Manager, Manufacturing
Company: Disability Solutions
Location: Severn
Posted on: September 28, 2024
Job Description:
Manager, ManufacturingSummary: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 Manager, Manufacturing is accountable
for leading teams to execute procedures for upstream, downstream,
and solution preparation manufacturing using SOP's and batch
records.-- Operating production equipment in support of all drug
substance manufacturing. The Manager, Manufacturing is accountable
for ensuring overall compliance and operational execution meets the
standards required, and that expectations established by leadership
are being met at all times.This is a full-time on-site position,
M-F 8am-5pmCatalent 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:
- Assure shift supervisors are leading their teams as
expected.
- Act as the single point of accountability during off-shift
operations.--
- Triage issues occurring on the floor and work with Quality and
SMEs to determine if deviations are required.
- Provide guidance for all shift supervisors with respect to
compliance, operational issues, personnel management challenges,
and logistics.
- Draft and revise official manufacturing documents, SOPs, Batch
Records, Validation Protocols.
- Lead initiation and closure of deviations; may serve as the
lead in the departmental investigation and be responsible for
closing out deviations and CAPAs.--
- Coordinate with other production supervisors, managers, and
project managers to execute production campaigns on-time.
- Ensure batches adhere to established Quality standards.
- GMP batch review and close-out with Quality Assurance
group.
- Collaborate with MST and development groups to assist with
tech-transfer, scale-up, and translation activities.
- Provide input for hiring new manufacturing associates and
conduct interviews.
- Provide daily production updates to production managers, client
representatives, and project managers.
- Provide guidance for continuous improvement initiatives with
Upstream team.
- Represent the department to clients and on cross-functional
project teams.
- Execute and monitor critical processes supporting production
areas.
- Extensive experience with the following: upstream, downstream,
and solution preparation equipment.
- Ability to contribute to the development of new concepts,
techniques, and standards.
- Assist Facilities and Engineering personnel as necessary on
equipment maintenance and calibration.
- Provide support to cross-functional teams to meet production or
timeline demands.
- Demonstrate understanding in scientific concepts, technical
operations, safety, and Good Manufacturing Practice.
- Adhere to Quality standards and learn and comply with
regulatory requirements.
- Provide suggestions for process optimization and efficiency,
where applicable.
- Write standard operating procedures (SOP's) and other documents
as necessary
- Complete manufacturing documents such as batch records,
logbooks.
- Assist in the execution of validation protocols.
- Ensure the completeness and accuracy of manufacturing
documentation per approved procedures.
- Identify and support the implementation of process efficiencies
and areas for improvement.
- Ensures solutions are consistent with organization's
objectives.
- Demonstrate ability to perform all process steps and/or support
production operations.
- Ability to generate SOPs for equipment and procedures used in
the manufacture of biological products.
- Leads by example, keeping in mind organizational values,
policies and goals. Develops people and team coaching and
collaboration.
- Proactively partners with Human Resources to attract and retain
top talent and takes an active role in ensuring new employee
onboarding is a success.
- Other duties as assigned.The Candidate:
- Masters' degree in a Scientific, Engineering or Biotech field
with 6 - 8 years' experience with upstream
(fermentation/bioreactor) biologic production processes under GMP
compliance recommended.
- OR
- 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.
- 3-4 years of progressive Leadership experience, experience with
Performance Management, Goal Setting and Managing through
Conflict.
- 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.Position Benefits:
- 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, Severn , Manager, Manufacturing, Executive , Severn, Maryland
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