Director/Senior Director, CMC

Regular, Full-time, Exempt

San Francisco, CA

Reports to

Chief Scientific Officer

SUMMARY

Assembly Biosciences (NASDAQ symbol ASMB) is a biopharmaceutical company developing innovative and curative treatments for hepatitis B virus infection (HBV), in addition to a large research effort in the microbiome space in partnership with Allergan. Both programs have breakthrough potential to provide higher cure rates for debilitating diseases.

Assembly Biosciences is committed to advancing science and enhancing the health and well-being of patients. This commitment, along with a vibrant team culture, drives our efforts to develop and commercialize novel approaches and therapies to address major medical needs.

The selected candidate will act as a primary liaison between Assembly and contractors involved in the manufacturing, testing, and packaging of drug products for clinical trial material (CTM) requirements and stability studies. Responsibilities include the general management of third party contract organizations, such as management of technical issues, quotations, contractor evaluation and selection, scheduling, batch review and release, and other technical operations activities. The individual will play a key role in the development of stable and commercializable pharmaceutical drug product formulations, particularly solid oral dosage forms, by working closely with third party contract organizations. In this role, the Director/Senior Director will be responsible for assisting experimental designs for formulation evaluation and development, review and oversight of CMC data, assessment of data trends, performance of batch record reviews, setting of specifications, trouble shooting, and assurance of drug product production standards.

Specific responsibilities include, but are not limited to:

  • Identify and manage third party contract organizations for development and manufacturing of small molecule drug products (including formulation, process, packaging, and analytical development activities)
  • Work with third party organizations for the following activities:
    • Exploratory evaluation and development of animal and human formulations for newly nominated clinical candidates
    • Develop formulations, processes, and analytical test methods for drug products
    • Develop and justify drug product specifications
    • Manufacture, test, package, and label supplies for clinical trials and stability
    • Select and justify primary container-closure systems for drug products
    • Develop protocols for development studies, stability programs, and validations
    • Execute stability studies, trend data, and determine expiration periods
    • Write technical and development reports
  • Review data and trends and make recommendations for next steps
  • Utilize scientific/technical expertise at third party contract organizations to achieve stable and commercialized drug product formulations and validated analytical methods
  • Develop strategy and tactical CMC plans and manage activities/timelines consistent with overall Project Team strategy and corporate goals
  • Write/review regulatory documents
  • Identify and utilize expert consultants, when necessary
  • Work with Legal department to establish agreements and contracts with CMOs
  • Writes Requests for Proposal (RFPs), receives and negotiates quotations, and verifies invoices are consistent with work performed by third party vendors
  • Interact cooperatively with other functional areas, including Discovery, Quality, Regulatory, Clinical Development, Project Management, and Legal
  • Adherence to Company's Business Code of Conduct
  • Other duties as assigned

PREFERRED QUALIFICATIONS:

  • PhD in pharmaceutical sciences with at least 7 years or BS/MS with at least 12 years of pharmaceutical experience (preference to candidates with background/experience in solid oral dosage forms)
  • At least 5 years in a scientific/technical CMC role with experience working with third party development/manufacturing/packaging/testing organizations
  • Demonstrated ability to independently write technical reports and regulatory documents (suitable for submission to FDA and other regulatory authorities)
  • Thorough understanding and competency in all aspects of drug product development
  • Thorough knowledge of GMPs, especially as related to a virtual environment where all development and manufacturing are outsourced to third party vendors
  • Motivated self-starter who can work independently with minimal supervision
  • Reliable and dependable, with close attention to detail
  • Excellent professional and interpersonal skills
  • Excellent oral and written communication skills, especially for development reports and regulatory documents
  • Ability to work efficiently and cooperatively in a virtual company environment
  • Goal oriented and ability to deliver on timelines and commitments
  • Exhibits a proactive, transparent, and rigorously objective confidence in all aspects of their work and CMC

AAP/EEO Statement

Assembly Biosciences is an Equal Opportunity Employer and prohibits discrimination and harassment of any kind. We are committed to the principle of equal employment opportunity for all employees and to providing employees with a work environment free of discrimination and harassment. All employment decisions are based on business needs, job requirements and individual qualifications, without regard to race, color, religion or belief, national, social or ethnic origin, sex (including pregnancy), age, physical, mental or sensory disability, HIV status, sexual orientation, gender identity and/or expression, marital, civil union or domestic partnership status, past or present military service, family medical history or genetic information, family or parental status, or any other status protected by the laws or regulations in the locations where we operate. We will not tolerate discrimination or harassment based on any of these characteristics.

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