Lab Assistant

Planet Pharma; Wayne (PA); Sur place; USD 48 000 - 58 000; Plein temps

Résumé du poste

Planet Pharma is seeking a scientist to assist in development and execution of analytical methods for biotherapeutics. You will work under minimal supervision on method feasibility, development, validation, and transfers in both R&D and cGMP environments, interfacing with clients to interpret data and report results.

You will perform routine testing using HPLC, CE, immunoassays and other analytical techniques, review data with senior staff, and contribute to final study reports while maintaining

Qualifications

• Bachelor's degree in Chemistry/Biotechnology or related field; MS/PhD preferred.
• Minimum 3 years of relevant CRO/pharma industry experience in characterization and analysis of biotherapeutics.
• Equivalent mix of education/experience may be accepted.

Responsabilités

• Perform and troubleshoot analytical experiments under cGMP and R&D environments.
• Conduct chromatographic analyses, ELISA/immunoassays, and amino acid analyses with high reliability.
• Review and present experimental data; prepare high-quality reports and integrate subcontractor data.
• Assist in SOPs, CTMs, and testing documentation; ensure timely reporting.

Connaissances

Analytical chemistry

Biotherapeutics characterization

Data analysis

Regulatory compliance

Formation

Bachelor's degree in Chemistry/Biotechnology

M.S. or Ph.D. preferred

Outils

HPLC

CE

Plate Reader

Spectrophotometer

Description du poste

BASIC SUMMARY

Assist in the development and execution of methods related to the testing and characterization of biotherapeutics using analytical instrumentation and methodologies. Under minimal supervision, may be responsible for method feasibility, method development, method optimization, method transfers, method qualifications, method validations and routine testing under both R&D and cGMP environments. Additionally, will be responsible for client interaction, interpretation and reporting of data of assigned research projects.

ESSENTIAL DUTIES AND RESPONSIBILITIES

• Perform and troubleshoot laboratory experiments, tests, and procedures within accepted regulatory compliance for the characterization and analysis of biotherapeutics through use of analytical testing and characterization instrumentation and methodologies.
• Perform routine testing techniques, such as the following, with a high degree of reliability, efficiency and accuracy: o Chromatographic Analyses including Process Related Residuals o Quantitative Monosaccharide and Sialic Acid Analysis o ELISA/ Immunoassay Analyses o Process Residual/Drug Product Excipient Analyses o N- Terminal Sequencing o Amino Acid Compositional Analysis/Extinction Coefficient Determination o Use of Empower and Chromelion Software
• Review, interpret, analyze, evaluate, integrate and present experimental data with the assistance of senior technical staff as appropriate.
• Perform tabulation and statistical analyses of study data, as required.
• Prepare high quality final reports appropriate for assigned study, including integration of supporting subcontractor(s)’s reports into final reports as required, with assistance from Senior personnel.
• Assist in the technical review of procedures and data and documentation.
• Assist in long-term projects (redesign of SOPs, CTMs, basic research procedures or report formats).
• Interact with clients regarding project design, scheduling and conduct as requested.
• Collaborate with appropriate departments to coordinate performance of projects, discuss issuesand prepare reports.
• Attend scientific meetings, conferences and training courses to enhance job and professional skills.
• For both cGMP and R&D grade routine testing, generate analytical data and technical report(s) on-time with respect to internal and client deadlines. Maintain a weekly schedule to ensure all timelines are met.
• Actively participate in laboratory instrumentation and equipment preventative maintenance and qualification programs.

JOB DESCRIPTION

• Maintain a safe working environment by adhering to Company policies or procedures. Actively participate in laboratory maintenance.
• Comply with all pertinent regulatory standards regarding environs, equipment and testing services.
• Perform equipment troubleshooting and repair (as applicable) with minimal guidance from senior members of the group.
• Make detailed observations and maintain clear, accurate and timely documentation of all laboratory work.
• Independently compose quality documentation including deviation reports and change control documentation with no/minimal guidance.
• Create, review and edit SOPs, protocols and other data Forms and testing documentation.
• Follow all SOPs, CTMs and cGMP as they relate to specific tasks.
• Assist in training and provide technical support of Junior staff.
• Participate in transferring and training of analytical technical staff on methodology for which qualification has been successfully completed.
• Maintain up to date training records on all procedures and protocols applicable to work duties.
• Ability to work in a structured and regulated environment
• Work productively in group situations as well as independently
• Perform all other related duties as required.

QUALIFICATIONS

• Education: Bachelor’s degree (B.A. /B.S.) or equivalent in Chemistry/Biotechnology or related scientific discipline. M.S. or Ph.D. preferred.
• Experience: Minimum 3 year’s relevant experience within a contract research, academic or pharmaceutical industry, including experience in the core competencies of characterization and analysis of biotherapeutics.
• An equivalent combination of education and experience with contract research or the pharmaceutical industry may be accepted as a satisfactory substitute for the specific education and experience listed above.

Certification/Licensure: None.

Other: Demonstrated knowledge of cGMPs or regulatory affairs pertaining to the pharmaceutical and biological industries is preferred. Ability to work on problems of moderate scope where analysis of situation or data requires a review of identifiable factors. Exercises judgment within defined procedures and practices to determine appropriate action. Demonstrated ability to operate typical laboratory equipment, specifically HPLC, Plate Reader, CE, spectrophotometer and other laboratory equipment required. Ability to handle multiple projects, prioritize work and meet deadlines within a cGMP environment. Capable of data interpretation of basic characterization and analysis of biotherapeutics (glycoproteins and peptides) using analytical laboratory tools and methodologies Capable of anticipating and recognizing potential problems. Demonstrated independent analytical and problem-solving abilities. . Must possess excellent interpersonal skills to maintain communication across functional groups. Ability to collaborate effectively within a group environment. Able to communicate (verbal and written) effectively in a small group or one on one setting. Computer proficiency in MS Word, Excel, Outlook, instrumentation and analysis software. Ability to understand and use internal software programs such as LIMS required.

PHYSICAL DEMANDS

• Must be able to remain in a stationary position 50% of the time while performing laboratory tasks.
• Regularly observes, inspects, and interprets laboratory experiments, requiring close vision and the ability to adjust focus and detect and differentiate colors.
• Frequently required to walk, sit, stand, reach with hands and arms, and use hands to finger, handle, or feel objects, tools, or controls.
• Frequently and accurately operate laboratory pipettes.
• Regularly lift and/or move up to 10 pounds and may occasionally lift and/or move up to 50 pounds.
• Regularly operates a computer and other office productivity machinery, such as a calculator, copy machine, and computer printer.
• Must regularly communicate with employees; must be able to exchange accurate information.

WORK ENVIRONMENT

• General laboratory working conditions.
• Regularly wears protective clothing (cap, gloves, scrubs, lab coat, and safety glasses).
• Regularly works with or near toxic or caustic chemicals.
• May be exposed to fumes or airborne particles.
• Regularly works in a chemical fume hood.
• Occasionally works near moving mechanical parts.
• Frequently works with biohazards.
• May be exposed to unpleasant odors.
• The employee may work with sharp objects (i.e. needles, glass pipettes, pipet tips).
• The noise level in the work environment is usually moderate.

COMMENTS

This position may require overtime, weekend, holiday, and/or after hours shift coverage, as needed.

Pay ranges between 35-42.35/hr for this position