Supervisor, Manufacturing (Downstream)
Company: Disability Solutions
Location: Severn
Posted on: October 25, 2024
Job Description:
Supervisor, 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 Manufacturing Supervisor is accountable
for leading teams to execute procedures for upstream manufacturing
and support area of manufacturing using SOP's and batch records.--
Operating production equipment for upstream processing that may
include process monitoring, media prep and harvesting.-- This
position is accountable for ensuring all team members are trained
and training is completed on time prior to entering the production
floor.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:
- Supervision of manufacturing processes and personnel
- Ensure staff are fully trained on all cGMP manufacturing
operations and documentation and adhering to safety
guidelines----
- 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.
- Oversee daily activity for the group to ensure quality results
Performance management for direct reports.
- Extensive experience with chromatography equipment, columns,
TFF, CIP procedures and of processes to purify bulk proteins,
antibodies, etc. (HIC, IEX, Affinity)----
- Coordinate with other production supervisors, managers, and
project managers to execute production campaigns on-time.
- Ensure batches adhere to established Quality standards.
- Lead initiation and closure of deviations; may serve as the
lead in the departmental investigation and be responsible for
closing out deviations and CAPAs----
- Collaborate with MST and development groups to assist with
tech-transfer, scale-up, and translation activities.
- GMP batch review and close-out with Quality Assurance
group.
- Conduct performance reviews of manufacturing associates.
- 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
Downstream team.
- Represent the department to clients and on cross-functional
project teams.
- Interface with Quality Control department to submit in-process
samples and coordinate environmental monitoring during key process
steps.
- Review GMP documentation and production records for
accuracy.
- Interface with Quality Assurance group to ensure completeness
of GMP documentation.
- Initiate non-conforming events and participate in
investigations as requested
- Draft and revise official manufacturing documents, SOPs, Batch
Records, Validation Protocols.
- Accurately follow SOP's for operating production equipment and
performing processing steps
- Collaborate with engineering group to validate equipment for
GMP production.
- 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 4 - 6 years' experience in downstream GMP production and
purification including aseptic processing, chromatography, TFF,
Final Formulation and buffer preparation processes under GMP
compliance.OR
- Bachelor's degree in a Scientific, Engineering or Biotech field
with 6 - 8 years' experience in downstream GMP production and
purification including aseptic processing, chromatography, TFF,
Final Formulation and buffer preparation processes under GMP
compliance.OR
- Associate Degree or HS Diploma with 8 - 10 years' experience in
downstream GMP production and purification including aseptic
processing, chromatography, TFF, Final Formulation and buffer
preparation processes under GMP compliance.
- Experience in Pharma/Biotech or other cGMP manufacturing
environment required
- Knowledge of GMP's, FDA regulations and documentation
procedures required
- Proficient originality and application of standard engineering
principles and methods in completing technical assignments.
- Work requires the application of standard engineering
principles and methods to the solution of process/production
problems.
- 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.
- Onsite work is required. No option for remote or hybrid
work.Position Benefits:
- 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 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, Wheaton-Glenmont , Supervisor, Manufacturing (Downstream), Other , Severn, Maryland
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