Project Manager

Stira Pharmaceuticals LLC; Fairfield (NJ); On-site; USD 90,000 - 130,000; Full time

Job summary

Stira Pharmaceuticals LLC, a sterile injectable CDMO, seeks an experienced Project Manager to lead CMC activities, manage development, manufacturing, and regulatory submissions to ensure timely delivery of quality products.

The role requires coordinating cross-functional teams across R&D, Manufacturing, Regulatory Affairs and Quality Assurance, with strong project management, regulatory knowledge, and excellent communication to advance innovative therapies.

Qualifications

• Proven ability to lead CMC projects and teams.
• Solid understanding of drug development and CMC regulatory requirements.
• Experience coordinating with R&D, Manufacturing, Regulatory Affairs and QA.

Responsibilities

• Lead planning, execution, and completion of CMC projects to meet timelines and quality standards.
• Collaborate with internal and external stakeholders to achieve CMC milestones.
• Develop and maintain detailed project plans including resources, risks, and budgets.
• Monitor project performance, identify risks, and implement corrective actions.
• Serve as primary CMC communications contact for internal teams and external partners.
• Oversee preparation and submission of CMC documentation to regulators.
• Align CMC activities with overall project goals and regulatory strategies.
• Provide status updates to senior management on risks and opportunities.
• Foster a collaborative, high-performing CMC project team.

Skills

Project management

Cross-functional teamwork

Regulatory knowledge

Communication

Education

Bachelor's degree in Chemistry / Chemical Engineering / Pharmaceutical Sciences

PMP certification

Job description

Stira Pharmaceuticals, a Sterile Injectable CDMO, specializes in the development and manufacturing of small molecules and peptides. Our team of skilled scientists leverages extensive experience to address complex pharmaceutical product development challenges. We offer a comprehensive range of services, including Analytical R&D, Preformulation, Formulation Development, Manufacturing, and Regulatory Support.

Position Overview:

Stira Pharmaceuticals is seeking an experienced and motivated Project Manager to lead Chemistry, Manufacturing, and Controls (CMC) activities. This role is essential in managing the development, manufacturing, and regulatory submission processes to ensure the timely delivery of high-quality pharmaceutical products. The Project Manager will collaborate closely with cross-functional teams, significantly contributing to advancing innovative therapies and achieving our company’s strategic objectives.

Key Responsibilities:

• Lead the planning, execution, and completion of CMC projects, ensuring adherence to timelines, quality standards, and regulatory requirements.
• Collaborate with internal departments and external stakeholders, including R&D, Manufacturing, Regulatory Affairs, and Quality Assurance, to achieve CMC project milestones.
• Develop and maintain detailed project plans, encompassing resource allocation, risk management strategies, and budget management for all CMC-related activities.
• Continuously monitor project performance, identify potential risks proactively, and implement corrective measures promptly.
• Act as the primary contact for CMC-related communications, ensuring clarity, transparency, and efficient coordination with both internal teams and external partners.
• Oversee the preparation and submission of CMC documentation to regulatory authorities, ensuring full compliance with relevant regulations and guidelines.
• Align CMC activities closely with overall project goals, corporate objectives, and regulatory strategies.
• Regularly update senior management regarding project status, risks, opportunities, and strategic recommendations.
• Foster a collaborative, team-oriented environment that encourages continuous improvement and effective teamwork within the CMC project group.

Qualifications:

• Bachelor’s degree in Chemistry, Chemical Engineering, Pharmaceutical Sciences, or a related field; an advanced degree is preferred.
• Minimum of 2 years of experience in pharmaceutical project management, specifically related to CMC or pharmaceutical manufacturing.
• Solid understanding of drug development processes and comprehensive knowledge of CMC regulatory requirements for early to late-stage product development.
• Demonstrated experience in effectively managing cross-functional teams and complex pharmaceutical projects.
• Exceptional organizational, problem-solving, and decision-making skills, with a proven ability to prioritize and manage multiple tasks simultaneously.
• Strong communication and interpersonal skills, with proven capability in influencing and engaging stakeholders at all organizational levels.
• Project Management Professional (PMP) certification or equivalent qualification is highly desirable.
• Familiarity with regulatory submission procedures (e.g., IND, NDA, BLA) and comprehensive experience with CMC documentation.
• Ability to thrive in a dynamic, fast-paced environment, emphasizing collaboration, adaptability, and teamwork.