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
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