Scientist I, Quality Control (4964)

Job Title - Scientist l, Quality Control

Work Location - Cranbury NJ

WuXi Biologics is a is a leading global open-access biologics technology platform offering end-to-end solutions to empower organizations to discover, develop, and manufacture biologics from concept to commercial manufacturing. WuXi Biologics' achievements are a direct result of the efforts made by our employees. We have built an extraordinary team motivated by our PROUD culture of Passion, Reward, Opportunity, Unity, and Determination. WuXi Biologics offers exciting job opportunities and careers around the globe. We currently employ over 12,000 people and provide services to more than 600 customers worldwide, including all the top 20 biopharmaceutical companies.

Job Summary

Rigorous, independent scientist who demonstrates innovative technical knowledge and significantly contributes to the overall operations of the lab. Demonstrates strong oral and written communication skills and actively contributes to training, report generation and documentation. Demonstrates excellent communication skills, and contributes to the achievement of company and departmental goals and objectives. Performs assays according to and in compliance with Good Laboratory Practice (GLP), current Good Manufacturing Practice (cGMP), Code of Federal Regulations (CFR) and/or Points to Consider (PTC) guidelines and Standard Operating Procedures (SOPs).

Responsibilities

• Demonstrates innovative and independent scientific technical expertise and proficiency in scientific theory and rigorous practical application in the completion of laboratory procedures and development of new procedures as it relates to Analytical methods, and cell based potency assays.
• Establish, develop, and/or optimize analytical methodology to test the potency of protein products (in-process and final) using binding or cell-based assays, understand and able to perform various microbiological tests as needed.
• Designs and independently conducts scientific development projects from inception to completion
• As assigned by management, supervises, plans, and reviews operations for assigned staff, including responsibility for training, managing, and evaluating, as well as coordinating, scheduling, and assigning work
• Recommends hire/transfer/promotion/discharge and acts on employee problems
• Effectively communicates and defends science through written and verbal communication
• Effectively communicates with internal departments to assure that appropriate testing information is effectively communicated and documented
• Provides training on areas of technical expertise and compliance issues relevant to the lab setting
• Conducts and directs assays and lab procedures according to and in compliance with GLP, cGMP, CFR and/or PTC guidelines and SOPs
• Prepares protocols, final reports, investigations, and deviations as needed
• Conducts critical review of results and reports data appropriately
• As assigned by Management, supervises personnel and assumes all associated responsibilities
• As assigned by Management, acts as Study Director, Lab Manager, Function Lead and/or Principal Investigator for specific assays and assumes all associated responsibilities
• Effectively interacts with clients to address scientific and project-related issues
• Maintains a laboratory notebook for Research & Development activities as required; reviews and signs laboratory notebooks
• Follows all general and laboratory SOPs
• Works on routine assignments per written procedures, where ability to recognize deviation from accepted practice is required.
• Normally receives minimal instructions on routine work and detailed instructions on new assignments.
• Ability to work in a team environment and independently as required
• May be required to work Holidays and weekends
• Contributes to the overall operations and to the achievement of departmental goals

Qualifications

Experience / Education

• Bachelor or advanced Graduate degree (MS/PhD) in Biology, Cell Biology, or equivalent field.
• A least 8+ years of relevant experience or equivalent for Bachelors', 5+ years for Master's in the Quality Control or related field or equivalent experience.

Knowledge / Skills / Abilities

• Extensive experience in mammalian cell culture
• Strong Technical and Scientific knowledge of real time PCR, protein based assays (i.e. ELISA), and cell based potency methods.
• Experience in assay development and optimization
• Ability to use proficiently advanced laboratory equipment, such as, but not limited to; automated cell counters, plate readers, real time PCR instruments, etc.
• Effective multi-tasking skills and time management required
• Ability to evaluate technical data and record data accurately and legibly
• Ability to use judgment as dictated by complexity of situations
• Ability to understand and follow verbal and demonstrated instructions
• Ability to clearly express and exchange ideas by means of detailed 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

Physical Requirements

• Must be able to work in Lab setting with Biohazards /various Chemicals
• Must be able to wear appropriate PPE.
• Must be able to work in environment with variable noise levels.
• Ability to stand or sit for long periods of time.
• Ability to perform light physical work, lifting up to 20 pounds as needed.
• Ability to crouch, bend, twist, and reach.
• Clarity of vision at all ranges, depth perception, and ability to identify and distinguish colors.
• Must be able to perform activities with repetitive motions.
• Inside working conditions.

The anticipated salary range for this position is $60k-90k

The job description does not intend to list all the duties and responsibilities assigned to this position. Employee holding this position would be required to perform other job-related duties/responsibilities based on their expertis and company business needs.