Jobs in Research

Lab Assistant 62
Integrated Resources, Inc    02-24-2020 Cambridge, MA, USA

Job Title: Lab Assistant I
Location: Cambridge, MA
Duration: 7 months+ Contract with high possibility of extension.
 
Job Summary:
· The preferred candidate will have experience in Media/Buffer Preparation, sterile technique, inventory management and customer service.
· Ability to multitask and deal with a constantly changing schedule is also required.
· Good communication and computer literacy are a must. 
Operational:

.  Understands and follows lab procedures and safety practices.
.  Provide solution preparations on request using electronic lab notebook under direction of Supervisor or designated personnel.
Scope of Understanding:

.  Focus on lab techniques and the development of individual unit operations. 
· Conduct chemical tests on patient samples according to policies and guidelines.
· Prepare standard volumetric solutions and reagents.
· Maintain laboratory by cleaning and sterilizing the equipment, keeping inventory, and ordering lab supplies.
· Analyze test results, produce reports, and consult with specialists as needed to reach diagnosis.
· Typically requires an associate's degree of Lab science and 1-3 years of experience. Open for BS candidates.

 

Manufacturing Operator 56
Integrated Resources, Inc    02-12-2020 Lenexa, KS, USA

Title: Manufacturing Operator

Location: Lenexa, KS

Duration:6 months

 

Job responsibilities:

Performs production procedures in accordance with Standard Operating Procedures (SOP), resulting in quality product.

Formulation Tasks:

  • Gather chemicals from different storage locations (i.e. room temperature, coolers and freezers)
  • Use designated weights from 1 gm to 250 kg to verify scales.
  • scoop and dump chemicals into containers up to 1,000 kg.
  • place finished containers on a scale to verify gross weight.
  • Use a computer to capture production information.
  • Approve related reports and complete related documentation.

Blending and Milling Tasks:

  • Check rooms and equipment for cleanliness and damage prior to use.
  • locate formulated chemicals for charging into blenders.
  • setup and operate blenders in accordance with required specifications.
  • setup and operate pin mill system in accordance with required specifications.
  • setup and operate nitrogen conveying system.
  • setup and operate clean-in-place (CIP) systems.
  • control and monitor processes with an operator interface terminal (OIT).
  • use a computer to capture production information.
  • approve related reports and complete related documentation.

Packaging Tasks:

  • Use designated weights from 1 gm to 25 kg to verify scales are in specification.
  • Confirm material and supplies are staged.
  • Set up and operate automated packaging equipment within specified tolerances.
  • Fill powder into final containers up to 100 kg in weight.
  • Perform label reconciliation to ensure proper package labeling.
  • Move pallets of product to finished goods storage.
  • Approve related reports and complete related documentation.
  • Must be able to properly gown and comply with all cGMP and PPE guidelines
  • Set-up equipment ensuring operations are consistent with current operating procedures.
  • Equipment components can weigh up to 50 kg and have critical tolerance requirements.
  • Report equipment failures and work with repair personnel to correct problems
  • Performs procedures resulting in the cleaning of manufacturing equipment and facilities.
  • Continually increases proficiency and understanding of manufacturing processes and systems.
  • Able to Read and Understand all written procedures as outlined in SOP's,
  • Work Instructions and Master Batch Records (MBR).
  • Completes all documentation in accordance with current Good Manufacturing Practices (cGMP) and SOP.
  • Perform operations in compliance with rules and in a safe, orderly manner.
  • Participates in training programs as directed by the Department Supervisor.
  • This may include monthly safety meetings, internal safety audits of operations, respirator training, and skill-based pay.
  • Follow production procedures and safety policies at all time.
  • Maintain good housekeeping in working areas.
  • Reports any unsafe working conditions or safety concerns through the corporate Medgate system.
  • Reports any property damage to the shift supervisor immediately Takes part in and contributes to a safe working environment by following corporate and departmental safety regulations.
  • Use, clean, and store all personal protective gear appropriately
  • Makes recommendations for continuous process improvements in the manufacturing area.
  • Actively participates in Quality systems practices.

 

Education

  • High school diploma or equivalent with good math and reading skills.
  • Experience
  • Experience in a manufacturing environment preferably with cGMP or regulatory compliance practices.
  • Demonstrated mechanical aptitude including previous maintenance experience with process equipment or mechanical systems.
  • Dry product processing and packaging experience.

 

Knowledge and Skills

  • Ability to read and follow written and verbal instructions.
  • Ability to perform basic metric and other mathematical calculations.
  • Ability to work independently and as part of a team.

 

Soft Skills

  • Works as a productive member of a team
  • Ability to effectively communicate with others.
  • Basic mechanical aptitude
  • Basic problem solving

 

Skills Required:

  • Must be able to lift 5 pounds for a six-hour period, or as required.
  • Occasionally required to lift up to 50 pounds.
  • Must be able to maneuver and position mechanical components up to 50 kg.
  • Must be able to stand for long periods of time
  • Must be able to work within a controlled space without excessive perspiration

 

 

PD Cell Science Lab Support 61
Integrated Resources, Inc    12-17-2019 West Greenwich, RI 02817, USA

Title: PD Cell Science Lab Support

Location: West Greenwich, RI

Duration: 09 Months+  

 

Description: 

When you are part of the team at client, you’ll do important work, like helping customers in finding cures for cancer, protecting the environment or making sure our food is safe. Your work will have a real-world impact, and you’ll be supported in achieving your career goals.

How will you make an impact?
· Drive excellence in key customer account logistics programs in GXP environments through metrics development, SLA adherence, development of savings initiatives, and service excellence.

What will you do?
· Willing to support weekend activities such as bioreactor sampling
· Inventory management, ordering, tracking, shipping/receiving
· Maintenance of analytical devices
· Hood Cleaning (monthly)
· Scale weight verification (quarterly)
· General lab support
· Process preparation, sample aliquots, pump calibrations, equipment prep, set-up and breakdown
· Build assemblies for autoclaving
· Passaging
· Bioreactor operations, set-up, teardown, sampling, autoclaving
· Daily data verification
· Performs other duties as assigned

How will you get here?
· Bachelor’s degree in a scientific discipline preferred.
· Experience in life sciences, pharmaceuticals, healthcare or related field
· SAP, SLA, KPI, and metrics development.
· Working in a laboratory environment preferred

Knowledge, Skills, Abilities
· Experience with GMP a plus
· Proficient Microsoft Office skills (Word, Excel, Visio, Outlook, Teams)
· Proficient verbal and written communication skills
· Detail oriented, problem solver, promotes a team environment
· Must be able to deliver excellent customer service
· Must possess the organizational skills to multi-task and meet deadlines as needed.

 

 

Drug Safety Associate 66
Integrated Resources, Inc    12-16-2019 South San Francisco, CA, USA

Job Title: PV Operation Associate/Drug Safety Associate

Location: South San Francisco, CA

Duration: 7+ Months (Possible of Extension)

Job Description:

  • Supports all MAP Operations related activities:
  • Perform reconciliation related activities for Market Research Patient (MAP) support programs and responsible for tasks related to MAP Global Tracking Tool (GTT) to ensure continuous data integrity.
  • Run operational metrics reports on a routine basis, identify follow-up’s required, and work with the appropriate PV Operations head and/or vendor lead to ensure appropriate follow-up is completed.
  • Oversees operational aspects of US MAP Service Provider Qualification Process including: curation and upkeep of US MAP Service Provider qualification portal, ensuring consistency and fidelity of all Service Provider lists, management and assignment of new assessments to PV Operations head and/or vendor lead.
  • Responsible for executing Source Data QC (SDQC) of in scope MAPs on a quarterly basis. This includes: a) Communication with MAP vendors; b) management of vendor conducting SDQC, including appropriate QC; receiving, QC and tracking data files.
  • Ensure all MRP and PSP programs documentation (including SP training, CTV, SDQC, contracts) are tracked in Tracking Tool ensuring continuous data integrity.
  • Provide support to business/functional partners by answering questions and providing advice on good MAP practices.
  • Act as point of contact in the region for all communications in relation to MRP and PSP including participation in regular MAP lead meetings and at regional Business Planning meetings.
  • Provide regular status updates, highlight potential risks and escalate issues to line manager.
  • Oversee and support implementation of CAPAs and support business units where required to determine appropriate CAPA to any findings and ensure effective closure in a timely manner.
  • Ensure any non-compliance or late ICSR from programs are identified and ensure deviations are filed in accordance with global processes.
  • Supports all study management related activities:
  • Responsible for oversight, triage, and tracking of incoming study document review request.
  • Responsible for performing Case Transmission Verification (CTV).
  • Ensuring all USMA studies have been reviewed by PV Clinical Group.
  • Performs Outbound Submission and Tracking (OST) for literature ICSRs and submits relevant documentation to health authority.
  • Able to identify potential business gaps and assists in the development and implementation of process solutions.
  • Assists or leads special projects as assigned by and under the direction of the Head of PV Operations and/or other Safety personnel.
  • Participates in the education of internal and external stakeholders in safety related activities.
  • Assists in the tracking and investigation of case processing related metrics as required.
  • Identifies compliance trends and formulates action plan as needed to address compliance issues.
  • Act as SME point of contact for any audit/inspection related activities.

 

 

Clinical Trials Associate 82
Integrated Resources, Inc    12-16-2019 Foster City, CA, USA

Job Title : Clinical Trials Associate

Duration : 12 months.

Location : Foster City, CA 94404

Description:

  • Skills required demonstrating key client core values of Integrity, Teamwork, Excellence, and Accountability
  • Strong analytical, conceptual and business judgment skills.
  • Excellent planning and organizational and administrative skills to demonstrate initiative.
  • Demonstrate core values of strong team work and accountability with ability to prioritize competing timelines and deliver excellent results while working independently
  • Significant technical expertise and learning ability with demonstrated flexibility required to maintain pace in the market.
  • Exceptional communication skills both oral and written.
  • Excellent problem solving ability.
  • Effective project and time management skills.
  • Tenacity and perseverance to ensure high level customer service.
  • Teamwork is a mandatory requirement as it involves building and maintaining internal/external networking and cross-functional collaboration.
  • High sense of urgency and commitment to excellence in the successful achievement of objectives and program execution.
  • Ability to demonstrate good business judgment.
  • Good understanding of financial systems: good understanding of contacting process (desirable, but not required).

 

Regulatory Affairs Associate 60
Integrated Resources, Inc    12-16-2019 Foster City, CA, USA

Job Title: Regulatory Affairs Associate

Duration: 18 Months.

Location: Foster City, CA 94404

Description:

Responsible for preparing regulatory submissions which require some interactions with other members in the Regulatory department for investigational and commercial products in line with ICH requirements, regional requirements and scientific and company policies and procedures.

Participates in group meetings and provides tactical approaches to addressing issues of moderate complexity.

Responsible for development and acquisition of required regulatory skills and knowledge, with manager support.

May contribute to routine local process improvements, which have an impact on the working of the Regulatory Affairs function.

Performs workflows and procedures regarding document tracking, indexing and retrieving, and disseminating information to the Regulatory department

Performs document filing and retrieval functions as directed, or in conjunction with departmental SOPs.

Performs workflows and procedures regarding document tracking, indexing and retrieving, and disseminating information to the Regulatory department.

Seeks assistance from appropriate internal and external resources.

 

Knowledge and Skills

Strong organizational and attention to detail, along with the ability to work on a number of projects with tight timelines.

Strong verbal and written communication skills and interpersonal skills.

Must have a reasonable understanding of regulatory requirements, including ICH requirements and regional requirements for assigned territories.

Proficiency in Microsoft Word and Excel.

Experience with Microsoft Power Point, Project and Visio a plus.

Act as a resource on limited topics within the department.

Work is performed under the general supervision of more senior Regulatory Affairs professionals and is reviewed for soundness of judgment and overall adequacy.

 

Education and Experience

 

Degree in a scientific field is preferred.

 

Regulatory Affairs Assistant 64
Integrated Resources, Inc    12-16-2019 Foster City, CA, USA

Job Title : Regulatory Affairs Assistant

Location : Foster City, CA

Description:

Partners with and leads interactions with Biometrics and Programming departments and demonstrates an ability to effectively collaborate cross-functionally

Manage anonymization output for study document that require public release

Participates in team meetings to understand anonymization requirements

Support continuous improvement and ensures processes are efficient, scalable, and effective

Acts as an advisor to various groups on appropriate strategies for anonymization activities

Demonstrates exceptional programming skills to ensure data transparency activities are performed accurately and with the highest of standards

Evaluates evolving Health Authority requirements regarding data anonymization to maintain confidentiality of data/information

Participates in training on business enabling documents, checklist documents, business practices, or standard operating procedures (SOPs)

Supports and consults with internal core team and/or sub-teams on strategic transparency initiatives

Develops and maintains anonymization process to optimize efficiency, and ensure quality.

 

Knowledge, Experience & Skills:

Have a working and detailed knowledge of multiple computer programming languages including but not limited to Python, JavaScript, C, C++, C#, Visual Basic, HTML5, CSS, XML, SQL, PL/SQL.

Experience with Adobe Acrobat Pro Action Wizard and a wide range of SharePoint functionality.

Develop the ability to execute test scripts and in comparing results to requirements to ensure compliance and reporting defects to team.

Works with Data Transparency team to drive development and implementation of processes, and standards.

Works effectively within an evolving and dynamic environment and has a proven track record to quickly adapt to changing regulations, processes, priorities, and deadlines.

Proven ability to anticipate and identify areas of change, assess potential impact, and propose strategic adaptability.

Drives internal departmental process optimization to improve quality, efficiency, and productivity.

Has excellent verbal and written communication skills and interpersonal skills. Shows flexibility in communication style to work effectively in a team environment.

Ability to build productive working relationships internally.

 

Desirable:

A BS degree

Preferably 1 or more years of direct experience in Regulatory, or Clinical Operations.

 

 

Microbiologist 78
Integrated Resources, Inc    12-13-2019 Vernon Hills, IL, USA

Job Title:               Microbiologist
Work Location:  Vernon Hills. IL.

Duration:             12 Months (Possibility of Extension)

 

JOB DESCRIPTION:  
Performing, with little or no oversight, a variety of tasks related to microbiological testing of products and raw materials.

  • Performing routine and some non-routine USP, ASTM and CLSI based microbiological testing for anti-infective and disinfectants.
  • Providing assistance to scientific staff to support current commercial products and line extensions by providing scientific review, investigation and support according to the established product development process and quality procedures.
  • Managing and maintaining every aspects of the microbiology laboratory to provide material and technical support to all microbiology staff members.
  • Writing study protocols and SOPs.
  • Preparing study reports and protocol completion summaries.

 

REQUIRED COMPETENCIES

Education

BS degree in Biological Sciences or Microbiology

 

SKILLS

  • Applies working process knowledge in resolving routine problem/issues
  • Coordinates problem resolution with supervisor as needed
  • With moderate or no supervision, applies comprehensive understanding of defined productivity goals and objectives
  • Applies knowledge and skills to complete assigned tasks within own area
  • Works within established SOPs and / or scientific methods and adheres to quality guidelines
  • Performs general laboratory duties such as preparing media, reagents and re-stocking supplies, and/or propagating important microbial cultures.
  • Performs routine microbiological assays such as ISO, USP and ASTM-based microbiological testing of products.
  • Maintains and propagates bacterial culture, and perform identification based on Gram stain and morphological characteristics
  • Uses theoretical knowledge to interpret data and to trouble-shoot experiments. Independence in problem-solving is highly encouraged.
  • Prepares and presents data at laboratory meetings.
  • Becomes more independent in planning and conducting experiments, and collaborates with scientists from other sections of the R&D organization.
  • Reports any incidence or malfunction of equipment in the lab
  • Assures that all aspects of their assigned areas are secure and maintained in accordance to all applicable procedural requirements
  • Performs other duties as assigned by management

 

EXPERIENCE

  • Minimum 1 year of work experience in a Microbiology Research & Development Environment or equivalent combination of education and experience
  • Specialized Knowledge
  • Ability to read, analyze, and interpret technical procedures or governmental regulations
  • Mathematical and reasoning ability: Ability to interpret a variety of instructions furnished in written, oral, diagram, or schedule form
  • Ability to work with colleagues and multiple clients in a professional and organized manner, and interact effectively with a variety of people from different nationalities, ethnic/cultural backgrounds, and educational levels.
  • Should be able to define problems, collect and interpret data, establish facts, draw valid scientific conclusions, and propose solutions or corrective actions
  • Ability to organize and prioritize work with limited guidance and to manage projects in a timely and effective manner.

 

Manufacturing Technician 68
Integrated Resources, Inc    12-10-2019 Lexington, MA, USA

Title: Manufacturing Technician

Location: Lexington, MA

Duration: 06 Months+

 

Description:

Performing cell culture sterilization techniques, support mammalian cell culture manufacturing processes, sustaining purification of biopharmaceuticals, operate various process equipment, documenting daily manufacturing operations in a cGMP environment, working with bioreactors, experience in upstream or downstream manufacturing, fermentation, and/or filtration, executing validation protocols

 

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