experience with fragment-based screening approaches (i.e. differential scanning fluorimetry, calorimetry, NMR, etc.) and champion next-generation fragment strategies.
• Build productive collaborations across diverse scientific disciplines, especially in context of project core team.
• Maintain high standards of laboratory safety and record keeping.
• Effectively communicate results in oral and written form, including publication in peer-reviewed journals.
• PhD degree in chemistry or chemical biology with an emphasis in synthetic organic chemistry.
• An ability to work independently and effectively in a matrix environment, coupled with a “whatever it takes” approach to move projects forward.
• Effective written/oral communication skills and a proven track record of problem-solving and publication.
• An ability to rigorously analyze large datasets and strong organizational/record keeping skills.

To apply for this position, please CLICK HERE

Temp. Admin. Associate III

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Temp. Contract, 1 month


The Administrative Associate plays an important role in ensuring the effective and efficient maintenance of departmental processes, procedures and programs. This role provides administrative support to the leadership (Director level and above) of the Commercial Operations team inclusive of travel arrangements, scheduling, vendor meetings and expenses. This position will report to the Vice President of Commercial Operations and support the Directors of Field Training, Field Services, Field Planning, Marketing Operations and Commercial Strategy teams.

Job Responsibilities:
- Provide logistical planning and administrative support for assigned teams (e.g. travel, expenses, scheduling, catering, document production)
- Serve as departmental liaison with outside vendors to complete the necessary contracts and provide logistical meeting support
- Ensure timely processing of group purchase orders, invoices and contracts
- Assist in the management of the budgeting and contracting processes
- Prepare agendas and meeting notes for various cross functional launch team meetings
- Work with Human Resources, Commercial departments, and other administrative associates to facilitate interview schedules, large team meetings, and outside vendor meetings
- Document and maintain group processes, procedures and programs relating to contracts and employee on-boarding
- Produces, formats and edits department deliverables such as presentations, policies, reference materials, and other related documents
- Participate in ad hoc projects as needed

Minimum Qualifications
- Bachelor’s degree with 3+ years of work experience

Preferred Qualifications

- Proven ability to successfully implement multiple projects
- Ability to clearly present project status and outline processes in oral and written formats
- Detail orientated with ability to communicate conflicts in scheduling/priorities
- Team player able to develop rapport and credibility with team members
- Familiarity with the biotech/pharmaceutical industry

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

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


To Apply for this position, please CLICK HERE

Associate Scientist, Cell Biology

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Excelimmune, Inc. is a biotech start-up based in Woburn, MA, focused on discovery and development of sets of human recombinant antibodies to target infectious disease. These sets of antibodies mimic the natural polyclonal antibody response, thus enabling multiple antigens to be targeted simultaneously. Excelimmune’s human recombinant polyclonal antibodies (HRPAs) are designed to treat diseases where monoclonal antibody approaches have failed or are not suitable. We are looking for hard-working, creative, and collaborative individuals, who are ready to contribute toward achieving our goals.

Qualifications

The applicant must have a BA or BS in life sciences or a related discipline, with 3+ years of relevant laboratory experience beyond coursework or a MA or MS with 1+ years of relevant laboratory experience beyond coursework. The candidate must be detail-oriented, reliable, highly motivated to thrive in a fast-paced work environment, and have excellent oral and written communication skills.

Success factors

Successful candidates want to make a difference in the world and work in a dynamic, exciting start-up environment where they can make a major contribution.

Responsibilities

Reporting to a PhD-level Scientist, the primary responsibility of the Associate Scientist will be to assist with the development of cell culture processes for the production of recombinant antibodies. This individual will help design, execute, and analyze mammalian tissue culture experiments. They will be required to perform activities in accordance with Good Laboratory Practices, maintain notebooks and electronic files associated with each experiment, and prepare experimental reports and presentations. This position requires working collaboratively with other team members to accomplish project goals and milestones. The ideal candidate must be able to take direction, as well as independently organizing and executing research projects.

Requirements

Basic Requirements:
The ideal candidate will have extensive hands-on experience with:

• Mammalian cell culture, including adherent and suspension cells.
• Gene delivery technologies, including transient transfections and/or retroviral transductions
• Generation and clonal selection of stable cell lines.
• Assay development and optimization

Desired Skills:
Applicant has an experience with:

• Optimization of recombinant protein expression
• Viral isolation and viral titer assays
• Analytical FACS
• QPCR
• Familiarity with liquid handlers
• Familiarity with batch, fed batch and perfusion bioreactor technology would be a plus.

How to Apply

Please send resume and cover letter to: jobs@excelimmune.com with AS-CellBio in the subject line of your email. Principals only; no recruiters.
Excelimmune, Inc. is an equal opportunity employer offering a competitive salary and benefits package including a 401(k) retirement plan and professional development in an open, growing, and supportive work environment. All applicants should be legally entitled to work for any employer in the US.

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