MEGAN BJELIS
Summary
Ambitious Production Manager with 4 years of experience in a Manufacturing environment. Motivates employees to align performance with company objectives in fast-paced production environments. Superior competency in resource allocation, production scheduling and workflow management.
Overview
6
6
years of professional experience
Work History
Production Manager
Novartis Pharmaceuticals
05.2023 - Current
- Create and validate the Standard Operating Procedures and Work Instructions related to production operations, ensure their strict implementation
- Ensure proper qualification and maintenance of the manufacturing department, premises, and equipment
- Ensure appropriate initial and continued training of the manufacturing department personnel
- Minimize the number of production related deviations by investigating the root cause thoroughly and implementing/monitoring appropriate CAPAs to ensure no recurrence
- Manage production planning, maintenance, and replanning of the production schedule in case of failure to ensure impact is mitigated
- Collaborated with cross-functional teams to ensure timely delivery of high-quality products according to customer requirements
- Support on site inspections through interview, SME knowledge, tours, and data/ document retrieval
- Coordinate and support the implementation and validation of new drug products and processes
Ad Interim Production Manager
Novartis Pharmaceuticals
12.2022 - 05.2025
- Ensure the effectiveness of the production team as it pertains to GMP, GDP, and good working practices
- Review, approve, and evaluate all documents including production batch records, Standard operating procedures, work instructions, and protocols
- Managing of production staff including staff planning and re planning in case of failure to mitigate the impact for the patient
- Support of site management on compliance activities and documentation onsite with existing statutory and corporate standards in the area of regulatory compliance, cGMP, GDP, Health, Safety, and Environmental Protection
Production Lead
Novartis Pharmaceuticals
09.2021 - 12.2022
- Supervise and support technical aspects relating to production readiness including cleaning/sterilization, material preparation, investigative writing, participation in qualification/validation activities, drafting standard operating procedures and document preparation
- Support production manager in planning, coordinating, and executing of production activities
- Served as a primary contact for technical troubleshooting and compliance related inquires
- Assisted in coaching operators to ensure on - boarding and trainings are consistently followed
- Serve as an SME for audits and inspections ranging from interviews to data retrieval
Production Technician
Novartis Pharmaceuticals
05.2019 - 09.2021
- Manufacture drug products (Luthathera and PSMA) using laboratory skills in an aseptic environment (GMP) while contemporaneously recording critical data during production process (GDP)
- Supported technical aspects related to production including preparing materials while maintaining material identity, sterilization of the isolators using hydrogen peroxide, and participation in validation activities
- Performed routine maintenance and calibration on testing equipment
- Adhered to safety and clean area procedures to comply with agency and regulatory mandates.
Education
Bachelor of Arts - Biological Sciences
CAREEROBJECTIVERUTGERS UNIVERSITY
New Brunswick, NJ05.
Skills
GMP
GDP
Multitasking
Critical Thinking
Problem Solving
Technical Writing
Timeline
Production Manager
Novartis Pharmaceuticals
05.2023 - Current
Ad Interim Production Manager
Novartis Pharmaceuticals
12.2022 - 05.2025
Production Lead
Novartis Pharmaceuticals
09.2021 - 12.2022
Production Technician
Novartis Pharmaceuticals
05.2019 - 09.2021
Bachelor of Arts - Biological Sciences
CAREEROBJECTIVERUTGERS UNIVERSITY
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