What are the responsibilities and job description for the Principal Consultant - CMC and Lab Operations position at Excelra Inc.?
Job Details
Job Summary: Principal Consultant - CMC and Lab Operations
We are seeking a highly skilled Principal Consultant with extensive experience in the CMC (Chemistry, Manufacturing, and Controls) space, particularly in drug product development. The ideal candidate will have a strong background in lab operations, including sample lifecycle management, stability program management, raw material sampling planning, and primary reference materials. Experience with rolling out Laboratory Information Management Systems (LIMS), preferably Sapio LIMS, and setting up SOPs for LIMS/ELN usage and onboarding is essential. The candidate should also have a deep understanding of lab workflows and be able to lead the implementation of LIMS and ELN in collaboration with Sapio and customer stakeholders.
Key Responsibilities:
- Oversee and manage lab operations, including:
- Sample Lifecycle Management & Coordination
- Stability Program Management
- Raw Material Sampling Planning
- Primary Reference Materials
- Lead the rollout and implementation of LIMS, with for Sapio LIMS.
- Develop and set up SOPs for LIMS/ELN usage and onboarding.
- Collaborate with Sapio and customer stakeholders to ensure successful LIMS and ELN implementation.
- Provide expertise in CMC, particularly in drug product development.
- Ensure compliance with regulatory requirements and industry standards.
- Manage and coordinate projects related to CMC and lab operations.
- Provide training and support to lab personnel on LIMS/ELN systems and workflows.
Qualifications:
- Extensive experience in CMC, particularly in drug product development.
- Strong knowledge of lab operations, including sample lifecycle management, stability program management, raw material sampling planning, and primary reference materials.
- Proven experience in rolling out LIMS, preferably Sapio LIMS.
- Experience in setting up SOPs for LIMS/ELN usage and onboarding.
- Deep understanding of lab workflows in a CMC setting.
- Excellent project management and coordination skills.
- Strong communication and collaboration skills.
- Ability to work effectively with cross-functional teams and stakeholders.
