The Executive Director defines and executes the analytical strategies for implementation of an integrated control system for the assigned programs, testing site selection and transfer, and monitors method performance and ongoing project deliverables. The position also oversees qualification of reference standards, completion of release and stability testing of starting materials, control strategies for clean room operations, participates in product quality data reviews, and provides technical input and leadership to laboratory and manufacturing investigations. Position requires a broad knowledge of analytical, microbiological and bioanalytical methods used in control systems for in-process testing, release and stability monitoring of products. Proficiency with cGMPs and multi-national regulations is required. Success is achieved through successful collaboration with internal and external partners in Quality Assurance, Regulatory, Research, Process Development and Manufacturing Operations to develop and execute strategies.
This is a critical and visible role by leading the overall strategy and focus of our analytical and microbiological team that will drive assay development and validation, release and stability testing strategies and implementation, and specification setting and justification in support of development and manufacturing of our products.
Essential duties and key job responsibilities:
- Defines and execute product quality and quality control strategy.
- Oversees analytical, microbiological and bioanalytical method life cycle from early development through commercialization.
- Provides technical review of test records and raw data related to release testing of starting materials, drug substance, drug product, and reference standards.
- Provides technical review of stability data and trending including statistical analyses
- Establish release and stability test methods, method controls and perform periodic review of method trends as part of method life cycle management.
- Provides technical review and input for product characterization and manufacturing process changes.
- Serve as the technical lead in developing specifications for starting materials, drug substance and drug product.
- Collaborates with regulatory in defining technical content for submissions as well as authors and review analytical sections for regulatory submissions.
- Authors and reviews analytical responses to health authority information requests and support regulatory inspections and internal audits as required
- Supports routine operations to establish and implement processes to enable effective collaboration with business partners to ensure efficiency and high quality of results.
- Partners with Quality Assurance, Manufacturing Operations, Development and Regulatory Affairs to ensure completion of documentation in accordance with cGMPs.
Duties and responsibilities are not limited to the work listed above and may include other assignments as necessary.
Minimum qualifications to perform the job; specific skills, education, knowledge and job experience necessary to perform essential duties; physical requirements for job if any.
- A degree in a scientific or technical discipline required (preferably a Ph.D. in Analytical Chemistry or related discipline)
- Demonstrated leadership experience and subject matter expertise in pharmaceutical analytical development with 15+ years in a biopharmaceutical organization.
- Broad and deep knowledge of the relevant cGMPs, ICH guidelines and QBD principles. Capable of executing QbD in a compliant, efficient, and cost-effective manner.
- Competencies: Strategic & Functional Leadership, Collaboration, Project Management, Adaptability, Problem Solving, Self-Motivated, Technical Writing and Presentation skills, Written and Verbal Communication skills, Professionalism
- A well-rounded technical background encompassing analytical methods, instrumentation, computerized systems, biology, chemistry, microbiology, statistics and/or thermodynamics is required
- Familiarity with pharmaceutical production and testing is required
- Ability to solve complex technical problems