Takeda 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.
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.
IG 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. 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.
Notice to Employment / Recruitment Agents:
Employment / Recruitment agents may only submit candidates for vacancies only if they have written authorization to do so from Shire, a wholly-owned subsidiary of Takeda s Talent Acquisition department. Any agency candidate submission may only be submitted to positions opened to the agency through the specific Agency Portal. Shire, a wholly-owned subsidiary of Takeda will only pay a fee for candidates submitted or presented where there is a fully executed contract in place between the Employment / Recruitment agents and Shire, a wholly-owned subsidiary of Takeda and only if the candidate is submitted via the Agency Portal. Candidates submitted or presented by Employment / Recruitment Agents without a fully executed contract or submitted through this site shall not be deemed to form part of any Engagement for which the Agency may claim remuneration.
Equal Employment Opportunity
Shire, a wholly-owned subsidiary of Takeda, is an Equal Opportunity Employer committed to a diverse workforce. Shire, a wholly-owned subsidiary of Takeda, will not discriminate against any worker or job applicant on the basis of race, color, religion, gender, national origin, ancestry, age, sexual orientation, marital or civil partnership status, pregnancy, gender reassignment, non-job related mental or physical disability, genetic information, veteran status, military service, application for military service, or membership in any other category protected under law.
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Pay Transparency Policy - https://www.dol.gov/ofccp/pdf/pay-transp_formattedESQA508c.pdf
Shire, a wholly-owned subsidiary of Takeda, is committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please call 484-595-8400 and let us know the nature of your request and your contact information.