Aerie Pharmaceuticals is currently hiring a Principal Scientist, Implant Manufacturing based in our Research Triangle Park, North Carolina headquarters. The person in this newly-created position will be responsible for leading the manufacturing of Aerie’s extended-release, sterile, ophthalmic products from early pre-clinical development through phase 3 clinical studies.
Essential Duties & Responsibilities:
This position will be responsible for leading the transition of drug product manufacturing processes from the formulation development group through process optimization and scale-up manufacturing, including participating in and leading the production of Good Laboratory Practice (GLP) and current Good Manufacturing Practice (cGMP) supplies. The Sr/Principal Engineer, GMP Manufacturing may support both aseptically manufactured and terminally sterilized products and/or devices.
This position will work closely with the formulation, non-clinical, clinical, regulatory, quality, and analytical teams. Provide leadership and support for drug product manufacturing activities conducted by third-party manufacturers (CMOs) and vendors.
The Sr/Principal Engineer, GMP Manufacturing will also write, review and approve of Chemistry, Manufacturing and Controls (CMC) documents, including development protocols and reports, and maintain compliance with GLP and cGMP standards as appropriate for pre-clinical and clinical development.
- Develop manufacturing plans for extended release products from preclinical through phase 3 clinical development
- Responsible for the development, tech transfer, and qualification of manufacturing processes for sterile drug products used in non-clinical (GLP and non-GLP) and cGMP clinical development
- Responsible for material sourcing, management, and distribution of processing/manufacturing equipment, APIs, excipients and pharmaceutical packaging
- Develop Standard Operating Procedures (SOPs), Installation/Operational/Performance Qualification (IQ/OQ/PQ) Protocols and Reports, and Batch Production documents for pharmaceutical development and manufacturing activities
- Analyze and summarize complex data sets, including the use of appropriate statistical tools for the identification of Critical Process Parameters (CPP) and Critical Quality Attributes (CQAs)
- Take a leadership role in the development of raw material specifications, drug product specifications and shelf-life estimates
- Create and review CMC project plans and timelines and assist in execution to ensure all projects are appropriately prioritized and key goals are met on time and within budget
- Develop and maintain an in-depth knowledge of drug product manufacturing and development technology, and the associated regulatory requirements
- Author and review CMC regulatory submissions
- Participate in formulation development as needed
- Communicate project status to management and project leadership
- Effectively work within the Development department and with cross-functional team leaders to achieve corporate and program goals
- Help ensure overall operational spend is within the approved budget and timeline
Education and experience:
- BS/MS degree in a related field with 10 years of cGMP drug product and/or medical device development experience
- Previous hands-on experience in pharmaceutical process development and drug product manufacturing is required
- A strong understanding of CFR Parts 210, and 211, ICH and FDA regulatory guidance related to pharmaceutical development, manufacturing and specifications is required
- Ability to travel domestically and internationally up to 25% required
Knowledge & Abilities:
- Previous experience with process development/manufacturing for extended-release dosage forms or devices, absorbable and non absorbable implants, drug eluting stents, and/or polymer processing preferred
- Excellent interpersonal verbal, written and presentation skills in communication with internal and external customers
- Strong team player with collaborative style working with both internal and external resources and stakeholders.
- Enthusiastic team player who enjoys both strategic and hands on work.
- Adaptable to changing business and organizational demands and priorities.
- Conduct and/or manage multiple projects with efficiency and effectivenes.
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.
- Work environment: Formulation/Chemistry Laboratories and Pilot Plant
- Must be able to lift 50 pounds and comfortably maneuver pilot plant equipment and machinery typically found in the pharmaceutical development environment.
- While performing the duties of this Job, the employee is frequently required to sit or stand for extended periods of time; use fine and gross motor hand skills to provide precise instrumentation
- Must be able to speak and hear appropriately to communicate effectively with each associate or vendor
- The employee is regularly required to stand; walk, twist the torso, bend over and reach with hands and arms
- Specific vision abilities required by this job include close, distance and peripheral vision with the ability to adjust and focus
- While performing the duties of this Job, the employee may be exposed to moving mechanical parts or airborne particles; toxic or caustic chemicals; blood borne pathogens (i.e. saliva, blood, instruments and sharps); dust and extremely hot water; and laboratory equipment
- The noise level in the work environment is usually mild.
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.