Project Manager, Chemistry, Manufacturing & Controls (CMC) (Transpire Bio)
Responsible for project management, with a focus on pharmaceutical chemistry, manufacturing, and controls (CMC), for early to late phase product development. Provide coordination, planning, execution and completion to specific project management / CMC project(s) ensuring consistency with organizational strategy, commitments, and goals. This is a hands-on position which requires daily tactical responsibilities leading up to strategic decisions.
Essential Duties and Responsibilities
In support of the CMC team, provide project management of CMC projects and programs including subcontractor management.
- Execute on project strategy, priorities, and milestones ensuring visibility and accountability.
- Proactively manage with integrity and engage cross functional project teams and stakeholders.
- Create/maintain project scope, timelines, budgets, team, project plan and project objectives/goals.
- Proactively track and monitor project progress including financials, schedule, resource constraints, risks and opportunities, contract status, and other appropriate project performance indicators.
- Facilitate strategic and tactical discussions / meetings within CMC and product development teams and cascade key communications.
- Provide project updates/reporting through program governance.
- Lead collaborative alignment efforts with technical (process, product, analytical) development, production, quality, and regulatory stakeholders.
- Identify resource constraints and collaborate to resolve issues.
- Identify and risk assess critical path activities and work to support mitigation and resolution efforts with functional leaders.
- Support organizational / departmental initiatives.
- Prepare and conduct presentations at targeted levels of the organization which may include project technical and budgetary information.
Requirements:
- Experience of project management in pharmaceutical product development is a must.
- BS with 3 to 5 years project management experience in pharmaceutical industry.
- Must possess working knowledge of pharmaceutical product development processes with a focus on formulation and/or analytical development.
- Experience of generic and/or inhalation/respiratory product development is a plus.
- Excellent project management skills including planning and coordination; ability to stay highly organized and balance multiple tasks and possess excellent communication skills.
- Experience using project management tools.
- Knowledge and understanding of global regulatory and quality requirements as applied to product development is a plus.
- Strong English language skills including writing ability and oral communication.
- Interpersonal – focuses on solving conflict, not blaming; maintains confidentiality; listens to others without interrupting; keeps emotions under control; remains open to others’ ideas and tries new things; treats others with respect and consideration regardless of their status or position; accepts responsibility for own actions; follows through on commitments.
- Teamwork – balances team and individual responsibilities; contributes to building a positive team spirit; puts success of team above own interests; able to build morale and group commitments to goals and objectives.
- Business acumen and ownership – understands business implications of decisions; aligns work with strategic goals; works within approved budget; develops and implements cost saving measures; conserves organizational resources.
Contact Information:
| Apply to: | Transpire Bio: 2945 W Corporate Lakes Blvd Weston, FL 33331 USA |
| Phone: | 954-315-0224 |
| Email: | brad.tompkins@transpirebio.com |
| Website: | https://www.transpirebio.com |
