Lab Tech III AKTA
Proclinical is currently recruiting for a Lab Tech III for a global pharmaceutical company located in Philadelphia, PA. Successful candidate will perform studies and equipment change over according to, and in compliance with, Good Laboratory Practices (GLP), Good Documentation Practices (GDP), Code of Federal Regulations (CFR) and/or Points to Consider (PTC) guidelines and Standard Operating Procedures (SOPs).
- Conduct viral clearance studies and lab procedures as outlined in testing record and regulatory guidelines.
- Accurately complete testing records and other required documentation according to company's Good Documentation Practices.
- Basic maintenance and inter-study changeover of AKTA Explorer, Avant 150 and Avant 25 FPLC systems.
- Support the team execution of nanofiltration and column chromatography steps in the performance of viral clearance studies. Report observations of ongoing studies to Study Director or Manager.
- Work with Remote Viral Clearance Manager and other colleagues to ensure sufficient resources are allocated to complete tasks in a timely manner.
- Prepare reagents needed to carry out AKTA maintenance and other associated duties.
- Maintenance of equipment and cleaning logs.
- Review of Change Controls when appropriate.
- May aid in the training of new employees as a qualified trainer.
- Participate in the issuance of nonconformance reports and laboratory investigations as required.
- Verify that all executed Test Methods are accurate and complete prior to submission for review.
- May be called upon to write Testing Methods and Standard Operating Procedures.
- Participate in internal and external Research and Development (R&D) projects and collaborations/ validations relevant to the Remote Viral Clearance Group.
- May be required to work overtime, holidays, and weekends as required.
- Contribute to the overall operations and to the achievement of departmental goals.
- Thorough understanding of Good Laboratory Practices and Good Documentation Practices.
- Perform other duties as assigned and may be required to assist other departments as needed.
Skills and Requirements:
- 2+ years of relevant experience in downstream purification, chromatography, nanofiltration, or combination thereof.
- Bachelors' degree in Biological Sciences or science related field or equivalent experience required.
- Previous Laboratory experience with a strong emphasis on column chromatography and nanofiltration.
- Must have AKTA FPLC and Unicorn Software experience.
- Possesses thorough knowledge of functional equipment.
- Knowledge of GDP, GLP and cGMP preferred.
- Effective multi-tasking skills and time management required.
- Ability to evaluate technical data and record data accurately and legibly.
- Ability to understand and follow verbal and demonstrated instructions.
- Ability to clearly express and exchange ideas by means of verbal and written communication.
- Ability to work effectively as part of a team and exhibit effective interpersonal skills.
- Ability to work under limited supervision and to handle problems of a difficult nature.
- Ability to crouch, bend, twist, and reach
- Ability to push/pull 20 lbs. routinely/ often / occasionally
- Proficient in Oral & Written communication skills.
- Proficient in Microsoft (Excel, Word, Outlook).
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 call Dominic Santoro at (+1) 215-531-5280 or upload your resume 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.
Proclinical Staffing is an equal opportunity employer.