Proclinical is currently recruiting for a Technician in Molecular Genetic Sequencing with a pharmaceutical company located in Philadelphia, PA.
- 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, Good Laboratory Practices, and standard operating procedures, including Good Documentation Practices. Has a working knowledge of the regulatory compliance requirements for the testing of biologics.
- Performs all Standard Operating Procedures (SOP's) and revisions, and Reagent Preparation Records as needed to accurately reflect testing procedures.
- Reviews data entries in lab notebooks, instrument logbooks, and lab cleaning forms to comply with regulatory requirements.
- Creates testing documents and performs revisions to existing documents (e.g., BRs, RPs, SOPs) following the DCR process.
- Initiating and assisting the completion of NCEs and LIRs within the Master Control environment with minimal assistance of a technical reviewer or supervisor.
- Maintains a working knowledge of the primers/probes/standards/reagents used for testing and preparing them when needed.
- Provides operational support for testing activities including reagent preparation, cleaning activities, and equipment maintenance. Demonstrates innovative technical knowledge and significantly contributes to the overall production efficiency.
- Supports technical transfer of assays from client to Technical Development to Operations; supports additional research level testing activities. Demonstrates strong oral and written communication skills and actively contributes to training, report generation and documentation.
- Analyzes scientific data with accuracy and precision, critical at time of processing.
- Ensures junior manufacturing personnel comply with Standard Operating Procedures (SOP's) and Batch Records and that training records for junior staff are accurate and current.
- Authors and reviews non-compliance reports, laboratory investigation reports, SOP revisions, and Batch Record revisions to ensure documents are accurate and complete.
- Functions as area operational leader providing both technical leadership as well as leadership to staff in area with respect to work assignments and schedules.
- Demonstrates strong oral and written communication skills and actively contributes to training, report generation and documentation.
- Works with senior personnel to improve and optimize molecular methods.
- Evaluates operating procedures for accuracy and efficient operation and makes corrections as necessary.
- Perform job specific tasks in compliance with applicable Regulations, International Standards, and our Policies and Standard Operating Procedures.
Skills and Requirements:
- A minimum of 4 or more years of relevant experience or equivalent
- Bachelor's degree with major in Biology, Chemistry or related Science major. Relevant prior work experience with nucleic acid techniques including end-point PCR, quantitative PCR, and gel electrophoresis required.
- Experience in PCR primer design, hybridization and blotting techniques, and data analysis a plus.
- 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.
- Proficient in Verbal & Written communication skills.
- Proficient in Microsoft (Excel, Word, Outlook). Must be able to work in an office environment with minimal noise conditions.
- Must be able to work in Lab setting with Biohazards /various Chemicals.
- Ability to stand /Sit/walk for long periods of time.
- Ability to identify and distinguish colors.
If you are having difficulty in applying or if you have any questions, please contact Mike Raletz at 267-428-7770.
ProClinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.
Proclinical Staffing is an equal opportunity employer.