Chemist Iii

**General information**:
**Reference **:2023-1499

**Position description**:
**Job Title**:
Chemist III

**Company Details**:
Septodont is a leading manufacturer of dental pharmaceuticals and medical devices. The French-based company employs over 2,000+ people globally. We have six manufacturing plants in France, India, North and South America, and an international distribution network that is dedicated to serving the needs of dental professionals in more than 150 countries. Our North American operations have facilities in Ontario, Montreal, and Pennsylvania. It also has Latin American operations with facilities in Brazil and Colombia.

Our Cambridge, Ontario site is also home to our Novocol Pharma division, which focuses on contract development and manufacturing, specialized in sterile injectable cartridge and combination product manufacturing.

Our employees are our number one asset We offer developmental opportunities, excellent compensation and benefit programs, discounted gym memberships, work/life balance programs, employee recognition, social events and spirit days.

**Job Summary**:
Reporting to the QC Manager, Chemistry, the Chemist III is responsible for providing technical leadership within the department.

There are various functional focus areas within the chemistry laboratory to which a Chemist III will have duties and responsibilities. While the Chemist III may predominantly be involved in one specific focus area as listed below, cross-training may be performed as needed to support other focus areas based on the decision of the department manager or designate.

**Responsibilities**:
**General Responsibilities (for all focus areas)**:

- Provides leadership, training, and technical guidance within the chemistry laboratory
- Acts as a Subject Matter Expert providing training in the respective focus area
- Leads troubleshooting activities and deviation investigations (MDI, DIR and
OOS/OOT) in their respective focus area, including proper technical write-up of the investigation
- Collaborates with other investigation leads in chemistry and QA on a routine basis to support detailed and productive investigation closures
- Ensures laboratory instruments are calibrated and maintained for their operation
in a timely manner, collaborating with other areas and departments, such as Health and Safety, QA and IT
- Participates in internal and external auditing and/or meetings with suppliers as required
- Writes protocols, SOPs, test methods and final reports as required
- Communicates with vendors, creates POs and initiates CCRs/DCRs/TCRs as required
- Follows GMP and regulatory requirements, and ensures quality standards are met
- Demonstrates the company mission, vision and values statements, policies, and current standard business practices
- Observes and supports all safety guidelines and regulations
- Performs other related duties assigned

**Focus Area - Instrument Specialist**:

- Supports the implementation of new equipment:

- Identifies and sources new equipment in conjunction with the testing requirements in the laboratory
- Prepares letters of justification and sets up capital requests in Novocol systems
- Executes data integrity assessments with software, ensuring it meets current GMP standards
- Writes and executes IQ/OQ/PQ documentation and test scripts for hardware and software
- Creates and reviews (as applicable) the change control and SOPs for use, operation, calibration and reconciliation of data for new equipment
- Coordinates the implementation of new equipment and software, working with technical IT, IT validation, Building Services, Health and Safety, Chemistry
and QA teams to ensure the project is completed on time and within budget
- Collaborates with instrument vendors and service providers for upgrades, repairs, purchases, preventative maintenance and calibration

**Qualifications**:
**Education**
- University degree in Chemistry or related discipline

**Experience**
- Minimum 4 years of experience in chemical pharmaceutical analysis or related field, or in performing IQ/OQ/PQ work with instrumentation (depending on focus area)
- Experience working in a self-directed team environment is essential
- Previous training or leadership experience is an asset
- Proven analytical and problem-solving skills with the ability to make recommendations
- Demonstrated organizational skills with the ability manage multiple projects and priorities with mínimal direction
- Strong interpersonal, verbal and written communication skills
- Experience using LIMS and Empower is an asset

**Contract type**:
Permanent

**Minimum level of education required**:
3- Bachelor

**Minimum level of experience required**:
2-5 years

**Languages**:
English (3- Advanced)

**Position location**:
**Job location**:
North America, Canada, Cambridge

**Location**:
25 Wolseley Court N1R 6X3 Cambridge