Chemistry, Manufacturing & Controls (CMC) Program Manager

Madison, WI

Job Description


JOB OBJECTIVE: The CMC Program Manager will provide project management support to Usona clinical programs. In conjunction with cross-functional teams and internal subject matter experts and consultants, the Program Manager will be responsible for managing the planning (including timelines, costs, and resources) and on-time completion of product development activities from discovery through NDA submission and post-approval activities. The candidate must possess a strong technical understanding of the inter-disciplinary nature of drug development, as demonstrated by previous drug development and/or manufacturing experience. The position will require timeline and deliverable management skills with close collaboration with the CMC team members to ensure timely development, manufacturing, and support in writing regulatory submissions and supply of clinical trial material.


CORE DUTIES:

1. Provide project management support for CMC and supply chain activities to support development, manufacturing, release, and shipments of drug substance and drug product; analytical method development; and transfer, stability, and supply chain related activities.


2. Facilitate planning of CMC activities across drug substance, drug product, and to aligning dependencies, schedules, and delivery commitments.


3. Develop project plans with minimal support from others, working closely with project leads and/or department head.


4. Create, manage, and facilitate regular meetings, including agenda development, issuance of written minutes, and follow-up on action items.


5. Provide proactive communication and interaction with cross-functional team to ensure key milestones are achieved.


6. Provide input on CMC-regulatory issues across the product lifecycle.


7. Proactively communicate key issues and any other critical topics in a timely manner to the appropriate management level and/or to any other relevant project team member(s).


8. Support CMC project lead/department head with the optimization of CMC project deliverables (schedules, resources, budgets).


9. Properly document study deviations in alignment with SOPs and regulatory guidelines.


10. Provide study updates to cross functional teams and upper management as necessary.


11. Maintain well documented, organized, and up-to-date CMC study files including study schedule, protocol, and correspondence.


12. Ability to work with teams in a highly demanding environment requiring collaboration and a positive attitude.


13. Effectively communicate with team members, senior leaders, and key stakeholders on the status, objectives, risks, and mitigation plans associated with projects; ensure team members are aware of integrated project timelines.


14. Prepare, plan and coordinate documentation for regulatory submissions (INDs, NDAs, etc.), with a primary focus on chemistry, manufacturing, and controls (CMC).


15. Work closely with the CMC team, Regulatory Affairs team, Clinical team, and other project team members in determining and preparing global regulatory strategies for the development and approval of products.


16. Provide regulatory input and advice on the creation, implementation, and revision of SOPs.


17. Perform other related duties as assigned.


18. Demonstrates inclusion through their own words and actions and is accountable for a safe workspace. Acts with kindness, curiosity and respect for others.


19. Embracing and being open to incorporating Promega’s 6 Emotional & Social Intelligence (ESI) core principles in daily work.


20. Understands and complies with ethical, legal and regulatory requirements applicable to our business.


KEY QUALIFICATIONS:


1. Bachelor’s degree in a scientific discipline such as Chemistry, Biology, Microbiology, or equivalent required.


2. 7+ years of experience with demonstrated biotech or pharmaceutical industry experience, with five years of increasing experience with regulatory issues involving drug substance and drug product.


3. Proficient in Project Management methodologies (i.e., Agile) and software tools.


4. Working knowledge of biotech R&D and regulatory processes.


5. Demonstrated experience writing/preparing regulatory submissions. International submission experience a plus. eCTD submission/maintenance experience required.


PREFERRED QUALIFICATIONS:


1. PMP Certification, or equivalent experience.


2. The ability to function in a fast-paced, high-growth, entrepreneurial environment.


3. Strong, professional interpersonal skills, including ability to communicate effectively with people both individually and in groups.


4. Good working knowledge of regulatory affairs, drug development, and manufacturing practices. Understanding of Good Manufacturing Practices (GMP) requirements.


5. Demonstrated ability to work independently and take initiative in scheduling and meeting deadlines.


6. Experience authoring CMC documentation and CMC-related eCTD modules.


7. Contributing team player who can work flexibly and enthusiastically within a small business environment.


PHYSICAL DEMANDS:


1. Ability to use a computer/Microsoft Office applications.

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