Evonik Corporation
Senior Manager, Development and Commercial Parenteral Services (CMO)
Evonik Corporation, Birmingham, Alabama, United States, 35275
Senior Manager, Development And Commercial Parenteral Services
The Senior Manager, Development and Commercial Parenteral Services oversees systems, processes, workforce, and culture to enable manufacturing of complex parenteral formulations and dosage forms (i.e., implants, injectables). Areas of responsibility include the implementation of general work expectations that are in alignment with corporate systems and processes. The position is responsible for the implementing of departmental and functional goals and objectives. Define workforces across flexible and dedicated work centers, shifts; maintain organizational structures through recruitment, training and development of the workforce as well as the continuous improvement programs to increase the level of performance. Responsibilities: Alignment with Functional Objectives; Purposeful Presence in Manufacturing Sets goals for the manufacturing unit, tracks appropriate KPIs to measure unit performance and develops appropriate action plans in order to increase or adjust performance Leads in short-, mid-term resource and cleanroom planning meetings (people, process, and equipment) Proactively identifies and communicates opportunities and weaknesses in the manufacturing overall system in conjunction with peers in engineering, quality, and supply chain. Workforce Development Leads recruiting of positions in cleanroom services and manufacturing based on strategic workforce plans, unit requirements and heat maps Manages department development and growth as necessary to support talent pipeline Identifies opportunities for employee development and manages employee performance Train and mentor supervisors and specialist direct reports and others in alignment with department objectives and personal development pathways System and Process Improvement Implements task teams to work on continuous improvement priorities Enforces internal department workflows and recommends improvements, as required Ensure compliance through cGMP, regulatory and ISO knowledge in department in order to improve operations as measured by key performance indicators (i.e., microbial control, cleanroom behavior, gowning processes) Customer Project Support Actively leads team to successful completion of scopes for active customer projects and opportunities, communication of strength, approach, capabilities, resource availabilities, costs, project scopes and timelines Leads and assigns batch review, deviation and root cause analysis in support of customer projects and release Internal Alignment and Communication Through own actions and team delivers on primary objectives with different departments onsite by aiding in prioritization and resource planning, supply planning. Implements manufacturing management control system (e.g., continuous improvement, quality or safety priorities, business priorities). Ensures internal and external regulations are followed and develops action plans to increase compliance. Ensures highest safety and quality standards are met within the unit and acts on issues, obstacles, and best practices. Maintain and increase current compliance knowledge through review of current good manufacturing literature. Requirements Education MS in a relevant scientific field (pharmaceutical science, chemical or biomedical engineering, biochemistry, chemistry or similar preferred) with sufficient years of experience (> 6 years); or a BS degree in a related science with a sufficiently demonstrated level of performance and capability, as determined by management. Experience Experience directing or managing functional areas and/or people with a demonstrated positive track record. Ability to articulate most important systems, processes and approaches for successful parenteral manufacturing is preferred; pharma or contract manufacturing background is preferred as well as significant experience aseptic parenteral/injectable. Application of continuous improvement approaches and development, change management and can articulate positive track record contributing to department continuous improvement initiatives regarding procedures, workflows, process standardization, waste reduction, etc. Experience in team leadership with a successful track record of leading individuals, groups and teams, can articulate team leadership and team development approaches; with coaching performance and developing personnel. Knowledge and experience of cGMPs, phase appropriate regulatory requirements, and the ability to appropriately scope complex parenteral formulation development projects with respect to technical scope, cost, and time. Knowledge of relevant engineering principles and theories as well as the capability to apply standard procedures to manufacturing equipment and techniques. Ability to recognize unanticipated or adverse outcomes or deviations, evaluate and identify causes of unanticipated or adverse outcomes or deviations, and take corrective action to resolve technical problems of suitable complexity. Excellent organizational and time-management skills; Ability to organize resources and schedules to accomplish supply plan and department objectives. Excellent written and verbal communication skills; experienced in the use of word processing, spreadsheet, presentation, and project management software programs. Knowledge of the use of personal protective equipment and safety protocols and practices related to working with or preventing exposure to active pharmaceutical ingredients, hazardous chemicals, and pharmaceutical processing equipment that could potentially affect the health of the employee. Ability to: Perform work utilizing a computer for extended periods of time Sit for extended periods of time without being able to leave the work area Stand for extended periods of time without being able to leave the work area Grasp objects utilizing the fingers (fine motor manipulation) Enter general chemical & pharmaceutical cleanrooms and associated laboratories and perform oversight and audit activities on regular basis. The Evonik Group adopts an Equal Employment Opportunity (EEO) approach. Candidates are assessed based on their educational qualifications, experience, job competencies and potential and shall not be discriminated against on the basis of race, ethnicity, age, gender, religion, nationality, disability or sexual orientation or other classifications protected by local, state, or provincial regulations. To ensure that your application is proceeded as quickly as possible and to protect the environment, please apply online via our careers portal. Further information about Evonik as Employer can be found at https://careers.evonik.com. Please address your application to the Talent Acquisition Manager, stating your earliest possible starting date and your salary expectations. Your Talent Acquisition Manager: Kelvin Seals
The Senior Manager, Development and Commercial Parenteral Services oversees systems, processes, workforce, and culture to enable manufacturing of complex parenteral formulations and dosage forms (i.e., implants, injectables). Areas of responsibility include the implementation of general work expectations that are in alignment with corporate systems and processes. The position is responsible for the implementing of departmental and functional goals and objectives. Define workforces across flexible and dedicated work centers, shifts; maintain organizational structures through recruitment, training and development of the workforce as well as the continuous improvement programs to increase the level of performance. Responsibilities: Alignment with Functional Objectives; Purposeful Presence in Manufacturing Sets goals for the manufacturing unit, tracks appropriate KPIs to measure unit performance and develops appropriate action plans in order to increase or adjust performance Leads in short-, mid-term resource and cleanroom planning meetings (people, process, and equipment) Proactively identifies and communicates opportunities and weaknesses in the manufacturing overall system in conjunction with peers in engineering, quality, and supply chain. Workforce Development Leads recruiting of positions in cleanroom services and manufacturing based on strategic workforce plans, unit requirements and heat maps Manages department development and growth as necessary to support talent pipeline Identifies opportunities for employee development and manages employee performance Train and mentor supervisors and specialist direct reports and others in alignment with department objectives and personal development pathways System and Process Improvement Implements task teams to work on continuous improvement priorities Enforces internal department workflows and recommends improvements, as required Ensure compliance through cGMP, regulatory and ISO knowledge in department in order to improve operations as measured by key performance indicators (i.e., microbial control, cleanroom behavior, gowning processes) Customer Project Support Actively leads team to successful completion of scopes for active customer projects and opportunities, communication of strength, approach, capabilities, resource availabilities, costs, project scopes and timelines Leads and assigns batch review, deviation and root cause analysis in support of customer projects and release Internal Alignment and Communication Through own actions and team delivers on primary objectives with different departments onsite by aiding in prioritization and resource planning, supply planning. Implements manufacturing management control system (e.g., continuous improvement, quality or safety priorities, business priorities). Ensures internal and external regulations are followed and develops action plans to increase compliance. Ensures highest safety and quality standards are met within the unit and acts on issues, obstacles, and best practices. Maintain and increase current compliance knowledge through review of current good manufacturing literature. Requirements Education MS in a relevant scientific field (pharmaceutical science, chemical or biomedical engineering, biochemistry, chemistry or similar preferred) with sufficient years of experience (> 6 years); or a BS degree in a related science with a sufficiently demonstrated level of performance and capability, as determined by management. Experience Experience directing or managing functional areas and/or people with a demonstrated positive track record. Ability to articulate most important systems, processes and approaches for successful parenteral manufacturing is preferred; pharma or contract manufacturing background is preferred as well as significant experience aseptic parenteral/injectable. Application of continuous improvement approaches and development, change management and can articulate positive track record contributing to department continuous improvement initiatives regarding procedures, workflows, process standardization, waste reduction, etc. Experience in team leadership with a successful track record of leading individuals, groups and teams, can articulate team leadership and team development approaches; with coaching performance and developing personnel. Knowledge and experience of cGMPs, phase appropriate regulatory requirements, and the ability to appropriately scope complex parenteral formulation development projects with respect to technical scope, cost, and time. Knowledge of relevant engineering principles and theories as well as the capability to apply standard procedures to manufacturing equipment and techniques. Ability to recognize unanticipated or adverse outcomes or deviations, evaluate and identify causes of unanticipated or adverse outcomes or deviations, and take corrective action to resolve technical problems of suitable complexity. Excellent organizational and time-management skills; Ability to organize resources and schedules to accomplish supply plan and department objectives. Excellent written and verbal communication skills; experienced in the use of word processing, spreadsheet, presentation, and project management software programs. Knowledge of the use of personal protective equipment and safety protocols and practices related to working with or preventing exposure to active pharmaceutical ingredients, hazardous chemicals, and pharmaceutical processing equipment that could potentially affect the health of the employee. Ability to: Perform work utilizing a computer for extended periods of time Sit for extended periods of time without being able to leave the work area Stand for extended periods of time without being able to leave the work area Grasp objects utilizing the fingers (fine motor manipulation) Enter general chemical & pharmaceutical cleanrooms and associated laboratories and perform oversight and audit activities on regular basis. The Evonik Group adopts an Equal Employment Opportunity (EEO) approach. Candidates are assessed based on their educational qualifications, experience, job competencies and potential and shall not be discriminated against on the basis of race, ethnicity, age, gender, religion, nationality, disability or sexual orientation or other classifications protected by local, state, or provincial regulations. To ensure that your application is proceeded as quickly as possible and to protect the environment, please apply online via our careers portal. Further information about Evonik as Employer can be found at https://careers.evonik.com. Please address your application to the Talent Acquisition Manager, stating your earliest possible starting date and your salary expectations. Your Talent Acquisition Manager: Kelvin Seals