Director Research & Development Formulation

Overview: The Director/Associate Director, Research and Development Formulation, will be responsible for managing all formulation activities to support the development of new products, specifically in the ophthalmic area, in a timely manner. This position will provide technical expertise across the entire portfolio of ophthalmic product development. The position is responsible for managing multiple projects, including CDMO, CMO, and external labs, oversight of the formulation 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: 

• Establishes formulation development strategy and direction, aligned with business strategy for product development for Ophthalmic dosage form
• Manage and work with development partners to develop new drug product formulations and manufacturing processes that are scalable and stable
• Provide guidance to CDMO to execute all formulation development activities for new products per Quality by Design guidelines to meet company objectives
• Drive and lead projects with respect to critical decisions and cross-functional communication and relationships to move projects forward
• Evaluate the need and expand the formulation team as per the requirements of the projects
• Participate and provide input in due diligence, new product selection, CRO/CMO visit, and assessment
• Prepare and/or Review/approve technical protocols, reports/summaries for all formulation development work
• Review, revise, and approve GMP documents and technical reports. (e.g. Master Batch Records, Executed Batch Records, process validation/verification protocols and reports, stability protocols, and reports, etc.)
• Prepare and review CMC documentation and actively contribute to the deliverables required for new regulatory filings. Serve as CMC project lead as needed
• Direct, coordinate, and prioritize activities to ensure assigned project timelines are met
• Work in collaboration with and provide technical assistance to other departments, e.g. Analytical Method Development/Method Validation/Stability, Regulatory Affairs, QA and QC, etc., to support timely new product development/submission of NDAs
• Participate in CMC deficiency responses to support project approvals
• Ensure all formulation development activities are in accordance with QBD, cGMP, SOP, FDA, and ICH guidelines
• Audit and review procedures, processes, data, and laboratory preparedness for inspections; Participate in FDA and internal audits
• Other duties and responsibilities as assigned

Skills/Qualifications: 

• MS with 10 years/PhD with 7 years in the chemical, pharmaceutical or life sciences with related experience and/or training; or equivalent combination of education and experience; Having Ph.D. is an added benefit for this position
• 6+ years of experience in Ophthalmic formulation development is required
• Experience in new Drug Product development and including working closely with external CDMOs
• Experience in understanding and interpreting Analytical data for formulation development.
• Experience with QbD and understanding of ICH Q8 (R2) Pharmaceutical development guidelines.
• Skill in the planning, execution, and analysis of experiments for drug product
  development, with experience in authoring or contributing to development reports and regulatory filings
• Good understanding of cGMPs, industry, and regulatory standards and guidelines
• Strong technical and interpersonal skills with strong pharmaceutical formulation background
• Demonstrated communication, problem-solving, leadership, and negotiation/decision-making skills
• Desire to work 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)