Work Schedule

12 hr shift/days

Environmental Conditions

Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Cleanroom: no hair products, jewelry, makeup, nail polish, perfume, exposed piercings, facial hair etc... allowed, Office, Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.)

Job Description

GROUP/DIVISION SUMMARY 

The Drug Product Division - North America (DPD-NA) is one of the five divisions that make up the Pharma Services Group. We are made up of approximately 4400 colleagues across six sites who specialize in taking sterile injectable and oral solid dose drug products from development to commercialization. 

Key Responsibilities:

• Provide leadership to assigned staff by leading organizational change, developing and empowering staff, encouraging relationships, and building effective teams that drive engagement and achieve common goals.
• Ensure that production standards for quantity and quality are met, taking direct action to rectify deviations and reporting variances to supervisors.
• Coordinate compliance with all Current Good Manufacturing Practices (cGMPs) and ensure area compliance for FDA, QAT, and OSHA inspections.
• Plan, monitor, and adjust daily production schedules to ensure efficiency and quality.
• Coordinate department safety programs and ensure a safe working environment.
• Evaluate personnel performance and skills, provide feedback, and conduct annual evaluations.
• Assist technical staff and customers with technical issues, ensuring robust and validated processes.
• Establish and approve technical requirements for production documentation, including SOPs and PMs or equivalent experience.
• Implement cost reduction programs to maintain competitiveness.
• Track employee attendance, approve time cards, and lead all aspects of training programs.

Qualifications:

• Bachelor’s degree in Physical, Biological, Chemical, or Production-related science preferred.
• 5+ years of manufacturing experience with at least 2 years in a leadership role; experience in a sterile pharmaceutical filling environment is preferred.
• Strong technical and operational knowledge of aseptic processing operations.
• Outstanding attention to detail, organizational skills, and the ability to prioritize tasks.
• Self-motivated individual capable of working autonomously and excelling in a fast-paced environment.
• Demonstrated proficiency in maintaining confidentiality, exceptional communication abilities, and adept at motivating and retaining team members.

Physical Requirements:

• Capability to stand, walk, bend, kneel, and squat intermittently for extended durations.
• Capability to manipulate light to medium weights (25-50 pounds) and occasionally push or pull more than 100 pounds.
• Ability to see clearly to use a keyboard, computer monitor, operate equipment, and read materials for extended periods.

Benefits:

We offer competitive remuneration, an annual incentive plan bonus, healthcare, and a range of employee benefits. Join us for outstanding career and development prospects in an innovative and forward-thinking environment that values integrity, intensity, involvement, and innovation!