Shire Supervisor, Manufacturing - Aseptic Filling in Social Circle, Georgia

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.

The IG Filling department has responsibilities for the setup (cleaning and sterilization) of components and vessels as well as the entire vial filling process (vial washing, depyrogenation, and filing within an isolator). As the department is responsible for the sterile preparation of components as well as the final filtration and filling of the product, attention to detail and compliance to procedures is critical to ensure the manufacture of a sterile product for our patients.

Each shift will be comprised of 6-12 manufacturing technicians that will have responsibilities on the setup and filling unit operations. In the Shift Lead Manufacturing Technician Role, the incumbent will have the following responsibilities:

  • Lead a team of 6-12 manufacturing technicians. Hold 1:1s with employees and create plans to support their career development. Perform all supervisory duties (hiring, onboarding, team building, absences, recognition, discipline). Ensure team is appropriately trained and develop plans for cross-training and development such that manufacturing goals can be obtained.

  • Coach the manufacturing lead to provide seamless continuity during absences.

  • Supervise all activities (manufacturing operations, maintenance activities, and validation activities) in the IG Filling production area by spending > 70% of shift on the shop floor. Accountable to ensure the team meets the daily goals (safety, quality, supply, value, and people). Properly communicate all issues and delays appropriately.

  • Throughout the shift, monitor the execution of production tasks to ensure all EHS guidelines and policies are followed, procedures (job aids/SOPs) are being compliantly adhered to, the production schedule is met and delays are minimized. Escalate to manager as needed.

  • Support the development of KPI’s (safety, quality, supply, value, and people) for the IG Filling manufacturing area and capture relevant data to determine shifts or trends that require investigation.

  • Become fully trained as an SME in all manufacturing operations to provide hands-on execution to support the team as well as troubleshooting as issues arise.

  • Independently operate automation systems (EBM, DeltaV, PLC) at supervisor level, including creating EBM WOs, having understanding to amend or force tags or syncs, complete manufacturing review of alerts, fully understand equipment dashboard.

  • Develop strong relationships with support functions (quality, maintenance, engineering, PCS, EBM, Utility operations) to ensure support when required. Lead the coordination of all activities with EHS, engineering, validation, and maintenance to ensure proper communication, equipment turnover, support, and equipment return to service activities are completed and documented to meet the production and maintenance schedule.

  • Investigate all events with potential product impact and engage with Quality to determine path forward. Escalate events resulting in material discard or vial rejects.

  • Create a continuous improvement mindset on the shop floor. Constantly work with the team members to develop and communicate process improvement ideas. Lead / support the implementation of process improvement ideas (5S, materials, job aids, tools, etc.) to support the team.

  • Be proactive (work orders, equipment preparation, materials, communication, etc.) to ensure the team does not encounter avoidable roadblocks during the shift.

  • Create new or update existing job aids based on process improvements or corrective actions to events. Lead document update through manufacturing management and quality assurance approval and submittal to the document control system.

  • Represent the dept. in cross functional teams as necessary.

  • May perform other duties as assigned

Requirements:

  • Ability to lead a team in a fast paced manufacturing area and manage multiple priorities.

  • Must possess excellent organizational, verbal and written communication skills; ability to effectively communicate with cross-functional teams and management on recommended course of action with minimal assistance

  • Knowledge of cGMP manufacturing and in-depth process knowledge of related manufacturing techniques/specialties.

  • Thorough knowledge aseptic manufacturing processes and equipment including but not limited to: COP washers, autoclaves, process tanks, CIP/SIP systems, isolators, and vial filling lines.

  • Must be able to apply quantitative analysis to analyze process performance.

  • 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. Good procedural writing skills.

  • Knowledge of chemical and biological safety procedures.

  • Good computer skills, knowledge of Microsoft Word and Excel.

  • Must have demonstrated interpersonal and leadership skills and be able to lead a work team effectively and efficiently in a team environment.

  • This position requires shift, weekend and holiday work. Overtime may be required at times.

  • The incumbent must work in a clean room environment wearing special garments. Additionally, personal protective equipment must be worn due to safety requirements.

  • May require immunization before performing work within the manufacturing area.Demonstrated interpersonal and leadership skills with ability to interface well with other departments, and lead effectively and efficiently in a team environment.

  • Must be able to work in controlled environments requiring special gowning. Will be required to follow gowning requirements and wear protective clothing over the head, face, hands, feet and body.

  • No make-up, jewelry, contact lenses, nail polish or artificial fingernails may be worn in the work environment.

  • May be working in a loud area that requires hearing protection and other protective equipment to be worn.

  • Will work around chemicals such as alcohol that may require respiratory protection.

Qualifications:

Leadership experience in a regulated production environment is desirable.

High School Diploma required; BS degree in a scientific or engineering discipline strongly preferred.

3+ years of related experience with 1+ years in a supervisor role.

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’s Talent Acquisition department. Any agency candidate submission may only be submitted to positions opened to the agency through the specific Agency Portal. Shire 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 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 is an Equal Opportunity Employer committed to a diverse workforce. Shire 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.

EEO is the Law - https://www.dol.gov/ofccp/regs/compliance/posters/pdf/eeopost.pdf

EEO is the Law – Supplement - https://www.dol.gov/ofccp/regs/compliance/posters/pdf/OFCCPEEOSupplementFinalJRFQA508c.pdf

Pay Transparency Policy - https://www.dol.gov/ofccp/pdf/pay-transp_formattedESQA508c.pdf

Reasonable Accommodations

Shire 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.

Shire is the leading global biotechnology company focused on serving people with rare diseases and other highly specialized conditions. We strive to develop best-in-class products, many of which are available in more than 100 countries, across core therapeutic areas including Hematology, Immunology, Neuroscience, Ophthalmics, Lysosomal Storage Disorders, Gastrointestinal/Internal Medicine/Endocrine and Hereditary Angioedema; and a growing franchise in Oncology.

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.