• WuXi AppTec
  • Philadelphia , PA
  • Pharmaceutical/Biotechnology
  • Full-Time
  • 1103 Market St

Overview

Technician in Remote Viral Clearance and AKTA Maintenance, who works under the guidance of a Supervisor/Manager. Performs 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). May serve as a point person to help organize workflow, resources, and day-to-day lab responsibilities. Sufficiently competent in several Downstream Purification and most general lab skills to serve as a Qualified Trainer as needed.

Responsibilities

* 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 WuXi's Good Documentation Practices
* Basic maintenance and inter-study changeover of AKTA Explorer, Avant 150 and Avant 25 FPLC systems.
* Supports 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.
* Works with Remote Viral Clearance Manager and other colleagues to ensure sufficient resources are allocated to complete tasks in a timely manner.
* Preparation of 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
* Perform job specific tasks in compliance with applicable Regulations, International Standards, and WuXi AppTec Policies and Standard Operating Procedures.
* May be required to work overtime, holidays, and weekends as required.
* Contributes 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.

Qualifications

Experience / Education

* At least 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
* Previous Laboratory experience with a strong emphasis on column chromatography and nanofiltration.
* Must have AKTA FPLC and Unicorn Software experience

Knowledge / Skills / Abilities:

* 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
* Proficient in Oral & Written communication skills
* Proficient in Microsoft (Excel, Word, Outlook)

Physical Requirements:

* Must be able to work in an office environment with minimal noise conditions.
* Must be able to work in lab setting with biohazards and various chemicals
* Must be able to wear appropriate PPE
* Must be able to work in environment with variable noise levels
* Ability to stand /sit/walk for long periods of time
* Ability to Lift 20 lbs. routinely
* Ability to crouch, bend, twist, and reach
* Ability to push/pull 20 lbs. routinely/ often / occasionally
* Clarity of vision
* Ability to identify and distinguish colors
* Must be able to perform activities with repetitive motions
* Ability to climb ladders / stairs / scaffolding
* Ability to work in variable temperatures high to freezing

An Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability


Associated topics: alcohol test, assistant, lab, lab support, laboratory, laboratory technologist, qc, quality, quality control, scientific associate

* The salary listed in the header is an estimate based on salary data for similar jobs in the same area. Salary or compensation data found in the job description is accurate.

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