Senior Director, Technical Services
Company: Disability Solutions
Location: Bloomington
Posted on: May 4, 2024
Job Description:
Job Title: Sr. Director, Technical ServicesLocation:
Bloomington, INPosition Summary:Catalent Biologics is a
fast-growing business within Catalent Pharma Solutions focused on
providing innovative technologies and solutions to help more and
better biologic treatments get to patients.--- The business
includes our proprietary GPEx cell line engineering platform, our
new state-of-the-art biomanufacturing facility in Madison, WI, and
our market leading biologics analytical services in Kansas City, MO
and Research Triangle Park, NC, as well as SMARTag Antibody Drug
Conjugate technology in Emeryville, CA.-- Leveraging our growing
differentiated technology portfolio, world class manufacturing
capability, and other integrated services across the Catalent
network, Catalent Biologics is positioned to drive significant
growth for Catalent.Working for Catalent Biologics is an
opportunity to join an entrepreneurial team.--- Catalent Biologics
is making significant investments in people and capabilities.
---This is a unique opening to join a small, fast-growing business,
backed by a global public company.--- People joining our team will
have the opportunity for career development as our business
continues to grow and expand.--- Catalent employees are helping to
improve future patient outcomes by working on products that are
designed to treat COVID-19, cancer, various autoimmune, fibrotic
and blood disorders, HIV, diabetes, heart, and lung diseases as
well as Alzheimer's.The Role
- The Technical Services function encompasses Engineering,
MS&T, Validation, and Continuous Improvement.
- Engineering is responsible for supporting CGMP operations
through process engineering, facilities and utilities engineering,
calibration, process improvement and automation, packaging, capital
projects, while maintaining compliance with regulatory
standards.
- Process Engineering has oversight of consumable and raw
material lifecycle management inclusive of process function
definition, design through drawing approval, onboarding support,
and change management. This function ensures integration of
consumables with equipment and associated manufacturing processes,
while maintaining larger strategy project ownership across the
facility (e.g., equipment methods, risk assessments, control
strategies, etc.).
- Equipment Engineering group has oversight of equipment
lifecycle management inclusive of equipment design (URS through
qualification support and release), equipment updates (design
modifications via change management), and general equipment support
through troubleshooting, training, and continuous
improvement.---This function also maintains ownership of the
capital expenditure (CapEx)
process.------------------------------------------------------------
- MS&T is responsible for the execution of clinical and
commercial manufacturing in accordance with regulatory, site, and
client requirements. Manufacturing cGMP production activities
include solution preparation, master/working cell bank production,
upstream cell culture, downstream protein purification, mRNA and
molecular therapeutics production, and small-scale fill/finish.
Further, manufacturing operations is tasked to utilize continuous
improvement methodologies to realize process optimization,
efficiency gains, and waste reduction to maximize capacity
outputs.--
- Continuous Improvement teams are responsible for leading
continuous improvement and operational excellence throughout the
organization by identifying, planning, facilitating, and
implementing projects for sustainable improvements.-- The
Continuous Improvement team is an effective change-agent who
collaborate continuously with front-line personnel and spends
extensive time in the areas of improvement.----
- The Technical Services Senior Director will receive assignments
in the form of annual (site specific) objectives (projects) and
develop goals to meet those project objectives. This individual may
establish new SOPs and/or recommend changes to current SOPs based
on facility needs. This person will work on complex problems
requiring in depth analysis of data to determine appropriate
action. Poor decisions could result in delay of business operations
and lead to project delays, which could ultimately jeopardize site
business activities. This person is expected to have extensive
communication with employees and cross-functional group
managers/departments on facility related issues.--
- This role will direct on-call and on-the-floor technical
support to manufacturing. The leader will be responsible for the
drafting and review of documentation, compilation, and assessment
of applicable data, change management, utilization, and monitoring
while providing technical input. This position will be client
facing and should possess the ability to work collaboratively with
clients and internal cross-functional stakeholders to move projects
forward.------
- This position must comply with all Security guidelines,
Environmental Health and Safety regulations and the current Good
Manufacturing Practices required by the job function.
- Responsible for the development, implementation, and ownership
of a comprehensive Engineering, Facility Maintenance, Technical
Services, Manufacturing Technology, Validation, and Continuous
Improvement.
- Take a proactive approach to shape and influence internal and
external executive stakeholder expectations across the
organization.
- Serve as a liaison between different sites and business units
for strategic programs and cross functional alignment.
- Effectively align and influence the interests of multiple
executive stakeholders (client programs and company) with different
priorities to quickly drive decisions to complex conflicts with
broad organizational impact.
- Help define department objectives to align with business unit
goals. Regularly communicate to team, department, and company about
department and company priorities. Monitor and evaluate social,
fiscal, and political trends that affect the plan.
- Make implementation plans and assignments that allocate
strategic and inter-site resources appropriately to complete
objective and drive development opportunities.
- Prepare strategies to deal with anticipated problems or drastic
changes for department and company initiatives and team's
projects.
- Identify activities with relevant milestones and schedules to
effectively manage the progress and performance of team and own
work developing metrics to monitor performance to goal and
establishing best practices with multiple site impact.
- Share own ideas in a compelling manner that gains commitment
from organization.
- Inspire and persuade others to pursue and achieve goals.
- Negotiate skillfully and professionally and persuade others to
approach complex organizational issues in the same manner.
- Win concessions while building relationships or knowing when to
yield to another's point of view. Teach peers the art of
persuasion.
- Anticipate reactions and positions of others and plan
accordingly. Mentor peers to do the same.
- Lead team members to improve and reinforce performance of
others.
- Take responsibility for direct reports' performance by setting
clear goals and expectations, tracking progress against the goals,
ensuring constructive feedback, and addressing performance-related
concerns and issues promptly.
- Work with, coach, and support direct reports in developing
knowledge, skills, and abilities in the interest of performance
improvement and employee's career development.
- Responsible for maintaining a high performing team by hiring,
training, motivating, evaluating, and developing staff (direct
reports and others).
- Contribute to the company's overall probability and growth
strategy.
- Performs additional duties as assigned.Engineering Specific:
- Organize, manage, develop, and implement project plans,
construction projects, designs, assembly of equipment, processes,
and systems to ensure timely project completion in compliance with
regulatory agency requirements, internal company standards, and
current industry practices.
- Manage multi-use facility, including HVAC systems and
bio-containment systems
- Responsible for acceptance and installation of manufacturing
equipment--
- Work with facility commissioning/validation team, including
operational protocol development, to implement compliance with cGMP
requirements.
- Draft Standard Operating Procedures (SOPs) for building
operation, maintenance, and security
- Manage facility preventative maintenance and provide guidance
and execution on facilities and equipment
projects.MS&T/Validation Specific:
- Apply technical, functional, business, and/or industry
knowledge to design experiments or project scopes; provide
scientific or business consultation to the site and executive
leadership team and manage multiple functions and/or focuses across
site disciplines.--
- Actively define and execute on the strategic direction of the
department by recommending expansion or curtailment of
investigations on the basis of experimental results or scientific
information.
- Work cross functionally with Process Development,
Manufacturing, Quality Assurance, Quality Control, Supply Chain,
Project Management, Facilities, and other departments to
effectively transfer and maintain processes in the facility.
- Lead and/or support the compilation of process data, including
communicating project status, trend identification, and delivering
internal or client presentations.
- Evaluate existing processes and identify process or equipment
improvements to advance efficiency, consistency, and
competitiveness within the market.--
- Act as the lead for technical support of risk assessments, gap
analysis, deviations, change controls, and CAPAs including
determination of product or process impact, root-cause analysis,
and corrective action identification.CI Specific:
- Oversees Continuous Improvement function including knowledge
dissemination, cost effective practices, standardization, Elements
of Six Sigma, best practices, knowledge creation, assessment,
technical expertise, and knowledge management to develop sustained
productivity improvement in the site and a superior site
performance.
- Develop site Continuous Improvement plan by partnering with
business leaders to meet their Strategic and Operational
goals.
- Facilitate impactful improvements through Continuous
improvement tools, Kaizen funnel process, and systems to improve
key performance indicators.
- Identify performance gaps through data, best practices and
prior lean deployment experience.
- Utilize a structured problem-solving approach to analyze
current conditions, identify improvement opportunities, and deploy
Lean and Six Sigma tools.
- Lead and coach Kaizen events through hands-on participation.The
Candidate
- Bachelor's degree in science field, required.
- Master's degree, preferred.
- 10+ years of relevant leadership experience
- GMP experience, required.
- Must be able to read and understand English-written job
instructions and safety requirements.
- Experience in report and documentation skills.
- Experience with statistical techniques for data analysis and
reporting.
- Direct personnel and organizational group management
experience, including mentoring and training staff members
cross-functionally.
- Experience in investigating and closing deviations, OOS, and
CAPAs
- Experience drafting and revising standard operating procedures,
batch production records, and reports.
- Experience with operating and troubleshooting process
equipment, including single-use systems and consumables.
- Experience working on late phase, process performance
qualification, and commercial programs is a plus.Why you should
join Catalent
- Comprehensive Benefit Package (Health, Dental, Vision, & Life
Insurance)
- Group Retirement Savings -Registered Pension Plan (RPP) with
employer contributions.
- Paid Time Off Programs incl. vacation, banked time & personal
time.
- Employee Reward & Recognition programs.
- Opportunities for professional and personal development &
growth including 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.--Catalent is committed to the health and safety of its
employees, visitors and the customers and patients we serve. As a
result of the global pandemic, we have modified many of our
recruitment and on-boarding processes to maintain everyone's
safety. The Human Resources teams will communicate all necessary
safety processes and procedures throughout each
stage.------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, Carmel , Senior Director, Technical Services, IT / Software / Systems , Bloomington, Indiana
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