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CMC Life Sciences Project Manager
Education and/or Experience
Our Customer is an emerging biopharmaceutical company developing a new class of biologics to break the cycle of injury and inflammation for patients with respiratory and inflammatory diseases. We are weeks away from submitting two IND’s for BPD (bronchopulmonary dysplasia) and Covid-19 indications and beginning two clinical trials.
• Report in a matrix role to CFO/COO operationally (and administratively) and SVP, CMC for CMC direction and technical aspects.
• Manage projects including activities related to the production and analysis of cGMP AT-100 (recombinant human surfactant protein D) and ongoing process development.
• The project manager must apply established scientific, operational and business principles in order to effectively manage the project(s) with external contract manufacturing and analytics organizations.
include the following. Other duties may be assigned.
• Manage GMP production project(s) with leading cmo(s) to provide drug product for ongoing clinical trials. Develop strong and detailed working relationship with counterparts at cmo’s to provide transparency to management of progress, obstacles, required interventions, etc. Prepare and maintain Gantt charts for key milestones and review with internal team routinely.
• Interface routinely with CEO, CFO/COO and SVP, CMC and assist in development and implementation of ongoing process development plan. Manage the project Gantt chart for the PD plan.
• Coordinate all the components of the project(s) which may include determining resources, timelines, communication among all involved stakeholders, motivating the participants and driving timelines, prioritizing tasks, managing change and analyzing the outcome.
• Keep management continually apprised of changes regarding risk, timelines or budget and provide proposals for solutions to issues.
• Use judgement in bringing issues to management attention as soon as necessary for intervention.
• Scheduling weekly technical/operational team meetings and keep minutes and note paths-forward.
• Minimum BS degree in a life sciences discipline preferred.
• Minimum 3 years’ experience in biopharmaceutical CMC project management preferred.
• Proactive, self-starter
• Outstanding communication and organizational skills
• Able and willing to work in a small dynamic team with ambitious goals
• Demonstrated ability to prioritize workload according to Company objectives
• Detail orientation including a critical degree of accuracy in work
• Strong leadership skills
• Ability to perform multiple tasks simultaneously while adhering to deadlines
• Problem-solving and analytical skills
• Understands business implications of decisions
Ability to utilize both oral and written English communication effectively.
To perform this job successfully, an individual should be proficient in MS Office, Mac experience is preferred.