Sr Director Analytical Development - Pharmaceutical:
Grimaldi Recruitment Services

908630628
Grimaldi Recruitment Services
Newark Delaware
Pharmaceutical
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Description

SUMMARY:

The Sr Director, Analytical Development will be responsible for all aspects of leading, developing and providing advanced technical oversight of the Analytical Development Department. The Sr Director will provide class leading, current, science-driven, phase appropriate analytical development to support clinical programs to commercial registration and post approval improvements both internally, within partnership operations and at third party contractors.
This position is a technical leadership position requiring a balanced approach to developing, validating and using advanced Analytical methodology and working in a collaborative manner with peers in the QC Department, and across other technical groups. The role requires high levels of GXP regulation knowledge.

RESPONSIBILITIES:

  • Serve as the primary Analytical Development technical expert of the company, internally, within collaboration and with CMO's and to US FDA and other regulatory agencies to ensure the company is appropriately represented in technical and compliance matters
  • Hire and develop team per company approved plans
  • Establish operation collaboratively with QC and R&D groups
  • Develop resourcing strategies, allocate budget for department to meet company objectives and efficient operations
  • Establish, maintain and improve technical operations and project outcomes in the Analytical Development area
  • Provide strategic direction directly and collaboratively for Laboratory Operations
  • Provide guidance for phase appropriate in-process and release methodologies and lead Analytical Development activities. Specifically, to develop, validate, deploy and manage analytical and biological methods ensuring compliance with applicable ICH guidelines and global regulations
  • Ensure adherence to GMPs, GLPs, GCPs and GDPs
  • Interact regularly with contract manufacturers and contract testing laboratories
  • Provide support for regulatory submissions
  • Participate as SME in regulatory agency (FDA, EMA, CDC), and state board health inspections as required
  • Train qualified staff and provide ongoing coaching to ensure effective execution of roles and responsibilities
  • Build, coach, mentor and assure appropriate management development for key personnel in his/her department

EXPERIENCE & EDUCATION:

  • Bachelor of Science degree in sciences/engineering
  • M.S / Ph.D. in relevant scientific discipline such as biochemistry, chemistry, pharmaceutical sciences or related filed
  • 15+ years of progressive experience in the biotechnology or pharmaceutical industry
  • 5+ years in related field at a senior level and leadership position

KNOWLEDGE, SKILLS & ABILITIES:

  • Analytical Development Expertise in Biologics and Biosimilar space
  • Broad laboratory Experience
  • Global GXP regulatory experience
  • Experience developing and organizing a team and respective budgets
  • Broad experience in analytical sciences supporting early and late stage clinical and commercial products
  • Strong commitment to purpose and communication skills
  • Proven track record with marketing applications
  • Working knowledge of statistics

PREFERRED:

  • Be a respected senior development executive in the bio-pharmaceutical field
  • Have a strong record of accomplishment in Analytical Development and Biosimilars, as demonstrated by successful regulatory approvals of drug candidates under his/her responsibility during development
  • Be able to communicate technically and strategically across an array of technical and operational activities and work collaboratively to help formulate and execute long-range and mid-term strategies
  • Possess excellent oral and written communication skills
  • Be a self-confident, proactive and decisive technically astute leader who has the talent to engage others to learn and succeed
Basic Qualifications
Requirement