Proclinical is advertising a vacancy for a Laboratory Technician II, Molecular Biology position with a leading pharmaceutical, biopharmaceutical, and medical device capability company. The organisation provides comprehensive platform capabilities in small molecule R&D and manufacturing, biologics R&D and manufacturing, and cell and gene therapy R&D. The Laboratory Technician will join this company in their office in Philadelphia. This is an exciting opportunity for an experienced and motivated applicant to develop a career in a truly revolutionary field.
The Technician will be responsible for performing assays and related activities within the testing facility to support manufacturing, as well as standard, and custom testing following cGMP Guidelines.
Job Responsibilities:
- Performs assays and lab procedures according to and in compliance with cGMP, CFR and/or PTC guidelines, and SOPs using appropriate laboratory techniques for the lab group assigned to.
- Performs laboratory support functions (e.g. materials stocking function) to help ensure lab is operational and contributes to the overall operations and to the achievement of departmental goals and objectives.
- Adheres to and understands the importance of Good Manufacturing Practices and standard operating procedures, including Good Documentation Practices.
- Performs basic Standard Operating Procedures (SOP's) revisions and Reagent Preparation Records as needed to accurately reflect testing procedures.
- Completes recording of data in instrument logbooks and lab cleaning forms to comply with regulatory requirements.
- Attend daily lab meeting on a regular basis and escalate issues/concerns at that forum to the supervisor for further investigation.
- Performs revisions to existing documents (e.g., BRs, RPs, SOPs) following the DCR process.
- Provides operational support for testing activities including reagent preparation, cleaning activities, and equipment maintenance.
- Supports technical transfer of assays from client to Technical Development to Operations; supports additional research level testing activities.
- Works on routine manufacturing assignments per written procedures, where ability to recognize deviation from accepted practice is required. Works with minimal supervision from supervisor or Technical Reviewer.
- Completes all requisite site-specific and job-specific training (e.g, Bloodborne Pathogens, Safety, GDP,
- Demonstrates technical knowledge and contributes to the overall operations.
- Contributes to the achievement of departmental goals and objectives.
- Understands the importance of the regulatory compliance requirements for the production of biologics.
- Authors Test Methods, Standard Operating Procedures (SOP's) and Reagent Preparation Records as needed to accurately reflect manufacturing processes.
- Ensures junior manufacturing personnel comply with standard operating procedures.
- Works on routine assignments as well as other assignments that are complex in nature where considerable judgment and initiative are required in resolving problems and making recommendations.
- Normally receives no instructions on routine work and general instructions on new assignments.
- Works under minimal supervision from the area supervisor or area leader.
- Serves to mentor junior staff.
- Ability to work in a team environment and independently as required
- Technician is required to work the assigned schedule
- May be required to work Overtime.
- Contributes to the overall operations and to the achievement of departmental goals
Skills and Requirements:
- A minimum of 2 or more years of relevant experience or equivalent
- Bachelors' degree with a major in Biology, Chemistry or related Science major including lab courses involving work with nucleic acids.
- Experience in aseptic processing techniques a plus.
- Ability to accurately and reproducibly perform arithmetic calculations including fractions, decimals and percentages and basic algebraic and geometric calculations.
- Clarity of vision at near and mid-ranges (less than 20 feet), depth perception and ability to identify and distinguish colors.
- Must be able to wear appropriate clean room attire (i.e. surgical masks) and all Personal Protective Equipment (PPE).
- Works in production environment with exposure to latex and bleach. Potential exposure to noise and equipment hazards (i.e. vacuum pumps, pressurized vessels), dangerous materials (i.e. chemicals, solvents, pathogens), freezer burns, allergens and strong odors.
- Based on work assignment, may be recommended to have medical testing in accordance with the company's Occupational Health Program.
- Demonstrable multitasking, project management, and execution skills.
- Good interpersonal skills, including communication, presentation, persuasion, and influence.
- Good organisational skills, including efficiency, punctuality, and collaboration in a team environment.
- Proficiency with computer skills, such as MS Office.
Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.
In case you have difficulty in applying or if you have any questions, please contact Mike Raletz at +267-428-7770 or upload your CV on our website - www.Proclinical.com.
A full job description is available on request.
Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.
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