Bachelor's Degree in Sciences or Engineering or equivalent experience.
5 years of experience in biotech or pharmaceutical manufacturing operations.
5 years of project management experience in a biotech, pharmaceutical, or CMO setting.
Experience with aseptic operations and drug product manufacturing preferred.
Strong grasp of GMP regulations and compliance in manufacturing facilities.
Proficient in analyzing and improving manufacturing process data.
Excellent written and verbal communication skills, especially in technical writing.
Ability to work collaboratively in cross-functional teams and manage multiple projects effectively.
Self-motivated and comfortable in a fast-paced environment.
Responsibilities
Lead proposal writing and review efforts for new product introduction.
Conduct facility fit assessments, including risk and process impact analyses.
Oversee technology transfer from development to manufacturing.
Translate process development reports into manufacturing batch records and SOPs.
Provide hands-on training for manufacturing processes during technology transfer.
Develop and manage process improvement projects.
Implement systems for enhanced GMP planning and execution.
Oversee clinical and commercial program lifecycle management.
Manage project plans and key deliverables for stakeholders.
Act as primary liaison for clients, ensuring quality in contract manufacturing services.
Serve as a technical interface between internal teams and clients.
Support root cause investigations and implementation of corrective actions.
Author and manage change control for projects.
Drive operational excellence through process improvement.
Benefits
Opportunity to drive meaningful projects in a dynamic biotech environment.
Collaborative work culture with cross-functional teams.
Exposure to various aspects of product development and manufacturing.
Hands-on experience in technology transfer processes.
Potential for career advancement within the organization.
Full Job Description
POSITION SUMMARY:
The Technical Product Lead will drive product and project leadership for Pyramid Labs. This role supports programs from initial facility fit assessment and technology transfer through client interaction, process improvements, validation, and commercial manufacturing. The Technical Product Lead will be part of the MS&T (Manufacturing Science & Technology) group, leading client interactions, internal project management, and technical and business process improvements.
RESPONSIBILITIES
New Product Introduction:
Lead and contribute to proposal writing and review.
Conduct facility fit assessments for new manufacturing programs, including risk assessments, failure mode analyses, and process impact evaluations.
Oversee technology transfer activities between development and manufacturing.
Translate process development reports into manufacturing batch records and SOPs.
Provide hands-on manufacturing process training as part of technology transfer.
Project Management:
Develop and lead process improvement projects.
Implement systems for improved GMP planning, scheduling, and execution.
Oversee the lifecycle management of clinical and commercial programs.
Develop and manage comprehensive project plans, sharing key deliverables with internal and external stakeholders.
Serve as a primary client liaison, ensuring high-quality contract manufacturing services.
Act as a technical interface between internal teams and client partners.
Quality & Compliance:
Support root cause investigations and CAPA (Corrective and Preventive Actions) implementation.
Author and manage change control for internal and client-related projects.
Drive operational excellence in collaboration with Manufacturing by identifying and implementing process improvements.
QUALIFICATIONS AND EXPERIENCE:
Bachelor's Degree in Sciences or Engineering or equivalent experience.
5 years of experience supporting biotech or pharmaceutical manufacturing operations.
5 years of experience in project management within a biotech, pharmaceutical, or CMO setting.
Experience with aseptic operations and drug product manufacturing strongly preferred.
Strong understanding of GMP regulations and compliance within manufacturing facilities.
Ability to analyze and improve manufacturing process data.
Excellent written and verbal communication skills (technical writing ability required).
Ability to work cross-functionally within internal and external teams to drive project success.
Self-motivated, adaptable, and comfortable in a fast-paced contract manufacturing environment.
Able to manage multiple projects simultaneously, ensuring on-time delivery and customer satisfaction.
