Associate Director CMC

Allucent·Remote·Work From Anywhere
Software Development
Excel

WFA Digital Insight

The demand for experienced CMC professionals has skyrocketed, with a 25% increase in job postings over the past year. As the pharmaceutical industry continues to evolve, companies like Allucent are seeking skilled leaders to oversee Chemistry Manufacturing and Controls. With a strong background in small molecule development and regulatory affairs, candidates can excel in this role. Allucent's commitment to bringing life-changing therapies to patients worldwide makes this an attractive opportunity for those passionate about making a difference. Before applying, candidates should be prepared to showcase their expertise in CMC, strategic thinking, and team collaboration.

Job Description

About the Role

The Associate Director, Chemistry Manufacturing and Controls (CMC) plays a vital role in assisting clients with CMC and related pharmaceutical development activities for drug, biologic, or medical device products. This position requires a deep understanding of small molecule development, including solid, liquid, oral, topical, injectable, and inhalation products. As a key member of the team, the Associate Director will lead and participate in Health Authority communications, review and author regulatory content, and contribute to strategic CMC discussions.

The Associate Director will work closely with cross-functional teams, including project managers, scientists, and regulatory affairs specialists. The ideal candidate will have a strong scientific background, excellent communication skills, and experience in managing multiple projects simultaneously. The role entails a high level of independence, with the ability to work remotely and collaborate with global teams.

The Associate Director will also be responsible for mentoring junior team members, providing guidance on CMC-related activities, and contributing to the development of regulatory strategies. This is an excellent opportunity for a seasoned CMC professional to join a dynamic team and make a significant impact on the development of life-changing therapies.

What You Will Do

  • Review and analyze drug substance synthesis, pre-formulation, and formulation evaluation data
  • Develop and implement regulatory strategies for CMC-related activities
  • Lead and participate in Health Authority communications, including correspondences, teleconferences, and meetings
  • Author and review CMC-related regulatory content for submissions, reports, and other scientific documents
  • Collaborate with cross-functional teams to develop and implement project plans
  • Provide guidance on CMC-related activities to junior team members
  • Contribute to the development of regulatory strategies and risk assessments
  • Manage multiple projects simultaneously, prioritizing tasks and meeting deadlines
  • Develop and maintain relationships with clients and stakeholders

What We Are Looking For

  • A B.S., R.Ph., M.S., Ph.D., or equivalent degree in a scientific area, with a minimum of 10 years of directly relevant experience in drug, biologic, or device development
  • Advanced scientific knowledge of Health Authority Regulatory Guidance and Regulations
  • Strong understanding of electronic common technical document (eCTD) format and requirements of regulatory submissions
  • Excellent written and verbal communication skills in English
  • Strong computer skills, including SharePoint, Word, Excel, and PowerPoint
  • Experience with small molecule development, including solid, liquid, oral, topical, injectable, and inhalation products
  • Strong analytical and problem-solving skills, with the ability to think critically and strategically

Nice to Have

  • Experience with regulatory submissions and approvals
  • Knowledge of current Good Manufacturing Practices (cGMP) and Good Laboratory Practices (GLP)
  • Familiarity with regulatory requirements for medical devices
  • Experience with project management tools and software
  • Certification in a related field, such as regulatory affairs or quality assurance

Benefits and Perks

  • Competitive salary and benefits package
  • Opportunity to work remotely and collaborate with global teams
  • Comprehensive health insurance and retirement plans
  • Paid time off and holidays
  • Professional development and training opportunities
  • Access to cutting-edge technology and tools
  • Recognition and rewards for outstanding performance
  • A dynamic and supportive work environment
  • The chance to make a meaningful impact on the development of life-changing therapies

How to Stand Out

  • Develop a strong understanding of regulatory requirements and guidelines for CMC activities
  • Showcase your experience with small molecule development and regulatory submissions
  • Highlight your ability to work independently and collaborate with cross-functional teams
  • Be prepared to discuss your experience with project management tools and software
  • Demonstrate your knowledge of current Good Manufacturing Practices (cGMP) and Good Laboratory Practices (GLP)
  • Showcase your analytical and problem-solving skills, with the ability to think critically and strategically
  • Be prepared to provide examples of your experience with regulatory submissions and approvals

This is a remote position listed on WFA Digital, the platform for professionals who work from anywhere. Browse more remote jobs across all categories.