Supervisor Production

Bora Pharmaceuticals; Baltimore (MD); On-site; USD 70,000 - 100,000; Full time

Benefits offered by this job

Competitive salary

Health coverage

Retirement plans

Paid time off

Professional development opportunities

Wellness programs

Job summary

Bora Pharmaceuticals in Baltimore is seeking a Production Supervisor to oversee fill line activities, develop procedures, train operators, support qualification activities, and ensure compliance with safety standards and established policies.

You will coordinate Equipment Preparation, review batch records for Good Documentation Practices, and collaborate with Quality Assurance, Facilities, Materials Management, and Manufacturing to resolve production issues.

Qualifications

• BA/BS in science or technical field with minimum of 3 years' experience in cGMP or regulated environment.
• High School/AA with a minimum of 8 years' experience in cGMP environment.
• 3 years previous supervisory experience in cGMP environment preferred.

Responsibilities

• Monitor and ensure cGMP compliance by personnel.
• Maintain visibility and access to employees during shift.
• Develop procedures and batch records for equipment preparation and train operators.
• Provide technical support for qualification activities.
• Review batch records for compliance with Good Documentation Practices.
• Coordinate equipment preparation activities and scheduling.
• Interface with QA, Facilities, Materials, and Manufacturing to resolve production issues.
• Understand vial washers, autoclaves, depyrogenation ovens and cleaning of equipment.

Skills

Communication

Leadership

Problem solving

Decision making

Time management

Adaptability

Education

BA/BS in science or technical field

High School/AA with 8 years cGMP experience

3 years supervisory experience in cGMP environment

Job description

About Bora

Bora Pharmaceuticals is a premier international contract development and manufacturing organization (CDMO) specializing in formulation development, clinical and commercial manufacturing, and packaging of complex oral solid dose, liquid, semi-solid, biologics, and sterile injectable pharmaceutical products.

From our world-class sites in North America and Asia, we deliver drug products with unparalleled quality to more than 100 markets around the world. Bora's teams, technologies, and facilities work seamlessly together to enable our clients to deliver much-needed therapeutics to patients worldwide.

At Bora Pharmaceuticals, we see it as our mission, our duty, our responsibility, to make our success and our customer's success more certain.

Job Summary

The Production Supervisor will be responsible for execution of preparation of activities associated with fill line, including development of procedures and subsequent training of operators, supporting execution of qualification activities, and ensuring compliance with safety standards and established policies and procedures.

Essential Functions

Reasonable accommodations will be made to enable individuals with disabilities to perform the essential functions.

• Monitor and ensure compliance by all personnel with cGMP regulations, Company policies, and SOP and Batch Record directions.
• Maintain a high degree of visibility and access to employees throughout the shift.
• Responsible for development of procedures and batch records associated with equipment preparation operations and subsequent training of operators.
• Provide technical expertise and support for execution of qualification activities.
• Review documentation, including executed batch records, and ensure that it complies with Good Documentation Practices.
• Coordinate, schedule, and oversee Equipment Preparation activities.
• Interface with the Quality Assurance; Facilities and Maintenance; Materials Management; and Manufacturing, Science, and Technology departments to resolve production, supply, and equipment issues. Document issues through deviations and assist with investigations, as necessary.
• Basic understanding and operation of vial washers, autoclaves, and depyrogenation ovens; basic understanding of manual cleaning of equipment in a pharmaceutical environment.

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 and Skills

• BA/BS in science or technical field with minimum of 3 years' experience in cGMP or regulated environment.
• Or High School/AA with a minimum of 8 years' experience in cGMP environment.
• 3 years previous supervisory experience in cGMP environment preferred.

Skills

• Good written and oral communication skills.
• The ability to lead a group including motivating and inspiring the team.
• Strong problem-solving skills as well as the ability to provide and accept feedback.
• The ability to identify and resolve issues in a timely manner.
• Willingness to make decisions and apply proper judgment based on sound, accurate information.
• Flexibility and the ability to maintain effectiveness when experiencing major changes in work schedule and priorities.
• The ability to handle multiple tasks and projects at the same time, and good time management.

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.

Salary range:

Compensation and Benefits

We offer a comprehensive benefits package designed to support our employees' wellbeing, including:

• Competitive salary and performance-based incentives
• Comprehensive health coverage including medical, dental, and vision insurance
• Retirement savings plans with employer matching contributions
• Paid time off
• Professional development opportunities
• Employee wellness programs and resources
• Employee Assistance Program and Mental Health Resources

Core Values

At Bora, our values guide everything we do - from how we solve challenges to how we support our people. We lead with a solutions-first mindset, strive to do the right thing, stay proactive, and above all, respect everyone.

Bora Pharmaceuticals is committed to providing equal employment opportunity to all applicants and employees according to all applicable equal opportunity and affirmative action laws, directives and regulations of federal, state and local governing bodies and agencies. In keeping with this commitment, Bora Pharmaceuticals will recruit, hire, train and promote persons in all job titles, without regard to race, color, creed, religion, sex (including factors related to pregnancy or child birth), national origin, age, marital status, familial status, disability, sexual orientation, gender identity status with regard to public assistance, employment status, local human rights commission activity, status as a protected veteran, genetic information, atypical hereditary cellular or blood trait, or any other protected category.