SUMMARY
This position is responsible for 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.
RESPONSIBILITIES
- Participates in lab development in support of Chemistry, Manufacturing and Controls (CMC) section of NDA or SNDA by direction and interaction with Quality Operations/Regulatory Affairs and CritiTech.
- Provides analytical support for proof of concept studies, feasibility studies, routine manufacturing, and troubleshooting using CritiTech’s Supercritical Precipitation equipment.
- Provides analytical support for proof of concept studies, feasibility studies, routine manufacturing, and troubleshooting using CritiTech’s spray drying equipment.
- Perform production activities in support of clinical trials, including filling, environmental monitoring, visual inspection, and packaging of vials for further processing.
- Suggest changes and improvements to CritiTech’s analytical services and product characterization, facilities, utilities, and other systems.
- Performs preventative maintenance and calibration checks on analytical equipment.
- Participates in the qualification of new equipment and facilities.
- Generates support data for CritiTech to be used in 3rd party development activities.
- Generates data in support of CMC documents, including out-of-specification (OOS) or deviation investigations, and helps execute action plans to meet sound scientific practices.
- Provides technical support for QO on complaint samples and manufacturing/packaging problems.
- Performs and assists in CritiTech compatibility and feasibility assessments for compounds being considered for development.
- Participate in the onsite review of data, facilities and laboratory operations of contract manufacturing and analytical laboratory.
- Suggests changes or edits to appropriate SOP’s for CritiTech.
- Performs release and stability analytical testing with QO in the coordination and management of retest/expiration dating.
- Executes testing and lab work in support of technology transfer and stability protocols, stability packaging and manufacturing jobs for CritiTech activities.
- Other duties as assigned.
EDUCATION, EXPERIENCE AND SKILLS
Required
- BS in chemistry, biology, engineering or related pharmaceutical field with 3+ years industry background in pharmaceutical product development – or –
- MS in chemistry, biology, engineering or related pharmaceutical field with 2+ years industry background in pharmaceutical product development.
- 2+ years preparing and supporting CMC documentation for IND’s and NDA’s.
- Experience in working with people in a multi-disciplinary team environment.
Preferred
- Advanced degree in chemistry or pharmacy or equivalent experience.
- Experience in pharmaceutics, analytical and organic chemistry.
- Experience in technology transfers to contract facilities.
- Experience with interactions with regulatory agencies.
- Experience in preparing and supporting Chemistry, Manufacturing and Control (CMC) documentation regulatory filings.
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.
- Knowledgeable in the overall drug development process.
- Knowledgeable in the 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 and manage personnel 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, an 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.