Upstream Manufacturing Supervisor

California Job Vacancies

IGM Biosciences (Nasdaq: IGMS) is a clinical-stage biotechnology company focused on creating and developing engineered IgM antibodies. IgM antibodies have inherent properties that we believe may enable them to improve upon the efficacy and safety of IgG antibodies in multiple therapeutic applications.We have created a proprietary IgM antibody technology platform that we believe is particularly well suited for developing T cell engagers, receptor cross-linking agonists, and targeted cytokines. Our lead product candidate, IGM-2323, is a bispecific T cell engaging IgM antibody targeting CD20 and CD3, and we have initiated a Phase 1 clinical trial for the treatment of relapsed/refractory B cell Non-Hodgkin’s lymphoma (NHL) patients in 2019. Our second product candidate is IGM-8444, an IgM antibody targeting Death Receptor 5 (DR5) for the treatment of patients with solid and hematologic malignancies, for which we have recently initiated a Phase 1 clinical trial. Also in our product pipeline is IGM-7354, a bispecific IgM antibody delivering interleukin-15 (IL-15) cytokines to PD-L1 expressing cells for the treatment of patients with solid and hematologic malignancies.IGM Biosciences is looking for energetic and talented team players to join our growing Manufacturing site located in Mountain View, CA. As an Upstream Manufacturing Supervisor, the candidate must possess strong leadership, organizational, technical writing, and presentation skills. The candidate will have the skills necessary to investigate issues associated with manufacturing operations, perform root cause analysis, and communicate results and solutions to technical and management staff.The Upstream Manufacturing Supervisor candidate will implement GMP and best practices to streamline operations within the manufacturing department. He/she will need to effectively communicate and collaborate with technical and management staff within Manufacturing, Project Management, Scheduling & Planning, Warehouse, Facilities/Engineering, Process Development, Validation, Quality Control, and Quality Assurance (Quality Operations, Quality Systems, Change Management). The candidate will be experienced with managing multiple priorities and demonstrate ability to resolve obstacles independently as needed to meet deliverables. He/she needs to have the ability and willingness to work any shift in support of operations as required.The qualified candidate is a person with strong customer-service instincts; outgoing, friendly, and collaborative. This position involves interacting and partnering with leadership and group leaders at the site and, due to the importance and frequency of these interactions, it is essential that the successful candidate possesses highly developed interpersonal, communication, and organizational skills. In this role, the candidate will report to the Upstream Manufacturing Manager.Responsibilities:* This position will be a key contributor to IGM Bioscience’s Manufacturing team and the Upstream Manufacturing group.* The candidate will supervise, provide coaching, feedback, and develop staff.* The candidate will oversee progression of the day-to-day operations and provide guidance to the staff regarding questions or troubleshooting issues associated with the preparation of media, buffer solutions, and bioreactor of IgM antibodies.* The candidate will utilize effective communication skills to collaborate with others to proactively avoid potential obstacles and to resolve exceptions resulting from process/equipment excursions. He or she, as an exception owner, will ensure that all exception reports are triaged, investigated, and resolved with the appropriate CAPAs within clearly defined timeframes.* The candidate will have responsibilities with Validation and Change Control activities, as they apply to the MFG operations. The responsibilities will include, but not limited to, change request ownership, and the development, writing, review and/or approval of the related documentation (change controls, protocols, summary reports, memoranda, action plans, etc.), and the training, execution and/or oversight of the related activities.* The individual should be able to develop novel solutions to complex problems and be able to implement those solutions into GMP processes.* The candidate will participate in inspections/audits from regulatory agencies (and internal auditors) and may have audit commitment ownership responsibilities.* Candidate may act as project lead and/or process owner for existing or new technologies as needed.* In addition, the position will require a solid understanding of the Manufacturing operations’ business needs. As such, the position will require the ability to create and maintain strong working relationships with multiple organizations, both on-site and externally.* Ability to effectively lead continuous improvement with cross-functional team support.* Lead and develop direct reports. Perform performance reviews as required.* Ensure a safe working environment.Qualifications:* High school/ Associate degree, from an accredited institution, with 7+ years of relevant experience OR Bachelor’s degree in science or engineering and 5+ years of directly related experience in a GMP environment. The experience must include at least 1 year in a supervisory/leadership capacity.* Must demonstrate strong Upstream (cell thaw/expansion, bioreactors, Single use technology, harvest systems) technical knowledge.* Demonstrated ability to generate and analyze key operating data and metrics for manufacturing. Able to provide and present biweekly/monthly reports using MS Office applications.* The candidate will have a track record of increasingly complex manufacturing experience in biotechnology, pharmaceuticals, or a related industry.* This person will also have experience that has provided him or her with a detailed understanding of the equipment, the commissioning and validation processes of equipment, and the quality considerations associated with GMP processing.* Experience with revision of Standard Operating Procedures (SOPs), Batch Production Records (BPRs), and executing change controls (change management) for business/process refinements.* Promote and contribute to sustaining a continuous improvement influence within the manufacturing workplace. Able to coordinate and foster training to staff on the concepts and application of Lean Manufacturing, and 5S principles. Generate metrics to track progression of improvements.* Possess a solid understanding of material inventory controls and associated business systems to help maintain accurate inventory.We offer a fast-paced, collaborative, team-based and family-like work environment.One of our top priorities is to maintain the health and wellbeing of our employees and their families. To achieve this goal, we are offering robust and comprehensive benefits with a variety of options:* Medical, dental and vision insurance. The full premium amount for our employees and their dependents is currently covered by IGM* STD, LTD, Basic Life and AD&D Insurance, Supplemental Life and AD&D Insurance* 401(k) Plan* 120 hours of Paid Time Off, 5 sick days per year, 10 holidays* Cell phone & internet subsidy* Employee Referral Bonus Program* Annual training budget for professional development* Commuter Benefit* Annual bonus program* New hire stock optionsIGM is an equal opportunity employer and prohibits unlawful discrimination based on race, color, religion, gender, sexual orientation, gender identity or expression, national origin or ancestry, age, disability, marital status and veteran status. All qualified applicants will receive consideration for employment.

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