Scientist Formulation Development

**JOB OPPORTUNITY**
**Title: SCIENTIST FORMULATION DEVELOPMENT**

**Reports to: Manager Formulation Development**
The formulation development scientist supports the development of new pharmaceutical solid 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 Formulations manager/upper management to meet the company's goals within the specified timelines. This position also requires documenting, reviewing, analysing 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 Harmonisation). 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 solid dose products per departmental SOP’s and ICH guidelines. This should be done with occasional consultation with the Formulations manager or upper management.
- Independently utilizes strong formulation/ pharmaceutical technology/ problem solving skills and all available resources to correctly identify process and/or formulation deficiencies and be proactive in implementing a solution. Thus, responsible and accountable for troubleshooting and resolving challenges during the manufacture of the dosage forms.
- Leads execution of trial and scale-up batches with support from technologist/ technicians to execute manufacturing plans as per approved protocols.
- Generates pharmaceutical development reports/protocols including formulation development, process development, literature review, 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. Leads communication/interaction with Production/Contract Manufacturing (CMO) during transfer of manufacturing process/scale up from R&D in a timely fashion.
- Authors/revises regulatory documents, and leads efforts to define formulation, manufacturing process and drug product specifications.
- Performs data collection and analysis, presents conclusions regarding progress of work, and effectively communicates technical discussion regarding development trials and scale-up.
- Ensures availability of APIs, excipients, capsule shells, etc., needed to carry out all formulation development tasks.

**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 pharmaceutical experience in solid dose product development. Must have in-depth knowledge of pharmaceutical solid dosage forms, including controlled release drug delivery technologies. Working knowledge and experience on formulation development. Good understanding of design of experiments, six sigma methodology, risk based assessment tools, quality by design, pharmaceutical manufacturing, scale up, and technical transfer. Experience with MINITAB software or related statistical 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

Pay: Up to $80,000.00 per year

Additional pay:

- Bonus pay

**Benefits**:

- Casual dress
- Dental care
- Disability insurance
- Employee assistance program
- 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

Application question(s):

- Currently resides in the GTA

**Education**:

- Bachelor's Degree (required)

**Experience**:

- Pharmaceutical Formulation Development solid dose : 5 years (required)

Work Location: In person