Product Development Analytical Manager

  • Rosemont, IL
  • $100,000 - $165,000
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A bit about us:

We partner with premier healthcare corporations at achieve new product approvals.

Why join us?

  • Competitive compensation
  • Company benefits

Job Details

Reports To - Director Product Development
Location - Corporate Headquarters, Rosemont, IL
Department - Product Development

Primary Role:
The Manager Product Development-Analytical is responsible for leading and managing analytical pharmaceutical development activities for the company. Responsible for developing and implementing analytical pharmaceutical development plans for a portion of the company’s R&D portfolio to insure the approval of well-designed, high-quality pharmaceutical drug products. Responsible for providing guidance and counsel to senior management and individual R&D project teams on technical matters. Works very closely and collaboratively with contract manufacturing organizations (CMO), contract research organizations (CRO), and vendors/suppliers.

Key Responsibilities:
Co-leads R&D project teams with formulation counterpart.
Co-develops individual Pharmaceutical Development Plans (PDPs) for the Company’s R&D portfolio.
Works closely with Regulatory Affairs (RA)/Quality Assurance (QA) to insure PDPs adhere to the Company’s development standards.
Ensures compliance to cGMP’s and other regulatory agency requirements and company initiatives.
Reviews and approves all analytical documentation including test methods, specifications, protocols, and reports.
Identifies and supports the qualification of contract research organizations (CRO), and vendors/suppliers.
Develops and manages Analytical Plans carried out by contract research organizations (CROs), which consist of development, characterization, validation/verification, release, and stability programs.
Works closely with CROs, providing analytical support to overcome any issues or challenges with the Analytical Plans in a timely manner.
Manages all analytical development and validation work for APIs, excipients, and drug products.
Creates excipient, drug substance, and drug product specifications.
Assist in developing and managing pre-formulation and formulation strategies.
Co-manage packaging and labeling of drug products.
Works closely with RA to define submission requirements and draft appropriate CMC sections.
Reviews change controls including manufacturing processes and procedures, analytical procedures, and related batch records/testing SOP’s.
Oversee the development and/or revision of Standard Operation Procedures as they relate to pharmaceutical development.
Budgetary responsibility for assigned R&D projects for analytical and stability testing.

Education/Experience Requirements:
BS/BA in Chemistry.
Minimum of 5 years’ experience in the pharmaceutical/biotechnology industry focused on research and development (R&D).
Experience with development and validation of analytical methods for APIs and drug products.
Hands-on experience with regulatory submissions including ANDAs and NDAs.
Experience with implementing ICH Q8 (Pharmaceutical Development).
Must have a solid knowledge of cGMP regulations and current industry trends as related to pharmaceutical and biological products.
Advanced degree in Analytical Chemistry.
Minimum of 5 years’ experience in the pharmaceutical/biotechnology industry focused on research and development (R&D) and experience in Analytical Development of both APIs and drug products.
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Job Details
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Rosemont, IL
Job Type
$100,000 - $165,000