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Manager, Fill Finish Technical Operations
5800 Park of Commerce BLVD NW Boca Raton, FL 33410 US
Job Description
The Manager, Fill Finish Technical Operations is responsible for managing the process and providing technical support and guidance for the Fill/Finish teams and projects.
Qualifications
ESSENTIALS OF THE JOB:
- Establish and maintain quality processes within Fill-Finish Operations
- Develop or revise procedures as needed in conjunction with the Quality Department for filling and finishing.
- Ensure proper documentation, procedures, batch records, improve quality, and Fill-Finish manufacturing efficiency.
- Establish weekly production schedules to ensure customer orders and product specifications are met.
- Direct Validation efforts, interacting with Quality Control Directors, Technical Services and Quality Assurance.
- Develop more efficient methods for departmental operations.
- Responds to reports from internal/external audits.
- Assign and supervise change controls or deviation reports as needed.
- Review statistical data with Scientific and Technical Operations, based upon trends and development work, modify procedures using the change control and process validation systems for the goal of optimum yields and productivity.
- Assure compliance with GMP including training, documentation and processes.
- Interact with the management of VP of Supply Chain Operations to establish production schedules and protocols, and provide input into new facility design, operation, and upgrades.
- Assist in preparation of Biological License Application for a new product.
Education Requirements: Bachelor’s degree or equivalent level of technical training/service.
Experience Requirements: 10+ years of related experience with 3+ years in a managerial role or 6+ in a supervisory role. Knowledge of GMP’s and all aseptic filling and finishing equipment. Good interpersonal skills. Intermediate proficiency in quality document systems, word processing and spreadsheet packages.
Equal Opportunity Employer: We are proud to be an equal opportunity employer. We welcome and encourage applications from all qualified candidates regardless of race, sex, gender identity or expression, disability, age, religion or belief, sexual orientation, or any other characteristic protected by applicable laws and regulations. It is our policy not to discriminate against any applicant or employee, and we are committed to fostering a diverse, inclusive, and respectful work environment across all locations in which we operate. We believe that diversity, equity, and inclusion are fundamental to our mission and enhance our ability to serve clients globally. If you have a disability or require any reasonable accommodations during the application or interview process, please inform your recruiter or contact us directly so that we can explore the appropriate arrangements.
Fraud Alert: Candidate safety is a top priority at Planet Pharma. The industry has seen an increase in people falsely representing themselves as recruiters to gather personal information from job seekers. For your safety, do not provide sensitive data to anyone you have not spoken with thoroughly, never provide banking information during the application process and always double check the email address of the Recruiter to ensure it’s from an official Planet Pharma domain (@planet-pharma.com, @planet-pharma.co.uk, and @ppgadvisorypartners.com) and not a domain with an alternative extension like .net, .org or .jobs.
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