Director, Operations
Company: Disability Solutions
Location: Chelsea
Posted on: April 24, 2024
Job Description:
Position SummaryThe Director, Operations is a hands-on, Senior
Leadership position responsible for the oversight, advancement and
flawless execution of early to commercial stage Spray Drying,
Filling and Packaging functional groups.-- The incumbent is
responsible for developing and implementing strategies driving
manufacturing schedule adherence to meet in full, on time delivery
of product to clients.-- Working together with Quality and
Technical Operations, the individual drives a client focus,
solution-oriented, continuous improvement, lean culture.--The
Role
- Establishes annual budgets, cost savings targets and
manufacturing goals.----
- Develops and implements short- and long-term CI strategies to
advance Spray Drying, Filling and Packaging operations, by
reviewing processes, identifying problem areas and establishing
action plans for improvement.--
- Works cross-functionally of Capital projects ensuring
Operational Readiness requirements are met.
- Ensures the timely procurement of all materials necessary to
meet production demand.--
- Interacts with clients, contractors and vendors in a
professional manner to identify solutions to meet company
objectives.--
- Provides ongoing coaching, mentoring, performance feedback and
development of staff.--
- Assists with talent recruitment and leads a highly motivated,
efficient, and effective team.--
- Creates standard procedures that facilitate operator
performance and compliance.
- Assures all activities of Manufacturing apply the appropriate
level of cGMP compliance.--
- Leads site meetings with clients, including presentation
materials and site tours.
- Interacts with Government agencies (FDA, TTB) to ensure site
compliance with applicable regulations.
- Operations SME on SAT, IOQ, PQ PPQ and Product Development
documents for approval.
- Overseas departmental deviations, investigations, change
controls, and CAPAs.The Candidate
- Bachelor's degree required. MS/MBA preferred.
- Minimum of 10 years of experience working in a pharmaceutical
or similarly regulated industry required.-- Minimum of 5 years of
direct experience managing manufacturing and operating at a 24h/7d
schedule or equivalent is required.-- A strong continuous
improvement background with a solid track history of delivering
sustainable results.----
- Strong knowledge of manufacturing technologies particularly
encapsulation, spray drying and blister sealing.
- Strong understanding of GMP compliance as it pertains to
clinical through commercial manufacturing.
- Knowledge of shipping and receiving techniques and
processes.----
- Knowledge of cGMP regulations as they pertain to final dosage
manufacturing and primary packaging.
- Must be proficient in MS Office Suite including PowerPoint,
electronic documentation, exception and inventory systems.
- Excellent written, verbal and presentation skills.Why You
Should Join Catalent
- 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--
- Dynamic, fast-paced work environment
- Generous 401K match and Paid Time Off accrual--
- Medical, dental and vision benefits effective day one of
employment--
- Tuition Reimbursement--
- GymPass program to promote overall physical
wellness-----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, Arlington , Director, Operations, Executive , Chelsea, Massachusetts
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