Senior Manager of GMP Operations

4 days ago


South Plainfield, New Jersey, United States Porton Pharma Solutions Ltd. Full time
Job Title: Manager / Director of GMP Kilo Lab Operations

Location: Onsite, South Plainfield, NJ

Position Type: Full-Time

Reports To: Sr. Director of GMP Operations

Key Responsibilities:
  • Lead the Kilo Lab team and GMP Kilo lab operations to ensure high performance and adherence to GMP standards.
  • Collaborate with Process R&D chemists to ensure smooth technology transfer of R&D processes into the GMP manufacturing suites.
  • Prepare batch sheets and manage technical input to batch records and other quality documents according to ICH and FDA guidelines.
  • Ensure adherence to EHS policies and maintain work areas in a safe, clean and orderly fashion.
  • Train GMP personnel on batch record writing and GMP related SOPs.
  • Oversee the receipt and storage of raw materials and ensure compliance with relevant SOP/GMP procedures.
  • Supervise the execution of batch records for API and intermediate production to ensure adherence to SOPs and regulations.
  • Oversee in-process testing and supervise cleaning protocols drafting and execution.
  • Perform equipment qualifications and ensure proper record-keeping.
  • Develop and implement team objectives, fostering a collaborative environment focused on continuous improvement and operational excellence.
  • Facilitate communication between the Kilo Lab team and other departments to ensure smooth workflow and effective collaboration.
Qualifications:
  • Bachelor's or Master's degree in Chemistry, Chemical Engineering, Pharmaceutical Sciences, or a related field.
  • Minimum of 5 years of experience in a GMP environment, specifically within a kilo lab or pharmaceutical production setting.
  • Prior experience in team leadership and management, ensuring high performance and adherence to company objectives.
  • Strong decision-making and problem-solving skills, with the ability to manage projects and resources efficiently.
  • Excellent communication and interpersonal skills to facilitate collaboration with internal teams and external stakeholders.
  • Strong organizational and time management skills, with the ability to manage multiple tasks in a fast-paced environment.
  • Detail-oriented with a commitment to maintaining the highest standards of quality and compliance.
  • Support is needed for the Cranbury site in NJ.


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