Senior Manager Production - Bora Pharmaceuticals : Job Details

Overview

Responsible for the direct management/supervision of production supervisors. Provide leadership and decision making for the Production department and oversee all aspects of prep, formulation, setup and operation of filling.

Responsibilities

• Oversee all equipment preparation, equipment operation, product formulation, and clean room procedures to ensure that Bora SOPs and policies are followed and that the highest standards are met.
• Monitor and ensure all personnel comply with cGMP regulations, adhere to Bora policies, safety regulations, and adhere to Bora SOP and Batch Record directions.
• Develop and train Technicians and Supervisors through counseling and guidance through Individual Development Plans and Coaching.
• Ensure appropriate training is provided to Technicians for them to successfully complete their job assignments safely, compliantly and on time.
• Recommend measures to improve performance and increase efficiency for Flex Filling Operations.
• Interface with the Quality Assurance, Maintenance, and Supply Chain departments to resolve production, supply, and equipment issues.
• Provide leadership and oversight of deviation investigations, CAPAs, change controls to drive continuous improvement to the department.
• Effectively troubleshoot equipment during operation to ensure effective and efficient operations while maintaining high quality and service to the client.
• Interact with clients and auditors to provide information and technical expertise on Component Preparation, Formulation, and Filling operations.
• Collaborate with Supply Chain to develop manufacturing schedule that ensures optimal use of resources.
• Review documentation for compliance with Good Documentation Practices.
• Review, provide technical expertise for, and assist in development of batch records to comply with cGMP regulations and to efficiently use Bora resources.
• Track and control expenditures to ensure budget and client requirements are met.
• Coordinate with the Validation and Maintenance team with the operation and execution of engineering projects. Provide technical expertise for these projects. Review and approve protocols and reports.

The above statements are intended to describe the nature of work performed by those in this job and are not an exhaustive list of all duties. Nothing in this job description restricts managements right to assign or reassign duties and responsibilities to this job at any time which reflects management's assignment of essential functions.

Minimum Education, Experience, Skills

• BA/BS in science or technical field with a minimum of 7 years' experience in cGMP or regulated environment
• RABs/Isolator technology experience preferred
• Lyophilization experience preferred
• Minimum of 7 years of supervisory experience
• Pharma Start Up experience preferred

Physical/ Mental Demands and Work Environment Characteristics

The physical/mental demands are representative of those that must be met by an individual to successfully perform the essential functions of the job. The work environment characteristics described here are representative of those an individual would encounter while performing the essential functions of the job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

Compensation

Compensation Range: $121,954.00 - $182,931.00

Bora Pharmaceuticals Injectables, Inc. is committed to providing equal employment opportunity to all applicants and employees according to all applicable equal opportunity laws, directives and regulations of federal, state and local governing bodies. Bora will recruit, hire, train and promote persons in all job titles, without regard to race, color, creed, religion, sex (including pregnancy or childbirth factors), national origin, age, marital status, familial status, disability, sexual orientation, gender identity status, or any other protected category.