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Sr. QC Lead / Molecular Diagnostics

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Duties:

  • Work closely with internal and external collaborators and cross-functional teams to validate standardized analytical methods for testing key reagents, including raw materials, buffers and solutions, specimens, controls, formulated reagents, and/or reference materials (RNA and/or DNA)
  • Conduct routine testing to ensure compliance to quality standards
  • Support technology-transfer for all analytical methods to pilot plant and manufacturing operations (QC) for QC release testing
  • Work with Quality team on all documentation

Skills:

  • Technical expertise in conducting analytical testing using PCR, RT-PCR, HPLC, CE, gel electrophoresis (including chip-based methods such as Agilent Bioanalyzer), Mass Spec, fluorescence and/or absorbance spectrophotometers, and other analytical methods in an industrial environment is required, preferably in a molecular diagnostic product development setting
  • Knowledge of biochemistry and analytical chemistry is essential
  • Experience in QC release testing and/or technology transfer to manufacturing, preferably in a diagnostic product development setting preferred. Knowledge of and experience in quality and regulatory requirements under which molecular diagnostic products are developed, commercialized and supported (for example 510k or PMA applications, GLP, GCP, and GMP, etc.)
  • Knowledge of FDA and CLIA regulations are important to understand. Hands-on experience in analytical QC testing of DNA/RNA controls and/or primers and probes for molecular diagnostic product development highly desirable

Education:

A Bachelor's degree with 7+ years of industry experience or Master's degree with 4+ years of industry experience in the area of QC.

 

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

Commonwealth Sciences is a professional recruiting firm specializing in Science, Engineering and Green Technologies. We unite industry professionals with exciting career opportunities by leveraging our technical expertise, advanced recruiting tools and years of staffing experience. CWS works with a variety of disciplines and levels from Research Associates to Scientists, Engineers, Managers and Directors. Our clients value the basic integrity, customer service and industry expertise that defines our organization.

Commonwealth Sciences, Inc.

www.cwsciences.com


Compound Management Associate

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Looking for an individual to be a key contributor in the Sample Management Group.  The successful candidate will be primarily responsible for processing new compounds and inventory requests.

Requirements: Primary responsibility will be the handling of all new compound orders Weighing solids in order to create solutions via Tecan liquid handler. Should have a thorough knowledge of activities related to compound management. Experience working with laboratory robotics Ability to diagnose and triage hardware and software issues quickly Experience with Tecan Genesis, Biomicrolab Volume Checker, Biomicrolab Tube Sorter is a plus

Education: AS/BS in life sciences

 

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

Commonwealth Sciences, Inc.

www.cwsciences.com

Research Associate - Biochemistry

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Description:  

Candidate will join a Bioanalytical/Biophysical group and provide protein analytics support for sample analysis and short term projects.  

Requirements:  

BS/MS with 1+ years experience analyzing proteins and have knowledge of protein purification and protein/protein interaction Must have hands on experience with peptides and intact proteins, with knowledge of handling complex biological samples Experience with HPLC, Size Exclusion Chromatography, Gel electrophoresis, and ELISA is a must Experience with UV/Vis, FT-IR, and Biacore is a plus

 

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. www.cwsciences.com

LC/MS Chemist

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Our client is looking chemist that will performing experiments, troubleshoot and performing data analysis and interpretation. Candidate will develop bioanalytical methods utilizing LC/MS and LC-MS/MS technologies for the quantitative determination of drugs and/or metabolites in biological matrices.

Requirements:
BS/MS in Biochemistry or related field with 2+ years of industry experience with LCMS Experience with HPLC, UPLC, and triple-quad mass spec is a plus Candidate must have experience analyzing biological samples.

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

Commonwealth Sciences, Inc.
www.cwsciences.com

Instrumentation Specialist

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  Looking for a candidate to troubleshoot and maintain analytical laboratory equipment.  

Responsibilities:

-          Troubleshoot and maintain LC-MS equipment

-          Experience with HPLC equipment a plus  

 

Requirements:   AS/BS life sciences or mechanical background and MUSThave experience troubleshooting and maintaining LC-MS equipment    

 

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.

www.cwsciences.com

 

Part Time Report Writer

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Looking for a candidate to compile reports for various labs in compliance with GLP and GMP guidelines.  

Responsibilities:  

-Interpret raw data to compile tables, figures, and reports -Maintain databases

 -Communicate with Study Directors to assure accuracy of reports  

Education:   AS or BS in Life sciences with experience with data entry, excel, and/or report writing.

 

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.

www.cwsciences.com

Research Associate

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Role and Responsibilities: 

We are seeking a highly motivated research associate. The position will involve molecular biology such as DNA isolation and quantification, PCR amplification, library preparation and mass-spec genotyping. Duties include operating and maintaining equipment, analyzing data to identify mutations in cancer samples, completing projects in a timely fashion, giving presentations at weekly meetings, and working in a collaborative, exciting and fast-paced team environment. 

Requirements

Bachelors/Masters of Science with 0-2 year experience in molecular biology or biochemistry. Prior experience in laboratory research is highly preferred; high-throughput experience in automation, genotyping or sequencing is a plus. 

Histotechnologist

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  • HT/HTL Certification preferred
  • Experience in the processing of tissue (embedding and microtome and slide mounting on slides)
  • ImmunoEnzymatic and /or fluorescence histochemistry assay experience (manual procedure and autostainer procedure) preferred
  • Good laboratory practice (GLP), Record keeping training, and Document writing skills

Research Associate

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Job Summary

We are seeking a Research Associate to carry out experiments with limited supervision. Position involves making contributions to experimental designs. Must have the capacity to adapt, and demonstrate a strong desire to learn new concepts and techniques. Expected to work well within a dynamic and team-oriented start-up environment.

Responsibilities

  • Animal work including basic injections and dissections.
  • Perform immunological-based techniques including ELISA-based assays, and functional T cell assays (e.g., ELISPOT).
  • Flow cytometry, cell culture.
  • Diligently analyze data and prepare summaries.
  • Maintain basic knowledge of principals in field(s) at hand.
  • Prepare slide decks independently and present them for internal company meetings.
  • Maintain literature files and accurate laboratory records and notebooks.
  • Troubleshoot issues during experimental process under supervision.
  • Attends team meetings for experimental planning and provides progress updates to the group.

Education/Experience

Minimum 1 year of relevant experience with MS or 3-5 years of relevant experience with BS. Industry experience required.

Competencies

Excellent communication, problem solving and analytical skills. Strong organization and ability to multi-task. Ability to prioritize. Displays solid technical knowledge and hands-on experience. The ideal candidate will have experience in Immunology with demonstrated knowledge of standard methodologies. Familiarity with cell culture and immunological assays are a plus.
Basic animal work experience is required (mice).

Sr. Scientist

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Requirements:

Ph.D. in Medicinal Chemistry with at least 8-10 years of combined postdoctoral academic and industrial experience in drug discovery, preferably in oncology.

Broad knowledge of synthetic organic chemistry, as well as modern preparative methods and common analytical techniques.

Proven ability to identify, develop and apply new technologies to address and solve synthetic challenges. 

Track record of accomplishments, including input into compound design, proposed experimental strategies, problem solving, significant contribution to the practical delivery of project compounds and data interpretation

Lab Manager

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Key Responsibilities and Duties:

  • Evaluate, develop, optimize and implement DNA/RNA 
  • Manage genomics projects, oversee and monitor ongoing work
  • Contribute to data analyses and compose scientific reports
  • Assist in finalizing projects, including reporting and billing
  • Assist with lab operations including: overall ordering and organization, interacting with vendors, coordinating equipment maintenance, updating lab budgets. 

Skills and Qualifications

  • PhD in molecular biology, genomics or related fields. 
  • Strong scientific background in molecular biology and next-gen sequencing, analytical acumen and attention to detail. 
  • Strong project management and supervisory skills, with the demonstrated ability to develop and manage complex projects in a matrixed environment 
  • Ability to interact with multidisciplinary staff in a fast-paced environment. 

RESEARCH LAB MGR, SR / 40 HOURS / DAYS / BWH CHANNING LABORATORY

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GENERAL SUMMARY/ OVERVIEW STATEMENT:
The Systems Genetics and Genomics Unit of the Channing Division of Network Medicine leads numerous national and international studies pertaining to the genetics of asthma, chronic obstructive pulmonary disease (COPD), allergy, and other complex diseases. The Molecular Genetics and Genomics Laboratory Manager is one of two managerial members of a dynamic and growing laboratory who works under the very general direction of the Chief of the Division; performs full scope of scientific and managerial responsibilities in a molecular genetics and genomics laboratory, including supervision of staff activities and project management. Independently manages highly sophisticated experiments and balances multiple studies and priorities. Participates with the principal investigators in the design of experimental protocols, quality control of all data, and interpretation of experimental results. Works closely with the Biorepository Manager and participates in preparing annual budget, tracking expenses, and ensuring activities stay within budget. A team player with strong management, oral and written communication, interpersonal, and computer skills and some database experience are required.   PRINCIPAL DUTIES AND RESPONSIBILITIES:
1. Supervises methods and projects performed by the laboratory, including general project management, overseeing the use of laboratory funds and staff activities to meet multiple deadlines and requirements of several long-term studies and specific projects being performed as part of those studies. 2. Manages 8 to 10 laboratory technicians, including hiring, firing, performance evaluation, disciplinary action, orientation and training. Deploys lab personnel to work on multiple projects with different deadlines. 3. Designs protocols and appropriate quality control measures for genome-wide and targeted genotyping, gene expression, next-generation sequencing, and DNA methylation analysis. Supervises cell culture and cell treatment/collection projects .4. Continually evaluates new technology and approaches to existing methods. Maintains active knowledge of current literature in genetics/genomics. Serves as the liaison with external laboratories to outsource additional technologies as needed. 5. Works very closely with Biorepository Manager to coordinate projects and ensure sample quality. 6. Tests, troubleshoots and participates in design of in-house LIMS and other software. Works closely with Bioinformatics Project Manager. Communicates with computer programmers and attends regular meetings with informatics team. 7. Develops and implements rigorous quality control procedures for all experiments. Data integrity checks, quality control verification, database curation (particularly genetic marker database), and sample and data tracking are required. 8. Works with the Biorepository Manager to oversee financial management of projects performed in research lab and provide budget estimates for all laboratory aspects of grant proposals. Advises Principle Investigators on study design as it pertains to use of the laboratory. 9. Reports on work in progress at weekly seminars. Develops rapport and excellent communication with multiple Investigators and Fellows, who require different levels of support. 10. Presents results and protocols at internal and external meetings. Participates in grant and manuscript writing, especially related to generating and writing up preliminary data and methods. 11. Trains staff in specialized lab techniques and serves as a mentor to junior technicians. 12. All other duties as assigned.
  QUALIFICATIONS:
7+ years of laboratory-based research experience required MS required in biological science; PhD with 2+ years of post-doctoral work/research preferred. Prior supervisory experience and/or demonstrated leadership ability required.   SKILLS/ ABILITIES/ COMPETENCIES REQUIRED:
• Must be able to make independent, effective decisions in appropriate situations.
• Must possess a scientific imagination commensurate with the independent execution of research projects.
• Must have aptitude for technical problem solving.
• Ability to effectively supervise others; excellent interpersonal skills.
• Excellent organizational skills to ensure smooth functioning of lab.
• Demonstrated analytical skills and ability to logically sequence experiments to maximize research.
• Must possess aptitude for budget management.
• High level of computer and database literacy.   WORKING CONDITIONS:
Variety of laboratory/office settings.
SUPERVISORY RESPONSIBILITY:
Responsible for supervising staff including hiring, firing, evaluating and disciplining. Will orient and train new staff members.
FISCAL RESPONSIBILITY:
Develop budgets, analyze trends, and produce reports for all financial aspects of the Biorepository lab. Track all laboratory expenditures and laboratory expenses charged to NIH grants. Participate in writing grant proposals.
Shift:   Day Shift  *TO APPLY* http://careers.brighamandwomens.org/JobDescription.aspx?Back=1&jobId=2234052 An EEO, AA, VEVRAA Employer

Clinical and Regulatory Associate

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Arteriocyte Medical Systems, founded in 2007, is a leading commercial stage biomedical company developing and marketing novel cellular therapy and medical device products focused on regenerative medicine, stem cell and tissue engineering therapies. Arteriocyte has launched rapid bedside processing of marrow and peripheral blood “from the patient for the patient in 15 minutes” for surgical use by medical professionals, to address serious unmet medical needs in cardiac, orthopedic and vascular surgery.

Arteriocyte’s mission is to help patients heal faster and our strategy capitalizes on growing evidence that the human body has built-in cellular repair mechanisms (Platelets and Stem Cells) to repair tissue injury. Concentrating those cells at bedside and re-delivering to the site of injury can speed up the repair process, and improve tissue function.

Arteriocyte markets and manufactures the Magellan line of devices and disposables. Magellan is a one-source biologic concentrator and delivery system, which collects and concentrates Platelet Rich Plasma (“PRP”) and white blood cells from the patient’s own blood, as a foundation for autologous platelet gel.

 Arteriocyte is currently seeking a Clinical and Regulatory Associate.  Reporting to the Vice President of Clinical Affairs, Quality and Regulatory, the Clinical and Regulatory Associate will have responsibilities in two primary areas:

 Regulatory Responsibilities

•             Assists the company’s Regulatory System, assuring compliance with domestic and international regulatory requirements.  Communicates and/or meets with representatives of the FDA, Notified Body, CE and other external regulatory parties for matters concerning: Vigilance/MDR and 510 filings

•             Supports Regulatory Affairs Management with the company’s compliance to FDA Quality System Regulations, ISO 13485 and related (US and International) regulations and requirements

•             Develops and prepares regulatory submissions (510Ks, PMAs, Device Listings, Technical Files, etc. and defines and manages the regulatory path and any other regulatory requirements for the introduction of products to the market

•             Complies with medical device reporting requirements (MDR, European “Vigilance”, etc.)

 Clinical Responsibilities

•             Assists with developing clinical trial documents, monitoring of trial sites, data management and related reporting

•             Assists in CRF/eCRF design, data collection, data retrieval, development, UAT, query management and coding for Phase 1 clinical trials

•             Develops Data Management Plan by providing professional input and drafting sections as assigned, participates in the validation of the clinical database, processing and reviewing the CRF data of a subject enrolled in a protocol

 Education / Experience Requirements

•             A BS or equivalent experience in engineering or science as well as several years of experience in the healthcare Quality/Regulatory field is preferred

•             Knowledge of medical device regulations, (FDA, Europe/International) and quality assurance principles and practices

•             A strong background in statistics with appropriate application to product development and manufacturing

•             Previous experience  with clinical trial management

•             Ability to organize and establish priorities and ability to generate and maintain accurate records

•             Effective verbal and written communication skills and the ability to communicate at multiple levels of the organization

•             PC, word processing, spreadsheet and database skills

Arteriocyte Medical Systems is conveniently located off of 495 in Hopkinton, MA.  We offer a competitive salary, comprehensive benefits package and dynamic corporate culture.  

Interested candidates should submit a cover letter, resume and salary requirement to: careers@arteriocyte.com

IT Commercial Data Systems Analyst

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Primary Role:
The Systems Analyst position will be providing expertise to acquire, manage, manipulate and analyze data and report results. The systems analyst will also be responsible for gathering requirements and developing new reports for the Commercial and Medical Affairs organizations at the Shire HGT business unit. The Software Developer will develop an in depth understanding of the Shire HGT business including the sales, patient services, and medical affairs functions. The developer will be required to work with data that from a variety of sources including Salesforce.com, SAP, and sales and shipment data from our specialty pharmacy partners.

Responsibilities:
- Data Capture (80%) In collaboration with others, develop and maintain databases and data systems necessary for projects and department functions.
- Acquire and abstract primary or secondary data from existing internal or external data sources In collaboration with others,
- Develop and implement data collection systems and other strategies that optimize data quality.
- Perform data entry, either manually or automated methods, when needed or required Data Reporting In collaboration with others,
- Interpret data and develop recommendations based on findings.
- Develop graphs, reports, and presentations of project results.
- Perform basic statistical analyses for projects and reports Create and present quality dashboards.
- Generate routine and ad hoc reports Daily Operations (20%)
- Identify problematic areas and conduct research to determine the best course of action to correct the data.
- Analyze and problem solve issues with current and planned systems as they relate to the integration and management of ex-factory sales, demand sales, patient statistics, and sales force activity data.
- Analyze reports of data duplicates or other errors to provide ongoing appropriate inter-departmental communication and monthly or daily data reports.
- Monitor for timely and accurate completion of select data elements (for example, daily sales orders)
- Identify, analyze, and interpret trends or patterns in complex data sets.

Education and Experience Requirements:
- Bachelor’s degree in Information Systems or Computer Science.
- Zero to two years of experience in an IT organization supporting commercial and medical affairs activities in the Biotech/Pharma industry.

Other Job Requirements:
Up to 5% of the developer’s time will be required for business travel.
Shire's Brave culture offers employees with diverse backgrounds the opportunity to enable those with life altering conditions to lead better lives.

Shire is an Equal Opportunity and Affirmative Action Employer.

To apply for this position, pleaseCLICK HERE

Director of Supply Chain

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Position Summary:

The Director of Supply Chain shall be responsible for forecasting and procuring manufacturing materials, managing Merrimack’s shipping and receiving functions, and materials and inventory management.  The Director of Supply chain will assume the lead Manufacturing Department role related to adoption and potential expansion of Oracle ERP system and must be able to develop solutions and drive implementation across the manufacturing department and supply chain parameters. 

 

Essential Job Functions and Accountabilities:

 

Forecasting and Procurement Management

  • Oversee the purchasing of manufacturing materials required based on planned demand from Project Teams / Clinical Department and / or ERP system
  • Determine long, medium and short term material      needs based on delivery lead times and manufacturing needs
  • Work with QA department  to integrate new materials and suppliers      and to support quality compliance audits
  • Participate in contractual negotiations with      potential and current suppliers to ensure proper legal terms, maximum      value / purchase discounts, supplier performance, the  highest quality of products and services
  • Ensure on-time ordering and processing of all Merrimack     manufacturing purchase orders and material supply contracts 
  • Install forecasting processes and tools for use      with Oracle Supply Chain Planning module
  • Track material forecast accuracy and consumption

 

Shipping and Receiving

  • Responsible for warehouse operations including      shipping, receiving, materials tracking, and for supervising materials      personnel
  • Communications with all related      shipping/distribution suppliers and CMO’s and the management of all      product and sample related shipment transactions within the supply chain
  • Manage GMP materials control and logistic      activities related to the initiation and management of allMerrimackincoming      materials, bulk drug substance/intermediates and finished drug products

 

Materials Management

  • Ensure materials are properly received, inspected, and logged into, tracked in, and released from the inventory ERP system
  • Track inventories throughout the supply chain and provide transaction/inventory status as requested 
  • Monitor on hand inventory levels for efficient working capital management and identification of excess and obsolete materials.  Establish a system to track and quantify scrap expenses
  • Establish and maintain systems properly release and track materials toMerrimackprojects and batches
  • Establish systems to properly mitigateMerrimackrisk related to product recalls

 

Process Management

  • Establish systems to track actual material cost      of goods vs. planned cost of goods by batch and by product
  • Study new industry trends and developments and      apply to future development approaches and strategies.  Identify best practices both within and      outside ofMerrimack     that can be used to accelerate the supply chain developments.
  • Manage and drive the overall Merrimack Supply      Chain to world class standards: balancing demand/operations/inventory, and      guarantee a cost efficient (optimal internal and external flows) supply      chain structure
  • Maintain and develop key metrics to support and      to drive continuously reducing lead times and costs (including      inventory) 
  • Proactive scheduling and communication of      timelines and inventory levels

 

Management

  • Have demonstrated ability to set clear goals and      expectations for the team with measurable outcomes
  • Proven to be able to communicate proactively      across functional areas even if the message is difficult

Minimum Qualifications and Requirements:

  • BA/BS Degree
  • 10+ years experience with materials logistics in a Biotech or Pharmaceutical manufacturing environment
  • Experience with biologics or nanoliposomes strongly preferred
  • Integral knowledge of Oracle      a plus
  • Enthusiastic and flexible      person who likes the challenge of working with a variety of teams in a      multi-tasking environment.
  • Must have great      leadership skills and be able to hold individuals accountable for      performance
  • Excellent time      management, decision-making and conflict management skills
  • Strategic sourcing      experience including supplier qualification and development
  • Must be able to operate      in both a strategic as well as tactical mode
  • Excellent oral and written communication skills

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

http://jobvite.com/m?3PyArfw8

 


Senior Clinical Trial Manager

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Merrimack Pharmaceuticals is a publicly traded biopharmaceutical company discovering, developing and preparing to commercialize innovative medicines paired with companion diagnostics for the treatment of serious diseases, with an initial focus on cancer.

Merrimack applies Network Biology, its proprietary systems biology-based approach to biomedical research, throughout the research and development process. Merrimack currently has five targeted therapeutic oncology candidates in clinical development.

Job Responsibilities:

  • Selecting and managing contract research organizations and other outside vendors to support clinical studies.
  • Independently manage study activities, including selection of investigators, study start-up activities, study monitoring activities and data collection.
  • Developing and managing study timelines.
  • Assisting in the development of study related documents (ICFs, protocols, IBs)
  • Preparing clinical study budgets and tracking budgets for variances.
  • Projecting study enrollment and drug supply.
  • Managing study drug packaging and distribution activities.

Requirements:

  • BA/BS and five or more years’ experience of direct clinical trial management, including management of vendors and CROs
  • Experience in oncology clinical development is required, Imaging and ex-US experience a plus
  • Experience as a monitor is strongly preferred
  • Experience in clinical operations and/or early clinical development is strongly preferred
  • Working knowledge of GCP, ICH and relevant CFRs is required
  • Project management skills, effective communication (written and verbal), adaptability and self-motivation are required attributes
  • Approximately 10% travel, primarily involving trips to conferences for Investigator meetings or co-monitoring

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

http://hire.jobvite.com/j/?cj=oDqRWfwA&s=Linked_IN

Formulation Consultant

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Zalicus is seeking an experienced formulation scientist to act as a consultant in managing its Contract Manufacturing Organizations in formulation development and manufacturing. This consulting role requires experience with pre-formulation and formulation    of small molecule, oral solid dosage forms as well as manufacturing scale-up and production clinical supplies. This individual will interact with and advise CMOs in order to achieve the project objectives and quality standards.

Preferred Qualifications and Experience:
- Strong track record in formulation of  solid oral dosage forms for small molecule, therapeutics, “new chemical entities” (NCEs) - Strong familiarity with a range of dosage formats, including liquids, solids and orals in a GMP environment. Additional formulation development experience with poorly soluble compounds would be beneficial
-  Previous participation in a multi-disciplinary, innovative team  beholden to strict timeline,  regulatory and cost oversight.
-  Strong verbal and written communication skills as well as the ability to present complex data to groups in a clear and concise manner
-Experience with preparing and reviewing manufacturing batch records(MBRs and SOPs), trouble shooting, product development reports and other development-related documents.
-Preparation  and review of  INDs, IMPDs  in addition to other regulatory documents.


Education & Experience:

The ideal candidate will have a Ph.D. or M.Sc. in pharmaceutics, chemistry. chemical engineering, or a related discipline with a 5+ years of formulation development of oral solid dosage forms. Experience with technologies used to improve the dissolution rate of poorly soluble drugs is highly desired.

Principal Investigator, Analytical Pharmacology/DMPK

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To apply, send email with a subject of “RBAP” to careers@ironwoodpharma.com. Please include a CV and cover letter with your email message.

Position description:

We are looking for a highly motivated analytical pharmacologist with an extensive knowledge of drug metabolism, pharmacokinetics, pharmacodynamics, and biomarker development.  This person will be responsible for overseeing internal and external research activities associated with understanding the ADME properties of compounds during the drug discovery and early development stage. This position requires key intellectual contributions to the implementation of new projects, the design of target product profiles, and the evaluation and selection of development candidates. This person will play an active role on cross-functional program teams and make hands-on contributions while managing and mentoring other scientists. The selected individual will also be responsible for contributing to IND/ CTA and other regulatory submissions.

Responsibilities:

  • Provide in-depth consultancy and strategic insights on various multi-functional drug discovery project teams in the evaluation and selection of development candidates;
  • As a DMPK expert, provide guidance for experimental design and interpretation of pharmacokinetic, toxicokinetic, and drug metabolism studies to support compound profiling and structure-property/structure-activity assessments;
  • Perform advanced PK and PK/PD analyses and provide result interpretation and guidance;
  • Ensure compliance with relevant regulatory standards (FDA, EMA, etc) during IND or CTA filings;
  • Act as an experienced and exemplary scientific leader within the entire Research and Development organization. Serve as a discovery core team member and department representative on interdisciplinary R&D project teams;
  • Supervise and mentor analytical pharmacology/DMPK scientists; create a positive, team-focused environment.

Requirements:

  • Ph.D. in Pharmacokinetics, Drug Metabolism, Biochemistry, Pharmacology or a related field and 12+ years of relevant experience in the pharmaceutical industry;
  • Hands-on experience and in-depth knowledge of the role of drug metabolism, pharmacokinetics, pharmacodynamics and biomarkers in drug discovery and early development;
  • Proven leadership skills in evaluating, establishing, and guiding successful drug discovery projects and moving compounds into the development stage;
  • An experienced manager with a passion for career development and scientific mentoring; successful track record of supervising, mentoring, and developing both Ph.D. and non-Ph.D. level scientists;
  • Exceptional communication skills and the ability to facilitate constructive, expedient problem solving;
  • Working knowledge of quantitative and qualitative bioanalysis a plus.

Associate Scientist, Analytical Pharmacology/DMPK

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To apply, send email with a subject of “Job Code WBAS” to careers@ironwoodpharma.com. Please include a CV and cover letter with your email message.

Position description:

Ironwood is a drug discovery and development company dedicated to the science and art of great drug making. We are seeking a talented, highly motivated Associate Scientist to join the Analytical Pharmacology / DMPK group to become part of cross-functional drug discovery teams in support of Ironwood’s therapeutic pipeline.

Responsibilities:

  • Perform a variety of in vitro ADME studies that will include protein binding, enzymatic and cell-based assays to better understand the drug-like or pharmacodynamic properties of our molecules;
  • Develop automated methods for in vitro ADME and bioanalysis;
  • Develop and perform bioanalytical LC/MS methods for pharmacokinetic studies;
  • Clearly communicate and present results in a collaborative multi-functional environment.

Requirements:

  •    BS in biochemistry, analytical chemistry, pharmacology or a related field with at least one year of laboratory experience is required;
  •    Practical experience performing in vitro ADME or enzyme assays is highly desired;
  •    Experience with lab automation, HPLC, LC/MS/MS and other analytical instrumentation is a plus;
  •    Excellent written and oral communication skills with an attention to detail.

 

Principal Scientist - Bioinformatician/Computational Biologist

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 Amgen is a leading human therapeutics company in the biotechnology industry. For more than 25 years, the company has tapped the power of scientific discovery and innovation to advance the practice of medicine.

 Amgen pioneered the development of novel products based on advances in recombinant DNA and molecular biology and launched the biotechnology industry’s first blockbuster medicines. Today, as a Fortune 500 company serving millions of patients, Amgen continues to be an entrepreneurial, science-driven enterprise dedicated to helping people fight serious illness

Principal Scientist - Bioinformatician/Computational Biologist

(position located in Cambridge, MA)

Amgen's Department of Comparative Biology and Safety Sciences is seeking a highly motivated and experienced Bioinformatician/Computational Biologist to support predictive toxicity screening and hazard identification in preclinical drug development.

 The position will be based at Amgen’s Cambridge, Massachusetts site with the primary responsibility of collaborating with toxicologists/biologists by leveraging information on biological pathways relevant to toxicity and using novel, cutting edge, computational algorithms to study internal and external high-content data types such as gene expression data, GWAS, next-generation sequencing.

 The candidate is expected to proactively interact with the Bioinformatics community in the Boston area and foster strong relationships that would advance our computational capabilities with the ultimate goal of promoting better solutions to understand mechanisms of toxicity as well as potential toxicity screens. By networking and collaboratively working with external experts and Amgen scientists across multiple sites, the successful candidate will integrate acquired knowledge into our efforts to inform decision-making in preclinical drug development.

 Developing state-of-art computational algorithms and utilizing complex high-content data for toxicity prediction applications are anticipated to be a substantial component of this job and the candidate is expected to provide leadership and expertise in these domains with minimal supervision.

 Preferred Qualifications include:

 • PhD in Bioinformatics, Computer Science, Mathematics, Statistics or related field
• 7+ years of relevant experience in biotech, pharmaceutical industry or academia
• Established eminence in the fields of applied mathematics or statistics and a stellar ability to analyze large-scale biological data sets such as those from microarray or next-generation sequencing platforms
• Ability to translate biological and medical questions into actionable data analysis plans or analytical models
• Extensive programming experience in languages such as R or Matlab
• Ability to create collaborative opportunities and work closely with others in team environment
• Track record of scientific excellence in publications
• Strong written and oral communication skills, self-motivation, independence and leadership

 Interested candidates please email resume to smaguire@amgen.com

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