Senior Scientist, Analytical Research & Development
Company: Disability Solutions
Location: Saint Petersburg
Posted on: October 17, 2024
Job Description:
Senior Scientist, Analytical Research & DevelopmentPosition
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.St. Petersburg is our primary
softgel development and manufacturing facility in North America
with a capacity of 18 billion capsules per year. --The featured RP
Scherer softgel technology is a proven oral drug delivery solution
to enhance bioavailability of poorly soluble Rx and OTC drug
candidates. --Non-gelatin based OptiShell-- and Vegicaps-- capsules
expand the range of molecules into softgel, ideal for challenging
fill formulation. Within the Catalent network, we offer a broad
range of integrated formulation.The Senior Scientist, Analytical
Research & Development will independently develop, validate, and
routinely execute test methods in support of Drug Substances and
Drug Products as required.-- The Senior Scientist, AR&D
analyzes data, document results, maintain laboratory notebook
according to cGMP and Internal guidelines. Communicate results in
written and oral presentations. 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
- Provides project support for new product development which
requires a close working relationship directly with Customers as
well as suppliers.
- Lead all analytical method transfer activities as required by
their area.
- Ability to independently develop and validate instrumental
methods in support of Drug Substances and Drug products.
- Expected to be the lead scientist for designated projects, to
include direct client communications and attendance at project team
meetings and teleconferences.
- Leads and coordinates training for new or existing personnel as
assigned by laboratory management.
- Ability to make autonomous decisions regarding day-to-day
activities.
- Analysis of finished products, in-process materials, fill
moisture, raw materials, and cleaning verification and validation
samples according to the assigned specifications, methods and
protocols.
- Tabulation and interpretation of results of analysis as
recorded in notebooks, reports and logbooks.
- Audits and verifies results, including but not limited to,
calculations in notebooks/logbooks and results in reports to check
for accuracy and integrity of data. Writes and reviews analytical
methods, deviations, protocols, SOPs and any other technical
document. Conducts and writes laboratory investigations using the
appropriate Root Cause Analysis tools.
- Other duties as assigned.The Candidate
- Doctorate in scientific field with 3+years' experience in lab,
2 in GMP required OR
- MS in scientific field with 5+yrs experience in lab, 3 in GMP
required OR
- BS in scientific field with 10+ yrs experience in lab, 8 in GMP
required.
- 5+ years' experience with identification or separation
techniques such as HPLC, UPLC, GC, MS, NMR and experience with
method development and or validation.
- Must possess good interpersonal skills.
- Ability to effectively communicate with co-workers.
- Good organizational skills required.
- Experience with drug development and regulatory requirements
for submissions
- Experience with common pharmaceutical laboratory equipment
including, but not limited to, U.V. spectroscopy or and AA
instrumentation.
- Expertise in wet chemistry techniques such as titrations,
extractions, digestions, and preparations of test solutions.
- Individual may be required to sit, stand, walk regularly and
occasionally lift to 15 pounds; no lifting greater than 44.09
pounds without assistance.
- Vision requirements include ability to differentiate color
(Pass the Ishihara Color Vision Screening) and obtain 20/30 acuity
in both far and near vision with or without corrective lenses. For
Catalent's in-house screening, the acceptable score is to identify
at least 4 of 6 numbers in the circle.Why You Should Join Catalent
- Tuition Reimbursement - Let us help you finish your degree or
earn a new one!
- WellHub program to promote overall physical wellness.
- 152 hours of PTO + 8 paid holidays.
- Medical, dental and vision benefits effective day one of
employment.
- Defined career path and annual performance review and feedback
process.
- Diverse, inclusive culture. Several Employee Resource Groups
focusing on D&I. Community engagement and green
initiatives.
- Dynamic, fast-paced work environment.
- Positive working environment focusing on continually improving
processes to remain innovative.
- Potential for career growth on an expanding team within an
organization dedicated to preserving and bettering lives.
- 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, Orlando , Senior Scientist, Analytical Research & Development, Other , Saint Petersburg, Florida
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