Aerie Pharmaceuticals seeks qualified candidates for a full-time position in our Manufacturing department located in Research Triangle Park, NC. This role will be responsible for oversite of outsourced analytical development activities associated with the development, validation and technology transfer of chemical reagents, starting materials, intermediates and active pharmaceutical ingredients. Manages a team who oversees multiple CMO’s to deliver comprehensive, consistent and compliant analytical results. Additionally, will manage the in-house analytical team that supports new synthetic route and process chemistry initiatives.
The successful candidate will have:
- Extensive experience and knowledge of the analytical method development and validation as well as specifications to appropriately control the manufacture of active pharmaceutical ingredients
- Strong experience managing CMO's
- Strong experience in authoring technical reports and CMC sections for regulatory filings.
Expert experience in the development and validation of analytical methods to support drug substance manufacturing development is required. Previous experience leading CMO’s is preferred. Strong problem-solving skills are essential. This role is a manager position; supervisory experience is required.
Essential Duties & Responsibilities:
- Oversees the development and validation of analytical methods for small molecules for starting materials, intermediates, and active pharmaceutical ingredients:
- Develops and/or assesses the suitability of the analytical methods for intended purpose: ensuring an appropriate characterization and control strategy is set to maintain a manufacturing process.
- Authors or approves analytical methods
- Authors or approves method validation protocols and reports
- Authors and/or reviews analytical specifications
- Oversees testing at CMO’s
- Reviews testing sections of process development protocols and reports
- Defines testing requirements
- Responsible for technical review of analytical data and laboratory documents
- Observes, as needed, testing at the CMO’s to assess technical abilities
- Monitors CMO’s performance and manages the relationship to ensure maximum quality and performance to meet target milestones.
- Leads technical analytical support of API for approved commercial products, including:
- Investigations of deviations / technical troubleshooting.
- API analytical method life cycle management and post marketing commitment effort
- Authors technical content of CMC sections of Regulatory filings (domestic and international)
- Address comments from Regulatory Agencies regarding analytical methods
- Provide subject matter expertise and support for Regulatory interactions – inspections / audits
- Performs assessments and assists in the selection of third-party contract laboratories.
- Manages a team of analytical chemists supporting all API analytical activities.
- Ensure all analytical activities are conducted in compliance cGMP and regulatory requirements.
- Collaborate cross-functionally and builds relationships with internal stakeholders such as Chemistry, QA, and Regulatory Affairs.
- Have a working knowledge of USP and EP pharmacopeia.
- Provide input to the development of manufacturing plans, budgets and timelines.
Required Education and Experience:
- Bachelor of Science degree with 10+ years of experience in pharmaceutical technology with a focus on API analytical development is required, or advanced degree plus 5-7 years’ experience (MS/Ph.D. An equivalent combination of relevant education and applicable job experience may be considered.
- Extensive experience and knowledge of the analytical method development and validation as well as specifications to appropriately control the manufacture of active pharmaceutical ingredients is required.
- This role is a manager position; supervisory experience is required.
- Demonstrated ability to lead projects conducted at third party manufacturers and laboratories.
- Experience in authoring technical reports and CMC sections for regulatory filings.
- Ability to manage multiple projects, set priorities, and work in a fast-pace environment.
- Demonstrated effective verbal and written communication skills.
- Experience must include hands-on use of HPLC and GC equipment.
Physical Demands and Work Environment:
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this position. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
- While performing the duties of this job, the employee may be required to sit or stand for extended periods of time, use fine and gross motor hand skills when using instrumentation.
- Must be able to speak and hear appropriately to communicate effectively with each colleague or vendor.
- Ability to travel up to 20%.
Aerie Pharmaceuticals is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or veteran status.