Scientist Formulation Development

3 weeks ago

Mississauga, Canada Biolab Pharma Ltd. Full time

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

**Reports to: Manager Formulation Development**
The formulation development scientist supports the development of new pharmaceutical 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 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 chemists / 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 product development. Must have in-depth knowledge of pharmaceutical dosage forms (preferably solids) 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

**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

Supplemental pay types:

- Bonus pay

COVID-19 considerations:
We are following all COVID19 protocols set by Peel Public Health

Application question(s):

- Currently resides in the GTA

**Education**:

- Bachelor's Degree (preferred)

**Experience**:

- Canadian Pharmaceutical industry: 5 years (required)

**Language**:

- English (preferred)

  • Associate Scientist Formulation Development

    1 month 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...

  • Associate Scientist Formulation Development

    3 weeks 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...

  • Associate Scientist Formulation Development

    4 weeks 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...

  • Scientist - Process Development

    1 month ago

    Mississauga, Canada Vital Biosciences Inc. Full time

    The science team at Vital is seeking a passionate and creative scientist to fill the role of Scientist - Process Development. We're looking for a teammate proficient in nanoparticle chemistry and manufacturing/modification, who is also knowledgeable about GMP manufacturing. Someone with exceptional leadership skills and experience who can help establish our...

  • Scientist - Assay Development

    1 month ago

    Mississauga, Canada Vital Biosciences Inc. Full time

    **About you**: You are a passionate and creative scientist who is proficient in the planning and execution of experiments, maintaining equipment, preparing high-quality reagents and buffers, and performing various molecular biology and biochemistry laboratory techniques. You enjoy playing a critical role in a fast-paced lab environment and do not shy away...

  • Scientist

    1 month ago

    Mississauga, Canada Microbix Biosystems Inc. Full time

    **R&D Position (full time)** **Molecular Diagnostics Product Development Scientist** Global job duties include: - Daily R&D activities including design, execution and interpretation of scientific experiments according to ISO 13485 Design Control, IVDR and the company’s quality system guidelines. - Research, analyze target sequences (DNA, RNA, protein)...

  • Bioinformatics Scientist

    2 days ago

    Mississauga, Canada Integrated Resources, Inc. Full time

    Client Sequencing Solutions (RSS), a business within Client Diagnostics, is focused on developing a disruptive Next-Generation Sequencing (NGS) platform along with a portfolio of reagents, assays and informatics solutions for multiple disease areas. We are looking for a Bioinformatics Scientist to support assay development efforts.In this role, you will...

  • Bioinformatics Scientist

    1 day ago

    Mississauga, Canada Integrated Resources, Inc. Full time

    Client Sequencing Solutions (RSS), a business within Client Diagnostics, is focused on developing a disruptive Next-Generation Sequencing (NGS) platform along with a portfolio of reagents, assays and informatics solutions for multiple disease areas. We are looking for a Bioinformatics Scientist to support assay development efforts.In this role, you will...

  • Bioinformatics Scientist

    2 days ago

    Mississauga, Canada Integrated Resources, Inc. Full time

    Client Sequencing Solutions (RSS), a business within Client Diagnostics, is focused on developing a disruptive Next-Generation Sequencing (NGS) platform along with a portfolio of reagents, assays and informatics solutions for multiple disease areas. We are looking for a Bioinformatics Scientist to support assay development efforts.In this role, you will...

  • Senior Global Development Scientist Director

    4 weeks ago

    Mississauga, Canada AstraZeneca Full time

    Job Title: Senior Global Development Scientist Director Locations: In Office in one of these locations - Boston Seaport, Warsaw PO, Barcelona SP or Mississauga CA As a Senior Global Development Scientist Director (SGDSD) you will independently provide scientific and clinical input to all aspects of late stage product development. This includes but is not...

  • Senior Global Development Scientist Director

    4 weeks ago

    Mississauga, Canada AstraZeneca Full time

    Job Title: Senior Global Development Scientist Director Locations: In Office in one of these locations - Boston Seaport, Warsaw PO, Barcelona SP or Mississauga CA As a Senior Global Development Scientist Director (SGDSD) you will independently provide scientific and clinical input to all aspects of late stage product development. This includes but is not...

  • Senior Global Development Scientist Director

    1 month ago

    Mississauga, Canada AstraZeneca Full time

    Job Title: Senior Global Development Scientist Director Locations: In Office in one of these locations - Boston Seaport, Warsaw PO, Barcelona SP or Mississauga CA As a Senior Global Development Scientist Director (SGDSD) you will independently provide scientific and clinical input to all aspects of late stage product development. This includes...

  • Senior Global Development Scientist Director

    3 weeks ago

    Mississauga, Canada AstraZeneca Full time

    Job Title: Senior Global Development Scientist Director Locations: In Office in one of these locations - Boston Seaport, Warsaw PO, Barcelona SP or Mississauga CA As a Senior Global Development Scientist Director (SGDSD) you will independently provide scientific and clinical input to all aspects of late stage product development. This includes but is not...

  • Late Clinical Development, Scientist

    1 month ago

    Mississauga, Canada AstraZeneca Full time

    Within Late Development Oncology, we push the boundaries of science to change the practice of medicine and transform the lives of patients living with cancer. With one of the broadest and deepest Oncology pipelines in the industry, there are many opportunities to work with new and novel drugs and help discover what’s next. Supportive team players, we draw...

  • Senior Analytical Scientist

    6 days ago

    Mississauga, ON, Canada Candoo Pharmatech Company Inc Full time

    Position Overview: We are seeking a highly skilled and experienced Senior Analytical Scientist (R&D) to join our team at Candoo Pharmatech Company Inc. The Senior Analytical Scientist will play a pivotal role in our analytical development and quality control processes. This position involves leading analytical method development, validation, and...

  • Bioinformatics Scientist

    22 hours ago

    Mississauga, Canada US Tech Solutions, Inc. Full time

    client Sequencing Solutions (RSS), a business within client Diagnostics, is focused on developing a disruptive Next-Generation Sequencing (NGS) platform along with a portfolio of reagents, assays and informatics solutions for multiple disease areas. We are looking for a Bioinformatics Scientist to support assay development efforts.In this role, you will...

  • Bioinformatics Scientist

    19 hours ago

    Mississauga, Canada US Tech Solutions Full time

    client Sequencing Solutions (RSS), a business within client Diagnostics, is focused on developing a disruptive Next-Generation Sequencing (NGS) platform along with a portfolio of reagents, assays and informatics solutions for multiple disease areas. We are looking for a Bioinformatics Scientist to support assay development efforts. In this role, you will...

  • Global Development Scientist Director, Late R&I

    1 week ago

    Mississauga, Canada AstraZeneca Full time

    At AstraZeneca, we pride ourselves on crafting a collaborative culture that champions knowledge-sharing, ambitious thinking and innovation – ultimately providing employees with the opportunity to work across teams, functions and even the globe. Recognizing the importance of individualized flexibility, our ways of working allow employees to balance...

  • Global Development Scientist Director, Late R&I

    7 days ago

    Mississauga, Canada AstraZeneca Full time

    At AstraZeneca, we pride ourselves on crafting a collaborative culture that champions knowledge-sharing, ambitious thinking and innovation – ultimately providing employees with the opportunity to work across teams, functions and even the globe. Recognizing the importance of individualized flexibility, our ways of working allow employees to balance...

  • Global Development Scientist Director, Late R&I

    1 week ago

    Mississauga, Canada AstraZeneca Full time

    At AstraZeneca, we pride ourselves on crafting a collaborative culture that champions knowledge-sharing, ambitious thinking and innovation – ultimately providing employees with the opportunity to work across teams, functions and even the globe. Recognizing the importance of individualized flexibility, our ways of working allow employees to balance...