Senior Manager
2 months ago
**Job Title:** Senior Manager / Director of Pharmaceutical Operations
**Location:** Onsite, NJ
**Position Type:** Full-Time
**Reports To:** Sr. Director of Pharmaceutical Operations
**Key Responsibilities:**
- Lead the Pharmaceutical Operations team and oversee the management of GMP Kilo lab operations to ensure high performance and adherence to GMP standards.
- Collaborate with Process Development chemists to ensure seamless technology transfer of R&D processes into the GMP manufacturing suites.
- Develop 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 Pharmaceutical Operations 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 Pharmaceutical Operations 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 NJ site.
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