Job Description:
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:
- 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.
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.