Scientist II, Biologics II
Location: Kansas City
Posted on: November 25, 2022
Catalent Pharma Solutions in Kansas City, MO is hiring a Scientist
II, Biologics II who is primarily responsible for method
evaluation, optimization, transfer and validation activities under
cGMP regulatory guidance for Large Molecules/Biologics product
development and related stability studies. Also responsible for
drafting technical documents such as methods, method forms,
validation protocols and reports. .
This is a full-time role position: Monday - Friday, days.
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.
Catalent's Kansas City facility is home to our Oral & Specialty
Drug Delivery, Biologics Analytical Services and Clinical Supply
Services businesses. The site provides a range of integrated
services for oral solid dosage forms, from formulation development
and analytical testing to clinical and commercial-scale
manufacture. The Kansas City facility is a Center-of-Excellence for
our Biologics Analytical Services business. Our talented team has
over 25 years of experience providing analytical services for
stand-alone and integrated biologics projects.
Catalent is committed to a Patient First culture through excellence
in quality andcompliance, and to the safety of every patient,
consumer, and Catalent employee.
- In support of Large Molecules/Biologics Therapeutics, will
execute laboratory testing using the following techniques as
required: HPLC/UPLC techniques/methods (e.g., SEC, IEX, RP-HPLC,
HIC, peptide map, glycan analysis, etc.), Karl Fischer, Compendial
assays, (i.e., appearance. pH, etc.)
- UV-Vis, Aggregation techniques such as MFI, AUC, SEC-MALS
- Successfully trains on 2-4 methods and/or techniques mentioned
above and perform adhoc sample testing activities and participate
with minimum guidance in method development, evaluation,
optimization, transfer, and validation activities under cGMP as
- Applies complex scientific and laboratory concepts and theories
related to specific testing in the group
- Train and coach peers on methods and laboratory instruments and
- Follow cGMP requirements for legible, accurate and thorough
documentation to meet regulatory compliance.
- Drafts and review technical documents such as methods, method
forms, validation protocols and technical reports with minimal
- All other duties as assigned;
- Degree in life sciences such as chemistry, biochemistry,
biology or closely related physical science.
- Required Bachelors Degree: 8+ years of relevant experience; OR
Masters Degree: 6 years of relevant experience; OR Doctorate
Degree: 2 years of relevant experience
- Ability to interpret a variety of instructions furnished in
written, oral, diagram, or schedule form. Capable of rapid learning
of unfamiliar principles or techniques with minimum training.
- Able to prioritize and suggest alternatives or contingencies to
achieve the correct technical solutions with most efficient
- Ability to identify aberrant/out of spec data and limited
interpretation of data expected
- Individual may be required to sit, stand, walk regularly and
occasionally lift 0-15 pounds;
Why you should join Catalent:
- Defined career path and annual performance review and feedback
- Diverse, inclusive culture
- 19 days of PTO + 8 paid holidays
- Several Employee Resource Groups focusing on D&I
- Dynamic, fast-paced work environment
- Employee Stock Purchase Program
- 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
- Competitive salary with quarterly bonus potential
- Community engagement and green initiatives
- Generous 401K matchand Paid Time Off accrual
- Medical, dental and vision benefits effective day one of
- Tuition Reimbursement
- GymPass 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.
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 Catalent Careers to explore career opportunities.
Catalent is an Equal Opportunity Employer, including disability and
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
DisabilityAccommodations@catalent.com . 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
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 firstname.lastname@example.org for us
to investigate with local authorities.
Keywords: Catalent, Kansas City , Scientist II, Biologics II, Other , Kansas City, Kansas
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