Description
The Director of CMC Project Management in External Alternative CMC Development (EACD) will provide project management support to ensure that EACD goals and milestones are achieved. This role involves providing technical project management expertise to the team, ensuring smooth and efficient operational implementation of agile CMC strategies that allow for timely project delivery in line with time, financial, and quality requirements. The Director-PM will leverage operational management experience to support alliances, collaborations, and third-party vendors (CROs, CDMOs and CMOs), handle contract writing/review, and interact with Legal and Patents departments. This role requires a high level of independence and moderate supervision.
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
- Lead and manage CMC project teams to ensure timely and successful completion of project milestones.
- Develop and implement non-traditional CMC project strategies for API and DP development through external collaborations, supplemented by internal BI capabilities.
- Oversee the preparation and submission of CMC regulatory documents, including INDs, NDAs, and BLAs.
- Collaborate with internal and external stakeholders, including R&D, Quality, Regulatory Affairs, and Manufacturing, to ensure seamless project execution.
- Identify and mitigate project risks, ensuring proactive problem-solving and contingency planning.
- Manage project budgets, timelines, and resources effectively.
- Provide leadership and mentorship to junior project managers and team members.
- Stay current with industry trends, regulatory changes, and best practices in CMC project management.
- Represent all CMC activities on internal project teams as the EACD Team Member.
- Develop effective partnerships and strong internal relationships based on trust, technical competence, and effective planning, resource management, and communication.
- Manage all EACD activities for relevant projects at all stages of development, especially up to Phase II a/b.
- Ensure timely and precise information sharing and project execution between EACD and other interface groups (external and internal).
- Devise and implement innovative yet regulatory/quality-approved agile approaches for EACD program support that improve project execution timelines.
- Enable appropriate communication to translate overall EACD development paradigms into appropriate CMC deliverables.
- Operationalize process development and improvement initiatives within the EACD department.
Requirements
- Onsite/Flex*: This position is site based with flexibility for remote working. Working onsite a minimum of 2-3 days per week is required. Remote working norms will be clarified during the interview process.
- Ph.D. Degree from an accredited institution or equivalent with ten-plus (10+) years of experience in pharmaceutical industry with minimum 5+ years in CMC project management/alliance management within the pharmaceutical industry.
- Proven track record of successful CMC project leadership and regulatory submissions.
- Strong knowledge of FDA, EMA, and ICH guidelines and regulations.
- Excellent organizational, communication, and interpersonal skills.
- Ability to work effectively in a fast-paced, dynamic environment.
- Demonstrated leadership and team-building skills.
- Experience in managing external investments and participating in various operational elements of the department, such as budget, time recording, and travel/training policy.
- Proven ability to manage, lead, and motivate others.
- Ability to creatively and independently propose, articulate, evaluate, and drive innovative strategies that bring value through improving efficiency and effectiveness in API (NCEs and ATMPs) and DP development.
- Demonstrates broad understanding of drug substance, drug product, delivery systems, and analytical sciences.
- Demonstrated ability to collaborate with, negotiate, and influence business partners in Global Development and other business functions (Operations, DRA, BIRI, etc.).
- Effective communication, coaching, and negotiating skills.
- Demonstrated ability to prepare/manage oral presentations to scientists (internally and externally) and senior-level management.
- Understanding of, and compliance with, all applicable regulations and relevant Boehringer Ingelheim business procedures.
Compensation Data
This position offers a base salary typically between $200,000.00 and $316,000.00 USD. The position may be eligible for a role specific variable or performance based bonus and or other compensation elements. For an overview of our benefits please click here.
Eligibility Requirements
Must be legally authorized to work in the United States without restriction.
Must be willing to take a drug test and post-offer physical (if required)
Must be 18 years of age or older
