Manufacturing Product Lead
Company: Disability Solutions
Location: Kansas City
Posted on: October 11, 2024
Job Description:
Manufacturing Product LeadPosition 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.----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 Pharma
Solutions in Kansas City, MO is hiring a Manufacturing Product
Lead. The Manufacturing Product Lead is responsible for providing
technical support for oral solid dose (OSD) process manufacturing
(tablets/capsules) including process improvements, tech transfer,
process investigations, and process troubleshooting.-- This
individual serves as a Subject Matter Expert (SME) for multiple
processing operations and provides technical leadership for
commercial product processes.This is a full-time salaried position:
Monday - Friday, on 1st shift 7am-4pm.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:
- Partner with commercial clients as required on technical issues
affecting their drug product(s).-- Act as product technical steward
on client interactions. Collaborates cross-functionally with
Manufacturing, Engineering, Maintenance, EHS (Environmental Health
& Safety) and Quality to optimize productivity, safety, product
quality and supply reliability for commercial products in
compliance with cGMPs
- Ensures commercial drug product manufacturing is Ready to
Execute (RTE): Authors, reviews and approves commercial product
manufacturing master batch records, BOMs, equipment recipes and
cleaning verification forms as necessary to ensure RTE
reliability
- Initiates process manufacturing area change proposals as
required for assigned projects or in support of Manufacturing.
Serves as a subject matter expert during internal audits and
regulatory inspections for technical aspects of the drug product
process
- Provides technical support for process manufacturing areas,
including investigation and correction of product/process-related
problems and deviations, process troubleshooting and
improvements
- Responsible for identifying, executing and implementing
continuous improvement projects to reduce product cost, improve
product quality, improve process safety and simplify processes to
improve compliance
- Supports Manufacturing aspects of annual product reviews,
continued process verification, product/process risk assessments,
FMEAs, etc. Minimum of 25% shop floor/unit operation presence is
required to successfully support manufacturing
- Leads technology transfer and implementation of new
technologies, equipment, and processes from R&D and other
sites, into the Kansas City facility or out to other Catalent
sites, as well as between clinical and commercial
manufacturing
- All other duties as assignedThe Candidate:
- Bachelor of Science degree required; preferably in engineering,
science or other related technical discipline.-- A minimum of 15
years of pharmaceutical manufacturing experience may be substituted
for the degree requirement
- Minimum requirement of one year of experience with Oral Solid
Dosage (OSD) manufacturing or pharmaceutical operations. Experience
in pharmaceutical production and process engineering preferred
- Must have familiarity with Microsoft Office (Word, Excel,
Outlook, Teams, etc.), and experience with Minitab and/or
SharePoint is preferred
- Must have client facing customer service experience
- Understanding of cGMPs, demonstrated leadership, management and
technical capabilities preferred
- Experience with equipment IQ/OQ/PQ preferred
- Experience in Lean Manufacturing/OpEx and Six Sigma is
desired
- Physical requirements: Individual may be required to sit,
stand, walk regularly and occasionally lift up to 25 pounds;
ability to communicate orally with customers, vendors, and
co-workers. Regular use of telephone and email. Hearing, vision,
and speaking within normal ranges is essential for normal
conversations, to receive ordinary information and to prepare or
inspect documents. Good manual dexterity for the use of common
office equipment such as computer terminals, calculator, copiers,
and fax machines. Good reasoning ability is important. Able to
understand and utilize management reports, memos, and other
documents to conduct businessWhy you should join Catalent:
- Defined career path and annual performance review and feedback
process--
- Diverse, inclusive culture--
- 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--
- 152 Hours + 8 paid holidays
- Several Employee Resource Groups focusing on D&I
- Dynamic, fast-paced work environment
- Community engagement and green initiatives--
- Generous 401K match--
- Company match on donations to organizations
- Medical, dental and vision benefits effective day one of
employment--
- Tuition Reimbursement--- Let us help you finish your degree or
start a new degree!
- WellHub program to promote overall physical wellness--
- Perkspot - offers exclusive or private discounts from
approximately 900+ merchants in a wide array of categoriesCatalent
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, Independence , Manufacturing Product Lead, Other , Kansas City, Missouri
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