Location: Everett, Pennsylvania, United States (On-site)
Reports to: Senior Leadership
Position Overview:
We are seeking an experienced Immunologist Project Manager to lead and manage the Polyclonal, Monoclonal, and Pharmacokinetic departments. In this role, you will ensure that client specifications and project timelines are met, while delivering high-quality products and services. You will be responsible for overseeing cross-functional teams, maintaining compliance with GLP/cGMP standards, and driving successful project outcomes.
Key Responsibilities:
Department Leadership: Oversee operations within the Polyclonal, Monoclonal, and Pharmacokinetic studies, ensuring adherence to client work orders and specifications.
Team Supervision: Manage and mentor project schedulers across the company, ensuring efficient project timelines and resource allocation.
Client Engagement: Serve as the main point of contact for clients, attending meetings, providing updates, and facilitating new business development opportunities.
Experiment Design & Collaboration: Work closely with research associates to design experiments, troubleshoot issues, and foster a culture of creative problem-solving.
SOPs & Documentation: Draft, review, and update Standard Operating Procedures (SOPs), Batch Records (BR), and other critical project documentation.
Compliance & Quality Assurance: Ensure all projects meet the required Good Manufacturing Practices (cGMP) or Good Laboratory Practices (GLP), based on study specifications.
Project Reporting: Provide timely updates on project progress to internal and external stakeholders, including laboratory and project reports.
CAPA Participation: Assist in preparing investigation reports as part of the Corrective and Preventive Action (CAPA) process, addressing any deviations or non-conformances.
Training & Development: Create training materials and collaborate with Sales and Marketing teams to develop content that supports business development efforts.
Pricing & Resource Management: Update pricing models as needed and ensure that all resources are optimally allocated for project success.
Industry Expertise: Stay up to date on advancements in immunology and related fields to inform departmental growth and development strategies.
Qualifications:
Master's degree in a scientific field (Immunology, Molecular Biology, or related disciplines) required; Ph.D. preferred.
Minimum of five years of experience in a scientific environment, with significant experience in antibody generation (polyclonal and monoclonal) and pharmacokinetic studies.
Strong working knowledge of GLP/cGMP quality systems and manufacturing operations.
Hands-on experience with various PK and toxicology techniques and studies.
Excellent verbal and written communication skills, with strong mathematical aptitude.
Proficiency with Microsoft Word, Excel, and other Windows-based systems.
Exceptional organizational skills, with the ability to manage multiple priorities simultaneously.
Experience in supervising teams and providing direction, training, and mentorship.
Familiarity with the metric system and laboratory processes.
Physical & Working Conditions:
Moderate physical activity, including standing, walking, bending, and moving throughout the lab.
Ability to lift and move items up to 50 pounds.
The work environment is generally quiet, though occasional noise from equipment may occur.
Why Join?
This role provides the opportunity to make a significant impact in the field of immunology while leading a dynamic team of professionals. You will work in a collaborative environment, engaging with clients and cross-functional teams to drive innovation and deliver top-tier solutions.