Analytical Development Scientist

**Title: SCIENTIST ANALYTICAL DEVELOPMENT**
**Reports to: Associate Manager Analytical Development**

The analytical development 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 independently through scientific rationale using Quality by Design principles to develop new products per departmental SOP’s and ICH guidelines. This should be done with occasional consultation with the Manager Analytical Dev or upper management.
- Applies strong analytical / problem solving skills and utilizes all available resources to correctly identify process and/or formulation deficiencies and proactively implement a solution. Thus, responsible and accountable for troubleshooting and resolving challenges during the development of analytical methodologies.
- Provides summary of pharmaceutical development report 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. Leads communication/interaction with QC/Contract Laboratory during transfer of analytical methodologies from R&D in a timely fashion.
- Authors regulatory documents, and leads 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 five years of relevant hands on **Canadian Industrial Pharmaceutical experience** in product development. Demonstrates strong knowledge and experience of analytical chemistry by successfully developing analytical methods for assay, dissolution and related substances. Good 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 $75,000.00 per year

**Benefits**:

- Casual dress
- Dental care
- Disability insurance
- Extended health care
- Flexible schedule
- Life insurance
- On-site parking
- 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**:

- Industrial Canadian Pharmaceutical: 5 years (required)

**Language**:

- English (required)

Work Location: In person

Application deadline: 2022-04-29