Business Description

The Biologics Clinical Operations & External Partnerships (BCO & EP) department is responsible for the production of Biologics Drug Substance (DS) clinical supplies at 3rd party contract manufacturing organizations (CMO’s), Drug Product/Drug Substance (DPDS) internal sites, and Innovative Medicine Supply Chain (IMSC) internal sites. The Malvern Clinical Operations (MCO) team is responsible for manufacturing the Biologics DS (drug substance) clinical supplies at the Malvern manufacturing site. Manufacturing technicians are responsible for performing manufacturing procedures and the execution of scheduled tasks within a cGMP environment to ensure the delivery of DS clinical materials per CMC (Chemistry Manufacturing & Control) timelines. Applicant will be maintaining the highest standards in compliance within company policies, procedures and all applicable regulations. Additionally, they will be responsible for encouraging site pride and J& J citizenship.

Essential Responsibilities

Clinical Manufacturing Activities and Schedule Attainment

• Independently execute clinical manufacturing or manufacturing-support processes according to standard operating procedures and current curriculum.

• Support manufacturing schedule to meet production, material receipt and shipping requirements; adjust as necessary to unplanned modifications.

• Develop expertise working with visual schedules and other planning tools.

• Retrieve and analyze trend charts and process data on trained procedures.

• Verify and enter production parameters per SOP and Batch Records; takes initiative to review entries made by their respective team

• Accurately complete physical and electronic documentation in batch records, logbooks, and other GMP systems.

• Utilize equipment and instruments in a safe and compliant manner while also taking ownership of their care and maintenance; encourages these behaviors amongst the team.

• Take ownership of training progression through assigned curricula; pursue training opportunities in multiple functional areas

• Accountable for maintaining in depth knowledge of cGMP requirements to ensure adherence to compliance policies and regulations

• Wear the appropriate PPE when working in manufacturing and other hazardous working environments.

• Proactively maintain a clean and safe work environment. Influence the team to take necessary action to eliminate safety hazards and communicate to others any observed unsafe behaviors

• Proactively ensure that all materials and equipment are ready for production not only for their shift, but follow-on shifts as well.

• Collaborate with different functions during project implementation and support IMSC partners as needed.

Additional Responsibilities

• Responsible for training on the manufacturing floor for all relevant procedures and work instructions

• Offer suggestions, follow up, and participate in process improvements related to safety, compliance, cost, yield and productivity.

• Carry out duties in compliance with all state and federal regulations and guidelines including FDA, EPA and OSHA.

• Adhere to the safety code of Conduct & J& J EHS policies and attend all required EHS training.

• Exhibit all Leadership Imperatives based on their leadership level within the organization (leadership development)

• Support production by reporting to their assigned work area on-time in accordance with their shift schedule.

• Attend departmental and other scheduled meetings, as necessary.

• Practice good interpersonal and communication skills.

• Demonstrate a positive, collaborative approach to the day-to-day execution of procedures.

• Learn new skills, procedures and processes as assigned by management and continue to develop expertise.

• Support “Operator Asset Care” program for manufacturing areas

• Accountable for audit preparation and participation; take proper ownership of assigned areas and equipment

• Review and understand non-conformances and other quality issues; participate in root cause problem solving sessions as necessary