Associate, Ch Com Rd7-Grd-c&c s

Job Summary

Primarily responsible for issuing and reviewing of complex technical reports such as structure elucidations, forced degradation studies, raw material evaluations etc. as well as for development and establishment of specifications for new products in collaboration with Analytical Development personnel. Prepares other technical reports and summaries for domestic and international new drug submissions and PLCM activities, responses to deficiency letters and correspondence for regulatory authorities worldwide.

Job Responsibilities

• Reviews drug master files from alternative drug substance manufacturers (suppliers) and writes raw material evaluation reports. Performs evaluation of the Apotex and the supplier's specifications (and Pharmacopoeias if applicable) to determine suitability of the Apotex test profile for the new source and issues a report, as applicable.
• Evaluates analytical impact of supplier driven changes for API
• Ensures correct identification of degradation pathways and correct interpretation of stress studies data and issues reports on forced degradation studies. Reviews similar reports prepared by other team members.
• Prepares structure elucidation reports and justifications for API's and impurity identification reports, ensures the full characterization of compounds to confirm their identity using adequate physico-chemical methods. Reviews similar reports prepared by other team members.
• Examines all available information and, in collaboration with Analytical and Formulation Development teams personnel, develops, justifies and establishes specifications for new drug substances and drug products, as well as for in-process specifications.
• Prepares other internal and external physico-chemical reports (risk assessments, special investigation reports, pharmaceutical development reports, deficiency letters responses, compendial submission reports, etc.). Reviews similar reports prepared by other team members.
• Evaluates analytical methods for their relevance to the control strategy for drug substances and drug products
• Initiates and supports change controls as relevant to R&D specifications
• Stays up-to-date with the relevant scientific literature and regulatory trends and guidelines
• Works in a safe manner collaborating as a team member to achieve all outcomes.
• Demonstrate Behaviours that exhibit our organizational Values: Collaboration, Courage, Perseverance, and Passion.
• Ensure personal adherence with all compliance programs including the Global Business Ethics and Compliance Program, Global Quality policies and procedures, Safety and Environment policies, and HR policies.
• All other relevant duties as assigned.

Job Requirements

• Education
  • PhD or MS or BS degree in organic, analytical or physical chemistry (or related field)
• Knowledge, Skills and Abilities
  • Good understanding of physical and analytical chemistry (chromatography, spectroscopy, solid state chemistry)
  • Demonstrated ability to collect, analyse and summarize scientific information from the literature and to clearly write scientific reviews, articles, reports and summaries.
  • Attention to details
  • Excellent communication skills, verbal and written.
  • Working knowledge of GMP, GLP and GDP; familiarity with ICH, TPD, FDA and other regulatory requirements for product development.
  • Familiarity with compendia: USP, EP, BP
  • Computer literacy: word processing, chemistry drawing and data generation software.
• Experience
  • min 3 years (PhD) or 4-7 years (MS) or 7+ years (BS) of R&D experience, preferably in the pharmaceutical industry
  • Hands-on experience with at least three of the analytical techniques: NMR, IR, UV, DSC, TGA, XRPD, ICP-OES, AAS, HPLC/UPLC, LC-MS, GC, GC-MS
  • Experience in interpretation of spectroscopy data (NMR, MS, IR, UV) and other physical testing data (DSC, TGA, XRPD, etc.)
  • Experience with scientific literature databases (e.g. SciFinder, Reaxys etc.)