Associate Lead II - Biomanufacturing, Compliance
Company: Disability Solutions
Location: Madison
Posted on: May 4, 2024
Job Description:
Associate Lead II - Biomanufacturing, ComplianceCatalent 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 Biologics is a fast-growing business within
Catalent Pharma Solutions focused on providing innovative
technologies and solutions to help more and better biologic
treatments get to patients.--The business includes our proprietary
GPEx cell line engineering platform, our new state-of-the-art
biomanufacturing facility in Madison, WI, and our market leading
biologics analytical services as well as SMARTag Antibody Drug
Conjugate technology in Emeryville, CA.-- Leveraging our growing
differentiated technology portfolio, world class manufacturing
capability, and other integrated services across the Catalent
network, Catalent Biologics is positioned to drive significant
growth for Catalent.The Manufacturing department is responsible for
the execution of clinical and commercial manufacturing in
accordance with regulatory, site, and client requirements.
Manufacturing cGMP production activities include solution
preparation, master/working cell bank production, upstream cell
culture, downstream protein purification, mRNA and molecular
therapeutics production, and small-scale fill/finish. Further,
manufacturing operations is tasked to utilize continuous
improvement methodologies to realize process optimization,
efficiency gains, and waste reduction to maximize capacity
outputs.--The role will focus on investigating to determine root
cause for deviations which occur during process execution.
Additional responsibilities include creation and implementation of
effective Corrective and/or Preventative Actions (CAPA) to prevent
recurrence of deviations. GMP production activities include, but
are not limited to, solution preparation, upstream cell culture,
downstream protein purification, mRNA production and filling of
Drug Substance.-- Candidates should possess strong technical
writing skills and the ability collaborate with subject matter
experts (SME's) from other departments.----This is a full-time
on-site hourly position, Monday - Friday, 8:00am to 5:00pmCatalent
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:
- Under minimal supervision, authors and revises complex
deviation records, preventative actions and other related cGMP
documents in a timely manner
- Familiar with upstream, downstream, materials management,
production facility, systems, and technologies to facilitate the
accurate completion of responsibilities
- Track/monitor and provide timely, accurate information
regarding status of open investigations
- Participate in initiatives to improve process compliance
culture, including on-going cGMP understanding and application
- Actively engage in Inspection Readiness activities and
teams
- Write and revise SOPs (Standard Operating Procedures) when gaps
are identified
- Provide support to internal and client audits as needed
- Responsible for exhibiting professional behavior with internal
and external associates that reflects positively on the company and
is consistent with the company's policies and practices
- All other duties as assignedThe Candidate: --
- Requires Bachelor's Degree in technical discipline (e.g.,
biology, biotechnology, engineering) or related life science field
with minimum of 1 years' related experience, OR
- Associates Degree in technical discipline (e.g., biology,
biotechnology, engineering) or related life science field with
minimum of 4 years' related experience, OR
- High School Diploma with minimum of 6 years' related
experience
- Must have fundamental understanding of pharmaceutical
production operationsWhy you should join Catalent:
- Defined career path and annual performance review and feedback
process--
- Diverse, inclusive culture--
- Potential for career growth on an expanding team within an
organization dedicated to preserving and bettering lives--
- 152 hours of paid time off annually +--8--paid holidays--
- Competitive salary with yearly bonus potential--
- Community engagement and green initiatives--
- Generous 401K match and Paid Time Off accrual--
- Medical, dental and vision benefits effective day one of
employment--
- Tuition Reimbursement--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, Madison , Associate Lead II - Biomanufacturing, Compliance, Other , Madison, Wisconsin
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