Position Summary

The Supervisor, Manufacturing is accountable for driving results in a fast-paced environment by leading daily manufacturing operations on second shift, including facility/equipment/component preparation, formulation and aseptic filling. The Supervisor, Manufacturing works directly with performance and engagement of manufacturing technicians who operate autoclaves, depyrogenation ovens, aseptic filling machines and other equipment for manufacturing operations. This leader is accountable for performing duties in accordance with Standard Operating Procedures (SOP) and driving the performance management, training and development and continuous improvement of the team. In addition to overseeing manufacturing personnel, this hands-on leader should have functional capability to perform the essential functions and activities alongside the manufacturing associates.  The position requires superior leadership behaviors of the Alcami core competencies and non-negotiables, as well as expertise in functional competencies included in this position profile.

Essential Functions

• Performs duties in accordance with Standard Operating Procedures (SOPs).
• Develops internal working relationships across business units.
• Leads internal investigations and works cross-functionally with other departments toward solutions.
• Clearly and effectively communicates with technicians, management, and clients as needed.
• Troubleshoots technical issues within the department.
• Monitor’s manufacturing personnel performance to meet output requirements for the department.
• Maintains personnel timekeeping and time off request to ensure uninterrupted operations of the department.
• Maintains and prioritizes personnel training steps.
• Monitors personnel progress within the department.
• Provides ongoing coaching and feedback to direct reports and updates to management.
• Ensures timely completion and compliance with cGMP and all other relevant company training requirements.
• Responsible for the selection, training and development, coaching/mentoring, engagement, retention and performance management of a high performing team to meet the current and evolving needs of the site.

Education and Experience

• High School Diploma or GED required.
• Bachelors degree preferred.
• Four (4) years or more of hands on working experience in a regulated (cGMP) environment.
• Five (5) or more years of direct leadership role with at least three (3) years in a cGMP environment
• Prior pharmaceutical or CDMO experience preferred.

Alcami Non-Negotiables

• Consistently demonstrates honesty and integrity through personal example.
• Follows all safety policies and leads by example a safety-first culture.
• Produces high quality work product with a focus on first time right.
• Complies with the company code of conduct and policies and regulatory standards.

Alcami Core Leadership Competencies

• Thinks strategically. Quickly identifies and acts on opportunities. Considers the downstream impact. Seeks to understand the why. Focuses on work that matters.
• Develops organization and others. Takes ownership to develop self and others. Seeks out new opportunities and experiences for continuous learning.
• Acts decisively. Makes and acts on decisions quickly. Makes decisions with the customer and their patients in mind. Meets commitments with a sense of urgency. Seeks ways to be more efficient.
• Drives performance. Holds self and others accountable. Delivers results first time right. Never settles for status quo. Willing to have tough conversations. Asks for feedback and takes action to improve.
• Passion for customers. Listens to understand. Asks the right questions. Gets to the heart of the matter and uses that insight to provide value.
• Works collaboratively. Seeks out the experience of others with the aim for better results. Open minded regardless of where ideas originate. Flexible and easy to work with.

Functional Competencies

• Knowledge of cGMP, SOPs, CAPAs and manufacturing required.
• Knowledge of pharmaceutical manufacturing and review of batch records preferred.
• Excellent communications, problem solving, organizational skills and ability to handle confidential documents required.
• Knowledge of basic computer skills, including Microsoft office and windows-based system required.
• Ability to train operators preferred.

Supervisory Responsibilities

• Directly supervises team of 4-12 direct reports.
• Participates in the hiring process of other employees.
• Makes hiring decisions of other employees.
• Schedules and reviews the work of other employees.
• Ensures accuracy and relevance of assigned training curriculum.
• Drives timely completion of training for employees to meet regulatory requirements.
• Coaches, mentors and develops other employees.
• Prepares and delivers performance evaluations of other employees.
• Makes recommendation of disciplinary actions of other employees.

Decision Making and Supervision Required

• Uses professional concepts and company policies and SOPs to solve a variety of problems.
• Receives general instructions on routine work, detailed instructions on new projects or assignments.

Travel Requirements

• Up to 5% domestic travel

Physical Demands and Work Environment

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. While performing the duties of this job, the employee is required to frequently stand; sit; walk; talk or hear; and reach with hands and arms. The employee is required some of the time to use hands to finger, handle or feel; and climb or balance. The employee is required to occasionally stoop, kneel, crouch or crawl. The employee must frequently lift and/or move up to 50 pounds. There is no special vision requirement for this job. The employee may frequently work near moving mechanical parts; fumes or airborne particles; and outdoor weather conditions.

Other Duties

Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities and activities may change at any time with or without notice.