Packaging Operations u2013 Team Lead

Profile

Who We Are For more than two decades, going our own way has led to countless breakthroughs, bettering the lives of those suffering from rare genetic disease. In 1997 we were founded to make a big difference in small patient populations. Now we seek to make an even greater impact by applying the same science-driven, patient-forward approach that propelled our last 25 years of drug development to larger genetic disorders, as well as genetic subsets of more common conditions. Through our unparalleled expertise in genetics and molecular biology, we will continue to develop targeted therapies that address the root cause of the conditions we seek to treat. Applying our knowledge to make a transformative impact is not just a calling, but an obligation to those who will benefit most. The end goal has always been better lives and now we can reach more. And the more people we reach, the more our impact can grow. We transform lives through genetic discovery. Our Culture Our desire to make a positive impact on our patients extends to our employees and BioMarin is committed to fostering an inclusive environment where every person feels seen, valued, and heard u2013 so employees can thrive in all areas of their lives, in and outside of work. We seek to provide an open, flexible, and friendly work environment to empower people and to provide them with the ability to develop their long-term careers. Ultimately, we want to be an organization where people enjoy coming to work and take pride in our efforts to help patients. BioMarinu2019s Technical Operations group is responsible for creating our drugs for use in clinical trials and for scaling production of those drugs for the commercial market. These engineers, technicians, scientists and support staff build and maintain BioMarinu2019s cutting-edge manufacturing processes and sites, provide quality assurance and quality control to ensure we meet regulatory standards, and procure the needed goods and services to support manufacturing and coordinating the worldwide movement of our drugs to patients. Come join our team and make a meaningful impact on patientsu2019 lives. u00A0Packaging Operations Team Leadu00A0Packagingu00A0u00A0u00A0u00A0 u00A0BioMarin International Ltd.BioMarin is the world leader in delivering therapeutics that provide meaningful advances to patients who live with serious and life-threatening rare genetic diseases. We target diseases that lack effective therapies and affect relatively small numbers of patients, many of whom are children. These conditions are often inherited, difficult to diagnose, progressively debilitating and have few, if any, treatment options. BioMarin will continue to focus on advancing therapies that are the first or best of their kind. BioMarinu2019s Technical Operations group is responsible for creating our drugs for use in clinical trials and for scaling production of those drugs for the commercial market. These engineers, technicians, scientists and support staff build and maintain BioMarinu2019s cutting-edge manufacturing processes and sites, provide quality assurance and quality control to ensure we meet regulatory standards, and procure the needed goods and services to support manufacturing and coordinating the worldwide movement of our drugs to patients. Come join our team and make a meaningful impact on patientsu2019 lives. Packaging Operations Team Lead is a role based in either Packaging Suite 1 (Vimizim, Naglazyme & Kuvan) or Packaging Suite 2 (Voxzogo & Palynziq).All packaging technicians and shift leads from respective shifts will report to the Packaging Operations Team Lead. Packaging Operations Team Lead will be responsible for people management of these direct reports including development, coaching, appraisals and performance management.Reporting to the Packaging Operations Manager, the primary role of the Packaging Operations Team Lead is to manage the daily packaging operations; coordinating resources, establishing priorities, being point of escalation for the team and ensuring schedule and deadlines are met. Packaging Operations team lead will lead the team through successful product launch activities, process validation and regulatory inspections.u00A0It is expected the Packaging Operations Team Lead will develop a high-performing, team based organization, where colleagues are flexible, multi-skilled and empowered to make decisions that result in safe, agile and compliant packaging of Finished goods. A high level of initiative, energy and motivation are key role requirements, as well as organizationalu00A0and people management skills.Main areas of responsibility: People management of direct reports of packaging technicians and shift Lead and support the packaging team to ensure delivery of the production schedule. Assist in troubleshooting and facilitate appropriate Support and partner closely with the Packaging BPS, Warehouse, Quality (QA & QC), Engineering and other colleagues. Represent the Packaging group as necessary at critical meetings (e.g Daily Ops meeting, S&OE , Functional Lead Team meeting etc.) Responsible for reporting out on key performance indicators (e.g Schedule adherence, Changeover performance, Unplanned downtime etc.) Develop and demonstrate an active approach to safety, industrial hygiene, environmental and regulatory compliance Responsible for ensuring training records and training plans are in place and up to date for all team members. Ensure training, master batch records, SOPs and other documents are current and compliant under cGMP. Lead and support daily operation of processing systems and partner with plant engineering colleagues to ensure equipment is reliably maintained and within appropriate calibration. Partner with validation subject matter experts, prepare/approve validation protocols, validation plans, protocol executions, and summary reports in support of ongoing revalidation and validation efforts required for commercial manufacturing. Instill the use of Right First Time (six-sigma) and lean manufacturing practices leading to operational excellence. Coach, mentor and train shift leads and packaging technicians on packaging processes, use of operational excellence tools, and high-performance team behaviors. Assist in preparation of performance evaluations and coaching of staff. Assist in the recruitment and hiring process for the Packaging operations team. Participate and support plant optimization that helps create a strong value proposition for future investment. (Including input into current capital projects) Required to worked closely with the Packaging project lead to support the delivery of the Packaging strategic master plan. Strong focus of visibility boards for packaging metrics and status with particular focus on schedule adherence & changeover performanceEDUCATIONState both the minimum and the preferred educational attainment (or equivalent experience), and describe essential and desired subject matter, certifications, special training, etc. Degree in science/engineering, operations management or industrial engineering or equivalent experience in a GMP environment is preferred.EXPERIENCEState both the minimum and the preferred number of years of relevant experience and describe the essential functions of the job.Demonstrated experience working with Packaging processes in production.Past experience and demonstrated ability to successfully influence team performance in a high-performance team is strongly preferred.Track record of embedding a strong Quality culture. Trackwise experience preferred.Demonstrate strong communication skills and the ability to interact across cross-functional teams.Demonstrated ability to train and coach colleagues in processing, operational excellence, team interactions and delivering results.Experience with regulatory inspections and direct interaction with regulatory inspectors.Highly developed organizational and leadership skills.Process development and/or technology transfer experience preferred.CONTACTSList the key positions, internal and external, with which the job incumbent must interact. Work closely with QA Operations, Packaging Development, Engineering , Material Operations & Packaging technicians & BPSu2019s to support escalation resolution and implement effective CAPAu2019s.SUPERVISOR RESPONSIBILITYList the number of personnel directly reporting to this position and their job titles. List the number of personnel functionally reporting to this position (i.e., supervised on a u201Cdotted-lineu201D basis), and their job titles. Specify the total number of personnel supervised by this position, both directly and through others. The Packaging Operations Team Lead of a given functional area will typically have ~8-15 direct reports; Packaging technicians and shift leads. The Packaging Operations Team Lead will be responsible for a group of ~8-15 staff including a full rotating 2 shift Operations shift pattern. (Early & lates Monday to Friday). The role may require the successful candidate to work shift operations that align with the business needs.Note:u00A0u00A0 This description is not intended to be all-inclusive or a limitation of the duties of the position.u00A0 It is intended to describe the general nature of the job that may include other duties as assumed or assigned. We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity, sexual orientation, national origin, disability status, protected veteran status, or any other characteristic protected by law.

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