Kelly Services® has been providing outstanding employment opportunities to the most talented individuals in the marketplace.
We are proud to offer a direct hire opportunity to work as an Aseptic Fill / Finish Manager located in Plantation, FL.
Job Type : Full-time
Job Description :
We are seeking a highly skilled and experienced Manager for Aseptic Fill Finish Manufacturing to oversee all aspects of our Fill Finish Manufacturing functions.
The successful candidate will have hands-on responsibility for operational management and planning of Fill Finish activities.
This role requires a strong understanding of GMP aseptic manufacturing processes and the ability to troubleshoot and execute these processes efficiently.
Key Responsibilities :
- Develop and maintain Subject Matter Expert (SME)-level understanding of GMP aseptic manufacturing processes.
- Expertly execute and troubleshoot automated and semi-automated fill-finish equipment.
- Maintain the Aseptic Fill and Finish training matrix, ensuring staff compliance.
- Provide operational support, including material stocking, kit preparation, and equipment maintenance.
- Review documents, including Batch Records and Logbooks, and support documentation needs.
- Lead Change Controls of SOPs, Batch Records, etc., as required.
- Contribute to interdepartmental projects and technical transfers.
- Mentor staff and identify training needs to ensure continuous improvement.
- Work independently and in a team environment, adhering to Good Manufacturing Practices (GMP) and Standard Operating Procedures (SOPs).
- Lead departmental projects and escalate issues to management as needed.
- Maintain compliance with regulatory requirements and ensure accurate data recording.
Required Qualifications :
- Bachelor's degree or some post-secondary education.
- Strong technical knowledge of automated aseptic processing in cleanroom environments.
- Experience in aseptic manufacturing processes for sterile biologic drug substances and products.
- Proficiency in Microsoft Excel, Word, and Outlook.
- Ability to perform arithmetic and algebraic calculations accurately.
- Proven leadership skills with experience in coaching, mentoring, and developing staff.
- Excellent communication skills and the ability to manage change effectively.
Preferred Qualifications :
- Minimum 2+ years of experience in pharma / biopharma GMP sterile manufacturing operations.
- Familiarity with GXP best practices and FDA regulations.
- Proactive, results-oriented self-starter with experience in complex manufacturing environments.
Visual Inspection Program :
- Must be able to pass a Vision Exam.
- Must not be color blind and must have 20 / 20 vision (can be corrected).
Interacts with :
All Cross-Functional Departments
APPLY NOW FOR IMMEDIATE CONSIDERATION!!
As part of our promise to talent, Kelly supports those who work with us through a variety of benefits, perks, and work-related resources.
Kelly offers eligible employees voluntary benefit plans including medical, dental, vision, telemedicine, term life, whole life, accident insurance, critical illness, a legal plan, and short-term disability.
As a Kelly employee, you will have access to a retirement savings plan, service bonus and holiday pay plans (earn up to eight paid holidays per benefit year), and a transit spending account.
In addition, employees are entitled to earn paid sick leave under the applicable state or local plan. Click here for more information on benefits and perks that may be available to you as a member of the Kelly Talent Community.
Why Kelly
Science & Clinical?
Kelly Science & Clinical is your connection to premier scientific and clinical companies looking to hire industry experts just like you.
Our team creates expert talent solutions to solve the world’s most critical challenges. Every day, we match science professionals with dream jobs that fit their skills, interests, and career goals it’s the way we think job searching should be.
Nearly 100 percent of our science recruiters have a professional background and education in science, so we know a thing or two about the science market and how to get your expertise noticed.
About Kelly
Work changes everything. And at Kelly, we’re obsessed with where it can take you. To us, it’s about more than simply accepting your next job opportunity.
It’s the fuel that powers every next step of your life. It’s the ripple effect that changes and improves everything for your family, your community, and the world.
Which is why, here at Kelly, we are dedicated to providing you with limitless opportunities to enrich your life just ask the 300,000 people we employ each year.
Kelly Services is proud to be an Equal Employment Opportunity and Affirmative Action employer. We welcome, value, and embrace diversity at all levels and are committed to building a team that is inclusive of a variety of backgrounds, communities, perspectives, and abilities.
At Kelly, we believe that the more inclusive we are, the better services we can provide. Requests for accommodation related to our application process can be directed to Kelly’s Human Resource Knowledge Center.
Kelly complies with the requirements of California’s state and local Fair Chance laws. A conviction does not automatically bar individuals from employment.
Kelly participates in E-Verify and will provide the federal government with your Form I-9 information to confirm that you are authorized to work in the U.S.