Sr. Scientist I (5119)

WuXi Biologics•Cranbury, NJ

67d•Onsite

About The Position

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 strong 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).

Requirements

Bachelor or advanced Graduate degree (MS/PhD) in Biology, Chemistry, Cell Biology, or equivalent field.
A least 8+ years of relevant experience or equivalent for Bachelor, 6+ years for Master, 2+ years for Ph.D in the Quality Control or related field or equivalent experience.
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 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

Responsibilities

Demonstrates reliable and independent scientific technical expertise and proficiency in scientific theory and rigorous practical application in the completion of laboratory procedures as it relates to qPCR, ELISA, and cell based potency assays.
Perform method evaluation and qualification for rDNA, rHCP, rProA, potency ELISA and cell based potency assays according to and in compliance with GLP, cGMP, CFR and/or PTC guidelines and SOPs.
Author and review SOPs, AMPs, protocols, reports, investigations, and deviations.
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
Conducts critical review of results and reports data appropriately
Strickly adhere to all SOPs in daily lab operations.
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
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
Provides training on areas of technical expertise and compliance issues relevant to the lab setting to junior analysts
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