Manufacturing Manager (Night)
Company: Disability Solutions
Location: Severn
Posted on: October 21, 2024
Job Description:
Manager, Manufacturing Position 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.--Our FDA-licensed, state-of-the-art CGMP manufacturing
facility for Gene Therapies is located on the Harmans/BWI campus.
The campus, featuring two manufacturing facilities is located 5
miles from the Baltimore Washington International (BWI) airport and
13 miles from our--. The campus is close to Washington, DC's I-270
Technology Corridor, top universities, and government agencies.The
Harmans/BWI-1 EMA and FDA approved facility, at approximately
200,000 sq. ft., houses 10 CGMP manufacturing suites, fill/finish,
central services, testing labs, and a warehouse.The Harmans/BWI-2
facility, at approximately 145,000 sq. ft., is under development
and will house 8 CGMP manufacturing suites and cold storage
warehousing.Both facilities support Phase 3 through commercial
manufacturing of advanced therapeutic products including AAV and
other viral vector-based therapies and vaccines.The Manufacturing
Manager is accountable for leading multiple teams to execute
procedures-- for downstream (purification)manufacturing and support
area of manufacturing using SOP's and batch records.-- Operating
production equipment for purification-- that-- may-- include--
process-- monitoring, purification and formulation. This position
is accountable for continuous improvement of the operations and
ensuring all team members are trained and training is completed on
time This is a full-time on-site position, 7pm-7amCatalent 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: --
- Manage and improve the purification operations of Contract
Manufacturing Facility.
- Ensure staff are fully trained on all cGMP manufacturing
operations and documentation and adhering to safety
guidelines.
- Establish a continuous improvement plan to achieve excellence
in accordance with The Catalent Way (TCW); deploy the plan and
coach others on the journey.
- Build effective teams that apply their diverse skills and
perspectives to achieve common goals.
- Drive engagement and create a culture where employees are
motivated to do their best.
- Ensure quality culture through the continuous pursuit of right
first-time performance.
- Understand company goals and practices and apply them when
resolving a variety of problems.
- Coordinate with production supervisors and project managers to
execute production campaigns on-time.
- Ensure batches adhere to established Quality standards.
- Write and/or approve manufacturing documentation, including
validation protocols, SOPs, and master batch records.
- Review client processes for compatibility with plant
capabilities and GMP requirements.
- Work with client representatives, Process Development, and
technical support to transfer manufacturing processes.
- Coordinate with other departments to schedule work in
processing and support areas or work that affects processing and
support areas.
- Identify and maintain relationships with quality vendors of
supplies, instruments, and equipment.
- Identify processing technologies and capabilities to add to the
Catalent portfolio.
- Work with QA to investigate and resolve nonconformance's.
- Other duties as assigned.The Candidate:
- Masters' degree in a Scientific, Engineering or Biotech field
with 6 -8 years' experience with upstream (purification) biologic
production processes under GMP compliance recommended.Experience
with chromatography equipment, columns, TFF, CIP procedures and of
processes to purify bulk proteins, antibodies, etc. (HIC, IEX,
Affinity)
- Bachelor's degree in a Scientific, Engineering or Biotech field
with 8 -10 years' experience with upstream
(fermentation/bioreactor) biologic production processes under GMP
compliance recommended.
- Associate'sDegree with 10 -12 years' experience in biologics
production recommended.
- 3 years of Progressive Leadership experience, experience with
Performance Management, Goal Setting and Managing through
Conflict.
- One (1) year of demonstrated leadership experience (Lead role)
at a Catalent site will be considered.
- Demonstrable leadership experience at Catalent (including but
not limited to participation in Catalent-sponsored leadership
programs such as NGGL, GOLD, GM Excellence, and GROW) may be
considered in place of external experience.
- Proficient knowledge and ability to apply scientific principles
utilized to solve operational, as well as routine production
tasks.
- Proficient knowledge of documentation including comprehension,
review & establishing Batch Production Records, SOP's, deviation &
summary reports.
- Actively pursues learning of required skills, new skills, and
new equipment.
- Possesses proficient equipment understanding, including
understanding equipment function and application.
- Creative thinking with the ability to multi-task
- Commitment to ongoing professional development
- Team player who thrives in collaborative environments and
revels in team success.
- Solid communication skills across technical and non-technical
audiences and the ability to create and communicate complex
concepts and analyses in easy-to-understand ways.Why you should
join Catalent:
- Defined career path and annual performance review and feedback
process--
- 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 ReimbursementCatalent 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, Columbia , Manufacturing Manager (Night), Executive , Severn, Maryland
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