Associate Scientist, Kilo

2 weeks ago

New Brunswick, United States Bristol-Myers Squibb Full time

**Working with Us**
Challenging. Meaningful. Life-changing. Those aren't words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the lives of patients, and the careers of those who do it. You'll get the chance to grow and thrive through opportunities uncommon in scale and scope, alongside high-achieving teams rich in diversity. Take your career farther than you thought possible.

Our Chemical Process Development group is a team of organic chemists, analytical chemists, and chemical engineers working together to design novel syntheses from raw materials to supply new medicines to patients. Our scientists focus on developing safe, economical, sustainable, and robust processes to support clinical trials and the launch of new medicines across various drug modalities including small molecules, peptides, oligonucleotides, and antibody drug conjugates. The work is driven by innovative science, data-driven decision-making, and collaborative teamwork. The scientific knowledge package from the manufacturing process, design parameters, and control strategies enables regulatory filings to bring these novel medicines to patients worldwide.

**Title**:Kilo-lab Analytical In-Process Control (IPC), Associate Scientist

**Location**:New Brunswick, NJ

**Position Summary**:
The Associate Scientist is responsible for the analysis and/or development of in-process control, equipment cleaning and mutagenic impurities (MI) methods. This includes contributing to the planning and/or leading the daily operations of the Kilo-lab In-Process Analytical Control Laboratory, which supports the manufacturing of Active Pharmaceutical Ingredient (API).

**Responsibilities**:

- Analysis and development of in-process control, cleaning, and mutagenic impurities (MI) methods.
- Planning and developing a daily sample analysis plan with the laboratory supervisor(s) to ensure the successful, efficient execution of in-process control test analysis to meet the kilo lab process requirements.
- Working closely with team members (Chemical Process Development Analytical leads and Kilo Operations) to circumvent and/or resolve any analytical issues as necessary related to in process control testing.
- Review and approval of analytical instrument calibration, batch records, equipment cleaning verification data, IPC test results and technology transfer documentation.
- Prepare and revise procedural documents (SOPs, Work Instructions and Guidelines) for the laboratory.
- Oversee and perform GMP compliance review of work to ensure the lab adheres to corporate policies, SOPs and good manufacturing procedures (GMPs).
- Oversee the implementation of corrective actions associated with all gaps identified in the annual departmental and Quality audits of the laboratory.
- Assists in investigations for the resolution of QEs, CAPAs and NTRs related to analytical data produced by the laboratory.
- Develop, optimize and/or implement analytical laboratory sample workflow improvement(s) as needed.
- Participating in long term planning for the laboratory equipment needs and purchases.

**Experience & Qualifications**:

- BS/BA (3-5 years of experience) or MS, (1-3 years of experience) in analytical, organic chemistry or related field with experience in chemical analysis in a QC environment and/or providing analytical support for Kilo-or pilot plant operations.
- Experience should include the ability to train, develop and provide guidance to staff.
- GMP experience in the pharmaceutical/ industry.
- Broad understanding and hands-on experience in a wide range of analytical instrumentation, (HPLC, GC, MS, Wet chemistry, spectroscopy (IR/Raman, etc.) and cGMPs.
- Flexible working hours which include working days, weekends, and evening shifts.
- Excellent oral communication skills with the ability to communicate effectively across project teams and departmental areas.
- Ability to quickly grasp new projects and/or juggle multiple project issues.
- Knowledge of various laboratory computer systems such as LIMS, Empower and electronic notebooks (ELNs)

**Why You Should Apply**

Bristol Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees with the resources to pursue their goals, both at work and in their personal lives.

**Uniquely Interesting Work, Life-changing Careers**

**On-site Protocol**

BMS has a diverse occupancy structure that determines where an employee is required to conduct their work. This structure includes site-essential, site-by-design, field-based and remote-by-design jobs. The occupancy type that you are assigned is determined by the nature and responsibilities of your role:
Site-essential roles requi

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