Associate Scientist, QC Microbiology
Company: Disability Solutions
Location: Severn
Posted on: September 28, 2024
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Job Description:
Associate Scientist, QC MicrobiologyPosition SummaryCatalent is
a global, high-growth, public company and a leading partner for the
pharmaceutical industry in the development and manufacturing of new
treatments for patients worldwide. Your talents, ideas, and passion
are essential to our mission: to help people live better, healthier
lives.--Catalent's Harmans/BWI, MD facility is a FDA-licensed,
state-of-the-art CGMP manufacturing facility for Gene Therapies.
The campus features two manufacturing facilities: The Harmans/BWI-1
EMA and FDA approved facility, at approximately 200,000 sq. ft.,
houses 10 CGMP manufacturing suites, fill/finish, central services,
testing labs, and a warehouse. The Harmans/BWI-2 facility, at
approximately 145,000 sq. ft., is under development and will house
8 CGMP manufacturing suites and cold storage warehousing. Both
facilities support Phase 3 through commercial manufacturing of
advanced therapeutic products including AAV and other viral
vector-based therapies and vaccines.The Associate Scientist, QC
Microbiology will assist with the end-to-end contamination control
and sterility assurance practices for Catalent's aseptic production
process. This position will support the following areas: Aseptic
processing, cleaning and disinfection process, microbiological
testing, environmental control and monitoring, compliance to
regulations and standards in the subject of sterility assurance and
contamination control. The Associate Scientist will work both
independently and with the team to perform routine and non-routine
microbiological testing, environmental monitoring, and/or
microbiology laboratory maintenance functions, where
necessary.--This position is 1st shift M-F 8AM-5PM and 100% on site
at Harmans/BWI, Maryland facility.Catalent is committed to a
Patient First culture through excellence in quality and compliance,
and to the safety of every patient, consumer and Catalent
employee.The Role:----- Ensure testing compliance meets the
requirements of ISO, USP, EU, CFR, cGMP, and GLP in the
Microbiology laboratory at all times; document laboratory test
results utilizing Good Documentation Practices.----- Perform
routine and in-process environmental monitoring in Grades A, B, C,
and D environments, including areas where full aseptic gowning is
worn for extended periods of time; conducts sampling and testing of
utilities such as USP water, WFI, clean steam, and CCA/Gas.-----
Maintain the Micro labs in a state of audit readiness; ensure daily
or weekly maintenance of all Micro laboratory instrumentation and
media usage dates; provide accurate product, raw material, and
Environmental monitoring microanalysis data.----- Perform Bacterial
Endotoxin testing using the kinetic chromogenic method; perform
bioburden testing using membrane filtration for cleaning,
in-process, buffer/media, and release samples; perform growth
promotion of microbiological media; perform microbial isolation
techniques, subculturing, and gram stain identifications.----- Send
out samples to contract labs and track results/reports; perform
general laboratory cleaning/wipe-down; maintain lab inventory and
partner with management to request order lab supplies and materials
to be ordered.----- Support continuous improvement projects related
to QC; support the revision of controlled documents such as
Standard Operating Procedures and controlled forms; assist with
investigations, change controls, and CAPAs associated with
microbiological testing; support data trending and tracking of
results.----- Communicate effectively with QC peers,
cross-functional peers, and management; actively participate in
training activities and managing individual training plan.-----
Other duties as assigned.--The Role:--------- --Bachelor in a
Microbiology, Biology, or related discipline required with
experience working in a cGMP QC laboratory preferred.---------
--Knowledge of cGMP, familiarity with Quality Tools such as SPC and
Root Cause Analysis, FMEA, HACCP, and technical writing
skills.--------- --Demonstrate knowledge of scientific
understanding of microbiological methods; demonstrated ability to
investigate and identify causes of suspect laboratory results;
comfortable working in cleanroom and BSC environments in aseptic
gowning for extended periods of time.--------- --Experience in
technical writing and use of Microsoft Office products; strong
attention to detail and strong organizational skills; strong verbal
communication skills with internal teams and outside contract
laboratories; ability to succeed in a team-oriented environment
under very dynamic conditions--------- --Must have the ability to
work an available set shift. There will be times when overtime is
required.--Why you should join Catalent:------- --Defined career
path and annual performance review and feedback process---------
--Potential for career growth on an expanding team within an
organization dedicated to preserving and bettering lives---------
--Dynamic, fast-paced work environment------- --Generous 401K match
and Paid Time Off accrual--------- --Medical, dental and vision
benefits effective day one of employment--------- --Tuition
Reimbursement--------- --Wellhub program to promote overall
physical wellness--------- --Perkspot - offers exclusive or private
discounts from approximately 900+ merchants in a wide array of
categories--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.--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, Severn , Associate Scientist, QC Microbiology, Other , Severn, Maryland
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