Company 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.
