Director, Operations and MS&T
Company: Disability Solutions
Location: Princeton
Posted on: September 28, 2024
Job Description:
Job Title: Director MS&T and OperationsLocation: Princeton,
NJPOSITION SUMMARYThe Director of MS&T and Operations is
responsible for leading teams while overseeing the GMP
manufacturing, and MS&T processes, through the broad knowledge
of theories and principles utilized to solve operational, as well
as routine tasks in the production of cell therapy products. The
incumbent is also responsible for managing day-to-day operations of
the department to ensure timely delivery of client- sponsored
projects by providing strong technical leadership and collaborate
effectively across groups within the organization.KEY
RESPONSIBILITIES
- Strategic client facing leader of the MS&T team on the
behalf of the organization.
- Leads a team of engineers and scientists responsible for the
effective technology transfer of processes into Manufacturing for
both internally and externally developed processes.
- Works cross functionally with process development,
manufacturing, quality assurance, quality control, supply chain,
and facilities departments to effectively transfer and maintain
processes in the facility.
- Participates and leads commercial manufacturing transition and
support for process development.
- Supports process characterization and validation in preparation
for commercialization.
- Lead the evaluation, remediation and optimization of products
and processes using statistical tools to ensure safety, quality,
delivery and cost standards.
- Enhance productivity by exploring, analyzing, facilitating and
leveraging efficiency initiatives for manufacturing processes.
- Ensure that changes to existing processes or the introduction
of new processes are carried out and documented according to
approved change control procedures and in compliance with cGMP
requirements.
- Bridge the focus areas of P&D, Quality, EHS, Production,
Supply Chain and Engineering to create common understanding and
objectives and ensure robust products and flawless
manufacturing.
- Works closely with manufacturing to provide on-the-floor
technical oversight through each product campaign startup as well
as in response to any process/equipment troubleshooting
requirements.
- Leads the compilation of process data, including communicating
project status, and delivering internal and client
presentations.
- Collects and trend process data for external (Clients) and
internal review to ensure process consistency.
- Evaluates existing processes and identifies process and/or
equipment improvement to improve efficiency, consistency, and
competitiveness within the market. This includes development of
project requirements, feasibility, and technical design for
implementation into cGMP environment.
- Provides business case for process improvement projects
- Authors and reviews technical reports, process tech transfer
summary reports, master batch records, product and equipment
specifications, and protocols in support of tech transfer and cGMP
activities.
- Acts as the lead for technical support deviations, change
controls, and CAPAs including determination of event impact,
root-cause analysis, and corrective action identification.
- Responsible for maintaining a high performing team by hiring,
training, motivating, evaluating, and developing staff.
- Oversight of cell therapy production operations including a
thorough understanding of producing autologous and allogeneic
products.
- Leads coordination and integration efforts among operations,
engineering, technology, and program management divisions to
produce smoother workflow and more cost- effective business
processes.
- Works closely with the production staff to troubleshoot process
and equipment problems while ensuring appropriate and proactive
client and internal stakeholder communication.
- Will oversee and ensure compliance when creating, revising, and
editing procedures and specs as needed.
- Lead in addressing deficiencies and ensure completion of all
follow-up actions, specifically those that target process fixes to
maintain consistent resolutions to all operational issues according
to GMP standards and company objectives.
- Leads development and maintains metrics to track operations and
training record turnaround time, errors, and document related
deviations.
- Leads by example, keeping in mind organizational values,
policies, and goals.
- Proactively partners with Human Resources to attract and retain
top talent and takes an active role in ensuring new employee
onboarding and OJT is a positive experience.
- Ensures the proper processes are in place for GMP and Safety
training of staff, with a focus on cross- training and continuously
improves production records.
- Works closely with senior management to initiate new production
projects and assists in developing processes/techniques to meet
contract objectives.POSITION REQUIREMENTS
- B.S. in Engineering or Science discipline and 10+ years of GMP
cell therapy and/or biologics/gene therapy manufacturing experience
OR M.S. in Engineering in a Science discipline plus 10+ years of
GMP cell therapy and/or biologics/gene therapy manufacturing
experience.
- Manufacturing experience includes autologous and/or allogeneic
manufacture, extensive experience with cell therapy equipment,
aseptic manufacture procedures and supply chain process and
material controls.
- Must have experience in a CDMO or CMO environment.
- Minimum of 6 years of leadership experience required.
- Proficient (excellent) in English verbal and written
communication skills to convey and receive ideas and instructions
to/from others within and outside the organization.
- Ability to effectively present information and respond to
questions from peers, management, suppliers and customers.
- Ability to work effectively under pressure to meet
deadlines.
- Be accessible to manufacturing floor and office staff and to
use required office equipment.
- Specific vision requirements include reading of written
documents and frequent use of computer monitor.
- 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.Why 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.
- Dynamic, fast-paced work environment.
- 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.--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, Trenton , Director, Operations and MS&T, Executive , Princeton, New Jersey
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