The final salary or hourly wage, as applicable, paid to each candidate/applicant for this position is ultimately dependent on a variety of factors, including, but not limited to, the candidate’s/applicant’s qualifications, skills, and level of experience as well as the geographical location of the position.

Applicants must be legally authorized to work in the United States. Visa sponsorship is not available.

Our client is seeking an Associate Research Scientist in Princeton, NJ.

Role Description

Job Description:
The Assistant Scientist will play a key role in ensuring successful manufacture of life-saving cell therapy products. The primary focus of the Assistant Scientist will be to support testing and implementation of operational improvements and resolve manufacturing process investigations at the BMS cell therapy GMP manufacturing facilities. The Assistant Scientist will be part of a team tasked with completing manufacturing support studies, including investigational, process improvement and process characterization studies. This individual will primarily execute experiments, evaluate data, and draft technical reports. The Assistant Scientist will also contribute to well controlled comparability and validation studies which enable regulatory filings for raw material and process changes.

Primary Responsibilities:
Execute experiments in the process development labs which includes aseptic processing and operation of automated process equipment.
Summarize experimental data and aid in analysis to draw conclusions.
Coordinate with the analytical group for timely delivery of process samples and turn-around of analytical data.
Support production related investigations, ensuring compliance with internal standards and regulatory requirements.
Develop and execute manufacturing process changes and improvement activities, and/or author technical reports for process changes and improvements.
Support process comparability and process validation studies including planning, execution, and documentation management. Support necessary technical experiments and analysis to enable decisions related to raw materials changes.
Flexibility with work schedule as maintenance of cell cultures on occasional weekends, early mornings, or evenings is required

Skills & Requirements

Required Qualifications:
Degree in Biological Sciences, Chemical/Biomedical Engineering, Life Sciences or related discipline.
Required BS degree with minimum of 2+ years of relevant experience, or MS degree with minimum 0+ years of relevant experience in biologic process/analytical development or commercial biologic manufacturing process support.
Excellent documentation skills and attention to detail with cGMP experience a plus.
Ability to effectively work in cross functional teams, meet deadlines, and prioritize responsibilities.
Experience working in a self-driven, performance/results oriented, fast paced matrix environment.
Excellent problem-solving skills.
Able to creatively manage time and elevate relevant issues to project lead and line management.
Strong scientific and technical writing with excellent oral communication skills.

Preferred Qualifications:
Experience with cell therapy process development or manufacturing
Proficiency utilizing MS Office products and working knowledge of statistical software (R, JMP, Minitab)
Experience supporting investigations in support of commercial manufacturing
Experience with commercial product support, i.e. post-marketing commitments, on-going validation and comparability
Combination of experience in process development, MSAT and quality.
Operational excellence training/background

Must Haves:
1. 1+ years of cell culture experience
2. 1+ years of laboratory experience
3. 1+ years Aseptic processing experience

Benefits/Other Compensation:

Health, Dental, Vision, 401K and PTO.

Why Hays?

You will be working with a professional recruiter who has intimate knowledge of the industry and market trends. Your Hays recruiter will lead you through a thorough screening process in order to understand your skills, experience, needs, and drivers. You will also get support on resume writing, interview tips, and career planning, so when there’s a position you really want, you’re fully prepared to get it.

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Hays is committed to building a thriving culture of diversity that embraces people with different backgrounds, perspectives, and experiences. We believe that the more inclusive we are, the better we serve our candidates, clients, and employees. We are an equal employment opportunity employer, and we comply with all applicable laws prohibiting discrimination based on race, color, creed, sex (including pregnancy, sexual orientation, or gender identity), age, national origin or ancestry, physical or mental disability, veteran status, marital status, genetic information, HIV-positive status, as well as any other characteristic protected by federal, state, or local law. One of Hays’ guiding principles is ‘do the right thing’.
We also believe that actions speak louder than words.
In that regard, we train our staff on ensuring inclusivity throughout the entire recruitment process and counsel our clients on these principles. If you have any questions about Hays or any of our processes, please contact us.

In accordance with applicable federal, state, and local law protecting qualified individuals with known disabilities, Hays will attempt to reasonably accommodate those individuals unless doing so would create an undue hardship on the company. Any qualified applicant or consultant with a disability who requires an accommodation in order to perform the essential functions of the job should call or text 813.336.5570.

Drug testing may be required; please contact a recruiter for more information.

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