CMC Project Management (REF7883L)
- Fleminggatan 18, 112 26 Stockholm, Sweden
- Employees can work remotely
ProPharma Group is an industry leading, single source provider for regulatory compliance, pharmacovigilance, and medical information services across the full development lifecycle for pharmaceutical, biotechnology, and medical device companies. Operating around the world with offices in Australia, Canada, Germany, Japan, the Netherlands, Sweden, United Kingdom, and the United States, ProPharma Group’s fully integrated service offerings will provide clients with a comprehensive suite of global support services that are required to be competitive in today’s dynamic markets. We build successful long-term relationships with clients by providing leading industry knowledge, experience, and proven processes.
This Senior Consultant Product Lifecycle Management position is considered a subject matter expert and will partner with the team leader to manage the development and execution of project team strategy for ProPharma Group clients. This position will be responsible for optimizing team effectiveness in achieving project objectives in alignment with budget and timeline. Some co-authorship of industry blogs and white papers on technical topics of current interest is expected.
Essential Functions Include:
- Senior Consultant Product Lifecycle Management will manage complex manufacturing projects to successful and timely decision points for products under development or currently licensed by the US FDA or other Government Regulatory Agency.
- Partner with the team leader/managing consultant to manage the development and execution of project team strategy and to optimize team effectiveness in achieving project objectives in alignment with budget and timeline.
- Establish and maintain functionally integrated project schedules to enable accurate project, financial and portfolio analyses and ensure accurate inputs are provided into business planning processes.
- Ensure alignment with project sub-teams and functional partners.
- Oversee and prepare project team budget including resources and costs, collaborating with finance and other cross-functional departments.
- Ensure project team activities and decisions are clearly communicated, documented and archived, act as a primary contact for project team related information.
- Facilitate project team meetings, cross-functional communication and decision making, ensuring alignment with internal and external stakeholders.
- Identify, recommend and manage the implementation of process and other improvements; whether pertinent to departmental and/or corporate.
- Assist Operations in staffing client projects to enable the company to execute the strategic plan efficiently and effectively, and to meet revenue and profit goals based on personnel skills development and client needs.
- Co-write “white” papers and blogs on the subject matter of the practice.
- Make industry association trade show and conference talks and presentations.
- Extensive travel required.
- Other duties as assigned.
Qualified candidates must have:
- B.S./B.A.in Life Sciences.
- Advanced degree as a minimum.
- A graduate degree in a scientific discipline is preferred.
- 15 or more years’ multi-disciplinary experience in the biotech/pharmaceutical/ATMP industry with 5-10 years’ direct CMC project management in drug development, tech transfers or method development. One of these areas needs to be an area of expertise.
- Depth in multiple areas of technical transfer, drug development activities.
- Ability to manage all project staff at client site. Includes scheduling, reviews, staff motivation, training and development.
- Ability to execute multiple tasks or projects.
- Ability to develop proposals and organize and conduct professional presentations to potential clients.
- Ability to identify and develop new clients.
- Assist with interviews of ProPharma Group candidates.
- Ability to identify and develop talent in project staff.
- Strong proficiency with project management practices, tools and methodology.
- Outstanding knowledge of overall drug development process and cGMP and ISO relevant to pharmaceutical/biotech and medical device organizations.
- Regulatory Affairs proficiency is a plus.
- Financial acumen; capable of planning and oversight of project budgets and product valuations and an understanding of portfolio management concepts.
- Excellent interpersonal skills, ability to develop important relationships with customers and key stakeholders, good conflict management skills.
- Experience with quality management and quality metric methodology, including Lean Manufacturing and Six Sigma tools a plus.
- Excellent analytical skills, with an ability to communicate complex issues in a simple way.
- Demonstrate ability to translate strategy into action; strong influence, negotiation and presentation skills.
- Proven track record of good decision making and exercising sound judgment.
- Results and detail-oriented; self-motivated.
- Proven experience using Project Management software to manage complex project timelines and resources.
- Working knowledge/understanding of best-practice alliance/collaboration management principles and concepts, techniques and tools.
- Successful experience in managing direct reports a plus.
- Proven experience using Project Management software to manage complex project timelines and resources (MS Project, or other PM Enterprise software).
We are an equal opportunity employer. M/F/D/V
Qualified candidates must be legally eligible to work for any employer in the EU.
***ProPharma Group does not accept unsolicited resumes from recruiters/third parties. Please, no phone calls or emails to anyone regarding this posting.***