Jobs

Description

Duties:

• Client setting the new standard for our clients through our disruptive products and for our employees through our industry-leading benefits that promote financial and physical health & well-being for all employees.
• The incumbent will be a part of the manufacturing organization and provide hands-on execution of tasks related to the cGMP manufacture of biopharmaceuticals working in aseptic fill-finish.
• The incumbent will demonstrate the ability to execute critical and complex cGMP tasks and will demonstrate flexibility to support business needs.
• The incumbent will work with area management to execute and maintain the production schedule.

ESSENTIAL DUTIES

• Perform routine procedures following written instructions (SOPs, batch records, solution documents, protocols, etc.) and can serve as the lead in these activities.

• Operate in a controlled GMP environment. Ensure compliance with established internal and external control procedures.
• Demonstrates operational proficiency in Drug Product-related process equipment. Assist in the execution of process, equipment and cleaning validation.
• Assist with support tasks within Drug Substance Manufacturing, as business needs permit.
• Responsible for revising and originating production records, standard operating procedures, protocols and reports. Initiate and supports the closure of Deviation Reports
• Supports the closure of CAPA and CR Tasks as required per business needs.
• Train and mentor new manufacturing associates on procedures, aseptic techniques, equipment and trouble-shooting skills.
• Review in-process and completed documents for accuracy and to make sure batch records are turned in to area management within specified days of completion.
• Work with Quality Control, Facilities, Materials Management, Quality Assurance and Validation to complete assignments.
•  Supports the ongoing continuous improvement within the Drug Manufacturing Process.
•  May schedule team activities within the manufacturing facility including the coordination of production schedules, calibration and validation.
• May coordinate schedule with process science teams, analytical testing personnel, microbiological support team, facilities and sanitization groups.

Skills:

• 3+ years of experience with pharmaceutical or biotechnology manufacturing processes; or equivalent education, training, and experience.
• Hands-on skills with Aseptic technique, cleanroom gowning and extensive knowledge of Good Manufacturing Practices (GMPs).
• Hands-on skills with aseptic fill finish operation.
• Hands-on experience with automated filling/capping machine, and Lyophilizer.

Preferred:

• Experience with process development, transfer, and optimization is a plus. Experience with execution of validation protocols is a plus.
• Experience working with potent/toxic agents is a plus. COMPETENCIES Key Competencies: · Integrity, Trust, Ethics, Values · Results oriented ·

Strategic Skills ·

Organizing/Priority Setting · Communication skills · Attention to detail · Decision Quality · MS Word Proficient · Flexibility · Interpersonal Savvy · Negotiating · Problem Solving · Listening & Approachability · Partnering

Education: 
High School Degree or Equivalent

Preferred: ·

• Bachelor’s degree in biological sciences, chemical engineering or related discipline