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Career postings for the Massachusetts Biotechnology Council

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    Position description:

    The Manager/Senior Manager, Medical Sciences (MMS/SMMS) will be a critical individual contributor in an evolving Medical Scientific Affairs (MSA) organization. This complex role is responsible for the strategic management of Ironwood MSA’s external research programs which includes phase 4 research (Collaborative Research (CR)) and Investigator Initiated Trials (IIT).  The individual will also be responsible for continuing medical education (CME). 

    This individual will be the operational leader and project manager for external research.  The individual will work across functions and with external partners in support of the overall objectives and priorities of the program.  This role will also oversee the implementation and adaptation of compliant processes, systems and budgets in support of the CME, and external research.  Through these activities, the MMS/SMMS will work to ensure that program deliverables are achieved on or ahead of schedule, on budget, and support the target product profile, business deliverables, and/or key decisions required. 

     Engagement through a highly innovative, collaborative, cross-functional, and analytical manner is essential to this role. This position reports to the Associate Director, Medical Sciences & Communications Operations.

     

    Responsibilities:

    • Act as Operational lead for the external research program and contribute to  the Sponsorship and Support Approval Group (SSAG)
    • Serve as project manager for external research, providing leadership, coordination, and cross-functional and external partner communication to enable the external research program to meet its goals
    • Effectively manage external research to facilitate decision making and resolution of conflicts and/or risks
    • Effectively manage external research team meetings by defining and communicating meeting objectives, capturing and disseminating meeting outcomes/information/action items, and following up on critical actions with the team in a timely manner
    • Facilitate strategy and budget consensus among stakeholders for external research and CME  programs for Ironwood and with collaboration partners
    • Coordinate joint review, approval and tracking processes for external research and CME
    • Design and implement intake mechanisms and tracking systems for both Ironwood-only and collaborative projects
    • Collaborate with internal subject matter experts, other MSA functions,  R&D leadership, and field-based Medical Scientists as required
    • Contribute to the evolution of team and process infrastructure to support product-focused medical activities
    • Assess performance of external research and CME programs related to key milestones/deliverables and recommend change as necessary 
    • Assists in identification and alignment of external research  project messages and major communications (internal and external) 

    Requirements:

    • R.Ph., B.S. (science), M.S. (science), Ph.D. (science) or Pharm.D;
    • 4-7 years pharmaceutical/biotechnology industry experience; minimum of 3 years in a role overseeing  external research and  CME or similar projects;
    • Experience in management of external research grants, and knowledge of pertinent regulations and guidelines, preferred;
    • Excellent project management skills; demonstrated ability to progress multiple tactics simultaneously; required;
    • Ability to proactively diagnose and resolve issues before timelines are compromised;
    • Ability to work successfully in cross-functional teams;
    • Record of accomplishment of successful collaboration and relationship building, including experience working in co-marketing or co-development arrangements is preferred.

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  • 01/07/16--23:03: Scientist I
  • Contract

    Scienist will work with the development team on NAT assays/technology platforms/reagent development through various stages of product development under design control process for all nuclear acid-based IVD products.

    For details visit:

    http://www.cwsciences.com/Current-Openings/Scientist-I-

     

    Candidates must live local and be a US Citizen or Green Card Holder

    Email resume to: jobs@cwsciences.com

    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.
    http://www.cwsciences.com
     


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    3+ Month Contract

    Clinical Operations Assistant will provide administrative support to Clinical Operations team.

    For details visit:

    http://www.cwsciences.com/Current-Openings/Clinical-Operations-Assistant

    Candidates must live local and be a US Citizen or Green Card Holder

    Email resume to: jobs@cwsciences.com

    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.
    http://www.cwsciences.com
     


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    Jr. Chemical/Materials Engineer will help develop and scale up materials production from batch processes to pilot-scale processes. 

    For details visit:

    http://www.cwsciences.com/Current-Openings/Jr-ChemicalMaterials-Engineer---

    Candidates must live local and be a US Citizen or Green Card Holder

    Email resume to: jobs@cwsciences.com

    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.
    http://www.cwsciences.com
     


     


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    Research Associate - Protein Purification will follow protocols for protein purification using AKTA protein purification systems. Will also make reagents and solutions required for production protocols.

    For details visit:

    http://www.cwsciences.com/Current-Openings/Research-Associate--Protein-Purification

    Candidates must live local and be a US Citizen or Green Card Holder

    Email resume to: jobs@cwsciences.com

    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.
    http://www.cwsciences.com
     


     


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  • 01/07/16--23:10: Chromatography Technician
  • Chromatography Technician will be responsible for maintaining a fleet of analytical instruments. Act as the primary support engineer for instrumentation within the  labs of various departments in Cambridge, MA.

    For details visit:  http://www.cwsciences.com/Current-Openings/Chromatography-Technician

    Candidates must live local and be a US Citizen or Green Card Holder

    Email resume to: jobs@cwsciences.com

    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.
    http://www.cwsciences.com
     


     


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  • 01/07/16--23:11: Analytical Chemist
  • Analytical Chemist will characterize and purify proteins in support of drug development activities.

    For details visit:

    http://www.cwsciences.com/Current-Openings/Analytical-Chemist--Protein

    Candidates must live local and be a US Citizen or Green Card Holder

    Email resume to: jobs@cwsciences.com

    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.
    http://www.cwsciences.com
     


     


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  • 01/07/16--23:13: QC Documentation Specialist
  •  QC Documentation Specialist will perform quality control reviews of clinical documentation and review/edit documentation for technical accuracy.

    For details visit:

    http://www.cwsciences.com/Current-Openings/QC-Documentation-Specialist

    Candidates must live local and be a US Citizen or Green Card Holder

    Email resume to: jobs@cwsciences.com

    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.
    http://www.cwsciences.com

     


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  • 01/07/16--23:14: Research Associate

  • Research Associate will execute bacterial sub-cloning, mammalian cell culture, and aseptic technique. Will also document and effectively communicate interpretation of data and results validation of assays.

    For details visit:

    http://www.cwsciences.com/Current-Openings/Research-Associate-I

    Candidates must live local and be a US Citizen or Green Card Holder

    Email resume to: jobs@cwsciences.com

    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.
    http://www.cwsciences.com

     


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  • 01/07/16--23:15: Analytical Scientist
  • Analytical Scientist will develop analytical methods as well as be responsible for formulation development. 

    For details visit:

    http://www.cwsciences.com/Current-Openings/Analytical-Scientist-

    Candidates must live local and be a US Citizen or Green Card Holder

    Email resume to: jobs@cwsciences.com

    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.
    http://www.cwsciences.com


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    Sr. Research Associate - In Vivo will develop in vivo assays and perform microsurgical techniques.

    For details visit:

    http://www.cwsciences.com/Current-Openings/Sr-Research-Associate--In-Vivo

    Candidates must live local and be a US Citizen or Green Card Holder

    Email resume to: jobs@cwsciences.com

    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.
    http://www.cwsciences.com
     


     


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    Research Associate - Molecular Biology will join a group dedicated to the discovery of therapeutics for neurological diseases.

    For details visit:

    http://www.cwsciences.com/Current-Openings/Research-Associate--Molecular-Biology

    Candidates must live local and be a US Citizen or Green Card Holder

    Email resume to: jobs@cwsciences.com

    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.
    http://www.cwsciences.com

     


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    Downstream Process Development Associate will support the development of biologics. This includes performing purification using AKTA systems.

    For details visit:

    http://www.cwsciences.com/Current-Openings/Downstream-Process-Development-Associate

    Candidates must live local and be a US Citizen or Green Card Holder

    Email resume to: jobs@cwsciences.com

    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.
    http://www.cwsciences.com

     


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    Our Client, a growing Biopharma company creating new and cutting edge therapies is seeking a diligent and highly motivated, hands on Research Associate.   Join the Formulation and Process Development team and execute solubility measurements of excipients and drug substances to support process development. You will put your basic lab skills to work as well as writing and reviewing technical reports.
    This amazing opportunity is looking for someone who also meets the following requirements:
    •    BS degree in Chemistry, Chemical Engineering, Materials Science/Engineering, Pharmaceutical Sciences (or related) and •    Experience in spray drying or solid-state analysis is preferred
    •    Thermodynamics, mass and heat transport and physical chemistry experience is preferred
    •    Excellent communication skills and the ability to operate and function in a highly collaborative, team-focused environment
    •    Strong technical writing skills
    About StratAcuity
    Whether you are seeking a career change or simply interested to become part of our network, you will appreciate the ethics guiding each StratAcuity team member. We build lasting relationships with exceptional scientists and take great care to protect your personal information. Upon receiving your inquiry, you may be directly contacted by a StratAcuity team member to discuss your career goals. We will not share your information with anyone without your direct prior consent.

    CHEMISTRY IS EVERYTHING™


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  • 01/08/16--00:49: QA Inspector - GMP
  • QA Inspector will work in a GMP setting and help monitor manufacturing operations and write SOP's to ensure GMP compliance.

    For details visit:

    http://www.cwsciences.com/Current-Openings/QA-Inspector-GMP

    Candidates must live local and be a US Citizen or Green Card Holder

    Email resume to: jobs@cwsciences.com

    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.
    http://www.cwsciences.com
     


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    Lead the Global Medical and Scientific Communications Center for Excellence for Aegerion.  This position will report directly to the Vice President, Global Medical Affairs and focuses across four areas: Medical Information, Publications, Scientific publications/communication.

    Key Responsibilities

    • Serve as a member of the Medical leadership team.  Work with internal stakeholders to define and implement medical and scientific communications strategy.
    • Lead the publications planning and strategy.  Ensure timely and effective publication and meeting presentation of all clinical trial results.
    • Manage the Medical Affairs presence at Major Medical Meetings
    • Ensure all Medical Communication and Medical Education planning and execution drives key messaging for Lomitapide.
    • Actively leads Aegerion’s medical society relations and planning.
    • Responsible for leading Aegerion’s Medical Grants process, planning and budgeting.
    • Ensure compliance with all relevant legal and regulatory requirements for scientific and medical communications.
    • Manage the development of medical information, scientific manuscripts, poster and presentations materials for medical/scientific meetings and advisory
    • Inspire and motivate the people working for him/her or with him/her.
    • Establish and maintain positive attitude, constructive communication and transparency within his/her team and various internal and external stakeholders. 

     

    Qualifications and Experience

    • Minimum of 10 years of experience in the pharma/biotech Industry with a focus on Medical and Scientific Communications.
    • Demonstration of strong leadership and the ability to generate credibility both internally (within a multicultural organization) and externally.
    • Proven successful track record of working in a high performance team and driving consistently strong results.
    • Results oriented and excellent analytical, strategic, business planning, communication, and decision making skills.
    • Entrepreneurial spirit, self-starter and able to set stretch goals.
    • Flexibility and ability to adapt to a rapidly changing environment.
    • Excellent problem solving, organizational, and negotiating skills.
    • Track record of diplomacy, judgment, and tact.
    • Ability to continuously demonstrate Aegerion’s core values.
    • Comfortable with a lean environment, cost conscious and creative with resources.

    Resumes from third party vendors will not be accepted.

    Aegerion Pharmaceuticals is an Equal Opportunity/Affirmative Action Employer: Minorities/Females/Disabilities/Veterans


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    The Senior Quality Assurance Audit Manager is responsible for oversight of selected quality systems and establishing and maintaining the Aegerion global internal and external audit/vendor oversight program.  Acts as primary quality contact/liaison with internal Pharmacovigilance (PV) and Clinical Development functions.  Leads quality initiatives such as regulatory inspection preparations and selection of GxP service providers (internal and external). Plans audit calendars and leads GxP audits of CROs, PV providers, and other service providers as needed. 

    Key Responsibilities:

    • Lead the development, implementation, and oversight of electronic quality systems (e.g. audits, CAPA)
    • Create tools and corresponding metrics to evaluate and maintain a database of qualified GxP vendors
    • Liase with PV, and maintain the Quality aspects of the Pharmacovigilance System Master File
    • Conduct internal and external audits of GxP vendors, and manage outsourced audits
    • Support regulatory inspections and lead inspection prep teams
    • Create and provide GxP training to cross-functional teams
    • Lead risk management activities and track mitigation plans through closure
    • Review regulatory submissions and reports for CMC, Clinical and PV sections
    • Support batch review and lot release for selected products

     

    Qualifications and Experience:

    • Minimum of Bachelor’s degree in a scientific discipline (Chemistry, Microbiology, etc.) with over 10 to 15 years quality assurance experience in the pharmaceutical industry
    • Should have demonstrated knowledge and experience in the interpretation and application of GMPs, GCPs and PV standards for domestic and international territories
    • Candidate will have experience in late-stage clinical and commercial manufacturing and testing oversight for small and large molecule drugs.
    • Must be an excellent verbal and written communicator.   
    • Ability to work well in both internal and external team environments, have a strong commitment to the accomplishment of tasks, adherence to procedures, and has the initiative to identify opportunities for improvements
    • Should possess a flexible approach to problem solving, be an adept negotiator and apply a risk based approach
    • Must have experience using and/or designing electronic quality systems for documentation and processes
    • Ability to Travel both domestically and internationally (varies)
    • Ability to work in a fast-paced environment
    • Able to partner with a diverse group of staff/consultants, ideally the candidate will bring strong working relationships with previous consultant Subject Matter Experts.
    • Ability to prioritize work and handle multiple assignments, while maintaining a high level of quality with attention to detail and accuracy


    Agency Notification: While Aegerion highly values its relationships with selected Recruitment Partners we are not accepting agency referrals for this position at this time

    Aegerion Pharmaceuticals is an Equal Opportunity/Affirmative Action Employer: Minorities/Females/Disabilities/Veterans


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    The Senior Manager, Regulatory Affairs (Operations) will be responsible for overseeing operational aspects of all Aegerion regulatory submissions, ensuring that the submissions are of highest quality, delivered on-time, and within established budget.  The position is also responsible for overseeing the effective and appropriate management of Aegerion’s regulatory documentation.

    Key Responsibilities:

    • Manage document publishing for regulatory submissions from all areas of company, in support of active INDs, (e.g. clinical trial applications, IND/ODA annual reports, amendments); may include both paper and e-filings
    • Manage publishing activities for marketing applications (original applications, supplements, advertising transmissions, periodic reports) in eCTD format (formatting, publishing, submitting, lifecycling, and archiving sequences)
    • Oversee the management of electronic and/or paper-based regulatory records
    • Provide recommendations on resource needs for regulatory operations and records management activities including the need for outsourcing (e.g., eCTD vendor, SPL vendor)
    • Provide oversight for the selection and management of any outsourced publishing and records management vendors
    • Create and manage submission plans, in conjunction with Regulatory colleagues
    • Represent Regulatory Operations in project teams to support submission planning and ensure coordination of system development activities
    • Manage selection, implementation, validation (as applicable) and maintenance of IT tools for regulatory team
    • Develop proposals for continuous improvement of internal systems and processes related to publication, submissions, and archiving of regulatory dossiers in a secure and readily-accessible manner
    • Apply knowledge of electronic publishing requirements to ensure compliance with agency submission requirements and remain current with evolving standards for electronic submissions and inform other staff of these standards
    • Direct the activities of regulatory operations personnel

    Qualifications and Experience:

    Bachelor's degree with a minimum of 8 years’ experience in a Regulatory Operations role; ability to work independently with moderate supervision; ability to communicate and interact with a variety of personnel, including management and external vendors; ability to direct operational staff to achieve submission publishing timelines successfully.  Excellent organizational skills, sufficient to multi-task and manage project timelines in an extremely fast-paced environment with changing priorities.  Knowledge expert regarding global regulatory submission standards, software validation concepts, and publishing best practices.  Excellent knowledge of Word and Adobe Acrobat Pro required.  Demonstrated expertise with submission publishing tools (eCTD building tools); hands-on experience with publishing, validating, and submitting a full marketing application in CTD format in the US/EU required.

     

    Resumes from third party vendors will not be accepted.

    Aegerion Pharmaceuticals is an Equal Opportunity/Affirmative Action Employer: Minorities/Females/Disabilities/Veterans


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    The Director, Quality Assurance (Americas) is responsible for 

    quality and compliance oversight of manufacturing, packaging, testing and distribution operations in North and South America that support global distribution of Aegerion products.  This includes oversight of active pharmaceutical ingredient (API) manufacturing operations as well as dosage form manufacturing operations.  Familiarity with international current good manufacturing practices (cGMPs) and other best practices for pharmaceutical manufacturing operations will be a critical component of this role.

     

     

    Key Responsibilities

    • Primary Quality contact/interface with Contract Manufacturing Organizations (CMOs) that are based in North and South America but that provide products and/or regulated services globally
    • Responsible for release of drug substance and drug product as well as any starting materials or intermediates, as required
    • Responsible for assessing and approving deviations and investigations
    • Responsible for coordinating analytical method transfer activities
    • Responsible for reviewing and approving analytical method and process validation protocols and reports
    • Conducts audits of CMOs, distribution centers, and suppliers of critical materials and services as needed
    • Responsible for developing Quality Technical Agreements and maintaining them in a current state
    • Primary contact with Country Managers regarding quality matters
    • Responsible for serving as person-in-the-plant when needed
    • Writes and reviews CMC sections as needed for regulatory submissions

     

    Qualifications and Experience

    • Minimum BS degree in a scientific discipline (e.g., biology, chemistry, engineering, etc.)
    • At least 10 years quality experience working in an API and/or dosage form commercial manufacturing, packaging and testing environment for small molecule commercial manufacturing
    • Must have experience with electronic document management and quality systems
    • Experience working with orphan or specialty drugs desired
    • Familiarity with cGMPs a must
    • Experience working with CMOs and contract laboratories
    • Ability to think intuitively and problem solve
    • Team player with excellent oral and written communication skills
    • International experience a plus
    • Travel approximately 20%

     

    Resumes from third party vendors will not be accepted.

    Aegerion Pharmaceuticals is an Equal Opportunity/Affirmative Action Employer: Minorities/Females/Disabilities/Veterans


    0 0
  • 01/08/16--01:30: Scientist I
  • Work with the development team on NAT assays/technology platforms/reagent development through various stages of product development under design control process for all nuclear acid-based IVD products.

    Independently design and perform experiments and studies; develop, introduce and implement technical methodologies and techniques; Work on experiment data collection, data analysis, and summary report.

    Use IVD product development tools (such as DOE and DFSS) and successful develop the robust NAT-based IVD diagnostics tests within defined timelines.

    Interpret study results, evaluates data and draws relevant conclusions. 

    Present scientific/technical work at internal/external meetings or recognized achievements in the development of new procedures.

    Maintain very good understanding of relevant technologies/principles/protocols in own discipline and closely related areas. 

    Communicates knowledge obtained from external sources to project team.

    Identify complex problems (e.g. overall raw data quality, inconsistency of results, appropriateness of study design/approach/technology, scientific approaches to address demanding issues) and devise creative and workable solutions.

    Publishes internally and/or externally as main contributor; patent applications; re-views current literature in own discipline and closely related areas.

    Create technical documentation including protocols, SOPs, and technical reports. Follow Good Laboratory and Manufacturing Practices, Standard Operating Procedures and Health, Safety and Environmental Protection.

    Supervise junior scientists and/or technicians, where applicable.

    Compliance to applicable US and international Medical Device regulations and standards including, but not limited to, 21 CFR 820, ISO 13485, 93/42/EEC, 98/79 EC, and the requirements of the Novartis CDx Quality Management System.

    Requirements:

    3 years industrial experiences for NAT assay development under design control process for IVD product. In-depth knowledge of nuclear acid biochemistry and 3 years of molecular assay and sample processing development experiences in IVD industry. Strong background in high-sensitivity nucleic acid amplification and detection coupled with automated sample processing platforms and technologies, extensive experience in the development of DNA/RNA based assays to detect genetic variation and mutation. Hands-on experience on nucleic acid sample preparation, gene expression profiling, real time PCR, digital PCR, next generation sequencing, mutation detection, and cell culture. Proven scientific achievements and track record for innovation; hands on experiences with molecular assay development, statistics tools (Minitab or JMP), and bioinformatics tools are desirable. Knowledge of DFSS, understanding the principles of DOE and working experience and knowledge of cGMP practices, documentations and quality control system are highly desirable. A great team player in multidisciplinary environment, capable of multiple tasking and able to be fully committed to product development timelines. Excellent verbal and writing skills and strong communication skills are essential.


    Education: BS, MS or PhD in Biochemistry, Molecular Biology or a related discipline with 3+ years' post-graduate research and development experience in cancer and genetic disorder.


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