Microbiologist III
Company: Disability Solutions
Location: Morrisville
Posted on: April 19, 2024
Job Description:
The Microbiologist III will perform microbiological method
development and verification, testing of raw materials and sterile
and non-sterile pharmaceutical dosage forms, and general support
activities within the Microbiology group. An individual in this
role functions as a microbiology technical lead, interacts with
external and internal customers for project support, and mentors or
provides technical guidance to junior analysts. Responsibilities
also include coordinating, performing and/or supporting
instrument/equipment qualification activities, as well as
associated maintenance and calibration programs. The Microbiologist
III will author and/or revise procedures/methods, as
appropriate.The Microbiology and Environmental Monitoring groups at
Catalent Morrisville are responsible for the microbial testing
support for internal and external customers including Catalent
sister sites. The microbiology team performs microbiology testing
(sterility, microbial limits, endotoxin testing, etc.) for API,
Finished Product, Stability, Raw Materials and Components. The
Environmental Monitoring team performs microbiology testing (TOC,
conductivity, bioburden, etc.) supporting onsite utilities and
manufacturing environments.The Role
- Develop and execute laboratory work plans/schedules
independently, using customer milestones and Division/site
performance standards and metrics.
- Authors technical documents, such as protocols, test methods,
text reports, certificates of analysis, operating procedures and
investigations.
- Review technical documents for accuracy, thoroughness and
regulatory compliance.
- Trains, coaches or mentors others on technical, personal
development or business issues.
- Responsible as Project Director with responsibility for project
outcome and customer interaction.
- Executes efficiency improvement project with guidance.
- Identify and recommend business opportunities on a project
specific basis.
- All other duties as assigned.The Candidate
- Doctoral degree, Masters degree, Bachelors degree, or
Associates degree in chemistry or closely related physical science
from a four-year college/university or equivalent education and
training.
- PhD and 0 years related experience OR MS and 4 years related
experience OR BS and 7 years related experience, or equivalent
education, experience and training.
- Maintain high quality laboratory documentation in accordance
with applicable regulatory guidance and Site SOPs.
- Develop and execute complex procedures or methods of moderate
complexity with high quality.
- Propose deviations from established procedures and methods
based upon sound judgment.
- Supervisory skills are expected for Scientists with
direct--reports.
- On an average 8-hour day this position requires the ability to
walk, sit and stand, use hands to handle or feel, reach with hands
and arms at or above shoulder height and below waist height, climb
or balance, stoop, kneel, crouch, or crawl; talk and hear, smell
and lift up to 40 pounds.
- Specific vision requirements including reading of written
documents, visual inspection of materials and use of computer
monitor screen frequently.
- May require the use of a respirator.Catalent offers rewarding
opportunities to further your career!-- Join the global drug
development and delivery leader and help us bring over 7,000
life-saving and life-enhancing products to patients around the
world. Catalent is an exciting and growing international company
where employees work directly with pharma, biopharma and consumer
health companies of all sizes to advance new medicines from early
development to clinical trials and to the market. Catalent produces
more than 70 billion doses per year, and each one will be used by
someone who is counting on us. Join us in making a
difference.--Catalent is committed to the health and safety of its
employees, visitors and the customers and patients we serve. As a
result of the global pandemic, we have modified many of our
recruitment and on-boarding processes to maintain everyone's
safety. The Human Resources teams will communicate all necessary
safety processes and procedures throughout each
stage.------personal initiative. dynamic pace. meaningful
work.Visit to explore career opportunities.Catalent is an Equal
Opportunity Employer, including disability and veterans.If you
require reasonable accommodation for any part of the application or
hiring process due to a disability, you may submit your request by
sending an email, and confirming your request for an accommodation
and include the job number, title and location to . This option is
reserved for individuals who require accommodation due to a
disability. Information received will be processed by a U.S.
Catalent employee and then routed to a local recruiter who will
provide assistance to ensure appropriate consideration in the
application or hiring process.--------Notice to Agency and Search
Firm Representatives: Catalent Pharma Solutions (Catalent) is not
accepting unsolicited resumes from agencies and/or search firms for
this job posting. Resumes submitted to any Catalent employee by a
third party agency and/or search firm without a valid written &
signed search agreement, will become the sole property of Catalent.
No fee will be paid if a candidate is hired for this position as a
result of an unsolicited agency or search firm referral. Thank
you.Important Security Notice to U.S. Job Seekers:Catalent NEVER
asks candidates to provide any type of payment, bank details,
photocopies of identification, social security number or other
highly sensitive personal information during the offer process, and
we NEVER do so via email or social media. If you receive any such
request, DO NOT respond- it is a fraudulent request. Please forward
such requests to spam@catalent.com for us to investigate with local
authorities.California Job Seekers can find our California Job
Applicant Notice .
Keywords: Disability Solutions, Raleigh , Microbiologist III, Other , Morrisville, North Carolina
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