Scientific Leader, Analytical Product Life Cycle Mgmt/Method Life Cycle Mgmt

Job Summary

Responsible for issuing and reviewing of global regulatory submission documents such as raw material evaluation, Synthetic route comparison, Supplier driven evaluation as well as for development and establishment of specifications for drug substances, drug products and excipients and issuing justification of specifications reports. Also responsible for closing validation gaps as per MLCM program for commercial test methods, comprehensive testing of API and finished dosages, laboratory support work for Manufacturing Technical Services and New Product Launch and generating regulatory submission documentation. Responses to deficiency letters from regulatory authorities worldwide concerning chemistry, stability, specifications, methodology etc.

Job Responsibilities

• Prepares reviews and oversees preparation of complex technical reports (within the team) 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 of Specifications 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 the issues related to chemistry, analytics and specifications of drug substance and drug product.
• Review and approve method validation gap analysis report and closing 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). Reviews similar reports prepared by team members.
• Responsible for preparation of responses to deficiency letters from regulatory authorities worldwide concerning chemistry, stability, dissolution, specifications, methodology etc.
• 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.), directly participates in resolution of complex technical issues.
• Makes complex interpretations and decisions with regards to the data and issues presented. Recommends and may implement amendments to proposed resolutions to address complex issues.
• Provides coaching and guidance to team members.
• Stays informed of “leading edge” techniques and technologies.
• Ensures all advice given to internal/external contacts and the complex decisions made at this level are compliant.
• Participate and lead performance conversations with employees, including monthly one on ones, to connect on performance; check in on employee’s progress toward achieving Objectives, offer support and remove barriers; and, communicate and revisit performance expectations to reinforce and encourage high performance culture and a safe working environment for all employees.
• Utilize open, honest, two way communication to build trust-based relationships with employees, business partners and direct leader while continuously improving leadership capabilities by personally seeking feedback and development.
• Create a culture which values trust and provides the opportunity for Employee development and growth in pursuit of our purpose and demonstrating our core Values – Collaboration, Courage, Perseverance and Passion.
• Utilize your networks to attract and hire talent in a comprehensive, differentiated and consistent manner essential to our continued growth; then, onboard new employees by providing a consistent experience that reflects the values and commitments made to candidates during the hiring process.
• Ensure adherence of team members (direct reports) with all compliance programs and company policies and procedures.
• All other duties as assigned

Job Requirements

• Education
  • 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).

• Knowledge, Skills and Abilities
  • Demonstrated leadership skills, 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 , verfication 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 of specification setting regulatory guidelines and scientific publications.
  • Understanding of basic principles of formulation development and design.
  • Demonstrated ability to collect, analyze and summarize scientific information and to write scientific reviews, articles, reports and summaries.
  • In-depth knowledge of ICH, TPD, FDA and other regulatory requirements for quality, pharmaceutical development, impurities, specification setting, analytical method validation and stability.
  • Excellent communication skills, verbal and written.
  • Working knowledge of GMP, GLP and GDP.
  • Computer literacy: word processing, chemistry drawing, literature search and data generation software.
• Experience
  • 3-5 years (PhD) or 6-9 years (MS) or 10+ years (BS) of R&D experience, preferably in the pharmaceutical industry.