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  1. Sr. Research Engineer

    Responsibilities: The research position will support activities in evaluation of engineering risk from failures of equipment and systems associated with our clients including those in the chemical, powergen, pulp& paper, semiconductor, and metallurgical industries.   The position will plan, conduct and direct development and evaluation of approved scientific and engineering projects or programs with minimal supervision that increase technical knowledge and provide ...

  2. Project Manager - Regulatory CMC Submissions

    Streffco Consultants, Inc., is an international staffing and systems integration organization. We provide technology and business operations resources on a project, contract, contract-to-hire or direct hire basis. Title: Project Manager Job ID: 4051 Industry: Biotech/Pharmaceutical Location: Cambridge, MA Duration: 6 Month Contract Pay Rate Range: Depends on Experience (W-2 all inclusive rate) Job Summary: The Project Manager, Regulatory Submissions, is responsible for the planning and managing ...

  3. Sr. Clinical Project Manager - Early Phase Oncology

    Required Qualifications: Must have early phase clinical trial experience, hands on!   Must have the oncology focus (this is not flexible).   Seeking someone who can come in, hit the ground running, manage clinical trials with limited supervision (not a lot of time to train). Must be mature, adaptable, flexible and can move with the punches in an environment that is constantly changes and processes and responsibilities, etc. may be readjusted at times. Role Accountability: Accountable to drive and ...

  4. Drug Safety Specialist

    Job Title:  Drug Safety Associate Assignment Duration:    3 months extendable   Job Description:  RN or BSN preferred     The Drug Safety Associate will provide technical and process-related support to drug safety management (clinical trial and post-marketed) and medical monitoring activities, ensuring compliance with relevant regulations and Standard Operating Procedures (SOPs). Qualifications Triage of incoming reports for completeness, ...

  5. Protein Scientist - Downstream Process Development - Cambridge, MA

    Seeking Ph.D and extensive general knowledge of clarification, purification, ultra-filtration, diafiltration and formulation to develop purification procedures from scratch, validate existing procedures and perform viral validation. This is a hands on role with large company leading to management position. Activities include, but are not limited to; extracting proteins derived from E-coli, Yeast and CHO cells; purifying Enzymes, MAB’s, Cytokines, and Growth Factors; detailing scale up and ...

  6. Sr. Administrative Assistant

    Green Key Resources is currently seeking a Sr Administrative Assistant for an immediate contract need. Job Title:  Administrative Assistant – Senior City/State: Cambridge, MA Assignment Duration:   5 months renewable   Job Description:  We are seeking a high-performing administrative professional to support our enabling functions within Global Oncology, specifically Communications, Human Resources and Transplant.  Job Duties:  Schedule, prioritize, and coordinate extensive internal and external ...

  7. Management Trainee, Level C, Life Sciences (copy 2)

    Job Description: Management Trainee sought to work directly in C Level suite with transformational drug delivery company in Kendall Square. The company develops transdermal versions of drugs which act locally such as in pain, sexual dysfunction, fungus infections and the like. The successful candidate will be highly motivated to learn all aspects of the business and to transition into a position of broad responsibility for the progress and success of the company. Major activities of the company ...

  8. Sr. Recruiting Partner

     My name is Myesha O and I represent The Fountain Group.  We are a national staffing firm and are currently seeking Sr. Recruiting Partner for a prominent client of ours.  This position is located in Weston, MA. Details for the positions are as follows:   Job Description: The primary responsibility involves driving the end-to-end recruiting process for open positions in the assigned client group(s). Activities include: • Developing a recruitment strategy for active and passive candidates; • ...

  9. BioPharma Sr. Validation Analyst- Weston, MA

    We have a Contract opportunity with a prominent client for a Senior Validation Analyst in Weston, MA.  Position Responsibilities:  The Senior Validation Analyst will be a Subject matter expert in validation and quality assurance of corporate systems. The position requires extensive experience with the validation of computer systems for compliance with GMP regulations and FDA regulated 21 CFR Part 11. The person will be responsible for Validation Strategy development, Execution and Testing. The ...

  10. 3730277 - Associate Investigator, Formulation Science

    We are looking for a highly motivated research Scientist dedicated to the design, development and evaluation of candidate vaccine formulations against infectious diseases. Responsibilities: • The successful candidate will work with other Formulation Scientists on in vitro and in vivo characterization and quantification of new vaccine candidate formulations. • This position requires excellent organizational skills, independence, enthusiasm and the ability to work in a highly collaborative ...

  11. Quality Assurance Contractor (6 Months)

    The GMP Quality Assurance Contractor will perform a wide array of Quality Assurance activities focusing on quality compliance as defined by the company Quality procedures in support of commercial drug product (DP) manufacturing (including secondary packaging and labeling activities).  Work closely with Contract Manufacturing Organizations (CMOs).   Duties and Responsibility:  Review manufacturing batch records including analytical and microbiological testing, CMO related external deviations and all ...

  12. Analyst Strategic Sourcing

     Hello,   My name is Bryson Jackson and I represent The Fountain Group.  We are a national staffing firm and are currently seeking a Analyst Strategic Sourcing for a prominent client of ours.  This position is located in Lexington, MA. Details for the positions are as follows:   Job Description:   The Strategic Sourcing organization at Cubist Pharmaceuticals is seeking a professional with strong analytical capabilities. As an Analyst, you will work closely with the Strategic Sourcing ...

  13. Clinical Medical Coder

    our client in cambridge, ma is looking for a clinical medical coder. This is a long term consulting position. “The Medical Coder is responsible for conduct of centralized medical coding activities. Responsibilities include coding all pharmacovigilance cases (postmarketing events as well as clinical trial serious adverse events) for the Safety and Benefit Risk group (SABR). The Medical Coder is also responsible for all coding for clinical trials in accordance with coding conventions. This individual ...

  14. Pharmaceutical Sales

     Description Candidate must be dedicated to addressing and solving some of the most important unmet medical needs in cardiovascular and metabolic diseases.   We work to bring innovative ideas, products, services and solutions to individuals with serious conditions, and to physicians throughout the world. We are nurturing an environment of performance excellence, built on trust, respect and accountability. Through an emphasis on strong leadership and people development, we will accelerate our sales ...

  15. IT Project Manager with Biotech Regulatory experience

    Our client is looking for a project manager with IT regulatory experience in the biotech industry. The position is located in cambridge, MA. Project Manager – Regulatory IT Job Summary: The INSIGHT Project Manager is responsible for the planning and execution of business process improvement and regulatory information management project. The INSIGHT Project Manager will work with business process owners, information technology staff, and subject matter experts to lead business process ...

  16. Associate QA Docs

    our client is a major biotech company looking for an associate with QA Docs experience. This position will work with a team to revise approximately 300-400 Solution Lot Records to incorporate a system enhancement. This role will ensure accuracy and compliance of the documents as well as manage the workflows within the Electronic Management System. Important: Accuracy is key, so experience working with batch records and team work is a strong plus.

  17. REBATE ANALYTICS, Sr. Analyst - PHARMA/Med Device ONLY

    PURPOSE AND SCOPE:   Supports company’s mission, vision, core values and customer service philosophy.  Adheres to the company’s Compliance Program, including following all regulatory and division/company requirements.  With minimal direction, maintains, investigates, analyzes and reconciles and processes rebates related to pharmaceuticals, in accordance with company guidelines and procedures in a timely manner.  Ensures correct calculations and payment of all PBM, GPO and Administration Fees.  ...

  18. Operations and Facilities Project Manager - Pharma

      Operations and Facilities Project Manager Primary Duties:  An experienced Project Manager able to coordinate internal cross-functional teams , facilitating projects with diverse scope. With the project team leader, able to define project objectives /or life-cycle plans and to ensure sound decision-making principles are applied to develop team agreement. Facilitate the execution of integrated project plan consistent with guidance documents. Apply project ...

  19. Senior Director of Regulatory-Medical Devices-work from locations-

     Our client has a number of possible locations this position can be based from. Including, Michigan,California,NJ,PA,CO among others with a possibility of working from home. Please contact me for details [email removed] 1. As the Director/Senior Director of Regulatory Affairs, you will use your extensive background in 510(k)s, IDE/PMAs, and Technical Files/Design Dossiers to establish regulatory strategy, and oversee the submission/approval process with domestic and international regulatory bodies. ...

  20. Mechanical Engineeer (medical devices)

    Position Summary: Assists in the development and analysis of products, materials, processes, or equipment. Under direct supervision/guidance, compiles, analyzes and reports operational, test, and research data to establish performance standards for newly designed or modified products, processes, or materials. Position Responsibility: Undertakes and successfully completes simple or basic project/product development tasks to include any of the following: writing and/or verifying ...

  21. Production Operator

    - Production Associate - The Manufacturing Associate 2 in the Manufacturing department operates ancillary equipment and operates process equipment downstream activities. Follows and maintains good manufacturing practices and standard operating procedures to comply with regulatory requirements. Experienced operator who continues to improve and refine knowledge of area/technologies. Receives minimal supervision, expected to make adjustments to day to day operations to ensure the schedule is met. ...

  22. Clinical Trial Manager- 91234

     Clinical Trials Manager/Lead Exciting opportunity for Clinical Trials Manager/Lead with early phase oncology hands on clinical trial experience to provide support to this leading pharmaceutical organization!    •             Accountable to drive and monitor protocol related activities throughout the lifecycle of the project ensuring argets are met according to timelines, budget and quality expectations •             As core member of the Clinical Operations Team and leader of the Clinical Protocol ...

  23. Professional Immunology Research

    Bacterial Immunology group in the Discovery Research Department is looking to temporarily fill a professional position. The position involves preclinical evaluation of vaccine and biotherapeutical candidates for bacterial targets. Experience in assay development and the screening of immune sera using both ELISA and cell-based assays considered an advantage. Job Responsibilities: Coordinate in vivo studies and participate in the performance of immunizations, sampling and sample processing from small ...

  24. Phlebotomist

    The Phlebotomist/BFDP Administrator provides daily program support, administration and phlebotomy services for the BIIB Body Fluid Donor Program including: Responsible for adhering to the site biosafety guidelines, the OSHA Bloodborne Pathogens Standard, (29 CFR 1910.1030), standards for medical record/information confidentiality and the rules and standards governing the art of phlebotomy and related recordkeeping. This includes using accepted sharps-prevention devices and preventing re-use of blood ...