Senior Scientist, Investigations Team
Company: Bristol-Myers Squibb
Location: Summit
Posted on: January 27, 2023
Job Description:
At Bristol Myers Squibb, we are inspired by a single vision -
transforming patients' lives through science. -In oncology,
hematology, immunology and cardiovascular disease - and one of the
most diverse and promising pipelines in the industry - each of our
passionate colleagues contribute to innovations that drive
meaningful change. We bring a human touch to every treatment we
pioneer. Join us and make a difference.PURPOSE AND SCOPE OF
POSITION:The Senior Scientist/Engineer is responsible for leading
manufacturing and QC investigation reports in support of S12 CAR T
operations. The Sr. role will be assigned more complex deviation
investigations, and often need to create and facilitate teams to
execute all elements in a timely matter. Deviation investigation
includes execution of thorough root cause investigations,
interviewing personnel, hypothesis testing and interpretation of
results, authoring investigation reports, identifying corrective
and preventive actions (CAPA), and troubleshooting complex
problems. The successful incumbent must interface closely with
different functional organizations and management, including
Quality Assurance teams.REQUIRED COMPETENCIES: Knowledge, Skills,
and Abilities:
- Advanced working experience of deviation investigations
utilizing root cause analysis tools.
- Working experience in the CAPA process and ability to identify
and verify effectiveness.
- Advanced technical writing skills, and capability to review,
improve, and approve investigation reports from more junior team
members
- Capability to kickoff and lead limited duration investigation
teams, to ensure timely completion of more complex investigations
requiring scientific work outside of S12 site
- Proven ability to accurately and completely understand, follow,
interpret, and apply Global Regulatory and cGMP requirements.
- Experience supporting health authority inspections. Sr.
scientists/engineers will often defend more complex investigation
reports in Regulatory Investigator questioning during Health
Authority audits.
- Knowledge of data trending and tracking, including use of
statistical analysis software a plus.
- Demonstrate advanced problem-solvingability /
mentality,technical adeptness and logical thinking.
- Ability to set priorities, manage timelines and effectively
react/manage changing priorities.
- Ability to work with management (global and site) and support
corporate and departmental goals.
- Ability to communicate honestly, transparently and effectively
with peers, department management and cross functional peers.
- Ability to utilize electronic Quality systems such as eQRMs
(Enterprise Quality and Regulatory Management system).
- Hands on experience preferred with CAR T or biopharmaceutical
manufacturing and Quality Control.
- Proven delivery of complex investigation reports is required
for the Sr. Level role.
- Ability to train and mentor junior associates to foster and
develop their expertise.DUTIES AND RESPONSIBILITIES:
- Conduct thorough investigations (OOS, OOT, Environmental
Monitoring, deviations, etc.) utilizing root cause analysis
tools.
- Lead medium and high -risk investigation teams with the ability
to summarize progress to Sr. Management, collect information from
the triage team, and gather necessary supporting data from
technical and quality teams outside of S12
- 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.
- Lead deviation investigation defense during audits and site
inspections for QC compliance related inquiries.
- Handle complex issues and solve problems with minimal guidance.
Manage teams to support more complex investigations
- Provide mentorship, guidance and training to junior
members.
- Serve as author or technical reviewer of departmental
procedures as appropriate.
- Support manufacturing and Quality Control testing of CAR- T
products as needed.
- 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.Education and
Experience:
- Requires a Bachelor's Degree in science or engineering,
preferably in Biochemistry, life sciences or related engineering
discipline (advanced degree preferred).
- Minimum 5 years of relevant work experience, preferably in a
health authority regulated environment.
- Sr Level requires demonstrated capability in medium and
high-risk deviation reports or equivalent proven experience
- Previous experiences working in a biopharmaceutical
manufacturing facility and an aseptic environment is preferred (CAR
T a plus).
- An equivalent combination of education and experience may
substituteBMSCARTVETERAN#LI-HybridAround 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. -Physical presence at the BMS
worksite or physical presence in the field is an essential job
function of this role which the Company deems critical to
collaboration, innovation, productivity, employee well-being and
engagement, and enhances the Company culture.To protect the safety
of our workforce, customers, patients and communities, the policy
of the Company requires all employees and workers in the U.S. and
Puerto Rico to be fully vaccinated against COVID-19, unless they
have received an exception based on an approved request for a
medical or religious reasonable accommodation. - Therefore, all BMS
applicants seeking a role located in the U.S. and Puerto Rico must
confirm that they have already received or are willing to receive
the full COVID-19 vaccination by their start date as a
qualification of the role and condition of employment. - This
requirement is subject to state and local law restrictions and may
not be applicable to employees working in certain jurisdictions
such as Montana. This requirement is also subject to discussions
with collective bargaining representatives in the U.S.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 approval of accommodation prior to accepting a job
offer. If you require reasonable accommodation in completing this
application or if you are applying to a role based in the U.S. or
Puerto Rico and you believe that you are unable to receive a
COVID-19 vaccine due to a medical condition or sincerely held
religious belief, during or any part of the recruitment process,
please direct your inquiries to . Visitto access our complete Equal
Employment Opportunity statement.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: Bristol-Myers Squibb, New York , Senior Scientist, Investigations Team, Other , Summit, New York
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