"Alerted.org

Description

Ensure the daily manufacturing schedule is clear, accurate and achievable and that the manufacturing plan optimizes equipment utilization. Oversee the execution of manufacturing, including allocation of resources and that operations conforms with all regulatory and Company guidelines. Flexible to support off⁃shift and weekend work when needed

Strategic responsibility: support and contribute to setting the business strategy by executing the manufacturing schedule (30%)

+ Manage the output and work practices of all assigned employees to insure that the highest quality product is made, that accurate batch records are kept and that Company policies and procedures are followed.

+ ensure work areas are maintained in compliance with current good manufacturing practices (cGMPs).

+ Capable of developing and using appropriate KPI's to track progress and gaps. Use them to identify major areas of opportunity to drive result improvement.

+ Manage the internal safety and OSHA guidelines for compliance: assure a safe work environment through standard operation procedure adherence and hazard elimination & mitigation (personal protective equipment policies (PPE), Lockout/Tag out (LOTO), Machine Guarding, etc.).

+ Oversee the creation and release of Rework Orders and coordinate the efforts with Research & Development and Process Development for successful outcomes.

+ Execute investigations for Out of Specification (OOS) batches manufactured by direct reports on shift, determine root cause and provide optimal solution(s) to resolve

+ Ensure team is properly executing aseptic techniques during micro⁃sensitive manufacturing,

+ Oversee and ensure training records are maintained and kept up to date,

+ Lead and/or participate on Continuous Improvement.

Planning and Scheduling Responsibilities (35%)

+ Ensure that the daily manufacturing plan optimizes the department's output through the timely release of work.

+ Recommend adjustments to resources for optimization of scheduling to maximize capacity,

+ Optimize equipment utilization by effective production scheduling.

+ Ensure effective execution of the manufacturing schedule to include Non⁃Standard Resource Activity (i.e. Pilots, First Production Batches, Test Fills, Preventative Maintenance).

+ Problem solving: resolve issues in a variety of complex situations, understand formula processes and workflow to align the labor resources, troubleshoot equipment processes and system issues.

+ Manage the execution of daily scheduling &/or changes.

+ Oversee the recording of the daily kilos produced for the Monthly Attainment Report, generate monthly monitor report to ensure process orders are reviewed and closed in SAP.

Personnel and Interdepartmental Responsibilities (35%)

+ Oversee that transition information is shared between shift personnel, be proactive at pre⁃production meetings with R&D to develop or refine processing procedures for new, reformulated or problematic formulas.

+ Manage the scheduling for maintenance, repair or installation of equipment with Facilities and Engineering.

+ Promote employee motivation and engagement and support the administration of programs such as the Behavior Based Safety Program.

+ Exercise good communication and diplomacy skills with clear written and verbal communications with direct reports, peers other departments and management.

+ Business expertise: must understand function of T/S department to embrace shared responsibility for volume, quality, timeliness of end results, planning and finances/budget.

Qualifications

+ 5 Years minimum experience

+ Chemical Engineering degree is preferred

+ Must possess excellent interpersonal, communication and analytical problem solving skills

+ Experienced in manufacturing in the controlled environment (over⁃the⁃counter drugs) preferred

+ Experienced in Continuous Improvement projects (Green belt or black belt preferred)

+ Experienced in managing the execution of the schedule is preferred

+ Must be able to apply root cause analysis for problem solving

+ Skilled in MS office is required, skilled in SAP applications is preferred

Equal Opportunity Employer

It is Company's policy not to discriminate against any employee or applicant for employment on the basis of race, color, creed, religion, national origin, ancestry, citizenship status, age, sex or gender (including pregnancy, childbirth and related medical conditions), gender identity or gender expression (including transgender status), sexual orientation, marital status, military service and veteran status, physical or mental disability, protected medical condition as defined by applicable state or local law, genetic information, or any other characteristic protected by applicable federal, state, or local laws and ordinances. The Company will endeavor to provide a reasonable accommodation consistent with the law to otherwise qualified employees and prospective employees with a disability and to employees and prospective employees with needs related to their religious observance or practices. Should you wish to apply for this position or any other position with the Company and you believe you require assistance to complete an application or participate in an interview, please contact [email protected].