Associate Scientist, Kilo - Lab Analytical In - Process Control

Company: Disability Solutions
Location: New Brunswick
Posted on: May 3, 2024

Job Description:

Working with UsChallenging. 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.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. Read more: careers.bms.com/working-with-us .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 ScientistLocation: New Brunswick, NJPosition 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).Job 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 Around the world, we are passionate about making an impact on the lives of patients with serious diseases. Empowered to apply our individual talents and diverse perspectives in an inclusive culture, our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.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.Our company is committed to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace adjustments and ongoing support in their roles. Applicants can request an accommodation prior to accepting a job offer. If you require reasonable accommodation in completing this application, or any part of the recruitment process direct your inquiries to adastaffingsupport@bms.com . Visit careers.bms.com/eeo-accessibility to access our complete Equal Employment Opportunity statement.If you come across a role that intrigues you but doesn't perfectly line up with your resume, we encourage you to apply anyway. You could be one step away from work that will transform your life and career. Uniquely Interesting Work, Life-changing CareersWith a single vision as inspiring as Transforming patients' lives through science--- , every BMS employee plays an integral role in work that goes far beyond ordinary. Each of us is empowered to apply our individual talents and unique perspectives in an inclusive culture, promoting diversity in clinical trials, while our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.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 require 100% of shifts onsite at your assigned facility. Site-by-design roles may be eligible for a hybrid work model with at least 50% onsite at your assigned facility. For these roles, onsite presence is considered an essential job function and is critical to collaboration, innovation, productivity, and a positive Company culture. For field-based and remote-by-design roles the ability to physically travel to visit customers, patients or business partners and to attend meetings on behalf of BMS as directed is an essential job function. BMS is dedicated to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace accommodations/adjustments and ongoing support in their roles. Applicants can request a reasonable workplace accommodation/adjustment prior to accepting a job offer. If you require reasonable accommodations/adjustments in completing this application, or in any part of the recruitment process, direct your inquiries to adastaffingsupport@bms.com . Visit careers.bms.com/ eeo -accessibility to access our complete Equal Employment Opportunity statement. BMS cares about your well-being and the well-being of our staff, customers, patients, and communities. As a result, the Company strongly recommends that all employees be fully vaccinated for Covid-19 and keep up to date with Covid-19 boosters. BMS will consider for employment qualified applicants with arrest and conviction records, pursuant to applicable laws in your area.Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.

Keywords: Disability Solutions, Sayreville , Associate Scientist, Kilo - Lab Analytical In - Process Control, Healthcare , New Brunswick, New Jersey