CMC Project Manager
3 weeks ago
CMC Project Manager
Department: CMC
Employment Type: Permanent - Full Time
Location: invoX Cambridge
Reporting To: Mateusz Wydro
DescriptioninvoX is a research-driven global biopharmaceutical company using next-generation technology platforms to discover and develop innovative medicines that can change the lives of people around the world. Our vision is to be a leading global biopharmaceutical company with an advancing pipeline of products addressing the unmet healthcare needs of patients.
To help continue our growth and success, we are looking for CMC Project Manager . As invoX continues to grow, this is a compelling opportunity to work in a fast-paced business.
invoX is a wholly owned subsidiary of Sino Biopharmaceutical Limited, a Hong Kong listed global top 40 pharmaceutical company with more than 24,000 employees.
Key ResponsibilitiesAs a CMC Project Manager at invoX, you will play a pivotal role in overseeing the development and execution of Chemistry, Manufacturing, and Controls (CMC) projects. You will collaborate closely with cross-functional teams to ensure the timely and successful delivery of projects in alignment with organizational objectives and regulatory requirements.
- Project Leadership: Lead CMC project teams, providing direction, guidance, and support to ensure project milestones are achieved within scope, timeline, and budget.
- Strategic Planning: Develop and implement comprehensive project plans, including resource allocation, risk management, and mitigation strategies, to drive project success.
- Cross-functional Collaboration: Foster effective communication and collaboration among internal stakeholders, including R&D, Regulatory Affairs, Quality Assurance, and Manufacturing, to facilitate seamless project execution.
- Regulatory Compliance: Ensure all CMC activities adhere to regulatory standards and guidelines, maintaining compliance with relevant regulatory authorities (e.g., FDA, EMA).
- Budget and Resource Management: Manage project budgets and resources effectively, identifying potential constraints and proactively addressing any issues to minimize impact on project timelines.
- Documentation and Reporting: Maintain accurate project documentation and prepare regular progress reports for senior management, highlighting key achievements, challenges, and recommended actions.
- Continuous Improvement: Drive process optimization and continuous improvement initiatives within the CMC project management function, leveraging best practices and lessons learned to enhance project outcomes.
- Bachelor's degree in a relevant scientific discipline (e.g., Biochemistry, Chemistry, Pharmaceutical Sciences); advanced degree preferred.
- Proven experience in project management within the pharmaceutical or biotechnology industry, with a focus on CMC development.
- In-depth knowledge of drug development processes, including CMC requirements for small molecules and/or biologics.
- Strong leadership and interpersonal skills, with the ability to effectively influence and collaborate across diverse teams and stakeholders.
- Excellent organizational skills and attention to detail, with the ability to manage multiple projects simultaneously in a fast-paced environment.
- Familiarity with regulatory requirements for pharmaceutical product development (e.g., ICH guidelines, GMP/GCP regulations).
- PMP or equivalent project management certification preferred.
- Strong communication skills, both written and verbal.
We get things done, we keep things simple and we are driven by the science. We are ambitious so we work hard to create an environment where we can take smart risks. We want to be innovative so encourage debate and collaboration to challenge the usual way of doing things. We love our celebrations and socialising, which make invoX a fun and diverse place to work. And most of all, everyone has the opportunity to make a difference.
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