Associate Scientist Formulation Development

7 days ago

Mississauga, Canada Biolab Pharma Full time

**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: Formulation Scientists, Manager or upper management.

Applies formulation/ pharmaceutical technology/ problem solving skills and utilizes available resources to identify process and/or formulation deficiencies to propose solutions.

Executes solid dosage manufacturing trials (blending, granulation, encapsulation, compression, coating) and documents critical observations and parameters to further product understanding.

Supports writing the summary of pharmaceutical development report including formulation development, process development, Quality Target Product Profile, Critical to Quality attributes, Critical Process Parameters of the manufacturing, 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 Production/Contract Manufacturing (CMO) during transfer of manufacturing process/scale up from R&D in a timely fashion.

Collaborates to align regulatory documents, and team efforts to define formulation, manufacturing process and drug product specifications.

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. Demonstratesknowledge of pharmaceutical dosage forms (preferably solids). Knowledge and experience with solid dosage equipmentis preferred. Understanding of design of experiments, six sigma methodology, risk based assessment tools, qualityby design, pharmaceutical manufacturing, scale up, and technical transfer. Experience with MINITAB software ispreferred.

Demonstrated ability to work independently or as a part of a team.

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

**Benefits**:

- Casual dress
- Dental care
- Disability insurance
- Extended health care
- Flexible schedule
- Life insurance
- Vision care

Schedule:

- 8 hour shift
- Day shift
- Monday to Friday
- No weekends

Ability to commute/relocate:

- Mississauga, ON L4W 0B3: reliably commute or plan to relocate before starting work (required)

**Education**:

- Bachelor's Degree (preferred)

**Experience**:

- Canadian pharmaceutical experience solid dosage forms: 3 years (required)

**Language**:

- English (required)

Work Location: One location

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