Associate Director of Manufacturing Operations

Alora Pharmaceuticals, LLC.; Marietta (GA); On-site; USD 95,000 - 150,000; Full time

Job summary

Alora Pharmaceuticals, LLC. seeks a Production Manager to lead solid-dose manufacturing for clinical, development, and commercial batches.

You will supervise staff, ensure safety, quality, and regulatory compliance, and collaborate with QA, Engineering, and Pharmaceutical Sciences. You will schedule production, review batch records, drive continuous improvement, and mentor team members toward career progression.

Qualifications

• Bachelor's degree in a science or technical area (chemistry, biology, quality, chemical or pharmaceutical engineering)
• 5 years’ experience in manufacturing of solid dose products, with at least 3 years’ experience managing direct reports
• Knowledge of pharmaceutical production and application of cGMP regulations in manufacturing environment

Responsibilities

• Manage a staff of production personnel to ensure safety and quality compliance for manufacturing goals
• Provide guidance to production staff for correct execution of production and packaging batch records
• Write and/or review production deviation reports
• Lead problem solving and process improvements to reduce operating costs
• Schedule manufacturing activities and coordinate equipment maintenance and validation
• Support Pharmaceutical Science team for process development activities
• Be a process expert and coach for the production team
• Ensure budget adherence and adequate staffing to meet production requirements
• Develop and maintain operator training programs and SOPs
• Foster continuous improvement focused on quality, cost reduction, and capacity
• Review/write operational SOPs and suggest changes as appropriate
• Contribute to operational strategic plans and ensure safety and regulatory compliance

Skills

Communication

Problem solving

Interpersonal skills

Decision making

Self-starter

Staff leadership

Education

Bachelor's degree in science/technical field

Tools

MS Office

Job description

Description

Manages all manufacturing and related activities required to support the production of clinical supplies, commercial batches, development, engineering and registration batches of oral solid dosage products. Responsible for leading the production of solid dose products to fulfill project schedules, within determined quality and safety standards. Supervises, develops and provides direction to assigned staff. This position works closely with Pharmaceutical Sciences, Engineering, Validation and Quality Assurance.

Essential Responsibilities

• Managing a staff of production personnel to ensure safety and quality compliance are prioritized for manufacturing goals of all manufacturing both commercial and product development.
• Responsible for providing guidance to production staff for the correct execution of production batch records and packaging batch records.
• Responsible for the writing and/or review of production deviation reports.
• Responsible for technical problem solving, operational improvements and efficiency improvements to reduce operating costs.
• Responsible for scheduling manufacturing activities as well as coordinating equipment maintenance and validation activities.
• Supports the Pharmaceutical Science team, as needed, for process development activities.
• Demonstrated experience, including troubleshooting, with, pilot scale and commercial-scale processing equipment and unit operations for oral solid dosage forms, is optional but desired.
• Recruiting, interviewing, hiring and training production staff and developing direct reports to establish career progression opportunities within the department and origination
• Serve as a process expert, technical resource and coach for the production team.
• Adhere to capital and expense budgets as well as manage to standards and manpower requirements to meet production requirements.
• Responsible for developing and maintaining operator training programs to standard operating procedures.
• Create and maintain an environment of innovative continuous improvement, focusing on quality, cost reduction, process development and capacity.
• Reviews/writes operational SOP’s, recommending changes as appropriate.
• Provides input into operational strategic plans and activities.
• Responsible for safety, and compliance with state and federal laws to include OSHA and DEA activities for the manufacturing department.
• Performs other duties as assigned or requested.

Core Competencies

• Good communication skills both written and verbal
• Ability to read, analyze and interpret technical procedures or government regulations.
• Ability to demonstrated good problem solving skills and conflict resolution.
• Excellent interpersonal skills and ability to effectively interact with different functional groups at all levels of management.
• Knowledge of cGMP’s, regulatory guidelines and validation principles
• Working knowledge in MS Office products
• Dynamic self-starter with ability to handle multiple projects in a high paced work environment.
• Must have a bias for action and ability to make decisions

Minimum Qualifications

• Bachelor's degree in a science or technical area (chemistry, biology, quality, chemical or pharmaceutical engineering)
• 5 years’ experience in manufacturing of solid dose products, with at least 3 years’ experience managing direct reports
• Knowledge of pharmaceutical production and application of cGMP regulations in manufacturing environment

Preferred Experience

• Six Sigma and/or Process Excellence and/or Lean certification

The above statements are intended to describe the general nature and level of work being performed. They are not intended to be construed as an exhaustive list of all responsibilities, duties and skills required of personnel so classified.