Associate Scientist II, Analytical Research & Development
Company: Disability Solutions
Location: Saint Petersburg
Posted on: April 19, 2024
Job Description:
Associate Scientist II, Analytical Research &
DevelopmentPosition Summary--Catalent 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.--St.
Petersburg is our primary soft gel development and manufacturing
facility in North America with capacity of 18 billion capsules per
year. ---Within the Catalent network, we offer a broad range of
integrated formulation and analytical services to solve difficult
development and manufacturing challenges.--The Analytical Research
and Development (AR&D) laboratory that supports evaluation and
testing of raw materials, excipients, APIs, in-process and finished
product samples.-- AR&D also performs development and
validation of methods used to support release and stability testing
of non-commercial products and materials.-- The department provides
analytical services to manufacturing, process development,
validation and new material qualifications. AR&D interacts with
clients to provide not only research and testing of products, but
also support CMC development activities in support of client
regulatory filings.-- Activities are performed in accordance with
specifications, standard operating procedures, approved test
methods and/or protocols, regulatory requirements, and St.
Petersburg's Quality departmental policies.Once trained, the
Associate Scientist II will independently test raw materials to
both compendial and non-compendial methods.-- Once trained, the
Associate Scientist II independently test pre-capsulation,
stability and finished product samples as per established
methods.-- Analyze data, document results, maintain laboratory
notebook according to cGMP and internal SOPs.-- Communicate results
in written and oral presentation as needed.-- Help in writing
procedures, specifications and test methods.-- Keep abreast of
literature in field; help train colleagues; contribute to
continuous improvement within the group. Comply with FDA, EPA and
OSHA regulations, performing all work in a safe manner. Maintain
proper records in accordance with all SOP's and policies.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----
- Analysis of finished products, in-process materials, fill
moisture, raw materials, and cleaning verification and Perform
compendial and non-compendial testing on raw materials, drug
substances, in-process samples, cleaning samples and finished
products as required.--
- Performs assay/CU/dissolution and other single analyte
chromatographic testing.
- Prepares reagents, standards, media and mobile phase as needed
for analyses.
- Required to work with potent and teratogenic compounds with
proper PPE equipment.--
- Disposal of hazardous waste according to environmental
regulations and company procedures.
- Tabulation/ interpretation of results of analysis as recorded
in notebooks, reports and logbooks.
- Assures right-first-time execution of departmental methods and
SOPs.
- Writes/ reviews analytical methods, deviations, protocols, SOPs
and other technical documents.
- Shares responsibility for the routine calibration of analytical
equipment such as, but not limited to balances, pH meters, KF
analyzers, etc.--
- Other duties as assigned.--The Candidate----
- AS in science with 10 plus years in an analytical lab, 5 in GMP
environment, or BS in science with 3 plus years in an GMP
analytical lab.
- Expertise in wet chemistry techniques such as titrations,
extractions as per compendia.
- Individual may be required to sit, stand, walk regularly and
occasionally lift 0-20 pounds.
- Working with potential hazards will require wearing proper
personal protective equipment.Why You Should Join Catalent--
- Competitive medical benefits and 401K--
- 152 hours of PTO + 8 Paid Holidays--
- Dynamic, fast-paced work environment--
- Opportunity to work on Continuous Improvement
Processes--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, Egypt Lake-Leto , Associate Scientist II, Analytical Research & Development, Other , Saint Petersburg, Florida
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