Scientific Leader, Analytical Product Cycle Management​/Method Cycle Management

Job Summary

Responsible for issuing and reviewing global regulatory submission documents such as raw material evaluation, synthetic route comparison, supplier-driven evaluation, and for development and establishment of specifications for drug substances, drug products and excipients. Includes issuing justification of specifications reports, closing validation gaps as per MLCM program for commercial test methods, comprehensive testing of API and finished dosages, laboratory support for Manufacturing Technical Services and New Product Launch, and generating regulatory submission documentation.

Provides responses to deficiency letters from regulatory authorities worldwide concerning chemistry, stability, dissolution, specifications and methodology.

• Prepares and oversees complex technical reports for regulatory submissions worldwide.
• Evaluates physico-chemical properties of API, synthetic routes, degradation pathways, impurity profiles, analytical techniques and specifications of drugs using DMF, scientific literature and compendia.
• Examines all available information, justifies and establishes specifications for drug substances, drug products and excipients; issues/reviews justification reports.
• Participates in complex investigations initiated in response to deficiency letters; works closely with RA personnel to ensure timely and scientifically sound responses to regulatory authorities worldwide.
• Provides consultation and technical support to other PD-SD units on issues related to chemistry, analytics and specifications of drug substance and drug product.
• Reviews and approves method validation gap analysis report and closes validation gaps as per MLCM program for commercial test methods.
• Prepares other internal and external physico-chemical reports (e.g., special investigation reports, justifications of specifications, general properties, impurities, structure, nomenclature) and reviews similar reports prepared by team members.
• Evaluates impact of compendial changes on Apotex products’ specifications, provides input to compendial petitions.
• Communicates with internal customers (R&D QC, Regulatory Affairs, GAPI, etc.), actively participates in resolution of complex technical issues, makes complex interpretations and decisions, and recommends and implements amendments to proposed resolutions.
• Provides coaching and guidance to team members, maintains up-to-date knowledge of leading-edge techniques and technologies, and ensures all advice and decisions are compliant.
• Participates and leads performance conversations with employees, including monthly one-on-ones, to reinforce high performance culture and safe working environment.
• Utilizes open, honest, two-way communication to build trust-based relationships with employees, business partners and direct leaders while improving leadership capabilities by seeking feedback and development.
• Creates a culture that values trust and provides opportunities for employee development and growth in pursuit of our purpose and core values – Collaboration, Courage, Perseverance and Passion.
• Attracts, hires and onboard new employees by providing a consistent experience that reflects the values and commitments made to candidates during the hiring process.
• Ensures adherence of team members with all compliance programs and company policies and procedures.
• Performs all other duties as assigned.

Strong theoretical background, PhD or MS or BS degree in chemistry or related field paired with a good understanding of organic, physical and analytical chemistry (chromatography, spectroscopy, solid state chemistry).

• Demonstrated leadership skills and experience in leading a team of chemists/researchers.
• Expertise in interpretation of spectroscopy data (NMR, MS, IR, UV) and other physical testing data (DSC, TGA, PXRD, AA, etc.).
• Expertise in liquid chromatography, analytical method validation, verification and transfer.
• Familiarity with basic principles of organic nomenclature, organic synthesis, degradation chemistry of drugs, solid state chemistry, stereochemistry and dissolution.
• Advanced technical writing skills.
• Sound knowledge…