Category: New Position

Project Engineer I || Ridgefield, NJ || Type-16- months Contract ||$40-50/hr

ashishsisodiya45 August 29, 2020
Job Role- Project Engineer I

Employment Type-16-months contract
Pay rate-$40-50/hr
Location-Ridgefield, NJ
Description:

 

Bachelor’s Degree/Undergraduate Degree in chemical or mechanical engineering, or related degree supplemented with relevant experience. Experience in pharmaceutical/biopharmaceutical industry. Experience with relevant quality standards, including commissioning, qualification and validation. Well-developed communication skills, both verbal and written. Based on level, should have demonstrated experience managing teams consisting of internal staff, supervising engineering and construction activities, and preparing turnover documentation from execution and as-built drawings. Based on level, demonstrated project controls skills such as estimating, scheduling and cost reporting. Larger projects may require earned value/progress tracking systems. Leadership skills. Proficient with Microsoft Project & Office products (Excel, Word, PowerPoint, etc.). Knowledge of computer software common to mission (AutoCAD) is preferred. Provide input to industrialization strategies and rationale for critical process parameters. Proficient with structured methodologies such as Good Engineering Practices, Quality by Design, Design Space, & Process Control Strategies to be employed in the course of industrial process design, validation and control. Ability to work in cross functional teams, provide strong analytical skills for troubleshooting and root cause analysis, and communicate with internal and external team members. Experience in equipment start-up, qualification and validation is preferred..
 
Years of Experience: 0 – 3 Years
 
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Clinical Project Lead III || Bridgewater, NJ || Type-1-Year Contract ||$60-70/hr

ashishsisodiya45 August 27, 2020
Job Role- Clinical Project Lead III

Employment Type-1-year contract
Pay rate-$60-70/hr
Location-Bridgewater, NJ
Description:

• Accountable of the customization and regular update of the activities/work packages under his/her perimeter
• Ensure the project strategy is reflected in terms of Planning into the operational plan in the customization horizon in consistency with resources and costs aspects
• Play an OPCM Leader role for the clinical studies, coordinating activities from Clinical Supply and TMED (CSD and PK) OPCM teams (Operational impact management and PPM interface )
• Analyze the project deliverable timelines and critical path activities
• Communicates planning information across the Clinical Sciences & Operations platform and to any key IPOM OPCM interfaces or Regulatory OPM as needed
• Identifies and anticipates any deviations, alerts key IPOM OPCM interfaces or Regulatory OPM in case of major events having an impact on project milestones and propose recommendations / facilitate decision making
• Provide reporting and analysis to support the project team and operational teams, including during project meetings
• Ensure a dedicated communication with the Capacity Management team within CSO OPCM group and Clinical Trial Finance (CTF) team in Finance.
• Ensure history data follow-up in the planning tool and coordinate quality controls of planning data
• Once agreed with Project actors, CSO OPCM is the single accountable person for the accuracy of the plan entered, its customization in the planning tool.
 
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Scientist-1 || Cambridge, MA || Type-1-Year Contract ||$50-60/hr

ashishsisodiya45 August 26, 2020
Job Role- Scientist I

Employment Type-1-year contract
Pay rate-$50-60/hr
Location-Cambridge,MA
Description:

We are seeking an energetic and motivated Scientist with deep scientific and technical expertise in immunology or immune-oncology with a track record of scientific excellence to join our team in Cambridge, MA USA. As a Scientist in Breakthrough Lab you will be a key member of a team focused on supporting immunology and immuno-oncology projects through the drug discovery and development process. You will bring your expertise to support translational studies towards the identification of clinical candidates and deliver datasets that will have direct impact on immune-oncology therapeutics. The candidate will have a unique opportunity to create innovative medicines for patients and could potentially be offered a permanent position in a promising start-up biotech company.

Job Summary
• Displays strong investigative or technological orientation with independence of experimental design in both cases by performing complex analytical procedures and implementing new techniques.
• May oversee lower level researchers in the execution, design and interpretation of experiments.
• Contributes to the scientific literature, external conferences and/or scientific patents, where applicable.
• Provides consultation to internal Research and Development groups.
• May lead some aspect of a project in a small lab group.
• Identify and develop assays to evaluate the therapeutic effects of clinical candidates in relevant in vitro and in vivo models

Key Responsibilities
• Develops strategy and technologies to conduct experiments and analytical procedures, applying a wide variety of scientific principles and concepts.
• Evaluates and defines appropriate approaches.
• Determines new methods and develops new procedures for accomplishing work.
• Serves as internal consultant in area of scientific expertise.
• Contributes to the completion of specific programs and projects.
• Interact with various cross-function teams and function in a project leadership role.

Basic Qualifications
• PhD with a minimum of 3 years of relevant experience in field of immunology or immune-oncology
• Molecular biology: molecular cloning, site-directed mutagenesis
• Cell Culture: primary cell isolation, stable cell line
• Protein purification: affinity, IEX, SEC and HIC; familiarity with GE AKTA system; automated liquid handling
• Biochemical and biophysical characterization: SDS-PAGE, Western blot, ELISA
• Cell-based assay: Multi-spectral flow cytometry
• Deep understanding of biologics drug development and experience in target validation, PK, PK/PD, in vitro and in vivo assays is preferred
• Excellent presentation, written, and oral communication skills.
 
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Research Associate-II || Waltham, MA || Type-1-Year Contract ||$40-45/hr

ashishsisodiya45 August 18, 2020
Job Role- Research Associate II

Employment Type-1-year contract
Pay rate-$40-45/hr
Location-Waltham,MA
Description:

 

Responsibilities:
• Perform in vitro and in vivo drug metabolism studies for discovery projects in various Sanofi R&D portfolios
• Prepare routine in vitro samples for metabolism identification studies including but not limit to incubation with hepatocytes, liver microsomes or other biological matrices
• Operate and maintain LC/MS systems
• Aid in performing routine tissue exposure and binding studies for LC-MS analysis
• Assist metabolism group in maintaining documentation, safety inspection, and instrument logbooks.
• Maintain general lab reagents and supplies inventory

Basic Qualifications:
• BS or MS in biology, chemistry, or pharmaceutical science discipline with experience in conducting drug metabolism studies using hepatocytes and liver microsomes
• Strong technical skills in handling hepatocytes, cells, and other biological matrices
• Experience in operating and maintaining LC and Thermo Scientific Orbitrap or AB Sciex triple-quadruple mass spectrometers
• Prior experience in Analyst® software for quantitative analysis and automation using Tecan liquid handling system for drug metabolism assays is a plus

Preferred Qualifications:
• Attention to details
• Critical analytical and problem solving skills
• Excellent communication and interpersonal skills
• Strong commitment to the assigned tasks and striving for on-time delivery
• Desire to work within a team in a highly dynamic environment
 
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Compliance Specialist II || Framingham, MA || Type-16 month Contract ||$28-30/hr

ashishsisodiya45 August 17, 2020

Job Title-Compliance Specialist II

Location: Framingham, MA

Pay Rate: $28-30 per hour

Description:   The Quality Assurance (QA) Operations department is responsible for quality oversight of operations at Sanofi Framingham Biologics facilities. QA’s main responsibility is to ensure adherence to CGMPs during manufacturing operations through partnership with the site and direct engagement with daily operations activities.  Quality Assurance Operations is responsible for providing support and guidance to the Sanofi Operations function in order to protect the safety, quality and efficacy of Sanofi’s products, thereby ensuring the availability of compliant and safe products for our patients and assuring the security of the company’s business and global markets.
Position Overview with Key Responsibilities:
Core Responsibilities
The Senior Compliance Specialist is responsible for providing quality support and direction to Manufacturing, Quality Control, and support functions to ensure continued compliance to CGMPs as well as being responsible for providing technical support serving as a Subject Matter Expert (SME) to the QA team.
•           Actively supports the QA Operations team by providing technical support
•           Completes Phenix/Trackwise Laboratory Investigations/Deviations/CAPA/Change Controls
•           Ensure all safety requirements are being met
•           Performs batch record and logbook review
•           Performs review of column packing and qualification records
•           Review and approve CRs related to EBRs
•           Function as SME on challenges related to production requiring quality input
•           Provide on the floor (OTF) support to the operations department, including OTF support for critical operations steps
•           Issue action notices and conduct affiliated provisional release
•           Conduct log book audits against compliance requirements
•           Review CV related documentation against specification
•           Perform media / buffer and intermediate release
•           Perform release of Cell Banks for forward processing (as applicable)
•           Support cross-functional internal audit activities and conduct walkthrough inspections
•           Execute containment activities
•           Provide expertise during procedure/SOP revision process and function as DCR approver for department related SOPs and PRs
•           Maintain a high level of personal compliance to the required standards
•           Partner with manufacturing and support operations to ensure a culture of continuous compliance

Basic Qualifications:
•           Master’s Degree & 2 years of experience or Bachelor’s Degree and 4 years of experience in a Quality and /or other cGMP related field.
•           Knowledge in external agency regulations (FDA, EMA, etc.)
•           Strong computer, verbal and written communication skills.
•           Experience in quality systems.
•           Experience with Trackwise or equivalent system.
•           Proficient in Microsoft Office

Preferred Qualifications:
•           Operations experience in one of the following areas: Quality Assurance, Quality Control, Manufacturing Technical Support, Facilities Engineering, or Automation.
•           Experience with Sanofi Manufacturing System (SMS) or comparable continuous improvement systems.
•           Experience with root cause analysis tools.
•           Demonstrated experience with change control, CAPA and deviation quality systems.
•           Experience in a Quality Assurance role.
•           Strong technical writing skills.
•           Effective time management, attention to detail, organizational skills, teamwork and collaboration.
•           Significant capability in problem solving methodology.
•           Experience training and technically developing employees.
•           Experience participating in external agency inspections.
•           Knowledge of regulatory enforcement trends.
•           Ability to work independently

Special Working Conditions:
•           Ability to gown and gain entry to manufacturing and Quality Control areas.
•           Ability to work a 12-hour rotating shift and every other weekend, including holidays.
•           Ability to lift 10 lbs.

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