Planet Pharma Jobs in Usa

Lab Assistant – Dover, DE

Contract: 3 months, contract-to-hire

Pay Rate: $24–$26/hr. DOE

Must-Have Skills: LC-MS, GC-MS, and sample preparation

Job Description Summary

The Instrument Readiness Specialist provides operational and technical support for LC-MS, HPLC, and GC-MS laboratories at Customer facilities in Delaware. This role includes routine instrument operation, sample preparation support, preventive maintenance, performance monitoring, and compliant documentation following Customer SOPs, validated methods, and regulatory requirements.

The position requires strong attention to detail, the ability to work independently in a laboratory environment, and effective collaboration with Customer scientists and project stakeholders to ensure reliable analytical operations.

Job Responsibilities

• Provide hands-on operational support for LC-MS, HPLC, and GC-MS instrumentation at Customer facilities, including the DuPont Experimental Station (Wilmington, DE) and New Castle, DE, following SOPs, validated methods, and compliance requirements.
• Perform routine operation of analytical systems: instrument startup/shutdown, method loading, sequence/sample queue setup, data acquisition, and basic system checks.
• Support sample preparation activities: dilution, extraction, filtration, derivatization (as applicable), reagent preparation, consumable selection, and proper sample labeling per Customer-approved procedures.
• Monitor and assess instrument performance: chromatographic stability, pressure/flow profiles, vacuum system performance, detector response, ion source condition, mass accuracy, and column integrity; promptly communicate deviations or abnormal trends.
• Conduct routine preventive maintenance and system upkeep: solvent/mobile phase preparation, degassing, tubing/fitting inspection, leak checks, column flushing, injector/ion source cleaning, vacuum pump monitoring, tuning verification, and routine calibration per manufacturer and Customer requirements.
• Support day-to-day lab operations: equipment readiness, workflow coordination, and effective communication with project leads and local stakeholders.
• Comply with all site-specific safety, laboratory access, emergency response, and environmental health requirements; participate in required safety, EHS, and instrumentation training programs.
• Maintain accurate documentation of instrument usage, maintenance activities, experimental observations, deviations, and corrective actions per Customer practices and data integrity standards.
• Prepare analytical summaries, instrument performance logs, and status updates as requested.
• Ensure proper archiving of raw data, chromatographic results, mass spectral files, electronic logs, and supporting documentation within Customer systems.
• Document and escalate deviations, nonconformances, or unexpected findings promptly; support quality assurance, audit readiness, and inspection activities as requested.

Note: Management reserves the right to assign or reassign duties at any time.

Critical Skills

• Working knowledge of LC-MS, HPLC, and GC-MS instrumentation and laboratory workflows
• Ability to operate analytical instruments according to SOPs, validated methods, and compliance requirements
• Strong attention to detail and commitment to data integrity
• Ability to monitor instrument performance, identify deviations, and escalate issues
• Hands-on experience with routine instrument maintenance, troubleshooting, and preventive care
• Strong organizational and time-management skills in a fast-paced laboratory environment
• Ability to follow instructions and adhere to established procedures
• Effective communication and collaboration with scientists, vendors, and site stakeholders
• Ability to work independently while supporting team objectives

Basic Qualifications

One of the following education and experience combinations:

• Bachelor’s degree in chemistry, biology, biochemistry, or related discipline + 3+ years of relevant lab experience supporting analytical instrumentation
• Associate’s degree in a scientific/technical discipline + 5+ years of hands-on experience supporting LC-MS, HPLC, or GC-MS systems
• High School diploma or GED + 7+ years of directly related laboratory experience in an analytical environment

Additional Requirements:

• Basic proficiency with Microsoft Office (Excel, Word, Outlook, PowerPoint)

Preferred Qualifications

• 5+ years supporting LC-MS, HPLC, and/or GC-MS in industrial, academic, or regulated labs
• Master’s degree in chemistry, analytical science, or related discipline
• Experience in SOP-driven or regulated labs (GLP, GMP, or similar)
• Familiarity with analytical data systems, ELNs, and data archiving
• Demonstrated ability to support audits, inspections, or QA activities

Working Environment

• Work in laboratory and controlled environments requiring PPE (lab coat, safety glasses, etc.)
• Fast-paced environment with high job completion demands
• Stationary work >25% of the time; occasional movement between labs, corridors, adjoining rooms, and buildings
• Frequent bending, squatting, stretching, and reaching for instrument operation
• Occasionally lift/move up to 25 pounds (potential up to 50 pounds)
• Vision requirements: close-range observation, color vision, peripheral vision, depth perception, ability to adjust focus
• Occasional use of computers and office machinery
• May handle hazardous waste per regulations
• Exposure to lab hazards: extreme temperatures, biological materials, hazardous chemicals
• May require medical clearance, respiratory protection training, and respirator fit testing

Responsible for the dispensing of raw materials liquids and powders (hazardous and non-hazardous), acids/bases, under cGMP conditions to support the manufacture of therapeutic proteins (API)

Individual will be required to perform and monitor all dispensing processes and weighs, including liquid, powder (hazardous and non-hazardous), acids and bases. All processes will be completed per cGMP guidelines to support the manufacture of therapeutic proteins (API).

• Required to attain a basic understanding of cGMP compliance while training under close supervision, demonstrating aseptic technique and cross contamination awareness in handling of products and materials.

• Expected to follow and adhere to all written procedures (SOPs), monitor equipment and processes, perform basic laboratory tasks, including pH, conductivity, and sampling as required. All tasks will be completed while gowned and wearing required PPE while working in a Class C environment.

• Expected to execute process recipes.

• Ability to qualify for all assigned tasks and maintain individual training plan.

• Ability to qualify and perform required functions and scheduled cleans on all Dispensing equipment through routine cleaning and sanitization.

• Perform peer, First Level Reviews of completed eDispense orders/kits, upon completion of WBT and LQM/PM signoff by area trainer.

• Ability to report to production via written and electronic documents in accordance with current good manufacturing practice (cGMP) and good documentation practice (GDPs). Complete documentation reviews as appropriate.

• Prepare materials for transport and delivery to manufacturing suites. Perform material movements both physically and in software systems.

• Participate in Safety Inspections and submit safety observations to provide safer working conditions for self and others.

• Administrative tasks to include attendance at shift exchange and required meetings, sending/receiving of emails, and participation in assigned projects.

• Performs other duties as they are assigned to support Logistics Team.

Associates Degree and/or equivalent experience

Job Summary

The Analytical Operations (AO) department is seeking an enthusiastic and motivated Research Associate to be part of our analytical testing team. This role utilizes analytical tools to characterize the physical and chemical properties of biopharmaceutical products. This work is essential for supporting both process development and validation, and for determining product quality, purity, and stability.

About Analytical Operations (AO)

Analytical Operations (AO) is a non-GMP department within the PTDA Analytical Development Quality Control organization, dedicated to advancing the company's R&D pipeline. The department is focused on providing technical expertise and analytical support for early-stage research, development, and process validation for departments across the South San Francisco campus as well as other internal sites. This support is delivered through high-throughput testing, automation, effective data management, and robust business processes, all of which facilitate timely and scientifically informed decisions.

Key Responsibilities

• Conduct routine and non-routine analytical testing using a variety of physiochemical techniques (U/HPLC, icIEF, CE-SDS, and LC-MS), according to established protocols.
• Maintain accurate, detailed documentation of assays and data results in an Electronic Laboratory Notebook (ELN), strictly adhering to ALCOA+ principles.
• Perform essential lab support tasks, including stocking consumables, checking for expired reagents and hazardous waste, and de-icing freezers.
• Comply with laboratory best practices, safety guidelines, and internal and regulatory standards.

Job Requirements

• Bachelors degree with a minimum of 3 years of relevant experience, or a Masters degree with laboratory experience in Chemistry, Biochemistry, or a related scientific field. Experience in the biotech or pharmaceutical industry is preferred.
• Must be highly organized, detail-oriented, and self-motivated, with a proven ability to successfully manage multiple tasks, both independently and collaboratively as part of a team
• Hands-on experience with HPLC/UPLC, CE, or LC-MS is required.
• Strong written and verbal communication skills are a must, with the ability to present technical work clearly.
• Knowledge of GMP compliance, experience with ELN, and intermediate proficiency in Microsoft Excel is highly desirable.
• Ability to lift 20 lbs. for laboratory-related tasks.

An Archivist Associate is responsible for: developing and applying acquired job skills needed to support the receipt, login, distribution, disposal, and general oversight of materials submitted for archival purposes; managing study-related records, biological specimens, and study samples; and supporting the archival process by storing, distributing, and maintaining materials within the archive management system.

Essential Duties and Responsibilities

-Perform and document all procedures, materials, and results in compliance with applicable regulatory standards (protocols, methods, SOPs, etc.).

- Identify and communicate any issues with data to management.

- Follow archive security procedures and maintain the integrity of archived materials.

- Perform tasks including but not limited to, organizing, filing, retrieving facility and study related records, biological specimens, and samples.

-Assist internal and external customers with requests for current and finalized study materials under the control of the Archives department.

-Utilize the archival management system for indexing and maintaining materials in the archives or records management area.

- Review departmental and study specific data to ensure adherence to SOPs,

methods/protocols, industry standards, and regulatory requirements, as applicable, in timely manner.

- Follow regulatory requirements for retention of archived materials, in accordance with SOPs and protocols.

-Perform all other related duties as assigned

Minimum Qualifications

Education and Experience: HS/GED/Associate’s degree with 1-2 years of relevant experience.

Certification/Licensure: None.

Other:

- Ability to communicate verbally and in writing at all levels inside and outside the organization.

-Basic familiarity with Microsoft Office Suite.

- Computer skills, commensurate with Essential Duties and Responsibilities, including the ability to learn a validated system.

- Demonstrated effective communication and organizational skills.

Role is with a formulation and delivery team. Will work with research scientists in developing next generation herbicide products and in supporting both R&D activities, and to some extent, commercially launched products.

Evaluates the chemical and physical properties of various organic and inorganic substances in order to investigate their applications in formulated products.

Requires a bachelor's degree and at least 1 year of experience in the field or in a related area.

Has knowledge of commonly used concepts, practices, and procedures within a particular field.

Relies on instructions and pre-established guidelines to perform the functions of the job. Works under immediate supervision. Typically reports to a supervisor or manager.

Diligently records all laboratory tasks performed and related procedures and findings in electronic laboratory notebook system.

Requires hands-on lab experience and interest in doing lab work.

Will work on various projects and follow SOP's and basic lab techniques, using equipment that includes - e.g., pH meters, mixers/agitators, homogenizers, and milling equipment.

***Rheometer and interfacial measurement experience is a plus, as is proficiency in chemistry/chemical engineering principles, including mass-balance calculations.

Some industrial experience in formulation development preferred -e.g., with pesticides, foods, cosmetics, consumer products, and/or paints & coatings.

Role:

The Intake Specialist role works to support the Patient Assistance Program (PAP) through providing initial triaging of patient applications, including data entry and coordination of work through the appropriate channels as determined by established business rules.

Responsibilities:

•Completes the intake process of all applications into Customer Relationship Management System (CRM)

•Associates and tags all images to the patient, data enters all information including patient demographic information, physician information, drug information, and all relevant application data such as income information, household information and insurance information into the CRM

•Conducts initial assessment of application for missing information and completes missing information patient outreach process to obtain required data

•Completes initial assessment of simplified application

•Identify appropriate work flow based upon business rules

•Collaborate cross functionally to ensure processes are followed according to business rules and policies

•Ensure all patient cases are documented in the CRM in accordance with all business rules and policies

•Conduct renewal and year end recertification’s process as determined by the Patient Assistance Program

•Readily assists on special project within job scope to improve reimbursement optimization when requested by management

Manages incoming and outgoing mail

Qualifications:

•High school diploma or equivalent required. College or a 2-year Associate Degree is preferred

•A minimum of 1-3 years’ experience within an office or administrative setting

•Exposure to core insurance (Medical and Pharmacy Benefit) knowledge a plus

•Strong attention to detail and work independently with minimal direction

•High quality customer service skills

•Ability to express ideas clearly in both written and oral communications

Miami, FL - 100% on site Monday-Friday

Study coordinator to support ongoing large clinical study in US. Completes all paperwork required to capture all data as specified by a study protocol, and for ensuring subject safety, understanding, and cooperation during the study process. Interacts with the research site team and other interdepartmental staff. Engages in the entire site operations process, which includes recruitment, enrollment, retention of study participants, data entry and query resolution.

Essential Functions:

• Conducts clinical studies according to FDA/GCP and ICH regulations and guidelines.

• Provides medical care to patients, always ensuring patient safety comes first.

• Schedules subject visits within protocol windows, ensuring scheduling capacity is maximized.

• Performs all defined study activities (i.e., informed consent, screening, and protocol procedures which include but not limited to vital signs, pregnancy tests, height, weight, ECG's, etc.).

• Records all patient information and results from tests as per protocol on required forms.

• Where required, may complete IP accountability logs and associated information.

• Reports suspected non-compliance to relevant site staff.

• Ensures that IRB approval is obtained prior to study initiation and IRB requirements are met throughout the study.

• Promotes the company and builds a positive relationship with patients to ensure retention.

• Attends site initiation meetings and all other relevant meetings to receive training on protocol.

• May be required to call patients, do patient bookings and follow-up calls to confirm bookings or provide information or results.

• Logs/completes information on sponsor systems and ensures all information provided is accurate (i.e., case report forms, EDC, etc.) and ensures it is completed within timeframe.

• Gathers and maintains source documents, updates patient files and notes, always ensuring relevant and most up to date information is recorded.

• Adheres to company COP/SCOP.

• May be required to dispose of waste according to standards and assist in keeping a general neat appearance of the facility.

Education and Experience:

• Bachelor's degree or equivalent and relevant formal academic / vocational qualification in the clinical / medical field

• Must hold a valid nursing license (RN, LVN, LPN) within the country operating. Must be registered with local health care authority.

• Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 2+ years’).

Knowledge, Skills and Abilities:

• Solid understanding of the clinical research process (i.e., GCP, SOPs, informed consent, safety monitoring, etc.)

• Capable of working independently, analyzing and working with attention to detail, processing and prioritizing sensitive complex information and problem solving

• Demonstrated ability to exercise discretion and sound judgement

• Good decision-making, negotiation and influencing skills

• Good communication skills and English fluency will be an advantage

• Good organizational skills

• Good proficiency in basic computer applications

• Good interpersonal skills to work in a team environment

The Intake Specialist role works to support the Patient Assistance Program (PAP) through providing initial triaging of patient applications, including data entry and coordination of work through the appropriate channels as determined by established business rules.

Responsibilities:

•Completes the intake process of all applications into Customer Relationship Management System (CRM)

•Associates and tags all images to the patient, data enters all information including patient demographic information, physician information, drug information, and all relevant application data such as income information, household information and insurance information into the CRM

•Conducts initial assessment of application for missing information and completes missing information patient outreach process to obtain required data

•Completes initial assessment of simplified application

•Identify appropriate work flow based upon business rules

•Collaborate cross functionally to ensure processes are followed according to business rules and policies

•Ensure all patient cases are documented in the CRM in accordance with all business rules and policies

•Conduct renewal and year end recertification’s process as determined by the Patient Assistance Program

•Readily assists on special project within job scope to improve reimbursement optimization when requested by management

Manages incoming and outgoing mail

Qualifications:

•High school diploma or equivalent required. College or a 2-year Associate Degree is preferred

•A minimum of 1-3 years’ experience within an office or administrative setting

•Exposure to core insurance (Medical and Pharmacy Benefit) knowledge a plus

•Strong attention to detail and work independently with minimal direction

•High quality customer service skills

•Ability to express ideas clearly in both written and oral communications

Shift Schedule:

Variable, including weekends and evenings as-needed, typically 8hr duration, always coordinated before shift assignment. The hours will be variable depending on projects at the clinic, and may include days for what would typically be screening assessments or admission assessments, or evenings/weekends for study-related procedures such as dosings, ECG review and interpretation, lab review and interpretation.

Description:

• The duties may include screening procedures such as routine physical examinations of healthy volunteers, ECG interpretation, review of labs, eligibility assessment for prospective study participants, management of adverse events, on-site supervision of investigational product dosing, and related duties.

• Delegates study responsibilities as appropriate to trained study staff

• Possesses a working knowledge of GCP/ICH guidelines, Clinic SOPs, QA/QC procedures, and Investigator 1572 Form

• Reviews Investigator’s Brochure prior to performing any study procedures

• Performs all study responsibilities in compliance with the IRB approved protocol

• Reviews screening documentation and approves subject for admission to study

• Reviews admission documentation and approves subject for randomization

• Interprets ECGs within agreed Sponsor timeline

• Documents all findings in subject specific source documents

• Provides ongoing assessment of the study subject/patient to identify Adverse Events

• Ensures proper documentation and reporting of all Adverse Events and Serious Adverse Events

• Reviews and evaluates all study data and comments to the clinical significance of any out of range results

• Performs physical examinations as part of screening evaluation and active study conduct

• Provides medical management of adverse events as appropriate

• Completes all study documentation in accordance with the study specific requirements

• Communicated with Sponsors and auditors as requested

• Participates in on-call activities as required to ensure adequate medical coverage

• Monitors safety and well-being of study participants at all times

• Provides coverage for the Clinic Principal Investigator

•They should be able to work and thrive in a team-based environment.

The Media Prep team within the STL Transformation Production Team is seeking a highly motivated and fast-paced individual to participate in the critical work to support the pipeline by supplying sterile agar and liquid products to customers around the world in a timely manner. The successful candidate will work with chemical components and different forms of equipment. Desire to work within a team environment is essential to deliver a high-quality product to the customer in a timely manner.

Required Skills: A Bachelor's degree in biology, chemistry, cellular biology or related field is required. Experience working in a laboratory environment is highly desirable. Attention to detail, database experience, ability to work in a team setting, and strong communication and organizational skills are essential. Sterile technique experience is a plus. Must be willing to work up to a 40 hour week with shift times at the discretion of the manager dependent upon production needs.