Vice President, Chemistry, Manufacturing, and Controls (CMC)

Location
South San Francisco, CA
Posted
Apr 08, 2021
Hotbed
Biotech Bay
Required Education
Doctorate/PHD/MD
Position Type
Full time

At DiCE Molecules, we design and develop innovative therapies in immunology for patients with debilitating disease. Seeking to create a future where convenient oral medicines with biologic-like efficacy are available to patients with serious medical conditions, we are developing oral alternatives to medicines currently limited to injectable forms.

 

Essential Functions:

Seeking an outstanding leader in Chemistry Manufacturing and Controls (CMC) with extensive experience in manufacturing and advancing small molecules through clinical trials to approval. The ideal candidate is one who has been involved in all aspects of drug product (API) and drug substance (DS) manufacture and can direct and oversee CMC regulatory strategy for multiple products.

The ideal candidate must be an outstanding leader with a proven track record of strategic planning and successful execution in advancing molecules from pre-clinical manufacturing to late-stage clinical trials. The candidate must be experienced in all aspects of DP and DS manufacture including selection and management CROs/CMOs, manufacturing of API under cGMP conditions, development of formulation strategies, and implementation of analytical methods consistent with regulatory guidelines. This role involves strategic oversight in anticipating drug supply needs for both preclinical and clinical studies, along with managing supply chain and logistics in support of multiple clinical trials. In addition, the role requires authoring, reviewing and editing CMC regulatory submissions and quality documents. The successful candidate will execute plans for the release, validation and registration of API and DP as required by regulatory and ICH guidelines. The candidate must have strong organizational and communication skills, be capable of strategically communicating to upper management, summarizing data, and effectively communicating across functions. Finally, the candidate must be comfortable with, and thrive in, a fast-paced entrepreneurial environment which necessitates a hands-on approach at all levels.

Key Responsibilities:

  • Develop and Plan CMC programs (drug substance and drug product manufacturing and analytical activities), from preclinical development through clinical supplies for Phase 3 registration studies, including projection of API/DP needs, budgets and timelines..
  • Execute plans in accordance with cGMP, ICH and FDA regulations.
  • Partner with and maintain regular contact with key stakeholders including, Discovery, Quality Assurance, Regulatory Affairs, Medical, Legal, Finance, and Program Management.Write and review relevant sections for regulatory submissions.
  • Identify, select, and manage Contract Manufacturing Organizations (CMOs) for process optimization, non GMP and cGMP manufacture and supply of Drug Substance (API) and Drug Product (DP) in support of ongoing clinical programs.
  • Implement stage appropriate analytical methods and protocols and ensure that all CROs and CMOs are using systems and processes in compliance with all relevant regulatory standards
  • Oversee the tactical implementation of the manufacturing programs, including delivery of scalable and cost-effective manufacturing routes that meet or exceed the target clinical profile. Design and develop formulations that meet target product profile
  • Manage supply chain and logistics in support of clinical studies.
  • Prepare, review, or edit cGMP batch records, CMC regulatory and quality documents
  • Anticipate drug supply needs for both preclinical and clinical studies, along with managing supply chain, drug labeling and logistics in support of multiple clinical trials
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    Preferred Experience and Education:

    Knowledge/Education:

  • PhD/MSinscience(e.g., organic chemistry, chemistry, pharmaceutical sciences, or related discipline)
  • Job Experience:

  • 10+ years of experience in a pharmaceutical or biotechnology CMC/GMP environment and experience in small molecule manufacturing and managing US/international CRO/CMOs for the manufacture of non GMP and cGMP APIs and DP. Experience with projects preclinical through Phase 3.Experience in supply chain management would be a plus.
  • Experience with IND, CTA and NDA filings; thorough knowledge of relevant FDA and EMEA regulations and guidelines.
  • Preferred Additional Skills:

  • Strong leadership skills with proven ability towork collaboratively internally and externally,with the ability to managemultiple stakeholders.
  • Strong oral and written communication skills.
  • Strong organizational skills.
  • Strong technical judgment with attention to detail.
  • Skills to proactively identify and manage potential risks.
  • DISCLAIMER

    The above information on this description has been designed to indicate the general nature and level of work performed by employees within this classification. It is not designed to contain or be interpreted as a comprehensive inventory ofall duties, responsibilities, and qualifications required of employees assigned to this job.