Shire Manufacturing Manager, Inspection & Packaging in Social Circle, Georgia

Description:

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 Inspection and Packaging department has responsibilities for the inspection of both empty vials (in preparation of filling) and product filled vials as well as the entire packaging line. As the department is responsible for the final inspection of the vials and final packaging prior to delivery to patients, attention to detail and compliance to procedures is critical to ensure product supply for our patients.

The Inspection and Packaging department will consist of 1-2 shifts of 12-24 manufacturing technicians that will have responsibilities in both the inspection and packaging unit operations. In the Manager Role, the incumbent will have the following responsibilities:

  • This position is responsible for managing all manufacturing operations within the department (potentially across multiple shifts) to deliver high quality products, safely and within the budget. This position will provide oversight either directly or through subordinates of all activities in the department to ensure manufacturing goals are reached while maximizing the efficient and safe use of staff and materials. The position will ensure manufacturing operations are performed in accordance with all applicable EHS and cGMP standards.

  • This position is accountable to ensure the manufacturing team meets all established goals (safety, quality, supply, value, and people). This role must properly communicate / escalate all issues and delays appropriately.

  • As a 1-shift operation, lead a team of 15-20 manufacturing technicians. Hold 1:1s with employees and create plans to support their career development. Schedule and plan employee training and inspection requalification. Develops staff and self through feedback and formal employee development processes. Accountable for staff performance including resolution of disciplinary issues up to and including suspensions and terminations. Transform team into a 2-shift operation when required by business needs. Accountable for employee hiring and staffing decisions. Assess manufacturing technician’s performance from a promotion, merit increase, and bonus perspective using a holistic viewpoint.

  • Create a safety first, right first time, high quality/compliance culture through leading by example and servant leadership. Ensure systems are in place for proper communication of schedule, issues, and successes through shift change and team meetings.

  • Become a process SME on the Electronic Batch Management (EBM) system and all procedural requirements. Provide knowledgeable support to team when issues arise. Drive cross-functional decisions related to quality systems and yield efficiencies.

  • Lead daily production update meeting with support groups. Lead the development of KPI’s (safety, quality, supply, value, and people) for the IG Inspection and Packaging manufacturing area to determine shifts or trends that require investigation.

  • Develop strong relationships with support functions (quality, maintenance, engineering, PCS, EBM, Utility operations) to ensure support when required. Support 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.

  • Champion process improvements to create a continuous improvement culture. Assign actions to team members and drive changes to implementation. Provide required input to cross-functional team on priority of process improvement needs based on pain points and inefficiencies.

  • Support product release processes to meet supply goals. Accountable for accurate and timely completion of production related EBM records

  • Coordinate with supply chain, planning, and warehouse personnel to manage JDE, work order transactions, BOM changes, and supplies inventories.

  • Support process improvements through the approval of change controls.

  • Responsible for representing department in cross functional teams and providing leadership in meetings, audits, and projects as required

  • Assists department leadership with creation and meeting the annual operating plan and budget commitments

  • May perform other duties as assigned

  • Thorough knowledge of inspection and packaging processes and equipment, including format changeover details.

  • 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.

  • Must have experience managing regulatory inspections and be confident leading area tours and discussing process/procedures with auditors.

  • Must have the following characteristics: passion to innovate and drive for solutions; personal accountability for results and integrity; eagerness to learn and continuously improve; uncompromising dedication to quality; relentless focus on rapid and disciplined action; respect for individuals and diverse contributions of all.

  • 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 a flexible work schedule to support all shifts, including weekend and holiday work.

  • 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.

  • No make-up, jewelry, 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.

Bachelor's degree required, preferably in science, engineering or other related technical field. Minimum 6+ years of related experience with extensive supervisory roles experience. Leadership experience in a regulated production environment is required.

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, gender identity, 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.