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Associate Scientist Analytical Development
2 weeks ago
**JOB OPPORTUNITY**
**Title: Associate Scientist Analytical Development**
**Reports to: Associate Manager Analytical Development**
The analytical development associate scientist supports the development of new pharmaceutical dosage forms in addition to improving existing products and procedures. These activities will be achieved by using knowledge and innovation of science, technology and chemistry to investigate the properties, components and abilities of chemicals and processes in the development of efficient manufacturing procedures and the development of appropriate analytical methodologies to create prototype formulations and clinical supplies. This position performs activities assigned by the manager/upper management to meet the company's goals within the specified timelines. This position also requires documenting, reviewing, analyzing and interpreting data, and interpreting scientific problems in support of HC, FDA, EMEA and ANVISA submissions in a timely manner while complying with departmental SOP's and guidelines set out by the regulatory agencies and ICH (International Conference on Harmonization). This will be achieved by working very closely with the analytical development and R&D QA teams.
**Key job responsibilities and duties**:
- Responsible and accountable for designing, planning and executing all aspects of assigned projects through scientific rationale using Quality by Design principles to develop new products per departmental SOP’s and ICH guidelines. This should be done in consultation with senior peers: Development Scientists, Manager or upper management.
- Applies analytical/problem solving skills and utilizes available resources to identify process and/or formulation deficiencies and propose solutions to be implemented. In addition to working with more experienced colleagues to troubleshoot and resolve challenges during the development of analytical methodologies.
- Supports writing the summary of pharmaceutical development reports including analytical method development, method validation, related substances identification, force degradation studies, stability reports and all other information required in the CMC sections of CTAs, NDS and S/NDS, in a timely fashion. Furthermore, provides the required information to support FDA, EMEA and ANVISA submissions.
- Supports internal projects and external Contract Manufacturing Organization projects in alignment with Biolab’s objectives and initiatives. Communicates/interacts as indicated by management with QC/Contract Laboratory during transfer of analytical methodologies from R&D in a timely fashion.
- Collaborates with regulatory documents, and team efforts to define formulation, manufacturing process and drug product specifications.
- Ensures all analytical activities meet good laboratory practices and company’s policies.
- Ensures the availability of chemicals, reagents, apparatus, HPLC columns, solvents, etc. needed to carry out all task in the analytical development area.
- Performs data collection and analysis, discuss conclusions regarding progress of work, and effectively communicates information to peers and management in the form of presentations and reports.
**Education and experience requirements**:
- Canadian equivalent to Master of Science, PhD or Bachelor of Science degree, preferably in Pharmacy, Chemistry or
Pharmaceutical Chemistry.
- More than three years of relevant hands on pharmaceutical experience in product development. Demonstrates knowledge and experience of analytical chemistry by developing analytical methods such as assay, dissolution and related substances. Understanding of DOE, risk based assessment tools, quality by design, method validation, equipment troubleshooting and technical transfer. Experience with Chromeleon software is preferred.
- Demonstrated ability to work independently or as a part of a team, and to coach less experienced colleagues.
- Highly motivated and have the skills to handle multiple projects and prioritize the work.
- Excellent communication skills (oral and written) and interpersonal skills are required
**Job Types**: Full-time, Permanent
**Salary**: Up to $65,000.00 per year
**Benefits**:
- Casual dress
- Dental care
- Disability insurance
- Employee assistance program
- Extended health care
- Flexible schedule
- Life insurance
- Paid time off
- RRSP match
- Vision care
Schedule:
- 8 hour shift
- Day shift
- Monday to Friday
- No weekends
Supplemental pay types:
- Bonus pay
Application question(s):
- Do you currently reside in the GTA?
**Education**:
- Bachelor's Degree (required)
**Experience**:
- Canadian Industrial Pharmaceutical: 3 years (required)
**Language**:
- English (required)
Work Location: In person
