R&D Associate Scientist Formulation Development

JOB OPPORTUNITY

Title: R&D Associate Scientist - Formulation Development

Reports to: Manager - R&D Formulation Development

We are currently hiring for an existing vacancy.

The Formulation Development Associate Scientist supports the development of new pharmaceutical dosage forms, in addition to improving existing products and procedures. These activities will be achieved by applying scientific knowledge, technology, and chemistry to investigate the properties, components, and capabilities of chemicals and processes, in order to develop efficient manufacturing procedures and appropriate analytical methodologies to create prototype formulations and clinical supplies. This position performs activities assigned by the manager or upper management to meet the company's goals within specified timelines. It also requires documenting, reviewing, analyzing, and interpreting data, as well as interpreting scientific problems in support of HC, FDA, EMEA, and ANVISA submissions in a timely manner, while complying with departmental SOPs and guidelines set by regulatory agencies and ICH (International Conference on Harmonisation). This will be achieved by working 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 through scientific rationale, using Quality by Design principles to develop new products per departmental SOPs and ICH guidelines. This should be done in consultation with senior peers, such as Formulation Scientists, Managers, or upper management.
• Apply formulation, pharmaceutical technology, and problem-solving skills, utilizing available resources to identify process and/or formulation deficiencies and propose solutions.
• Execute solid dosage manufacturing trials (blending, granulation, encapsulation, compression, coating) and document critical observations and parameters to further product understanding.
• Support the writing of the Summary of Pharmaceutical Development report, including formulation development, process development, Quality Target Product Profile, Critical to Quality attributes, Critical Process Parameters of manufacturing, and all other information required in the CMC sections of CTAs, NDS, and S/NDS in a timely manner. Furthermore, provide the required information to support FDA, EMEA, and ANVISA submissions.
• Support internal projects and external Contract Manufacturing Organization (CMO) projects in alignment with Biolab’s objectives and initiatives. Communicate and interact, as indicated by management, with Production/CMO during the transfer of manufacturing processes and scale-up from R&D in a timely manner.
• Collaborate to align regulatory documents and team efforts to define formulation, manufacturing processes, and drug product specifications.
• Perform data collection and analysis, discuss conclusions regarding progress of work, and effectively communicate information to peers and management through presentations and reports.
• Ensures availability of APIs, excipients, capsule shells, etc., needed to carry out all formulation development tasks.

Education and experience requirements:

• 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. Demonstrates knowledge of pharmaceutical dosage forms (preferably solids). Knowledge and experience with solid dosage equipment is preferred.
• 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 is preferred.
• 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

jobs@biolabpharma.ca

Job Types: Full-time, Permanent

Pay: Up to $65,000.00 per year

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

Education

• Bachelor's Degree (required)

Experience

• Pharmaceutical experience solid dosage forms: 3 years (required)

Work Location: In person