Director, External CDMO Management (Analytical)

Proclinical seeking a Director, External CDMO Management (Analytical) for a leading pharmaceutical company located in New Jersey.

Must be eligible to work in the US.

Job Responsibilities:

• Leads analytical development activities for externally developed brand and generic products, including drug substance and drug product, at approved CDMOs
• Guides external method development and validation strategies to ensure all current scientific and regulatory standards are met
• Reviews and approves all related methods, protocols, reports, specifications, change controls, etc. generated by CDMOs
• Critically reviews and trends data generated by CDMOs
• Reviews and approves all investigations and Corrective Action Preventive Action (CAPAs), related to analytical methods and results
• Manages CDMO chemical development activities including, but not limited to: impurity profiles, reference standards, structure elucidation, etc. as needed
• Authors, reviews and approves analytical related regulatory submission documents and modules (both drug substance and drug product) of externally developed projects at CDMOs
• Conducts due diligence pertinent to analytical for products/assets being considered by acquisition or in-licensing

Skills and Requirements:

• Minimum education and years of relevant work experience
  Masters degree in science field and minimum 10 years related pharmaceutical or biotechnology laboratory experience in positions of increasing technical and leadership responsibility ORD. degree in science field and minimum 8 years related pharmaceutical or biotechnology laboratory experience in positions of increasing technical and leadership responsibility.
  Proven success in overseeing and guiding CDMOs and other external partners on analytical development strategies and execution for brand and generic products
• Proven success in leading analytical development, including method development and validation, with high scientific standard
• Current working knowledge and experience with physical characterization, thermal, spectroscopic, and chromatographic techniques and concepts
• Working knowledge of FDA, cGMPs, Drug Enforcement Agency (DEA) and Occupational Safety and Health Administration (OSHA) regulations and guidance
• Excellent ability to trouble-shoot, prioritize and critically review technical document
• Ability to influence without direct authority
• Proficiency with Microsoft Office
• Excellent verbal and written communication and skills
• Ability to work independently and collaboratively, as required, in a fast paced, matrixed, team environment consisting of internal and external team members
• Analytical thinking with excellent problem-solving skills and the ability to adapt to changing priorities and deadlines
• Excellent planning, organization and time management skills including the ability to support and prioritize multiple projects
• Fluent in English (verbal and written)

If you are having difficulty in applying or if you have any questions, please contact Sam Jankura at +(1) 617-671-0335 or s.jankura@proclinical.com.

Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.

Proclinical Staffing is an equal opportunity employer.

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