Senior Project Leader, Biopharmaceuticals

 Description The Project Manager and their team are responsible for the service delivery to the client. The functional areas typically involved are Process Development, Manufacturing, Quality, Supply Chain and Business Development. Leading and managing (planning, controlling, monitoring and reporting) of assigned projects for the process development and manufacturing of biotechnological products are key to role. This can be BI’s own NBEs (New Biological Entities) or products from external clients with BI as Contract Manufacturing Organization (CMO). The projects can include all activities from cell line development, process development, transfer into GMP production, production and testing of clinical material and market material through submission.
 
 As an employee of Boehringer Ingelheim, you will actively contribute to the discovery, development and delivery of our products to our patients and customers. Our global presence provides opportunity for all employees to collaborate internationally, offering visibility and opportunity to directly contribute to the companies' success. We realize that our strength and competitive advantage lie with our people. We support our employees in a number of ways to foster a healthy working environment, meaningful work, diversity and inclusion, mobility, networking and work-life balance. Our competitive compensation and benefit programs reflect Boehringer Ingelheim's high regard for our employees.
 
 
Duties & Responsibilities:

• Responsible for achieving project goals  (timelines, budget, scope)
• Defines and requests required resources at the responsible decision committees, requests team members from line management
• Participates in CGMP compliance audits initiated by FDA, international governmental agencies and customers. 
• Supports CMB with verification of final proposal and contract
• Generates updates and monitors the project plan (incl. milestones and decision points) together with the team, defines work packages according to project scope (what and when).
• Responsible for necessary updates of the project plan and for preparation of additional or modified work packages and for initiation of corresponding updated offers to the clients (after agreement in the relevant Steering Committees)
• Leads the project team
• Maintains project documentation (project charter, project reports etc.).
• Prepares management decisions together with the team and brings about these decisions in a timely manner
• Communicates project updates to the relevant steering committee at predefined milestones and at defined intervals
• Identifies, mitigates and escalates project risks (timelines, budget, scope) ensures formal project closure (best practice identification, lessons learned, documentation)
• Gives guidance to the team on the contractual situation (CMO projects)
• Initiates and monitors the generation of regulatory documents by the CMC DRA representative and relevant team members
• Is the primary contact person during the project phase for the clients or BI R&D team leader and international project manager and coordinates the flow of information from and to the client
• organizes and conducts meetings with external clients (incl. agenda, meeting notes, action items, follow-up of action items) Collects customer feedback at agreed intervals.

Requirements:

• Requires a Bachelor of Science Degree in Engineering/ Chemistry/ Microbiology or relevant experience.
• Excellent leadership and communication skills; is able to energize and motivate a team; excels in teamwork and integration of stakeholders;is assertive and persistent;is able to illustrate complex issues and to evaluate them critically as well as to navigate a goal-orientated decision process;possesses planning and organizational skills; is able to professionally prepare presentations and present data to BP steering committees, BI committees and external clients; able to manage a number of projects simultaneously ,has experience in multicultural environments;is willing to travel.
• Strong communication (both oral and written) and negotiation skills to interface with other organizational areas and/or customers in order to diffuse conflicts and facilitate productive solutions as well as the ability to multi-task and work under pressure and timelines.
• Capable of working independently with minimal supervision.
• Proficiency in the use of Microsoft Office products including Word, Excel, Access and other software relevant to the performance of the job.

Eligibility Requirements:

• Must be legally authorized to work in the United States without restriction.
• Must be willing to submit to a background investigation, including verification of your past employment, criminal history, and educational background
• Must be willing to take a drug test and post-offer physical (if required)
• Must be 18 years of age or older

Our Culture:
 
Boehringer Ingelheim is a different kind of pharmaceutical company, a privately held company with the ability to have an innovative and long term view.  Our focus is on scientific discoveries that improve patients' lives and we equate success as a pharmaceutical company with the steady introduction of truly innovative medicines.  Boehringer Ingelheim is the largest privately held pharmaceutical corporation in the world and ranks among the world's 20 leading pharmaceutical corporations.  At Boehringer Ingelheim, we are committed to delivering value through innovation.  Employees are challenged to take initiative and achieve outstanding results. Ultimately, our culture and drive allows us to maintain one of the highest levels of excellence in our industry.  Boehringer Ingelheim, including Boehringer Ingelheim Pharmaceuticals, Inc., Boehringer Ingelheim USA, Boehringer Ingelheim Roxane Inc., Roxane Laboratories Inc., Boehringer Ingelheim Chemicals, Boehringer Ingelheim Vetmedica Inc. and Ben Venue Laboratories Inc., is an equal opportunity employer. M/F/D/V
 
Boehringer Ingelheim is firmly committed to ensuring a safe, healthy, productive and efficient work environment for our employees, partners and customers.  As part of that commitment, Boehringer Ingelheim conducts pre-employment background investigations and drug screenings.
 
 
 

 Requirements.