Error 2318 ::The remote server returned an error: (404) Not Found. Biology Job Newark Delaware | Research Scientist, Iba QPS, LLC

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Biology Job in Newark, Delaware : DE 19711

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Research Scientist, Iba

QPS, LLCLogo
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QPS, LLC
Pharmaceutical, Research, Biotech
1 Innovation Way
Newark
Delaware
19711
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Research Scientist, Iba Job Description

QPS, LLC is an innovative and dynamic Contract Research Organization (CRO) that strives to employ talented, caring, and committed employees who work together collaboratively towards achieving our mission of improving human health and the quality of life.  QPS, LLC has been assisting pharmaceutical, biotechnology, and medical device companies with their drug development efforts by providing a full range of GLP-compliant bioanalysis, DMPK, and protein/genomic biomarker services.  QPS welcomes employees who want to be part of a growing organization.

Summary

The Research Scientist, IBA is a key contributor in the Immunobioanalysis (IBA) laboratory Operations unit within QPS, Department of Translational Medicine.

Laboratories of a Contract Research Organization such as QPS, LLC. are dynamic and full of activity that is regulated by the Federal Government. Clinical and pre-clinical trial samples from pharmaceutical and biotech clients are tested by laboratory analysts using various molecular technologies, and the results are returned to the sponsor for evaluation and delivery to the FDA.

This is a laboratory role focused on the analysis of drug or other targets in complex biologic matrices using immunologic methods. Responsibilities include laboratory stewardship, wet-lab operations as well as data reduction and documentation. The work is done in a regulated environment controlled by company SOPS, analytical procedures and department policies and governed by the Good Laboratory Practices (GLPs), Good Clinical Practices (GCPs) and Good Documentation Practices (GDPs). Much of the work is independent and comprehensive – from frozen sample to data point - not piecemeal, though each staff member is also a part of team. Team-members cooperatively support one-another's timelines, quality and high performance. Each team is self- and externally-supported by process and technical experts. There are multiple daily interactions with teammates and staff from other units within TLM, other support groups within QPS as well as Clients and regulators. The ability to effectively communicate scientific concepts and explain laboratory events to clients is vital.

This role requires attention to detail, organization, multi-tasking, and comfort interacting with people who might be junior or senior to the incumbent. The role is for a team player who can share responsibilities and do what is needed in the moment – especially in a dynamic environment.

A senior role such as Research Scientist, IBA includes, but is not limited to, the following activities: conceive and develop new, quantitative, bioanalytical methods; improve assay quality and technical operations; troubleshoot analytical issues and transfer existing assays from pharmaceutical organizations; prepare controlled procedures and reports of results with data interpretation; remain informed of leading edge techniques that can be implemented to enhance assay diversity, quality or throughput; author scientific papers to be published in peer reviewed journals and finally, present at scientific meetings as needed.


Newark Biology Job

Research Scientist, Iba Job Requirements

Essentials

Roles

  • Mastery of GLP                                

  • Independent executor

  • Author all Final Reports

  • Laboratory analyst

  • Troubleshoot complex assays

  • PI complex validation (VAL) studies

  • Lead/Design complex method development (MD) studies

  • Explore, then lead new technology implementation

  • Manage Quality Assurance (QA) interactions              

  • Lead Sponsor TCons            

  • Potential Multiple Direct Reports

    Safety

  • Follow safety requirements, all TLM policies as well as company and Sponsor-specific standard operation procedures (SOPs), precisely                              

    Laboratory Stewardship

  • Assist in monitoring, addressing, and correcting environmental and equipment alarms

  • Help to keep the laboratories and all the devices clean, operational and presentable

  • Interact with support teams for maintenance and qualification issues

    Basic Assay Execution

  • Perform routine mathematical and chemical calculations.                                                        

  • Quality control (QC) data transcription and calculations           

  • Proficiently execute all routine lab operations, such as preparing reagents, pipette, weigh, monitor, record and replenish supplies

  • Set-up, use and maintain complex instrumentation

  • Proficiently execute complete assays, daily and independently, in accordance with the GLPs and governing policies and SOPs to avoid failed runs and study findings

  • Document results, accurately record observations, and maintain study records in accordance with the GLPs and governing policies and SOPs to avoid failed runs and study findings

  • Author Final Reports

    Readiness

  • Monitor the levels of general and key, assay-specific reagents

  • Follow proper laboratory and Sponsor-specific procedures to procure sufficient material, in advance, so as to meet and beat Sponsor timelines

    Analytical Thinking

  • Verify and QC review study data, notebooks, and study reports

  • Author deviations (DEVs) and CAPAs, then execute specified actions to regain compliance

    Communication

  • Respond to every communication, internal and external, in real-time.

  • If this is not possible, respond within a few hours; preferably before close of business (COB) for that day.

  • If the response requires examination or coordination with others, immediately reply as such, and set a time to provide a resolution, preferably within a business day.

  • Immediately update superiors and/or internal stake holders regarding lapses in project timelines, assay performance, data, or reports and work with them to effectively address any issues that may arise.

    Analytical Communication

  • Communicate assay issues clearly and completely; include breakdown analyses for technical lapses and list potential paths forward solutions.

    Time Management

  • Suggest, lead and/or participate in activities that promote growth for departmental needs

  • Manage schedules for junior staff

  • Coordinate team schedules and priorities

    Managing up. Work with Upper Management

  • Prepare documents, presentations, and/or other tools to increase department performance

  • Participate in departmental management and inter-departmental management meetings

  • Alert upper management if unexpected events arise and proactively assist in addressing issues

    New Technology Implementation

  • Research literature and external sources and identify new techniques and procedures that strengthen QPS’ capabilities.

  • Lead effort in implementation of new biological assays and processes, as well as in trouble-shooting various bio-chemical procedures.

    QA Engagement

  • Engage QA as needed; then prepare and shepherd QA-related documents as needed

    Leadership I

  • Supervise, train and mentor junior scientific staff. Be a resource for others

  • Coordinating daily/weekly activities to address changing priorities

    Leadership II

  • Proactively coordinate with client and internal resources to plan, design and conduct studies to beat timelines while providing industry leading efficiency and quality.

  • Prepare, and/or review study protocols that are scientifically sound and with compliance consideration.

  • Prepare materials for presentations and publications.

    Metrics

  • Number of runs performed (when appropriate)

  • Plate pass rate (when appropriate)

  • Communication quality and timeliness

  • Timelines met

  • Number of successful PI-ships

  • Findings per study rate

  • Quality of Sponsor interactions

  • Growth and contribution of Direct Reports

  • Quality of QA interactions

  • Quality and quantity of OPS contribution

  • Creativity and savvy of original assay designs

Knowledge / Skills / Abilities (i.e., knowledge of GLP regulations, operation of lab equipment, mathematical ability)

The successful candidate has both the desire and ability or aspiration to…

 

  • Communicate, clearly and cooperatively, in both oral and written forms.

  • Interact comfortably and constructively with supervisors, peers and juniors.

  • Work productively and professionally with teammates.

  • Work independently, and make independent decisions, as needed.

  • Recognize issues, solve problems and improve processes.

  • Understand and properly use chemical- and bio-hazards and comply with all laboratory safety methods, procedures and policies for their own safety and the safety of their workmates.

  • Know, adhere to and comfortably work within the GLPs and other corporate regulatory methods, procedures and policies.

  • Proficiently operate all relevant laboratory equipment.

  • Repeatedly execute laboratory methods, precisely and objectively.

  • Carefully collect and organize data per written methods.

  • Accurately reduce data and make calculations on forms and worksheets.

  • Prepare accurate, complete, comprehensive and properly formatted reports based on multiple different document formats.

  • Interact with personal and device-associated computers proficiently.

  • Employ office software packages, laboratory data management systems such as: Watson LIMS, ELN, and device-specific control interfaces with a high level of expertise.

Competencies (“soft skills”, traits, behaviors – i.e., adaptability, analytical thinking, tenacity, initiative, results orientation)

The successful candidate has both the desire and ability or aspiration to be…

 

  • Innovativeness

  • Independence

  • Concern for Impact

  • Interpersonal Awareness

  • Development Orientation

  • Initiative

  • Critical Information Seeking

  • Efficiency Orientation

  • Results Orientation

Education / Experience (minimum degree level and/or minimum number of years experience – including field of study and/or experience)

The successful candidate will hold an advanced degree in Biochemistry, Immunology, Pharmacology, Medical Technology, Biology or a related field as follows:

  • Ph.D.  Experience in an industry setting is beneficial

  • Master's Degree plus  ≥ 8 years relevant industry experience or 4 years CRO experience

  • Bachelor's Degree plus  ≥ 10 years relevant industry experience

  • Experience in a Regulated industry laboratory required

QPS, LLC is an Equal Employment Opportunity/Affirmative Action Employer.  In accordance with federal, state, and local laws, we recruit, hire, promote and evaluate all personnel without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, citizenship status, physical disability, protected veteran status, or any other characteristic protected by law. Job applicants and present employees are evaluated solely on ability, experience, and the requirements of the job. In addition, QPS, LLC is a federal contractor and desires priority referrals of protected veterans. 

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