Job Specific Information
Summary
Responsible for project management (PM), with a focus on pharmaceutical chemistry, manufacturing, and controls (CMC) and research and development (R&D) function, for early to late phase product development. Provide PM leadership in the direction, initiation, planning, coordination, implementation, execution, control, and completion of specific 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 Product Development Teams, provide leadership in the management of the CMC projects and programs including subcontractor management.
- Execute on project strategy, priorities, and milestones ensuring visibility and accountability.
- Proactively lead 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 within CMC sub-teams and product development teams.
- Facilitate strategic and tactical discussions between R&D teams and other functional groups.
- Facilitate project meetings (to include minutes) and cascade key communications.
- Provide technical leadership to Emergent manufacturing sites and contract manufacturers in the resolution of technical issues.
- Provide project updates/reporting through program governance.
- Provide decision quality leadership through program governance and support across multi-functional groups.
- 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.
- Provide leadership and support for inter-site best practices (technology transfer, process validation, etc.) and phase appropriate guidelines and policies.
- Support organizational / departmental initiatives.
- Prepare and conduct presentations to all levels of the organization which may include project technical and budgetary information.
Qualification Requirements
- Experience with pharmaceutical product development/R&D is a must to have.
- A Ph.D., in Pharmaceutical Sciences, Pharmaceutics, Material Sciences, Chemistry, Chemical Engineering, Analytical Chemistry or related discipline with 6 to 12 years, MS with 12+years research experience in pharmaceutical or related field.
- Must possess working knowledge of pharmaceutical product development with a focus on formulation and/or analytical development.
- Experience with pharmaceutical product development with a focus on generic product development is a plus.
- Knowledge of manufacturing processes of formulations and drug delivery concepts is a plus.
- Knowledge and understanding of global regulatory requirements as applied to product development is a plus.
- Working knowledge of USP methodologies, ICH guidelines, FDA, EMA, MHRA cGMP requirements as they apply to the pharmaceutical industry is a plus.
- Strong English language skills including writing ability and oral communication.
- Leadership – inspires and motivates others to perform well; effectively negotiates and influences actions and opinions of others; inspires respect and trust; accepts feedback from others; provides vision and inspiration to peers and subordinates; gives appropriate recognition to others.
- Managing across reporting structure – includes personnel in planning, decision-making, facilitating and process improvements; takes responsibility for team members’ activities; develops team members’ skills and encourages growth; fosters quality focus in others; sets expectations, monitors, and delegates activities; provides recognition for results.
- 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.