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Career postings for the Massachusetts Biotechnology Council

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

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

    Role Description
    This position will provide support for the Validation Program and Validation projects at Pfizer Andover site.
    The Validation Scientist / Validation Engineer is expected to utilize their own subject matter expertise (SME), as well as collaborate with other site validation SMEs, to define, standardize and support the validation programs and procedures in compliance with corporate, regulatory, and industry standards and regulations.
    The incumbent in this position will be responsible for supporting and implementing the established validation approach and is accountable for supporting the site's successful adherence to the Validation Master Plan, Validation SOP's, and the integration of the Master Plan with the Strategic Planning Process.
    The incumbent will be expected to partner with the SME's of the site Quality Assurance Validation group to ensure all validation strategies and validation executions meet all applicable Pfizer quality and compliance standards, local SOP's, as well as applicable regulatory standards. The incumbent will be responsible for providing Validation supporting during regulatory inspections. The incumbent will support the development, implementation and maintenance of system(s) for tracking and measuring validation status, resource utilization and effectiveness.
    The Validation Scientist / Validation Engineer will also be responsible for supporting the development the next generation validation program.

    Responsibilities
    * This position will provide support to the Cleaning/Disinfectant validation, Sterilization validation, Equipment validation, Instrumentation validation and Shipping validation.
    * Foster a Quality and Compliance culture for the validation program
    * Support the validation program and procedural changes that enhance safety, compliance, and overall operational efficiency.
    * Continuously evaluate and identify opportunities for improvement in existing validation programs and procedures.
    * Support on site governance team that oversee or impact validation program and procedures.
    * Accountable for the quality and robustness of validation program and procedure design.
    * Represent validation program during audits and inspections

    Qualifications
    The position requires BS engineering or science with 5+ years of experience in the area of validation activities supporting manufacturing and development operating in regulated environment. Candidate is required to be experienced with Pharmaceutical Validation requirements (CFR 211, ICH, Annex 15) and or Medical Device Validation requirements (CFR 811)
    Experience also required, background in problem solving, negotiations, project management/support in a matrixed reporting environment. Six Sigma certification or background is preferred.

    EEO & Employment Eligibility
    Pfizer is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status. Pfizer also complies with all applicable national, state and local laws governing nondiscrimination in employment as well as work authorization and employment eligibility verification requirements of the Immigration and Nationality Act and IRCA. Pfizer is an E-Verify employer.

    Please apply at: Application URL:http://www.aplitrak.com/?adid=SmltLlRhdm9saWVyaS40NjExOS4zMTY3QHBmaXplci5hcGxpdHJhay5jb20


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

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

    Role Description
    * Responsible for the development of robust and reliable ligand binding and /or cell-based assays suitable for characterizing the disposition and immunogenicity of biotherapeutics in various matrixes using a range of potential screening platforms and assay techniques.
    * Responsible for the design, trouble shooting, validation and conduct of the assay to support biotherapeutic programs.
    * Timely delivery of concentration and immunogenicity data to PDM BioTX principal investigators and other partners in compliance with local or global regulatory requirement.
    * Advancing bioanalytical capabilities to improve efficiency, cost effectiveness and appropriateness of assay for regulated support.
    * Development and validation of assays to be governed per departmental SOP.
    * Accurate execution and documentation of bioanalytical method in a regulatory compliant manner.
    * Ensure GLP compliance is maintained in laboratory during study support.

    Responsibilities
    * Design, develop and implement ligand binding assays (e.g. ELISA, ECL detection) to measure compound concentration, detect the presence of anti-drug antibody and neutralizing anti-product antibody activity in a regulated (GLP, GCP) environment.
    * Participate in the design, development and implementation of cell-based assays.
    * Perform data analysis and interpretation and be able to draw conclusions regarding progress and results of work, utilizing the data in appropriate decision making.
    * Gathers input from colleagues, literature, and additional resources to assist in driving the project forward. Knowledge and hands-on experience developing ligand binding assays, utilizing various platforms.

    Qualifications
    * BSc with at least 5+ years relevant GLP/GCP laboratory experience, with a focus on ligand binding assay development, cell-based assay experience; MSc with at least 2+ years relevant GLP/GCP laboratory experience with a focus on ligand binding assay development, cell-based assay experience.
    * Industry experience with a focus in biotherapeutics and a strong record of scientific achievement; excellent communication skills.
    * Proven track record in the area of biotherapeutics bioanalysis with understanding of a broad range of bioanalytical platforms.
    * Skills in GLP/GCP complient analysis including following SOP and provision of quality regulatory documents.
    * Excellent communication and presentation skills

    Technical Skill Requirements
    * Knowledge and hands-on experience developing ligand binding assays, utilizing various platforms.
    * Knowledge and hands on experience working under GLP/GCP regulations
    * Some knowledge and experience working with mammalian cells.
    * Broad understanding and skill in areas of bioanalytical laboratory techniques for biotherapeutics.
    * Proven experience generating analytical data in a regulated environment
    * Proven analytical problem solving skill.
    * Proven ability to generate high quality data against challenging time lines
    * Ability to communicate across site and discipline to enable maximum impact of bioanalytical science.
    * Knowledge of biotherapeutic structure, pharmacology, disposition and immunogenicity and the impact on assay selection.
    * Ability to author technical documents like SOPs, data summary reports and analytical procedures.
    * Collaborative skills and effective partnering skills in a complex, multi-discipline organizational model.

    EEO & Employment Eligibility
    Pfizer is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status. Pfizer also complies with all applicable national, state and local laws governing nondiscrimination in employment as well as work authorization and employment eligibility verification requirements of the Immigration and Nationality Act and IRCA. Pfizer is an E-Verify employer.

    Please apply at: Application URL:http://www.aplitrak.com/?adid=TWVnYW4uSGFycmlnYW4uNjg1MDcuMzE2N0BwZml6ZXIuYXBsaXRyYWsuY29t


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

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

    Role Description
    Performs administrative duties for executive management including providing senior level administrative support to the Senior Vice President (SVP), Head of PharmaTherpeutics Clinical Research & Development Head. Will be responsible for calendar management, meeting coordination, meeting preparation and travel planning for senior leaders.

    Interfaces regularly with department members as well as colleagues from related functions and will be expected to interact appropriately with scientists, academic collaborators, vendors and all visitors. Requires learning and execution of internal procedures of Pfizer, ensuring 100% adherence to compliance regulations. Exemplary organizational skills, strong computer and internet skills, flexibility, excellent interpersonal skills, project coordination experience, and the ability to work well with all levels of internal management and staff are critical for success in this role.

    Requires seamless partnership with other administrative staff members in a professional and team oriented approach and will contribute to and/or lead selected business operations functions and initiatives for the RU. Sensitivity to confidential matters required. The role is based in Cambridge, MA.

    Responsibilities
    * Manage day-to-day operational and administrative duties to support the SVP, Head of PTx Clinical R&D.
    * Coordinate and proactively manage hectic calendars and meeting schedules, using prioritization skills and a high level of interpersonal refinement
    * Plan and optimize all travel plans for the Head of PTx Clinical R&D and selected functional groups within the department, as needed
    * Coordinate logistics and materials for meetings and presentations including offsite and all hands meetings
    * Collation of information (agendas, pre-read material etc) in advance of meetings
    * Prepare reports by collecting and analyzing information.
    * Gain a thorough understanding of all corporate goals, policies, personnel, processes and procedures and incorporate in RU business and administrative processes.
    * Proactively identify or anticipate issues and use judgment to expeditiously resolve all issues including the most urgent
    * Review and process expense reports and invoices.
    * Interview scheduling as required including liaison with interviewers, HR, candidates plus associated activities (travel, room bookings, processing expenses, etc).
    * Contribute ideas toward new administrative procedures to enhance effectiveness of self and others within the department.
    * Support other administrative or contracted staff in the fulfillment of their job duties.
    * Maintain professional knowledge base and seek opportunities to enhance skills and abilities; seek new areas of responsibility and perform new tasks; recommend process improvements.
    * Handle all duties with a high degree of integrity, professionalism and confidentiality.
    * Demonstrate commitment to providing customer-focused quality service.
    * Contribute to positive group dynamics and public relations by developing professional relationships with internal stakeholders and external visitors.
    * Assist and perform ad hoc duties for members of the executive team, as necessary.
    * Able to work flexible hours and to be accessible after hours, as needed.

    Qualifications
    Training & Education:
    * Qualified candidates will have a minimum of a high school diploma or equivalent and 7-10 years administrative experience that demonstrates ability to carry out tasks proficiently and to complete quality work on a timely basis; excellent attention to detail.
    * College degree strongly preferred with a minimum of 5 year work experience.
    * Experience as an administrative assistant or project manager required.
    * Preferred C-level executive support experience.
    * A healthcare background is beneficial.
    * Demonstrated proficiency in assigned technologies.
    * Excellent communication, interpersonal and influencing skills at a global, cross-line level.
    * A strong sense of personal integrity; able to maintain confidentiality and handle highly sensitive information; demonstrated good judgment and decision-making skills.
    * Demonstrated success supporting large and complex projects.
    * Demonstrated ability to transform collections of ideas into finished products and to manage a wide variety of activities while accounting for changing priorities.
    * Experience within the pharmaceutical research and development industry preferred, along with understanding of the drug discovery environment and scientific disciplines.

    Technical Skills Requirement
    * Superior attention to detail and able to multi-task and change priorities quickly
    * Strong sense of urgency and efficiency in completing work
    * Exemplary time management and prioritization skills
    * Must be able to maintain composure under pressure and manage unforeseen situations
    * Excellent judgment, problem resolution and decision-making skill
    * Excellent communication skills (verbal and written)
    * Ability to identify, propose and develop new solutions to further the effectiveness of the Clinical group
    * Excellent organizational skills with the ability to plan and execute projects
    * Work autonomously and thrive in a fast-paced environment.

    Desired
    * Evidence of desire for excellence and striving for constant improvement
    * Displays personal leadership to ensure success
    * Proactively identifies opportunities for development of self
    * Knowledge of the tools and processes used to develop the appropriate resources to support exploratory research
    * Proven track record of leading and delivering on multiple projects in parallel
    * SharePoint; Microsoft Outlook, Excel, Word, PowerPoint, Project

    PHYSICAL/MENTAL REQUIREMENTS
    Ability to work on a computer and to conduct phone conversations

    EEO & Employment Eligibility
    Pfizer is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status. Pfizer also complies with all applicable national, state and local laws governing nondiscrimination in employment as well as work authorization and employment eligibility verification requirements of the Immigration and Nationality Act and IRCA. Pfizer is an E-Verify employer.


    Please apply at: Application URL:http://www.aplitrak.com/?adid=ZWRkeS5uaWNvbGFzLjQ0ODExLjMxNjdAcGZpemVyLmFwbGl0cmFrLmNvbQ


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    Summary

    Assists in visually inspecting, labeling and packaging pharmaceutical products

    Responsibilities and Tasks

    • Assists in performing visual inspections, labeling, and packaging of liquids, suspensions, and lyophilized pharmaceutical products in vials
    • Assists in entering batch documentation into computer system
    • Cleans up labeling and packaging assembly operations
    • Complies with all policies and procedures related to personal safety and job area safety
    • Maintains manufacturing records and completes all required paperwork/documents to comply with Federal Regulations and FDA
    • Reports variance or deviations from standard procedures to department management
    • Stocks materials utilized by the department

     Knowledge Skills and Abilities

    • Familiarity with, and the ability to follow established Standard Operating Procedures (SOPs), Master Batch Records, and adhere consistently to current Good Manufacturing Practices (cGMPs)
    • Works under direct guidance of the supervisor or lead technician
    • Ability to visually inspect small print/printed labels
    • Basic math skills
    • Ability to read, write and follow written and verbal instructions/procedures in English
    • Ability to work independently or in a group setting
    • Trained in Current Good Manufacturing Practices
    • Experience in pharmaceutical cGMP/FDA regulated manufacturing environment
    • Operates semi-automatic inspection machine, vial label applicator and box imprinting machines

     

    Education and Experience

    • High School Diploma; Biotechnology certificate preferred or equivalent experience
    • Minimum 0-2 years related experience

    Pharmalucence is an Equal Opportunity Employer

    Individuals with Disabilities and Protected Veterans are encouraged to apply.

    If you need help applying online, please contact joyce.robbins@sunpharma.com or call

    Joyce, HR Assistant at 781-275-7120


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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.

    Summary:
    The US Senior Product Manager, Brigatinib reporting to the Senior Director, Brigatinib will be responsible for the development and implementation of the launch planning activities in the US for the initial indication of ALK+ Non-Small Cell Lung Cancer. This position offers the opportunity to be involved in the strategic aspects of the launch on a very fast paced and dynamic launch marketing team.

     

    Duties and Responsibilities:

    • Support development of overall launch strategies by leading preparations for various launch scenarios; define critical success factors, market developments, assessment of emerging data, and competitive entries
    • Assess market opportunities through effective synthesis of multiple sources of information, including quantitative and qualitative tracking/market research, and oncologist/nurses/PA advisory board sources
    • Develop and implement scientific and strategic narrative in collaboration with cross functional partners
    • Be the lead with the agency of record for all promotional materials development and activities planning
    • Manage vendors as appropriate
    • Develop and implement HCP engagement strategy and execution, including KOL development, speakers bureau, advisory boards
    • Collaborate with the Iclusig team members to coordinate US congress activities
    • Collaborate and communicate with the US cross-functional team to ensure brand perspectives are shared and aligned where appropriate
    • Develop and implement a launch communication plan across all stakeholders
    • Contribute to the development of Brigatinib Product Plan, 1 Year Tactical Plan, and on-going business reviews
    • Collaborate with and influence cross-functional partners and numerous stakeholders
    • Develops and manages US budgets for assigned brand marketing activities
    • Complies with all laws, regulations and policies that govern the conduct of promotional activities
    • Support his/her manager in broader leadership projects and endeavors
    • Business travel is required for regular internal and external business meetings

     

    Key competency profile:

    • Strategic Agility
    • Teamwork and Collaboration
    • Leading/influencing
    • Communication
    • Decision Making

     

    Qualifications and Experience:

    • Bachelor’s Degree required; MBA, MPH, PharmD, or other related graduate-level degree strongly preferred
    • 5 years or more previous experience in product marketing, field sales, or marketing planning management in the pharmaceutical/biotech industry
    • Experience in oncology, especially lung cancer marketing
    • Experience within marketing and key support functions a plus
    • Prior launch experience preferred
    • Strong customer orientation/focus including a willingness to work closely with internal teams to meet and exceed customer expectations
    • Demonstrated ability to create presentations and distill team thinking into clear and actionable recommendations
    • Demonstrated strategic thinking, initiative, creativity and proven track-record for innovation
    • Proven track record for consistently meeting or exceeding financial and/or other quantitative targets, as well as qualitative goals
    • Strong organizational and project management skills, along with solid decision making skills, ability to work on multiple and often diverse areas and to prioritize effectively
    • Ability to collaborate with and influence cross-functional partners without direct authority is very important
    • Strong verbal and written communication skills are essential

     

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



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

    Click here to apply:
    http://ariad-openhire.silkroad.com/epostings/submit.cfm?fuseaction=app.dspjob&jobid=609&company_id=16419&jobboardid=306

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


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    Research Associate– Lead Discovery

    Our Lead Discovery group is seeking a RA in Compound Management. This individual will be responsible for the execution of the day to day procedures necessary to accomplish the business critical function of compound management. This includes compound plating, inventory management and utilization of laboratory robotics. This individual will be critical to daily operations as well as troubleshooting process design to support the drug discovery programs in an automated environment. 

    Qualifications:

    • The candidate will have a scientific background, an aptitude for laboratory instrumentation, and an interest in working in a biotechnology environment. 
    • The ideal candidate will have knowledge of liquid handling technologies, be detail oriented and be able to troubleshoot routine equipment issues. Experience in compound management in a high throughput screening facility and an ability to impact process design is preferred.
    • Strong documentation, communication, organizational and problem solving skills are required.
    • Able to work independently as well as in a team setting.
    • A B.S. or M.S. degree in a science related field with 0-3 years industrial experience is desired.

    Responsibilities:

    • The researcher will support the drug discovery process through assay ready plating and delivery of our small molecule libraries.   
    • Primary responsibilities include the execution of work orders for compound plating, routine maintenance, quality control of instrumentation, utilization of inventory management software and communication with the internal scientific community.

    Constellation Pharmaceuticals is an Equal Opportunity Employer and a participant in E-Verify, and offers a comprehensive benefits package, including health, dental, 401(k), paid vacation, tuition reimbursement, and much more.


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  • 01/15/16--07:14: Veterinary Technician
  • Job Description:

    Veterinary technician. New Paradigm Biosciences (NPB) is seeking a Licensed Veterinary technician to join the team in our Woburn MA based laboratory. The successful candidate will support a fast-paced and exciting research program in humanized mouse modelling and drug development. The job entails responsibility for the day to day husbandry of research animals, management and maintenance of the NPB vivarium and requires participation in the weekend and holiday husbandry coverage rotation. In addition the technician will participate in research programs and work closely with scientists as well as performing administrative and support duties related to the animal program. Support duties include: maintenance of mouse colonies; ordering supplies and maintaining reagent inventories; preparation of research materials; insuring compliance with ethics, health and safety regulations; maintaining vivarium equipment and training users.

     

           

    Job Requirements:

    REQUIRED: Authorized to work in the US; Associates Degree (Veterinary Technician) or Bachelors (Biological Sciences) required; Must be licensed (LVT); Must be comfortable with equipment maintenance (specific training will be provided).  Proactive ability to follow and enforce safety standards; Assure compliance with all federal, state and local laws, regulations and guidelines for animal care and use; strong interpersonal skills; meticulous attention to detail; ability to work independently; and practiced documentation skills.

    PREFERRED: Prior experience working with laboratory mice; AALAS certification at the ALAT level; familiarity with immune compromised animals and barrier facilities. Proficient with handling, weighing, blood sampling and performing IV injections in laboratory mice.

    To apply please email a CV and cover letter including at least two professional references to adrake@npbiosciences.com.


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    Merrimack is a fully integrated biopharmaceutical company that views cancer as a complex engineering challenge. Through systems biology, which brings together the fields of biology, computing and engineering, Merrimack aims to decrease uncertainty in drug development and clinical validation, and move discovery efforts beyond trial and error. Such an approach has the potential to make individualized treatment of patients a reality. Merrimack's first commercial product, ONIVYDE™ (irinotecan liposome injection), was approved by the U.S. FDA on October 22, 2015. With four additional candidates in clinical studies, several in preclinical development and multiple biomarkers designed to support patient selection, Merrimack is building one of the most robust oncology pipelines in the industry.

     

    This position is responsible for managing all aspects of Merrimack’s computer related systems validation program for cGxP systems requiring validation/qualification. 

     

    Job Responsibilities:

     

    • Manage, coordinate, and/or perform the development of validation protocols, the execution of validation studies, data analysis, and compilation of the data and results into final reports.  Schedule and lead meetings with information technology, quality assurance, and system end user personnel to gain consensus on protocol content, protocol execution, and resolution to failures to meet protocol acceptance criteria.  Lead or coordinate, as applicable, investigations into failures to meet protocol acceptance criteria. Review and approve validation protocols and reports. (40%)
    • Review proposed changes to validated computer systems and identify the validation requirements necessary to maintain the system’s validation status after execution of the change. (20%)
    • Author and administer a corporate computer system validation policy and chair the associated computer system validation panel.  Develop and standardize appropriate procedures to be used in validating computer systems, manage and control validation documentation in collaboration with QA.  Ensure the validation policy is focused towards achievement of 21 CFR Part 11 compliance. (10%)
    • Develop validation lifecycle master plans and execution plans for computer system validation projects; develop and manage the associated validation project budgets. (10%)
    • Train internal or contract personnel who will be executing computer system validation protocols on how to execute the protocols. (5%)
    • Review proposed new computer systems or software applications that require validation and provide Validation’s perspective on these systems. (5%)
    • Work with other Validation Personnel to assure consistency in computer validation of testing, utility, process, and equipment/instrument control and data acquisition systems. (5%)
    • Perform qualification audits of IT vendors and resources. (5%)
    • Identifying current and anticipated requirements for compliant computerized operations and suggesting methods for the identification, implementation and maintenance of the procedures, actions and documentation necessary to assure compliance with the appropriate federal and international regulations.
    • Developing computer validation policies, procedures and protocols; investigating/troubleshooting validation problems for computer systems, automated equipment, and control systems. 
    • Keeping abreast of evolving federal and international regulatory requirements, government audit policies, the availability of current techniques and literature regarding compliant computer operations, and serving as an information resource.

     

    Requirements:

    • B.S. with 7-12 years of validation experience or M.S. with 5-10 years of validation experience.
    • Experience in validating computer systems in the biopharmaceutical or pharmaceutical industries.
    • Demonstrated experience in successfully managing complex validation projects is required.
    • Preference given to candidates with previous and successful validation of Laboratory Information Management (LIMS) systems, system control and data acquisition systems, electronic Quality Management Systems (eQMS), Enterprise Resource Planning systems (ERP), and in implementing 21CFR Part 11 requirements.
    • This position requires excellent leadership, organizational and communication skills, and a thorough knowledge and understanding of FDA and international validation requirements and expectations.  The incumbent must be self-motivated, able to correctly set his/her own priorities for the multiple projects that will be simultaneously managed, and meet project deadlines and budgets.
    • The incumbent will be involved in a wide range of complex, cross-functional area problems, which require the regular use of ingenuity and creativity, working without appreciable direction, and exercising considerable latitude in determining assignment objectives.   She/he may determine the methods and procedures used on new assignments.  Completed work is reviewed from a relatively long term perspective for desired results.
    • Travel to other locations and to vendors for audits will be occasionally required. 
    • While this position may not have direct reports, it is expected to provide guidance or oversight to company personnel and contractors.
    • This position will have frequent contact with senior management and outside senior professionals and act as the prime validation contact for the project group.
    • The position will also be the point person for the CRS validation program to inspectors during regulatory inspections/audits.

     

    If you are interested in a great opportunity with a fantastic company, please click the link to apply!

    https://app.jobvite.com/j?cj=oKm71fwY&s=Mass_Biotech_Council

     

     


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    Commercial Compliance Director (Needham, MA)

    Overview:

    This position would manage compliance for late stage products in preparation for pre-approval regulatory inspections at Celldex and Contract Manufacturing sites. 

     

    Position Responsibilities:  

    • Management of late stage CMO compliance, change control, product complaints, and annual product reviews
    • Preparation and management of Pre-approval regulatory inspections
    • Assist with the development of a Commercial Quality System
    • Oversee internal auditing including internal inspection readiness
    • Coordinate inspection and audit follow-up and corrective action planning

     

    Required Skills:

    • Knowledge of FDA regulations, European Directives, ICH guidelines, and cGMP regulations
    • FDA/regulatory inspection experience required
    • Strong written and interpersonal communication skills
    • Strong knowledge of MS Word, and Excel

     

    Education/Experience:

    • Bachelor Science or MS degree in biological sciences or related discipline
    • 8+ years of experience in a Quality Department preferably in the biologics/biotech industry
    • 6+ years of management experience
    • Prior experience with biologics products a plus

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    Director US Medical Affairs - Late Stage Clinical Assets (NJ or MA)

    Overview:

    The Medical Director will be responsible to provide and execute the US strategic vision, leadership, and management for key medical affairs activities supporting late-stage clinical assets, including advisory boards, KOL identification and engagement, congress coverage, publications, medical communications, and promotional material reviews. The successful candidate will report to and work closely with the Vice President of Medical Affairs to deliver strategic and operational support for the successful execution of US Medical Affairs goals and objectives.

    Position Responsibilities:  

    • Collaborate closely and interface with fellow Medical Affairs, Clinical and Commercial team members and all other functions at Celldex Therapeutics to support the development of late-stage cancer therapeutics
    • Ensure, by working with HEOR and access teams, that all late-stage assets if approved are available to patients in need
    • Actively participate in the design of strategic development medical plans to support the brand strategy and life cycle, as well as for future products
    • As appropriate, be a key member chairing, co-chairing or participating in all late stage clinical assets’ medical affairs, clinical development and commercial teams/committees 
    • Contribute to clinical trial concepts for company-sponsored and cooperative group studies (when company sponsored)
    • Contribute to concept review of Investigator Initiated Research (IIR) proposals. Support IIR committee feedback communications with investigators 
    • Establish strong professional rapport with key customer segments (US KOLs, OLs, relevant HCPs and other key groups e.g. payers, patient advocacy and others)
    • Design and implement advisory board plan 
    • Develop and oversee brand publication and medical communication strategies, including health economics and outcomes research
    • Lead medical review of promotional and advertising materials
    • Collaborate with European colleagues to ensure global consistency of medical affairs plans and implementation

     

    Required Skills:

    • Ability to work effectively in cross-functional teams; proven ability to identify, select and manage a variety of external resources related to execution of medical affairs functions
    • Ability to lead a team of cross-functional experts
    • Experience and expertise in clinical trial design, interpretation of scientific data, market research, competitive intelligence tools, and medical marketing strategies
    • Excellent written and verbal communication skills, strong presentation skills, and good negotiating skills
    • Available for domestic and international travel

    Education/Experience:

    • Advanced Scientific Degree (e.g. MD, PharmD or PhD)
    • Minimum of 3 years of pharmaceutical/biotechnology medical affairs industry experience
    • Medical expertise in oncology preferred

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    National Medical Liaison Director – Field Lead (NJ, MA, CT)

    Overview:

    The National Medical Liaison Director is a Senior Director level position who manages a field-based team of Medical Science Liaisons, including all personnel decisions, developing key performance indicators, and performance reviews.

    Position Responsibilities:  

    • Responsible for developing field force of Medical Science Liaisons. 
      • Determines Key Performance Indicators and manages toward achieve them
    • Participates in the design of internal and external education initiatives being mindful of national and regional needs
    • Coordinates pre-meeting scientific preparation and summarizes competitive information
    • Works to craft Celldex LCM strategy; communicates back to organization evolving trends/changes in treatment and healthcare delivery

    Required Skills:

    • Ability to motivate independent employees and provide metrics to internal stakeholders
    • Expert at translating the work of field-based personnel to colleagues across key disciplines
    • Able to manage several national efforts via chosen MSL leaders and subteams
    • Requires outstanding communication skills and the ability to function within a team environment
    • Can live anywhere nationally, within 1 hour of major airport 
    • Travel up to 40% including some weekends

    Education/Experience:

    • PhD, PharmD, or MD required
    • Extensive 10+ years oncology medical affairs experience including at least 5 years management experience

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    National Medical Liaison Director – Field Lead (NJ, MA, CT)

    Overview:

    The National Medical Liaison Director is a Senior Director level position who manages a field-based team of Medical Science Liaisons, including all personnel decisions, developing key performance indicators, and performance reviews.

    Position Responsibilities:  

    • Responsible for developing field force of Medical Science Liaisons. 
      • Determines Key Performance Indicators and manages toward achieve them
    • Participates in the design of internal and external education initiatives being mindful of national and regional needs
    • Coordinates pre-meeting scientific preparation and summarizes competitive information
    • Works to craft Celldex LCM strategy; communicates back to organization evolving trends/changes in treatment and healthcare delivery

    Required Skills:

    • Ability to motivate independent employees and provide metrics to internal stakeholders
    • Expert at translating the work of field-based personnel to colleagues across key disciplines
    • Able to manage several national efforts via chosen MSL leaders and subteams
    • Requires outstanding communication skills and the ability to function within a team environment
    • Can live anywhere nationally, within 1 hour of major airport 
    • Travel up to 40% including some weekends

    Education/Experience:

    • PhD, PharmD, or MD required
    • Extensive 10+ years oncology medical affairs experience including at least 5 years management experience

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    The purpose of this position is to:  Lead and take responsibility for the regional PVQA to assure and manage a compliant and effective PV hub and regional PVQA oversight programme which drives compliance with existing and emerging regulations.

    • Provide assurance that assigned external vendors and internal TDC hub region, PV systems meet Takeda and regional regulatory quality standards.
    • Provide assurance that all PV activities performed by the Licensees for the licensed-out marketed products and Licensors for the licensed-in marketed product meet the quality standards agreed upon in the safety agreements for European region countries.
    • Verify that the Pharmacovigilance activities for Takeda IMPs and Marketed Products for TDC  region responsibility are conducted in compliance with applicable legislation and Volume 9a of The Rules Governing Medicinal Products in the European Union/EU pharma-package legislation 1235/2010 and directive 2010/84/EC, Good Clinical Practice (GCP) regulations, International Conference on Harmonisation (ICH), Takeda Policies and Procedures and all applicable local and international regulatory requirements.
    • Plan regional requirements in the, planning, implementation and system audits of partner and alliance Pharmacovigilance systems to assure suitable quality oversight.  
    • Collaborate with global PDDQA leaders to develop goals and strategies to support PDDQA business objectives in PV and QA Compound Support (development and commercial products) programmes.
    • Contribute regional regulatory intelligence for PV to the global regulatory intelligence process
    • Lead regional planning and support by QA TDC for internal, external and corporate audits/inspections.
    • Ensure that critical compliance risks and observations are communicated and escalated through QA and PV senior hierarchies, provide data trends and CAPA progress reporting regularly to identify and plan process improvements.

    ACCOUNTABILITIES:  Leadership

    • Lead and manage regional PV process assessments  (and auditors and consultants when used), to give direction, drive for results and provide input on regional PVQA strategy in line with PDD Mid Range Plans, PDD QA initiatives and day to day activities to deliver these.
    • Influence and contribute to the development, planning and implementation of TDC quality strategy and policy for PV/PVQA. Support Global Compound Support roles in PDDQA in key PV QA initiatives acting as a subject matter expert, regional lead and uphold principles of QMS
    • Represent QA and present at internal TDC QA and PV meetings, represent QA at Regional hub PV meetings, and where appropriate at external meetings and training courses as agreed/appropriate.
    • Development and maintain key relationships with regional hub PV groups and key personnel, and in particular form a strong alliance and support with regional PV stakeholders.

    PV Systems

    • Develop and manage, a strategic (using a risk based approach (ICH Q8/9/10)) Audit Programme to cover all PV QA activities for: TGRD (Europe) PV, (and all Marketing partners including the licensees and licensors located in European region), and CROs for Clinical Trials and marketed products covered by PV systems.
    • Collaborate with GxP colleagues in QA groups and with colleagues at TDC to deliver joint audits (i.e. at the GMP-PV interface and validation, computer system audits)
    • Act as lead QA representative for, and coordinate all PV QA activities and Agency Regulatory Inspection activities within assigned Takeda Region. Work closely with QPPV office to plan and deliver a robust inspection readiness programme.
    • Provide input into SOP updates and review all TDC, TPC Global SOPs for PV.
    • Review and act as QA approver PVQA SOP’s for the relevant region.
    • Collaborate with PV Departments within all assigned Takeda LOCs, Regions, for the development and delivery of PV training programmes.

    Performance monitoring and improvement

    • Select, engage and manage qualified contract auditors to execute PV audit activities for TDC partners, vendors and CROs.
    • Review and approve audit reports, provide consistent application of standards, ratings and ensure the observations and CAPA meet required standards of compliance, rigorous application of root cause and appropriate timelines.
    • Prepare and present metrics relating to PV Audit activities/observations/issues, identify root cause and appropriate CAPA ensuring the escalation critical issues to senior management as they emerge.
    • Identify and communicate key risks and mitigation plans

    Regulatory Intelligence/Awareness

    • Maintain up-to-date knowledge of PV legislation requirements and communicate and actively liaise with PV Departments within Takeda Europe Region locations to exchange information on emerging Regulatory requirements, industry trends.
    • Maintain an active interest in industry trends through networks, training opportunities and professional conferences and forum.

    People Management

    • Manage and oversee the day to day activities and assignments of in house staff and external contractors engaged in PV QA oversight activities, audits and follow up with observations and issues.
    • Oversee the use of consultants for specific work tasks and /or training package provision.
    • Train and develop PV Compound Support Specialists within TGRD Europe.
    • Provide clear plans, goals, leadership, motivation and development the team capabilities.

    Qualifications

    EDUCATION:

    • Bachelor's degree in life sciences, Pharmacy or Nursing.

    EXPERIENCE:

    Required:

    • Minimum of 7 years in regulated pharmaceutical environment
    • Minimum of 5 years experience in a regulated QA environment
    • Minimum of 5 years of experience of auditing internal and external quality systems, including experience of GxP regulatory authority inspections
    • Solid understanding of the European Pharmaceutical regulated environments, with particular understanding of QP duties, role and responsibilities.
    • Experience of QMS/QA/PV system design, development, implementation and maintenance; including the QA processes that support and oversee processes related to PV.
    • Experience in regulatory agency inspection planning, preparation, conduct, management and agency interactions
    • Experience working within a complex organisation and demonstrated ability to work across functions and regions at a variety of levels.
    • Experience operating in a global multi disciplinary drug development/production environment, including exposure to international regulations.
    • Demonstrated knowledge of international GxP regulations, guidelines and emerging regulatory progress, ability to interpret regulatory intelligence and translate into effective policy and procedure in the QMS

    Preferred:

    • Management experience highly desirable

    Skills:

    • Solid science based understanding of products, therapeutic areas and an appreciation of the medical background to diseases, treatments and drug therapies. Understands medical terminology and is familiar with standards of care and disease states
    • Leadership, influence and people management
    • Demonstrated ability to act as a lead auditor, trainer and mentor for regulated audit requirements in the pharmaceutical environment with a broad understanding across GxP’s and QPs roles and responsibilities.
    • Strong planning and organization skills, including project management,  prioritization and on time delivery
    • Risk management; issue identification, problem solving, decision making and mitigation
    • Strong communications skills – written and verbal
    • Clear and professional communications to third parties (eg alliance partners, regulatory agencies)
    • Management of multiple tasks of varied complexity
    • Influence, diplomacy and negotiation skills; ability to resolve conflict where opinions differ, particularly with third parties
    • Cultural awareness and sensitivity
    • Presentation skills – create and deliver presentations with appropriate messaging and focused recommendations
    • Microsoft Project Professional, Excel, PowerPoint & Word

    LICENSES/CERTIFICATIONS:

    • Completed training or eligible for QP preferred.

    PHYSICAL DEMANDS

    • This is an office based role with a requirement for regular travel to other locations in the region, and on occasions to other international locations
    • Ability to drive or fly to attend meetings, audits, and training.
    • Manual dexterity required to operate office equipment (i.e. computers, phones, etc.)

    TRAVEL REQUIREMENTS:

    • This job will require national and international travel, likely maximum 20%.

    we are driven to improve people's lives

    www.takedajobs.com

    Takeda is an EEO employer of minorities, women, disabled, protected veterans.

    For more information, visithttp://www.takeda.us/careers/EEO_Policy_Statement.aspx

    No Phone Calls or Recruiters Please.


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    AMAZING opportunity for an analytical scientist to have an immediate impact on discovery with our biotech Client focused on developing novel drugs for oncology.   They are looking for a scientist who can perform spectrometry based testing of research materials from small molecule to biologis.  Perform HPLC and LC/MS analysis and routine maintenance on analytical instrumentation (Shimadzu / Agilent), and participate in the development/evaluation of new analytical methods.  Here are some requirements this opportunity is looking for:
    • B.S. or M.S. degree in chemistry, biochemistry with 1-2 years of industrial experience preferably within the pharmaceutical setting
    • Experience with biologics or protein analytics is required
    • Hands on experience in instrumental analysis, including operation, and maintenance of HPLC equipment is required
    • Experience in sample analysis from biological matrices is desired
    • Have collaborative teamwork and communication skills, as well as highly self-motivated and able to work efficiently and productively in a start-up company environment        
    About StratAcuity
    Whether you are seeking a career change or simply interested to become part of our network, you will appreciate the ethics guiding each StratAcuity team member. We build lasting relationships with exceptional scientists and take great care to protect your personal information. Upon receiving your inquiry, you may be directly contacted by a StratAcuity team member to discuss your career goals. We will not share your information with anyone without your direct prior consent.

    CHEMISTRY IS EVERYTHING™
           


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    GENERAL SUMMARY OF POSITION:

    Under the general direction of the Department Administrator, or designee, the Grant and Contract Specialist II is responsible for performing diversified and complex administrative, financial, and pre and post-award budgetary functions in support of departmental activities, to include both responsibilities for both restricted and unrestricted departmental funds.

    The position does require Pre Award experience.

    MAJOR RESPONSIBILITIES:

    • Provide assistance in the management of all pre-award administration, to include, but not limited to, advising Administrator and PI of sponsor guidelines, participation in application assembly, budget preparation, faculty guidance, e-submission processes, UMMS required paperwork, etc. and other administrative requirements for the submission of all federal and non-federal grants and contracts
    • Monitor regulatory and compliance requirements for all sponsored research activity, keeping detailed files and a tracking mechanism for annual renewals. Inform Administrator of variances
    • Assist in analytical studies of existing or proposed clinical trials to provide the economic basis for management decisions to improve operational/financial performance and to realize productivity improvements
    • Monitor all clinical trial funding sources by tracking revenue and expenditure activity and monitoring of trial milestones, identify variances and assist in resolving account variances
    • Monitor contracts, extensions, and amendments with outside vendors, private agencies, and consultants in conjunction with Purchasing and legal offices; monitor the contracts for cost effectiveness and quality performance standards
    • Prepare data for financial reports, budgets, budget and research fund reconciliations, forecasting, analysis, and ad-hoc reports for Administrators and PI”s as needed. Perform analysis of data as required
    • Work with the Administrator, principal investigators, and staff to resolve problems and to optimize the use of funds as required; finalize all expenditure activity of expired grants; deposit checks to any income and service fund accounts
    • Manage all phases of post-award grants and contracts administration, to include monitoring budgets, expenses, and recovered overhead. Advise Administrator and PI of reporting requirements
    • Assist faculty in finding possible funding opportunities
    • Coordinate pre-award submission activity for the department
    • Monitor post-award activities to insure adherence to sponsor guidelines and all reporting requirements are met. Inform Administrator and PI on budget variances
    • Oversee changes to award budgets and the submission of the necessary paperwork for approval of such actions
    • Prepare reports for federal and sponsoring agencies
    • Assist and participate with Grant Accounting in award termination process to close-out accounts. Notify Administrator and PI of final status
    • Monitor operating expenses, prepare monthly variance-to-budget reports, Departmental voluntary and mandatory cost sharing, and advise the Administrator on reconciliation actions
    • Responsible for the process of initiating and submitting payroll personnel action forms related to transfers, funding changes etc. Audit the accuracy of employee payroll data
    • Oversee the processing of consultant agreements, travel vouchers, purchase orders, reallocation of expenditures, and other expenses
    • May act as an external liaison
    • Perform other duties as required.

    REQUIRED QUALIFICATIONS:

    • Bachelor's degree in Business Administration, Finance, or Accounting, or equivalent experience
    • 3 years of relevant job experience, or equivalent, preferably in an academic environment.
    • Demonstrated ability to analyze and interpret financial documents, such as system reports, at both account and summary levels
    • Proficiency with Microsoft Office applications (Word, Excel, Access and, PowerPoint), or similar software applications. Knowledge of enterprise financial products
    • Excellent interpersonal skills (verbal and written) needed to present and communicate effectively with all levels of management.

    PREFERRED QUALIFICATIONS:

    • Experience in both Pre and Post Award is preferred

     

    Apply Here

    PI92700044


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  • 01/15/16--00:34: Bioinformatician
  • GENERAL SUMMARY OF POSITION:

    We are seeking a highly motivated individual with expertise in computational and statistical methods to analyze large datasets such as Next Generation Sequencing (NGS) data. The individual will spearhead the computational biology efforts in the lab and closely interact with other lab members to design and evaluate their studies. Depending on qualifications and level of expertise of the individual the position will primarily focus on applying and developing computational and statistical methods to analyze large data sets for ongoing projects addressing the (epi-)genetic basis of stem cell differentiation and cellular dysfunction relevant to immune syndromes (e.g. Type 1 diabetes).

     

    Additional responsibilities include:

    • Enable, perform and support computational analyses for a wide range of research projects.
    • Implement and adapt programs for high-throughput sequencing data analysis, cis regulatory motif identification, and DNA-binding protein motif searches.
    • Independently develop, implement and maintain custom designed computational solutions relevant for ongoing lab-based projects.
    • Independently develop, implement and maintain computational methods for meta-analysis of data generated in the lab as well as publicly available data.
    • Interpret and present study results in support of laboratory members.

    The ideal candidate will posses the following qualifications:

    • BS in computer science, or equivalent experience
    • 2 years of experience in relevant setting
    • Strong background in statistical methodology, software languages and computer systems (R, Bioconductor, Python, Perl, C++, etc.)
    • Excellent communication skills, both oral and written, and interpersonal skills necessary to interact with a wide range of individuals.

    MAJOR RESPONSIBILITIES:

    • Establish general bioinformatics resources for day-to-day use by members of the laboratory
    • In collaboration with a faculty member, generate customized programming solutions to improve user interaction with available bioinformatics resources
    • Assist in the implementation of programs for microarray analysis, high-throughput sequencing data analysis, cis regulatory motif identification, and multi-genome protein motif searches
    • Local establishment and customization of model organism genomic databases and tools for batch sequence analysis utilizing these resources
    • Interpret and present study results in support of laboratory members
    • Provide tabular and written summaries of approaches and analyses in a form suitable for inclusion in manuscripts or grant applications, as well as media for presentation at scientific meetings
    • Develop and implement custom bioinformatics programming solutions in collaboration with lab as necessary
    • Coordinate and collaborate with other research computing expertise at the Medical School as necessary
    • Participate in conference calls and data management meetings as needed
    • Perform other duties as required.

    REQUIRED QUALIFICATIONS:

    • BS in computer science or a related discipline. Previous work experience desired, but not required; candidates with advanced degrees will be considered.
    • Strong background in statistical methodology, software languages and computer systems (Perl, C++, R, MySQL, etc.)
    • Experience in writing basic search algorithms and the ability to generate new algorithms and programs for custom data manipulation and analysis
    • Excellent communication skills, both oral and written, and interpersonal skills necessary to interact with a wide range of individuals

    PREFERRED QUALIFICATIONS:

    • Experience with Next Generation Sequencing data (RNAseq, ChIPseq, DHS etc)
    • Experience in writing basic search algorithms and the ability to generate new algorithms and programs for custom data manipulation and analysis is a plus
    • Experience using a compute cluster (LSF, SGE)



    Apply Here

    PI92700062


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    The DNA Enzymes Division at New England Biolabs invites applicants for the position of Postdoctoral Fellow to apply and develop new nucleic acid amplification technologies for various point-of-need diagnostic targets. Successful candidates will have a strong interest in applied research as part of a multidisciplinary team at NEB.

    Primary Responsibilities:

    • Adapt new technologies and methods to usable amplification tests.
    • Communicate developments to the scientific community through publication and presentation.
    • Collaborate with internal and external partners to support and develop relationships in diagnostic amplification.

    Required Qualifications and Experience:

    • Ph.D. in molecular biology, biochemistry, or a related discipline.
    • Excellent verbal and written communication skills.
    • Ability to come up with creative solutions to difficult scientific problems.
    • Ability to manage multiple projects and quickly adapt to change.

    Preferred Qualifications and Experience:

    • Demonstrated experience in novel method or assay development.
    • Familiarity with molecular diagnostic techniques and field or point-of-care applications.
    • Background in DNA amplification and nucleic acid modification enzymes.
    • Publication of original scientific work in high-quality journals.

    This position offers exciting opportunities for broad research training, collaboration with academic and industrial institutions, publishing in peer-reviewed journals and participation in national and international conferences.

     

    New England Biolabs is an Equal Opportunity/ Affirmative Action Employer of Minorities, Females, Disabled and Protected Veterans

    Candidates
    may apply online at
    www.neb.com or by accessing the
    following link: Postdoctoral
    Fellowship – DNA Enzymes Division


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    Using extensive knowledge of customer needs and market trends, the Product Marketing Manager is accountable for developing and implementing the strategic direction and global marketing tactics to drive the revenue and brand growth for the DNA Amplification range of products within New England Biolabs’ product portfolio.

    Primary Responsibilities:

    • Act as a champion for the given range of products, both internally and externally, to achieve the goals set for the products.
    • Represent the Marketing Department on the cross-functional DNA Amplification Advocacy Group to develop the strategic and tactical plans for this product portfolio.
    • Develop and maintain a strong knowledge of market trends and customer needs for the given range of products. This will include deploying appropriate market research activities to ensure that this knowledge is both up-to-date and of the necessary level of detail.
    • Develop and implement marketing strategies, including digital marketing strategies, which meet the customer needs with the specific benefits, to create unique and sustainable market positions.
    • Identify new product and market opportunities related to the given range of products, and work with the DNA Amplification Advocacy Group and all departments, internally, to realize them.
    • Develop and manage the implementation of creative promotional tactics that align themselves with the buying process of the customer, and drive brand awareness and product revenue growth.
    • Propose and manage product pricing for the given range of products. This includes working with the individual NEB Subsidiaries to gain price agreement, globally.
    • Propose and support the optimum channel through which to market and sell the different products.
    • Manage all aspects of the product lifecycle and ensure appropriate post-launch support.
    • Monitor the revenue, profitability and market share of each product in the range to assess strategy and build a knowledge base of best practices in order to increase the success of future plans.

    Qualifications and Experience: 

    • Bachelor’s degree or higher in one of core life science disciplines; biochemistry, genetics, molecular biology, etc. MBA preferred, but not necessary.
    • At least 5 years’ marketing experience in the life science industry, including direct experience managing products that serve the DNA amplification field.
    • Strong understanding of the core principles of marketing and how to best apply them to the life science market, including knowledge and experience of digital marketing strategies and tactics.
    • Good understanding of the selling process and how it is used effectively with varying product types in different segments of the life science market.
    • Experience managing the lifecycle of a range of products from idea conceptualization through launch, and growth and maturity.
    • Proven leadership skills, with ability to motivate and direct a cross-functional team.
    • Strong communication and presentations skills; both written and verbal.
    • Strong project management skills and the ability to multi-task, prioritize and manage multiple projects simultaneously.
    • Ability to travel up to 25% of time, including overseas.

     

    New England Biolabs is an Equal Opportunity/ Affirmative Action Employer of Minorities, Females, Disabled and Protected Veterans

    Candidates may apply online at www.neb.com or by accessing the following link: Product Marketing Manager, DNA Amplification


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    The VP Business Development-Transactions is charged with identifying, structuring, executing, and launching creative and value-creating transactions that enable FMI to advance its mission to transform cancer care. Key areas of impact include M&A transactions, collaborations, and/or licensing deals that support our molecular information products and services, our commercialization activities, and our clinical product pipeline development.

    • Collaborate with senior management team to set corporate development strategy and priorities;
    • Create and manage a deal pipeline process to identify, evaluate, and advance target transactions;
    • Create and manage cross-functional Deal Teams that are tailored to deal stage and focus (e.g., scouting team, diligence team, negotiation team);
    • Structure and execute data and technology partnerships to enable FMI's molecular information strategy;
    • Partner with the commercial team to structure and deliver collaborations with cancer centers/networks, laboratories, and other players in healthcare delivery;
    • Partner with Product Development and Marketing leadership to scout, vet, and close deals that advance FMI's clinical product portfolio;
    • Lead detailed diligence activities for candidate deals;
    • Partner with senior leadership on special/high profile/strategic projects
    • Support the BioPharma team as needed in structuring and executing new biopharma deals (note: this role does NOT have primary accountability or responsibility for the biopharma business);
    • Build Alliance Management capability to transition collaborations from deal to operational stage;
    • Lead cross-functional “Corporate Development Team,” the executive committee accountable for stage-gate decisions on major transactions.



    • Accomplished. 7-10 years of relevant, post graduate, life sciences industry experience with an impressive Deal Sheet of both buy- and sell-side transactions, including ideally M&A, commercially-oriented, and large-dollar collaborations (tech licensing deals only will not be sufficient);
    • Content-rich. Training and/or hands-on experience in science and with an aptitude to quickly understand new science and technology;
    • Value-focused. A strategic and shrewd business thinker laser-focused on the creation of business value for FMI, not afraid to “call the question” or take a firm stand in deal evaluation and negotiation;
    • Driven. Evidence of being a self-starter, of resilience in overcoming professional and/or personal challenges, ability to thrive in a fast-paced, demanding environment;
    • Creative. Many relationships will be novel by their very nature, requiring the incumbent to “connect the dots” to create structures that truly leverage technical and data assets
    • Meticulous. Demonstrated attention to detail — both in building relationships internally and externally, and in negotiating and executing deals;
    • A great Leader. Demonstrated success building and leading cross-functional teams that have delivered meaningful transactions;
    • A great Coach. As the primary “dealmaker” in the company, bring a teaching mindset to supporting others in the team, the Biopharma team, and more broadly in the organization.



    Apply Here

    PI92720936


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