Senior CMC Project Manager
Proclinical is currently recruiting for a Senior CMC Project Manager for a global pharmaceutical company located in Cambridge, MA. Successful candidate will be responsible for managing deliverables required to fulfill projects for technical Operation and Quality as well as CMC requirements and timelines for all regulatory submissions.
- Partner with CMC Technical Leads to manage multiple complex development projects to achieve product development and manufacturing goals
- Collaborate with technical lead and expertise areas (Regulatory Affairs, Manufacturing, Manufacturing Operations Support, Process Sciences, Supply Chain and Quality) to establish project plans including resource loading and risk mitigations for the Technical Operation and Quality Organization.
- Support the management of internal and external technical requirements with partners, CMOs, and CROs to ensure project success and that contractual obligations and deliverables are met.
- Management of project plans and timelines for the completion of all activities required to develop, prepare and submit the Chemistry, Manufacturing, and Controls (CMC) sections of registration dossiers and amendments for all products
- Schedule and run cross functional team meetings to manage execution of project plan, including authoring of minutes, assignment of action items and tracking of performance metrics
- Facilitate the process for evaluation of alternative actions to operationally deliver plan. Influence and drive development of solutions, criteria, and implications.
- Drive timely decisions and facilitate active communication and information flow between team members, Program Teams and impacted sites / expertise areas.
- Prepare and present project status reports and metrics to Program Teams and Management.
Skills and Requirements:
- Bachelor's degree in life sciences/engineering. Advanced degree Required.
- 5-10 years of development & project management experience within the biopharmaceutical or pharmaceutical industry.
- Ability to lead cross-functional teams required.
- Preference for CMC experience, particularly with programs in early stage clinical trials
- Exceptional planning and organizing skills to plan and manage resources against timelines and commitments; must excel in a dynamic environment.
- Ability to negotiate and influence partners towards an appropriate path forward.
- Strong interpersonal and communication skills.
- Successful track record of both internal and external alliance management.
- Ability to sustain 10% domestic and international travel
Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.
In case you have difficulty in applying or if you have any questions, please Nikki Ranieri at (+1) 215-531-5281 or upload your resume on our website - www.proclinical.com.
A full job description is available on request.
Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.
Proclinical Staffing is an equal opportunity employer.
A leading Pharmaceutical company focused on the development and commercialisation of therapeutics for the treatment of chronic infections, is currently recruiting for a VP of Medical Affairs position.
A leading biopharmaceutical company is currently looking to hire a Procurement Specialist to be based at their offices in Leicester, UK.
A leading medical technology and devices company is currently recruiting for an Associate Director Market Access EMEA position.
A great career opportunity has emerged at a multinational pharmaceutical company. They are currently recruiting for a Manager, Global Advertising and Promotional Compliance position.
A job vacancy for a S/CRA has arisen at a leading global pharmaceutical company specialising in development of biological therapies.
A global healthcare company is advertising a vacancy for a Director of Drug Product Development position.
A leading pharmaceutical company that accelerates the launch and listing of drugs across China is seeking a Global Study Leader to join their office in Shanghai.