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

APOTEX; Canada; On-site; CAD 83,000 - 116,000; Full time

Benefits offered by this job

Bonus programs

Pension plan

Disability accommodation

Learning and development opportunities

Job summary

Apotex is seeking a Scientific Leader for Analytical Product Life Cycle Management. This role focuses on chemistries, regulatory submissions, and development of specifications for drug substances, products, and excipients.

You will interact with RA, QC, and development teams to address complex analytical challenges. The position requires leadership experience in R&D, extensive knowledge of spectroscopy and analytical methods, and strong writing skills to generate regulatory documents.

Qualifications

• PhD, MS or BS in chemistry with strong organic/physical/analytical chemistry background.
• Experience leading chemists/researchers and regulatory submissions.
• Deep knowledge of regulatory guidelines and analytical method validation.

Responsibilities

• Prepare complex technical reports for regulatory submissions worldwide.
• Evaluate API properties, synthetic routes, impurities and analytics.
• Establish specifications for drug substances, products, and excipients.
• Lead investigations in response to deficiency letters from authorities.

Skills

Leadership skills

Spectroscopy data interpretation

Analytical method validation

Strong communication skills

Education

PhD in Chemistry

MS in Chemistry

BS in Chemistry

Tools

ChemDraw

Job description

Select how often (in days) to receive an alert:

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

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.

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.

Benefits and Compensation

• The hiring range for this position is $83,126.43 - $116,377.00 per year.
• Apotex offers bonus programs based on your position in the organization, you can excel based on our pay-for-performance philosophy.
• With comprehensive benefits, a pension plan to help you save for retirement and learning and development opportunities, we provide a comprehensive package for your personal and professional development.
• 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.

The final agreed-upon salary may vary based on factors such as job-related knowledge, skills and experience.

We are looking for top talent. If your qualifications differ from those listed above, the scope of work and final agreed-upon salary may be adjusted to reflect your individual qualifications.

Apotex will use artificial intelligence to screen, select and/or assess your application for this job.

This job posting is for a role that is currently available and vacant at Apotex