Associate Director, Biologics CMC

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To apply for this postion please fill out the fields below and attach your resume.

Altavant is seeking an Associate Director of CMC to play a critical high-level role providing strategic oversight and end-to-end supervision of all CMC operational activities related to one or more of Altavant’s clinical development programs. This person will be responsible for ensuring that CMC timelines stay on track and will be the key point of contact between Altavant and all vendors and consultants that support CMC. A successful candidate will have a demonstrated track record of technical and program leadership.

This is an excellent opportunity for a highly motivated self-starter and creative problem solver who has a strong desire to make an important contribution to the development of biologics for lung diseases. This is a high-profile position with the opportunity to innovate in an entrepreneurial and high growth organization.

RESPONSIBILITIES AND SKILL REQUIREMENTS:

  • Play a key role in advancing experimental therapeutic molecules to the clinic by providing planning, expertise and oversight on all CMC-related activities and issues, including but not limited to cell line development (including GMP MCB), process development (upstream, downstream, formulation), analytics, release assays, GMP DS manufacturing, GMP DP manufacturing, device performance and selection, label/pack/storage/distribution, regulatory activities, QC/QA
  • Ensure that CMC-related applications, such as CTAs and INDs, are complete, well written, and meet all relevant agency requirements and standards
  • Proactively identify CMC risks and provide recommendations on mitigation
  • Represent CMC at program team meetings providing timely updates on progress and recommendations on strategy with ability to effectively communicate subject matter specific topics to a non-CMC audience and senior leadership
  • Ensure that CMC activities remain within projected timelines and budget
  • Identify, review and select the best external CROs, CDMOs and key consultants that are needed to allow smooth, efficient and cost-effective CMC support for programs advancing to the clinic

EDUCATION AND EXPERIENCE:

  • Master’s Degree or PhD in a pertinent scientific discipline with at least 12+ years of industry experience in CMC
  • Proven track record of successful CMC project management experience supporting early stage programs
  • Experience in early drug development including the transition of novel candidates from discovery through to IND, Phase 1 and Phase 2 clinical trials
  • Prior experience managing or working within cross-functional project teams with timeline management and budgetary responsibility
  • Experience working with CMC budgets both in development and managing budgets
  • Strong knowledge of current Good Manufacturing Practices (GMP), including familiarity with CMC operations, including Quality and Manufacturing technical strategy
  • Strong knowledge of project management tools and software

CAPIBILITIES

  • Ability to act decisively and with urgency to solve problems
  • Strong leadership and interpersonal skills in order to influence decision-making in a diplomatic manner
  • Excellent oral and written communications with ability to present data to all levels of expert and non-expert audiences
  • Accountability and self-awareness to drive positive results
  • Strong Vendor Management skills
  • Effective organizational and planning skills
  • Flexibility to switch from strategic thinking to operational details
  • Ability to travel as needed

Please CLICK HERE to apply to this role (https://www.linkedin.com/jobs/view/2425899302/).