Director, MS&T
Company: Disability Solutions
Location: Severn
Posted on: October 27, 2024
Job Description:
Director, Manufacturing Sciences & Technology (MS&T)Position
Summary:The Manufacturing Sciences and Technology Director will
develop and lead a new group to technically support the
manufacturing group, including the transfer between external
clients or Process Development and Manufacturing. The director is
responsible for leading the team of strong engineers and scientists
to be technology transfer process owner to deliver excellent
services to internal and external customers.The position will
direct a group of engineers and other direct reports to drive the
facility fit and technical transfer of mammalian, microbial, Gene
and Cell Therapy and viral vector biologic processes, including the
evaluation, alignment and recommendation of equipment/process
improvements.-- This role will also support on-the-floor technical
support to manufacturing. The director will be responsible for
supporting the preparation and review of documentation, compiling
and analyzing of process data, and provide technical input in the
deviation investigation, change controls, and CAPAs. The individual
will work closely with Clients, Process Development, Manufacturing,
and Quality to ensure successful implementation of cGMP drug
substance and drug product manufacturing processes.The Role:
- 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.
- Leads strategic alignment across Catalent Cell and Gene Therapy
sites.
- 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 R&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.The
Candidate:
- PhD in Biotechnology, Chemical or Pharmaceutical Engineering,
or related field, with minimum of 8 years of relevant experience;
or
- M.S./M.A. in Biotechnology, Chemical or Pharmaceutical
Engineering, or related field, with minimum of 12 years of relevant
experience; orB.S./B.A. in Biotechnology, Chemical or
Pharmaceutical Engineering, or related field, with minimum of 14
years of relevant experience.
- Experience with Upstream and Downstream processes at the small
to intermediate scale of cGMP biologics production
- Prior experience in process scaling and technology transfer is
required
- Advanced project management experience/skills required
including method transfers, and risk assessment. Knowledge of
regulatory, validation and documentation requirements for product
development, commercial production and site transfers. Experience
in investigating and closing out deviations, OOS, CAPAs, and change
controls
- Ability to write SOPs, batch production records and reports
independently. Strong technical knowledge in operation and
troubleshooting of a wide variety of equipment and data
systems.
- Strong interpersonal and presentation skills to discuss
technical concepts internally and with clients.
- Demonstrated understanding of multiple applicable techniques,
including: purification, buffer preparation, chromatography and
filtration, operation and troubleshooting of stirred vessel
bioreactors, incubators, chromatography columns, and filtration
apparatus.
- Ability to formulate complex and comprehensive materials such
as authoritative reports and/or to create/deliver formal and
informal presentations. Ability to write, edit and review SOPs and
reports with guidance..
- Provides reliable / defendable interpretations of regulatory
guidance for the customer and is capable of defending these
positions to regulatory agencies.
- Demonstrable leadership experience at Catalent (including but
not limited to participation in Catalent-sponsored leadership
programs such as NGGL, GOLD, LEAD Now, GM Excellence, and GROW) may
be considered in place of external experiencePay:The anticipated
salary range for this position in Maryland is $188,320-$258,940
plus variable incentive compensation. The final salary offered to a
successful candidate may vary, and will be dependent on several
factors that may include but are not limited to: the type and
length of experience within the job, type and length of experience
within the industry, skillset, education, business needs, etc.
Catalent is a multi-state employer, and this salary range may not
reflect positions that work in other states.Why you should join
Catalent:
- Comprehensive Benefit Package (Health, Dental, Vision, & Life
Insurance)
- Paid Time Off Programs incl. vacation, banked time & personal
time.
- Employee Reward & Recognition programs.
- Opportunities for professional and personal development &
growth including 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 , Director, MS&T, Executive , Severn, Maryland
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