Those who join Emergent BioSolutions feel a sense of ownership about their future. You will excel in an environment characterized by respect, innovation and growth opportunities. Here, you will join passionate professionals who advance their scientific, technical and professional skills to develop products designed-to protect life.
- JOB SUMMARY
The Project Manager has total responsibility and accountability for the integration of the needs and requirements of the customer, QA, Regulatory, Manufacturing Operations and Engineering. The Project Manager leads the technical transfer of products by coordinating the execution of the transfer procedures, assisting production startup by communicating and negotiating client requirements, ensuring adherence to CGMPs and quality standards, and safeguarding Emergent’s company interests. The Project Manager coordinates all activities surrounding the ongoing manufacture of clinical and commercial products including, receipt of client supplied material, production record generation, sample shipping, product shipping, invoicing and non-conformance resolution.
Reasonable accommodations will be made to enable individuals with disabilities to perform the essential functions.
- Develop and maintain project plan documents including Technical Baseline, Risk Management Plan and Gantt charts to track and report project status. Identify, report, and document changes to the project.
- Build and lead cross-functional project teams to implement the project plan to achieve project deliverables, timelines, schedules and budgets. Lead technical transfers to onboard new clients and products.
- Manage the contractual, technical and financial requirements of each project with general instructions.
- Monitor and manage day-to-day aspects of project and scope, including regular meetings, minutes and reporting with general supervision to ensure schedule adherence.
- Identify and manage project dependencies and critical path. Manage projects to completion on time in full and remediate roadblocks that impact adherence to schedule.
- Review and evaluate deliverables prepared by the project team, lead communication and delivery to the sponsor/client and resolve difficult problems to complete deliverables.
- Develop and deliver engaging, informative and well-organized presentations. Provide regular updates and recommendations on the project status, including milestones achieved, mitigation plans for identified delays or risks, and changes in project scope and project financials.
- Coordination and control of the project progress, including: continuous contact with clients, identification and troubleshooting of technical problems, managing the project team until the problems are resolved, production and QC assistance in the project introduction initial phases, i.e.: analytical transfer, installation feasibility studies, trials, batch validation, etc.
The above statements are intended to describe the nature of work performed by those in this job and are not an exhaustive list of all duties. Nothing in this job description restricts managements right to assign or reassign duties and responsibilities to this job at any time which reflects management’s assignment of essential functions.
III. MINIMUM EDUCATION, EXPERIENCE, SKILLS
- Bachelor’s degree in science, engineering or business; MBA highly desirable
- Minimum 3 years of project management experience or 5 years experience in the Pharmaceutical Industry, in a Contract Manufacturing related setting or suitable experience
- Demonstrated experience building and leading strong cross-functional teams
- Experience in managing drug (small molecule), biologic, and vaccine development projects
- including technology transfer is desired
- Excellent written and verbal communication skills
- Excellent interpersonal skills including negotiating, influencing, and active listening
- Fluent with regularly used software applications (MS Word, MS Excel, MS Project, MS
- PowerPoint, SharePoint, Visio)
- Familiarity with Earned Value Management
- Familiarity with FDA cGMP and FDA regulations relating to biologic and drug products
- Working knowledge of SAP
Successful applicants for this position that are required to be onsite at any Emergent site at any time, must be fully vaccinated against COVID-19 as a condition of employment, subject to legally required exemptions.
There are physical/mental demands and work environment characteristics that must be met by an individual to successfully perform the essential functions of the job. This information is available upon request from the candidate.
Reasonable accommodations may be made to enable individuals with disabilities to perform all essential functions.
Emergent BioSolutions is an Equal Opportunity/Affirmative Action Employer and values the diversity of our workforce. Emergent does not discriminate on the basis of race, color, creed, religion, sex or gender (including pregnancy, childbirth, and related medical conditions), gender identity or gender expression (including transgender status), sexual orientation, age, national origin, ancestry, citizenship status, marital status, physical or mental disability, military service or veteran status, genetic information or any other characteristics protected by applicable federal, state or local law.
Emergent BioSolutions does not accept non-solicited resumes or candidate submittals from search/recruiting agencies not already on Emergent BioSolutions’ approved agency list. Unsolicited resumes or candidate information submitted to Emergent BioSolutions by search/recruiting agencies not already on Emergent BioSolutions’ approved agency list shall become the property of Emergent BioSolutions and if the candidate is subsequently hired by Emergent BioSolutions, Emergent BioSolutions shall not owe any fee to the submitting agency.