Upstream Manufacturing Manager

2 weeks ago


Baltimore, United States latitude Full time

JOB SUMMARYThe Senior Manager Manufacturing position reports to the Sr. Director of Manufacturing & Supply Chain at our client's Manufacturing Operations Baltimore (EMOB). The position is responsible for manufacturing operations. This includes management of manufacturing staff, manufacturing budgets, developing standard operating procedures and training, interacting with other departments and being on-call during critical process operations.ESSENTIAL FUNCTIONSReasonable accommodations will be made to enable individuals with disabilities to perform the essential functions.Provides hands-on supervision of manufacturing staff in the operation of pharmaceutical manufacturing equipment such as: incubators, wave reactors, single-use bioreactors, depth filtration skids, TFF skids, chromatography skids, single-use mixers and in process testing equipmentEstablishes performance standards and goals for Manufacturing Supervisors and AssociatesDemonstrates and enforces understanding and adherence to our client's policies, GMP standards and safety proceduresHires, evaluates, trains, develops and terminates staffOversee development and maintenance of management processes including, but not limited to: Employee job descriptions, Integrated Performance Management Process (IPMP) documentation, staffing models, resource allocation models.Effectively delegate decision making into the department. Empower direct reports to make level-appropriate decisions.Updates the Sr. Director of Manufacturing & Supply Chain on process status and achievement of objectivesResolves problems of manufacturing staff and manages manufacturing resourcesDevelops and maintains manufacturing budgetsFrequently Interacts with other site group leaders including Sr. Director and VP level staffPrepares and conducts technical presentations of manufacturing processesPerforms annual performance appraisals of staff reporting to the positionGenerate Batch Records, SOPs and Protocols as requiredReviews Batch Records, SOPs and Protocols as requiredVerifies manufacturing readiness including raw materials, staff training, suite cleaning and equipment operationResponds to or delegate duty as primary, manufacturing alarm response representative according to site alarm response policyWorks with subject matter experts to trouble-shoot and/or optimize processes as requiredSupports the technical transfer of new products into the manufacturing areaSupports Validation, Engineering and Facilities personnel in start-up, testing and operation of manufacturing process equipmentSupports QA during audits and regulatory inspectionsSupports other manufacturing process teams and other EMOB groups as necessary to achieve Manufacturing team goalsThe above statements are intended to describe the nature of work performed by those in this job and are not an exhaustive list of all duties. Nothing in this job description restricts managements right to assign or reassign duties and responsibilities to this job at any time which reflects management's assignment of essential functions.III. MINIMUM EDUCATION, EXPERIENCE, SKILLSBS degree in biology, chemistry or related scientific or engineering fieldMinimum 8 years of GMP pharmaceutical experience; Minimum 5 years supervisory experience; Hands-on experience with the installation, operation, cleaning and maintenance of pharmaceutical GMP equipmentComputer literate (Word, Excel and PowerPoint)



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