Director Analytical Research And Development

Overview: The Director/Associate Director, Analytical Research and Development, will provide Analytical expertise across the entire portfolio of ophthalmic product development. The position is responsible for managing multiple projects, at times simultaneously, reviewing data and reports from method development, method validation, analytical testing for formulation support, exhibit batch testing, stability testing etc. This position includes managing CDMO, CMO, and external labs, oversight of the Analytical activities, supporting NDA, 505(b)(2) filings, and deficiency letter responses. This individual will also be responsible for helping set and achieve department objectives.

 

Responsibilities: 

• Plan and work with CDMO to execute all Analytical development activities for new products to meet the company objectives
• Manage and guide CDMO to develop stability-indicating methods for pharmaceutical APIs/excipients and finished dosage forms for routine analytical testing during development and for exhibit batches
• Assist in sourcing APIs, excipients, and packaging components for new products to meet regulatory requirements
• Provide guidance by compiling test data for calibration and troubleshooting of lab equipment whenever needed
• Work with development partners regarding analysis of API and drug products, and
  development of appropriate control procedures
• Assist in the development of drug products and raw material specifications
• Write/review Analytical development reports, Method validation protocols and reports, SOPs, stability protocols/reports, Quality Overall Summaries, etc.
• Coordinate and supervise method transfers from development labs to Quality Control labs
• Responsible for working with cross-functional departments such as Regulatory Affairs, Quality Control, Production, Quality Assurance and Project Management to expedite the development and approval of new products by FDA
• Assure that all analytical activities are reviewed as per cGMP and SOPs
• Assist with Out of Specification (OOS) and Out of Trend (OOT) investigations
• Formulate responses to FDA comments on Analytical development, validation, and testing
• Prepare and review CMC documentation and actively contribute to deliverables required for new regulatory filings. Serve as CMC project lead as needed
• Use technical expertise to assist in due diligence of new technology in-licensing opportunities
• Other duties and responsibilities as assigned

 

Skills/Qualifications: 

• MS/PhD in Chemistry, Pharmaceutical, or life sciences with at least 10 years related experience and/or training; or equivalent combination of education and experience; Having an MBA is an added benefit for the position
• Leadership experience in managing analytical projects with contract testing labs and/or CDMOs
• Expertise in analytical techniques used for molecule analytical method development and analysis
• Experience providing guidance to Quality Control laboratories
• Expertise in the Development and validation of Dissolution, and IVRT studies for complex ophthalmic products
• Experience with stability requirements and understanding ICH stability guidelines
• Knowledge of cGMP regulations, ICH guidelines, and FDA requirements
• Demonstrated communication, problem-solving, leadership, and negotiation/decision-making skills
• Desire and ability to lead, execute work, and achieve departmental and corporate goals in a fast-paced, innovative environment
• Standing or sitting for long periods of time: may spend many hours in meetings, reviewing data, and working on projects: This may require standing or sitting for extended periods, which can be physically demanding
• Fine motor skills: review and interpret complex data, which requires good hand-eye coordination and fine motor skills
• Travel: travel to different facilities or meet with clients within the US and international CDMO sites up to 5 percent of the time. This can involve long periods of sitting, standing, or walking, and may require navigating airports, hotels, and other unfamiliar environments
• Vision: detailed visual inspection and analysis of samples and data
• Exposure to hazardous materials: may be exposed to hazardous materials such as chemicals or biohazards; this requires proper training and the use of personal protective equipment to minimize exposure and ensure safety

Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities

The contractor will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractor’s legal duty to furnish information. 41 CFR 60-1.35(c)

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