SUMMARY

This position is responsible for leading and support of CMC activities as well as working with Scientists and management for specific compound development at CritiTech in support of CritiTech product development and associated affiliates/partners for the global development and regulatory approval of New Chemical Entities (NCE’s), Active Pharmaceutical Ingredients (APIs) and support of research and development of any/all product activities.

RESPONSIBLITIES 

• Participates in lab development and helps prepare the Chemistry, Manufacturing and Controls (CMC) section of NDA or SNDA by direction and interaction with Quality Operations/Regulatory Affairs and CritiTech
• Independently performs and assists proof of concept studies, feasibility studies, routine manufacturing, and troubleshooting using CritiTech’s Supercritical Precipitation equipment
• Independently performs and assists proof of concept studies, feasibility studies, routine manufacturing, and troubleshooting using CritiTech’s spray drying equipment
• Independently performs and assists production activities in support of clinical trials, including filling, environmental monitoring, visual inspection, and packaging of vials for further processing
• Suggests and writes changes and improvements to CritiTech’s manufacturing processes, facilities, utilities, and other systems
• Independently performs and assists preventative maintenance and calibration checks on manufacturing equipment
• Participates in the qualification of new equipment and facilities
• Generates and represents support data for CritiTech to be used in 3rd party development activities
• Generates and reviews data in support of CMC documents, including out-of-specification (OOS) or deviation investigations, and helps develop and execute action plans to meet sound scientific practices
• Provides technical support to and advises QO on complaint samples and manufacturing/packaging problems
• Independently performs and assists and assists in CritiTech compatibility and feasibility assessments for compounds being considered for development
• Participates and advises in the onsite review of data, facilities and laboratory operations of contract manufacturing and analytical laboratory
• Suggests and writes changes or edits to appropriate SOP’s for CritiTech
• Independently performs and assists release and stability analytical testing with QO in the coordination and management of retest/expiration dating
• Initiates, prepares and executes testing and lab work in support of technology transfer and stability protocols, stability packaging and manufacturing jobs for CritiTech activities
• Provides expertise on product packaging
• Other duties as assigned

EDUCATION, EXPERIENCE AND SKILLS

Required

• BS in chemistry, biology, engineering or related pharmaceutical field AND 5-8 years of experience in pharmaceutical product development, 2 years of CMC documentation

-or-

• MS in chemistry, biology, engineering or related pharmaceutical field AND 3-5 years of experience in pharmaceutical product development, 1 years of CMC documentation
• Experience with pharmaceutical manufacturing equipment
• Experience in technology transfers to contract facilities
• Experience with interactions with regulatory agencies
• Experience in working with people in a multi-disciplinary team environment

Preferred

• PhD or experience/background working with INDs for NDA
• Experience in preparing and supporting CMC documentation regulatory findings

KNOWLEDGE AND SKILLS 

• Knowledgeable (including hands-on experience) in the use of analytical methods for active pharmaceutical ingredients and drug product (i.e. HPLC, GC, IR, etc.) and formulation development/manufacturing and the relation of these to overall pharmaceutical development
• Knowledge and understanding of current Good Manufacturing Practices (cGMP) as well as other pertinent national regulations
• Current knowledge of CMC regulatory and ICH guidelines
• Knowledge of the overall drug development process
• Knowledge in application of compendia requirements and procedures to testing and developing pharmaceutical products
• Leadership Skills - knowledge and interpersonal skills to help others towards the accomplishment of CritiTech’s goals and objectives
• Analytical and Problem-Solving Skills - ability to identify problems or opportunities using appropriate information; determines the causes and possible solutions to the problem
• Teamwork - the ability to work well in a highly cross-functional team environment
• Communication Skills – ability to express one’s self clearly and concisely to CritiTech personnel over the phone or with others within the team; documents issues and/or concerns concisely and comprehensively; adjusts language and/or terminology appropriate for the audience
• Interpersonal Flexibility – ability to adapt to other personalities in a respectful manner that is conducive to goal achievement
• Knowledge Sharing – ability to capture knowledge within the organization; improves solutions, processes and deliverables through the use of information; improves information capital by contributing experience, theories, deliverables, and models for others to use
• Resource Management – ability to work with internal and external resources and to coordinate individual goals and objectives to align with business imperatives