Shire is the leading global biotechnology company focused on serving people with rare diseases and other highly specialized conditions. We have best-in-class products available in more than 100 countries across core therapeutic areas including Hematology, Immunology, Neuroscience, Lysosomal Storage Disorders, Gastrointestinal / Internal Medicine / Endocrine and Hereditary Angioedema; a growing franchise in Oncology; and an emerging, innovative pipeline in Ophthalmic.
Our employees come to work every day with a shared mission: to develop and deliver breakthrough therapies for the hundreds of millions of people in the world affected by rare diseases and other high-need conditions, and who lack effective therapies to live their lives to the fullest.
Supervise process manufacturing personnel while maintaining cGMP, environmental health and safety guidelines and any other related regulations that apply. In addition to being fully accountable and involved in all production processes, may problem solve in other functional areas. The incumbent acts as a delegate to the superintendent and may conduct departmental activities in their absence. Will need to fully understand the regulations and may make recommendations according to their interpretations. Will be responsible for the successful transfer of new processes/methodologies into the manufacturing area.
Essential Duties & Responsibilities
• This position may require back shift and weekend work.
• 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 execution of all manufacturing processes with strict compliance to cGMPs and EHS regulations.
•Perform or support 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/participate 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.
•Frac supervisors must understand and implement the escalation process so that issues are resolved in a timely manner.
•The individual should be able to identify errors or faults in process and recommend or implement solutions.
•Intiaiting and closing processing related CAPAs.
•Must be able to work 12 hr. 2-2-3 shift structure.
•Basic supervisory and leadership skills.
•Able to manage multiple priorities in manufacturing plant setting.
•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.
•Basic professional writing skills and ability to prepare and write technical reports
•Basic 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.
Education and/or Experience
Associate's Degree preferred with 3-6 years of manufacturing experience, or Bachelor's Degree preferred plus 1-3 years of manufacturing experience. Leadership experience and scientific/engineering degree preferred.
A little about us:
At Shire, we help people with rare diseases and specialized conditions live their lives to the fullest.