Our client – a Contract Development and Manufacturing Organization (CDMO) focused on drug discovery, development, and optimization – is seeking a highly qualified candidate to serve as Manager / Director of GMP Kilo Lab Operations in at their central NJ location. The selected individual will be responsible for overseeing their 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.

Responsibilities:

• Overseeing GMP Kilo Lab operations ensuring compliance with regulatory requirements.
• Developing and implementing best practices for lab processes and documentation.
• Managing a team of lab professionals and coordinating with other departments.
• Managing the Kilo Lab team and GMP Kilo lab operations to ensure high performance and adherence to GMP standards.
• Working with Process R&D chemists to ensure smooth technology transfer of R&D processes into the GMP manufacturing suites.
• Preparing batch sheets and managing technical input to batch records and other quality documents according to ICH and FDA guidelines.
• Adhering to EHS policies and maintaining work areas in a safe, clean and orderly fashion.
• Training GMP personnel on batch record writing and GMP related SOPs.
• Overseeing the receipt and storage of raw materials and ensure compliance with relevant SOP/GMP procedures.
• Supervising the execution of batch records for API and intermediate production to ensure adherence to SOPs and regulations.
• Overseeing in-process testing and supervising cleaning protocols drafting and execution.
• Performing equipment qualifications and ensuring proper record-keeping.
• Developing and implementing team objectives, fostering a collaborative environment focused on continuous improvement and operational excellence.
• Facilitating 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.
• 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.

The above requirements and qualifications are meant to describe the general nature of the position and do not represent all duties to be performed by the selected candidate. Please note that only candidates who are under consideration for the position will be contacted. The Company is an equal opportunity employer. All employment is decided on 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.