Product Development Associate

**Product Development Associate**

The product development associate provides hands-on support to product development activities associated with product development projects and commercial products.

**Responsibilities**:

- Prepare and execute lab-scale batches.
- Perform physical testing of PDS batches.
- Write Lab-scale batches reports and MEMO.
- Ensure that all lab-scale batches work is performed in compliance with GMP, SOP, and regulatory standards.
- Provide support to formulator with documentation, preparation and execution of lab-scale batches.
- Operate, maintain and control de conformity of PDS laboratory equipment.
- Perform swabbing for the equipment cleaning assessment and cleaning validation;
- Write protocols and reports for the cleaning assessment and cleaning validation activities;
- Coordinate the analytical works with chemistry and microbiological laboratories;
- Participate in the technical assessment of new projects, working in close collaboration with internal and external collaborators;
- Provide on-the-floor oversight of the manufacturing and packaging processes, as necessary;
- Participate in problem solving and investigations for PDS batches and cleaning activities;
- Document activities and data in a timely manner, ensuring pertinent information can be retrieved within a reasonable period of time;
- Provide support to project manager with documentations, sourcing, shipment, assistance with weekly planning and occasional follow up with clients;
- Participate in the drafting of forms, procedures, manufacturing and packaging batch records, protocols and reports necessary for the proper functioning of the PDS department;
- Coordinate and support the inventory (raw material, API and packaging components) of product development batches;
- Participate in the creations, execution and closure of change controls and CAPA;
- Provide support to other product development production activities.

**Skills and experience required**:

- DEC or Bachelor’s degree in Science (Chemistry, or related technical/scientific field), from a Canadian University, or an equivalent scientific diploma recognized by a Canadian University or an accredited Canadian organism.
- Minimum of three (3) year of experience in a cGMP pharmaceutical environment.
- Some practical experience in semi-solid dosage forms and/or process development and/or cleaning assessment,
- Experience in formulation (Asset)
- Dynamic and multitasking ability
- Good working knowledge of GMP, GLP, Safety and FDA guidelines,
- Very organized and detail oriented, with a strong focus on accurateness,
- Good interpersonal and communication skills (both in English and French; written and spoken),
- Strong problem solving, technical writing,
- Proficient in Process Safety concepts and methodology,
- Able to lead and assist in training others,
- Able to be flexible and adapting to process schedules.

**What we offer**:

- Flexible work schedule
- Medical - dental & travel benefits
- Group retirement plan
- Recognition program & social activities
- Personal days
- Employee assistance program & online medical service
- Hot Beverages (Hot chocolate, Coffee, Mokaccino)
- Accessible by public transit or free parking
- Referral program
- Subsidized meal program

GP1

**Job Types**: Full-time, Permanent

**Salary**: $55,000.00-$70,000.00 per year

**Benefits**:

- Dental care
- Disability insurance
- Discounted or free food
- Employee assistance program
- Extended health care
- Life insurance
- On-site parking
- Paid time off
- RRSP match

Schedule:

- Monday to Friday

**Experience**:

- Pharmaceutical experience: 3 years (required)

Work Location: In person