Director of GMP Kilo Lab Operations

13 hours ago

Reston, Virginia, United States TPG Staffing, LLC Full time

Job Title: Manager / Director of GMP Kilo Lab Operations

Location: Central NJ

TPG Staffing, LLC is seeking a highly qualified candidate to serve as Manager / Director of GMP Kilo Lab Operations at their central NJ location. The selected individual will be responsible for overseeing the Kilo Lab and ensuring that best practices are followed in all areas of its operation and documentation. In addition, the Manager / Director of GMP Kilo Lab Operations will be responsible for training team members in performing critical duties and effectively communicating with other teams within the organization.

The selected applicant must be currently able to legally work in the U.S.

Key Responsibilities:

  • Oversee GMP Kilo Lab operations to ensure compliance with regulatory requirements.
  • Develop and implement best practices for lab processes and documentation.
  • Manage a team of lab professionals and coordinate with other departments.
  • Manage the Kilo Lab team and GMP Kilo lab operations to ensure high performance and adherence to GMP standards.
  • Work 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.
  • Adhere 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.

Requirements:

  • Bachelor's or Master's degree in chemistry, Chemical Engineering, Pharmaceutical Sciences, or a related field.
  • Extensive knowledge of regulatory compliance and GMP lab documentation.
  • Minimum of 5 years of experience in a GMP environment and proven experience in GMP Kilo Lab operations management, 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-orientation with a commitment to maintaining the highest standards of quality and compliance.

TPG Staffing, LLC is an equal opportunity employer. All employment is decided on the basis of qualifications, merit, and business needs without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or veteran or disability status.

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