- Supervise the day to day production, scheduling, staffing, material management, compliance, training, and auditing activities for area of responsibility.
- Supervisor on the floor 75% of the time
- Develop and manage performance of direct reports.
- Support and ensure the execution of all manufacturing processes with strict compliance to cGMPs and EHS regulations.
- Lead technical reviews, investigation and process improvement projects.
- Provide input into integration and validation of new equipment and process.
- Resolve technical, material, and cGMP issues.
- Review, approve, and manage documentation for batch and system records for production.
- Interface with other departments to help resolve issues related to equipment, process and compliance including facility support departments and external vendors.
- Lead in technical reviews, investigation and process improvement projects in order to meet objectives
- Assess impact of new regulatory guidelines on current practice, initiate document change proposals, prepare/review protocols to justify process changes, assist with training and auditing as appropriate.
- Owner for implementation of new equipment, system and/or procedures.
- Participate in Internal or external audits as SME for department.
May perform other duties as assigned. Education & Experience Requirements:
Bachelor's Degree preferred plus 3-6 years of manufacturing experience, or AA Degree with 5-7 years of manufacturing experience, or HS Diploma with 7-10 years of manufacturing experience. Minimum of 2-4 years of leadership experience. Scientific or engineering degree preferred. Key Skills and Competencies:
- Demonstrated supervisory and leadership skills.
- Able to manage multiple priorities in manufacturing plant setting.
- Employee maybe required to manage hazardous wastes in compliance with company procedures & State/Federal/Local hazardous waste regulations. Duties may include: Identifying, handling, generating, accumulating, storing, labeling, and on-site transporting of hazardous wastes.
- Knowledge of Cell Culture, Purification, and Buffer/Media manufacturing operations.
- Understands Manufacturing Production Process for all functional areas. Expertise grows in depth and breadth as individual moves up the career ladder.
- Knowledge of Utility Systems and how they impact the Manufacturing Departments.
- Understands the flow and design/interdependency of manufacturing support departments.
- Knowledge of manufacturing equipment operation, including set up and changeover, as well as commissioning, validation, and troubleshooting.
- Basic scientific understanding of biology (cell culture, microbiology) and chemistry/ biochemistry as it applies to the manufacturing process.
- May have more specific skill sets in areas depending on need/ opportunity: Aseptic technique, column packing, inoculum operations, chromatography operations, etc.
- Knowledge of clean room management.
- Strong professional writing skills and ability to prepare and write technical reports
- Strong verbal and written communication skills across multiple functional areas.
- Computer skills, including PowerPoint, Word, Excel, Access.
- Knowledge of basic chemical and biological safety procedures.
- Incumbent must be proficient in a variety of mathematical disciplines and be able to work with both the metric and USA standards of measurement.
- Must be able to read and follow detailed written instructions and have good verbal/written communication skills.
- Must be able to read, write, and converse in English.
- Must be able to navigate, conduct searches, and fill on line forms on Personal Computer for the purposes of training, performance management, and self service applications.
- Must have the ability to navigate electronic mail systems and intranet for communication purposes.
- Advanced word processing skills.
- Advanced spreadsheet skills.
- Advanced typing skills.
- Good interpersonal skills and be able to work effectively and efficiently in a team environment.
- Passion for Improving Lives. Must be able to put our patients at the center of everything we do.
- Quest for Innovation. Must be able to operate with agility and a learning mindset so that we can accelerate breakthrough innovations.
- Inspired Teams environment. Must be able to thrive in diverse high performing teams.
- Engaged with the World Around Us. Must be able to embrace change and seek diverse perspectives and partnerships to benefit patients and make a positive impact on the world.
- Be Positive
- Be Accountable
- Be Results Oriented
Be An Excellent Manager of Self and Others
A little about us:
At Shire, we help people with rare diseases and specialized conditions live their lives to the fullest.