Manufacturing Manager

Planet Pharma; Philadelphia (Philadelphia County); On-site; USD 80,000 - 100,000; Full time

Job summary

An innovative company in the pharmaceutical manufacturing sector is seeking a Manufacturing Manager to lead compliance and operational excellence. This role involves overseeing manufacturing processes, ensuring adherence to cGMP standards, and managing relationships with contract manufacturing organizations. You will be responsible for project execution, documentation enhancement, and supporting regulatory filings, all while fostering a culture of continuous improvement. If you are passionate about advancing cell therapies and have a strong background in pharmaceutical manufacturing, this is a fantastic opportunity to make a significant impact in a dynamic environment.

Qualifications

• 6+ years of experience in pharmaceutical manufacturing and technology transfer.
• Expertise in cGMP and regulatory requirements for biopharmaceuticals.

Responsibilities

• Oversee manufacturing operations and ensure compliance at CDMOs.
• Manage relationships and support regulatory filings for continuous improvement.

Skills

Pharmaceutical Manufacturing

Project Management

Regulatory Compliance

Relationship Management

Aseptic Processes

Education

Bachelor’s Degree

Tools

cGMP Standards

KPI Monitoring

Job description

This range is provided by Planet Pharma. Your actual pay will be based on your skills and experience — talk with your recruiter to learn more.

Base pay range

$60.00/hr - $80.00/hr

Senior National Recruiter at Planet Pharma

Manufacturing Manager needed!

This role reports to the Director of External Manufacturing and Supply and will be responsible for managing manufacturing compliance through: change control management, project execution, manufacturing procedure/workflow development, onsite oversight at CDMOs (Person In Plant - PIP responsibilities). Additionally, the role includes tactical planning, project management support, and oversight of on-the-floor manufacturing operations in Philadelphia. Occasional travel (10–15%) to headquarters in the Bay Area may be required for meetings and functions.

Requirements:

• Bachelor’s degree with 6+ years of experience in pharmaceutical manufacturing, technology transfer, and process development.
• At least 2 years of experience in cell therapies.
• Prior experience providing manufacturing oversight at a CMO (Person In Plant).
• Expertise in cGMP manufacturing and regulatory requirements for biopharmaceutical products and ATMPs.
• Strong knowledge of manufacturing operations for clinical trial products, including aseptic processes with a focus on cell therapies.
• Proven ability to manage relationships within a CMO network.

Responsibilities:

• Serve as Person In Plant (PIP), overseeing manufacturing, shipping, receiving, and warehousing operations within a network of Manufacturing CDMOs.
• Conduct batch record reviews and deviation initiation, acting as the first responder to any issues that arise during manufacturing.
• Develop and enhance documentation, process flows, and internal business processes, collaborating with internal and external stakeholders to evaluate business needs.
• Act as a liaison between the sponsor and CDMOs, coordinating with internal quality and supply chain teams to improve Vein-to-Vein time, support regulatory filings, and drive continuous improvement.
• Manage and execute change controls as required.
• Implement tracking, analysis, and solutions to ensure operational excellence across key Suppliers/CMOs, utilizing KPIs/KQIs/KRIs to monitor vendor performance.
• Work with functional leadership to design, implement, and maintain Risk-Based Quality Management strategies in support of clinical programs.
• Support business development due diligence projects, assessing external opportunities as needed.
• Ensure timely issue resolution and that all deliverables are met as required.
• Identify and document best practices for supplier partnerships and develop a supplier contact database.
• Use an operational excellence mindset to review and refine processes, procedures, and documentation, ensuring simplicity, accuracy, and robustness.
• Collaborate with program teams to support and execute program goals, including document revisions and process definition.

Seniority level

Mid-Senior level

Employment type

Contract

Job function

Management and Manufacturing

Industries

Pharmaceutical Manufacturing, Biotechnology Research, and Medical Equipment Manufacturing