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Associate Scientist, MSAT Investigations in Summit, NJ

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Bristol Myers Squibb

1mo ago

  • Job
    Full-time
    Junior Level
  • Science
    Research & Development
  • Summit

AI generated summary

  • You need a Bachelor's in science/engineering (Biochemistry preferred), 1 year relevant experience in a regulated environment, and flexibility for extended hours and occasional travel.
  • You will lead investigations, conduct root cause analysis, develop CAPAs, assess change impacts, support audits, and implement continuous improvement using lean and Six Sigma principles.

Requirements

  • Requires a Bachelor's Degree in science or engineering, preferably in Biochemistry, life sciences or related engineering discipline (advanced degree preferred).
  • Minimum 1 year of relevant work experience, preferably in a health authority regulated environment.
  • Previous experience working in a biopharmaceutical manufacturing facility is preferred (CAR T a plus).
  • An equivalent combination of education and experience may substitute.
  • The incumbent will be working 80% to 90% of the time in an office environment. The incumbent will be working 10% to 20% of the time in a manufacturing and/or laboratory setting.
  • The incumbent may travel between NJ sites for training, meetings or corporate events on occasion.
  • The incumbent will need to have flexibility to work extended hours (>8 hours/day), weekend and/or holidays when required to meet deadlines.

Responsibilities

  • Conduct thorough investigations (Environmental Monitoring, deviations, etc.) utilizing root cause analysis tools.
  • Lead investigations and cross functional investigation teams, and close reports in a timely manner.
  • Perform GEMBA walks with stakeholders to better understand process steps and evaluate Root Cause Analysis.
  • Work with functional teams to propose effective CAPAs, develop CAPA plans and assure CAPA effectiveness.
  • Assess potential impact and risk to product or process associated changes may have upon change implementation and develop an appropriate mitigation strategy.
  • May Initiate change control documentation.
  • Identify functional area SMEs to perform impact assessments as part of the change management process.
  • Ensure all investigations are completed in a timely manner. Notify stakeholders of any delays in a timely manner.
  • Provide technical support for manufacturing investigations / CAPAs / change controls as needed.
  • Support deviation investigation defense during audits and site inspections related inquiries.
  • Handle complex issues and solve problems with minimal guidance.
  • Serve as author or technical reviewer of departmental procedures as appropriate.
  • Employ lean manufacturing / six sigma principles to continuously improve products, processes and systems.
  • Continuously support S12, living the patients first mission and fostering a Right First Time mindset.

FAQs

What is the job title for this position?

The job title is Associate Scientist, MSAT Investigations.

Where is this position located?

This position is located in Summit, NJ.

What are the primary responsibilities of the Associate Scientist, MSAT Investigations?

The primary responsibilities include leading investigation reports, conducting root cause analyses, authoring investigation reports, identifying corrective and preventive actions (CAPA), and troubleshooting complex problems related to S12 CAR T operations.

What are the work hours for this position?

The work hours are Monday to Friday, from 8am to 5pm.

What qualifications are required for this position?

A Bachelor's Degree in science or engineering, preferably in Biochemistry, life sciences, or a related engineering discipline, is required, along with a minimum of 1 year of relevant work experience.

Is experience in biopharmaceutical manufacturing preferred for this role?

Yes, previous experience working in a biopharmaceutical manufacturing facility is preferred, especially in CAR T operations.

What skills are important for the Associate Scientist role?

Important skills include experience with deviation investigations and root cause analysis, technical writing, understanding of global regulatory and cGMP requirements, advanced problem-solving abilities, and the ability to communicate effectively with cross-functional teams.

Will training or travel be required for this position?

Yes, the incumbent may travel between NJ sites for training, meetings, or corporate events on occasion.

Are there opportunities for career growth at Bristol Myers Squibb?

Yes, Bristol Myers Squibb offers various opportunities for career growth and development in a diverse and supportive work environment.

What is expected in terms of work environment for this position?

The incumbent will work 80% to 90% in an office environment and 10% to 20% in a manufacturing or laboratory setting.

Does Bristol Myers Squibb encourage applications from candidates who do not meet all qualifications?

Yes, candidates are encouraged to apply even if their experience does not perfectly line up with the job requirements.

What are some of the key components of the company culture at BMS?

BMS promotes a culture of passion, innovation, urgency, accountability, inclusion, and integrity, valuing the unique talents and perspectives of its employees.

Is there a commitment to workplace accommodations for applicants?

Yes, BMS is dedicated to ensuring that people with disabilities can excel through a supportive recruitment process and reasonable workplace accommodations.

What health guidelines should employees follow related to COVID-19?

BMS strongly recommends that all employees be fully vaccinated for COVID-19 and keep up to date with COVID-19 boosters.

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Bristol Myers Squibb

Manufacturing & Electronics
Industry
10,001+
Employees

Mission & Purpose

At Bristol Myers Squibb, we work every day to transform patients’ lives through science. That work inspires some of the most interesting, meaningful, and life-changing careers you’ll experience. Join us and pursue innovative ideas alongside some of the brightest minds in biopharma, collaborating with a team rich in diversity of experiences, and perspectives. We have built a sustainable pipeline of potential therapies and are leveraging translational medicine and data analytics to understand how we can deliver the right medicine to the right patient, at the right time, to achieve the best outcome. Whether in a scientific, business or supporting function, a career at BMS means you’ll be inspired every day to grow and thrive through opportunities that are uncommon in scale and scope. Here, you’ll be on the cutting edge of powerful innovation in oncology, hematology, immunology, cardiovascular disease, and fibrosis, with colleagues united in the mission to help patients. Through the Bristol Myers Squibb Foundation, we also promote health equity and seek to improve health outcomes of populations disproportionately affected by serious diseases and conditions. Our mission is to give new hope to help patients prevail over serious disease – it drives everything we do.