Director, CMC

Location
92130, San Diego
Posted
Oct 16, 2021
Hotbed
Biotech Beach
Required Education
Bachelors Degree
Position Type
Full time

HUYABIO is the leader in accelerating the global development of novel biopharmaceutical product opportunities originating in China enabling faster, more cost-effective and lower-risk drug development in the global markets. Through extensive collaboration with biopharmaceutical, academic and commercial organizations, it has built the largest China-sourced compound portfolio covering all therapeutic areas. With offices in the US, Japan, South Korea, Canada, Ireland and eight strategic locations across China, the Company has become a partner of choice to accelerate product development and maximize value globally. For more information, please visit www.huyabio.com.


Job Summary


HUYABIO is seeking an experienced, self-motivated, goal-oriented, independent individual to take an active role as Director, CMC. Responsibilities include but are not limited to lead the pharmaceutical development activities of small molecule portfolio drug candidate(s). The role includes management of development activities such as preformulation, formulation and process development, manufacture, release, and stability with a particular focus on early-stage development activities as well as knowledge and assistance with analytical method development and validation activities. In addition, the role includes authoring and review of regulatory filings and reports.
This is an office-based position that works in a cross-functional and dynamic environment. Clear, timely, professional and effective communication is critical for success.


Primary Duties and Responsibilities

  • Lead pharmaceutical development activities for early-stage portfolio drug candidates such as preformulation, formulation and process development.
  • Oversee the planning and execution of vendor GMP manufacture, release, and stability of portfolio drug candidates.
  • Assist in the development and validation of analytical methods.
  • Assist in the technical transfer, process and method development, optimization, qualification, and validation of activities related to all manufacturing operations in an out-sourced operating model.
  • Evaluate third-party manufacturers working with Quality Assurance and Regulatory Affairs, assist in negotiating effective supply/technical agreements and scopes of work.
  • Identify and manage contract analytical laboratory site(s) required to guide and support third party manufacturing relationships.
  • Design and oversee execution of necessary Design of Experiments (DOE) and process development activities in preparation for Registration and Validation activities.
  • Assist in the management and execution of IND enabling activities in preparation for regulatory filings.
  • Author relevant sections of regulatory documents, including Investigator’s Brochure, Pharmacy Manual, Study Protocols, IND filings, IMPD, and DMFs
  • Review and approve master and executed batch records from all manufacturing activities, analytical release testing, stability studies and investigations.
  • Participate in product development project teams as CMC functional area representative.
  • Track proposals and invoices to insure alignment with approved CMC budget
  • Manage consultants, vendors, and CROs to meet agreed upon program timelines/budgets
  • Perform other duties as required


Job Qualifications and Requirements

  • BS degree in a scientific/engineering discipline
  • M.S. degree or Ph.D. Degree in Pharmaceutics, Chemistry, Chemical Engineering, or closely related field is desirable
  • 10-15 years of experience in the pharmaceutical/biotech industry
  • 10+ years’ experience in small molecule drug product process development/manufacture and analytical methodology development/validation
  • 8+ years of experience in pharmaceutical development of small molecules drug candidates
  • 5+ years of experience in formulation/process development of poorly soluble drug candidates
  • Authored CMC sections of regulatory filings for US, Europe, or Asian markets
  • Fluent in written and spoken Chinese (mandarin), ideally with experience of working with China based CMOs
  • Strong knowledge of current US and EU regulations and cGMPs
  • Strong experience with CTD format and content regulatory filings
  • Exceptional written and oral communication
  • Strong cross-functional team experience
  • Demonstrates strong problem-solving and leadership skill sets
  • International experience is a plus
  • Travel, as needed

The position is full‐time, and the candidate must be within commuting distance to HUYABIO’s Del Mar, CA office.