Senior Manager, Quality Control

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Essential Functions:

  • Manage method validation activities at Contract Testing Organizations (CTO) for drug substances and drug products in various stages of clinical development
  • Manage method transfer activities between contract testing labs and/or contract manufacturing organizations to support manufacturing and testing of drug products, drug substances and raw materials as required
  • Manager release testing of drug substances, drug products and raw materials
  • Develop and oversee stability programs for drug substance and drug products at contract testing labs, including ICH registration stability studies and commercial products stability programs
  • Perform technical review of release and stability data, provide stability summaries and trends for regulatory submissions.
  • Develop specifications for drug substances and drug products
  • Maintain Reference Standards Program
  • Support quality investigations related to release and stability testing.
  • Work closely with Quality Assurance and Regulatory groups to ensure compliance to cGMPs and regulatory filings and requirements.
  • Develop QC documentation, processes and procedures to support growing infrastructure and train and monitor personnel in complying with those activities.
  • Write and review regulatory documents to support regulatory filings (IND, NDA, etc.)

Nature and Scope:

Interacts with various levels of personnel internally and externally, requiring the ability to clearly understand and communicate policies and procedures.  Requires a solid working knowledge relevant to the applicable field.   Must be able to coordinate and plan activities involving multiple functional groups. Ability to work independently and make decisions is essential.

Education:

B.A./B.S. degree in a scientific discipline or the equivalent education and experience.

Experience:

At least 10 (ten) years of experience in pharmaceutical drug development focusing on Analytical Development/QC.  Experience in analytical testing of sterile products is preferred. Experience in analytical testing of biologics is highly desirable.  Experience in conducting ICH registration stability studies, release and stability testing at CTOs is required. Hands on experience and a solid understanding of a variety of analytical methods, and regulatory guidelines related to testing of drug substances and drug products, method validation and transfers is required. Ability to communicate technical information and details clearly and effectively both verbally and in writing is required. Ability to exercise sound judgment, reasoning and problem solving with minimal guidance is essential. Experience in writing regulatory documents for regulatory submissions is highly desirable.

Working Conditions:

Typically works in an office environment.  May, on a continuous basis, sit at desk for a long period of time; intermittently answer telephone and write or use a keyboard to communicate through written means. Some walking and lifting up to 20 lbs. may be required.  The noise level in the work environment is usually low to moderate.  Must be flexible to work varying schedules and hours as needed.  Occasional local travel required.  The physical demands described above are representative of those that must be met by an employee to successfully perform the essential functions of this job.  Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

Equal Opportunity Employer/Females/Minorities/Veterans/Disability

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