Assistant Manager Manufacturing Technical Services
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Monthly Salary:
Posted on:
22 hours ago
Vacancies:
1 Vacancy
Job Summary
About Apotex Inc.
Apotex is a Canadian-based global health company. We improve everyday access to affordable innovative medicines and health products for millions of people worldwide with a broad portfolio of generic biosimilar innovative branded pharmaceuticals and consumer health products. Headquartered in Toronto with regional offices globally including in the United States Mexico and India we are the largest Canadian-based pharmaceutical company and a health partner of choice for the Americas for pharmaceutical licensing and product acquisitions.
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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.
At Apotex we are committed to fostering a welcoming and accessible work environment where all everyone feels valued respected and supported to succeed.
We offer accommodation for applicants with disabilities as part of its recruitment process. If you are contacted to arrange for an interview or testing please advise us if you require an accommodation.
Required Experience:
Manager
Key Skills
- Lean Manufacturing
- Six Sigma
- Continuous Improvement
- ISO 9001
- Lean Six Sigma
- Management Experience
- Manufacturing & Controls
- 5S
- Manufacturing Management
- Kaizen
- Chemistry
- Manufacturing
About Company
Apotex is the largest Canadian-owned pharmaceutical company providing patients around the globe with quality, affordable medicines. We are an innovative global research and technology leader in generic pharmaceuticals that serves customers and partners in the U.S. market, as well as 1 ... View more
