Senior Manager, Development and Commercial Parenteral Services (CMO)

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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

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