Job Opportunity

Job Opportunity

Senior Scientist I, Quality Control

Senior Scientist I, Quality Control

United States Posted 2025-05-07

Job Title – Senior Scientist l, Quality Control

Work Location – Cranbury NJ

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 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.

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