Assistant Manager - Manufacturing Technical Services

Job Summary

Job Summary

• Statistical Support is an integral requirement during the technology transfer of products and during the product life-cycle management. 

• This role is responsible and accountable for providing Statistical Support to MS&T within the ARPL and GTA.

• This group is also responsible for driving consistent statistical approaches across the manufacturing sites.

• The Assistant Manager - Statistical Support acts as a project leader, overseeing the approach to and resolution of all technical issues related to MS&T tasks by implementing sound statistical methodology

Job Responsibilities

• Contributes to decision-making on study design, data collection, and analysis by recommending statistical methods aligned with objectives and regulations.
• Oversees sample size calculations for complex experimental and validation protocols.
• Authors/reviews statistical methods sections and writes analysis plans for protocols and reports.
• Collaborates with stakeholders to define specifications and acceptable ranges.
• Performs risk assessments, point/interval estimates, and optimization/validation using sound statistical methodology.
• Investigates out-of-specification (OOS) or out-of-trend (OOT) results.
• Leads statistical support for product lifecycle changes (e.g., formulations, analytical methods, raw materials, manufacturing processes).
• Oversees junior staff on statistical activities (e.g., JMP analysis).
• Liaises with stakeholders on data attributes/formatting for tables, listings, and figures (TLGs).
• Prepares statistical justifications and responds to complex issues with concise, scientific interpretation under tight deadlines.
• Provides statistical advice, mentors juniors, and explains concepts to non-statisticians.
• Offers expertise on process optimization, improvement, equipment utilization, and best practices across MS&T and other departments.
• Guides junior staff on technical support for product submission documents involving major process changes.
• Contributes to justifications and whitepapers on novel statistical tools/methodologies.
• Delivers senior-level statistical support, innovative solutions, and tools to meet group goals.
• Stays current on regulatory changes in study design, data analysis, and reporting.
• Participates in regulatory inspections and represents Apotex at meetings.
• Recommends revisions for continuous improvement of departmental processes and SOPs.
• Ensures compliance with Apotex Code of Conduct, Business Ethics, legal/regulatory requirements, and Values (Integrity, Teamwork, Courage, Innovation).
• Works collaboratively as a team member to achieve outcomes.
• Performs all other relevant duties as assigned

Job Requirements

• • Education
  • Graduation in Mathematics (Statistics) or related Pharmaceutical/Engineering subjects.
  • Knowledge, Skills and Abilities
  • Extensive knowledge and experience in applied statistics
  • Strong verbal and written English communication skills
  • Knowledge on pharmaceutical oral solid dosage processes, formulation and equipment
  • Excellent organization, troubleshooting, report writing and analytical skills.
  • Intermediate to Advanced level of computer skills in Microsoft Office (Word, Excel,

  PowerPoint and Outlook)

  • JMP and related statistical software proficiency is a must.
  • Well-developed interpersonal and team skills.
  • Multi-tasking and project management skills
  • Ability to make timely evaluations which are appropriately supported by data.
  • Experience: Minimum of Eight years of successful working experience in a regulated industry (preferably Pharmaceutical) with related experience in supporting statistical analysis and evaluations.