Cannabis jobs at Certified Group

Certified Group has an exciting opportunity for an accomplished Senior Director Commercial Product Development and Regulatory Affairs to join our team!

Reporting to the SVP Operations, the Senior Director Commercial Product Development and Regulatory Affairs is a strategic and tactical leader for ideation, development and commercialization of new methods, technologies and services within the nicotine/tobacco (Chemistry) and cannabis/hemp space. He/she leads a team from ideation until deployment of method/technology/service into production at all Labstat locations. The incumbent is a recognized Regulatory Affairs thought leader and expert in worldwide tobacco/nicotine regulations as well as current regulations for cannabis and hemp. He/she insures that Development and Regulatory Affairs give Labstat a competitive advantage and are revenue drivers.

ESSENTIAL FUNCTIONS:

• Builds the Development and Regulatory Affairs team ensuring it is structured and organized for long-term success and effectively uses current and envisioned future regulations to determine strategy for the Labstat labs.


• Leads a team that is responsible for the ideation, development, validation/transfer and commercialization of methods and assays, technologies and services in the field of chemistry for the product classes the business is active in.


• Effectively influences future regulations by being an active member of task forces, engaging in conversations with regulators and direct conversations with the industry.


• Develops vision and strategy for next generation analytical needs for the industry including new analytical technologies and computational methods for New Generation Products.


• Works closely with business developent, operations, strategic marketing and commercial enablement to define the needs being addressed in each project ensuring projects are delivered on time. Co-leads the definition, documentation and approvals of the needs and customer requirements being addressed in each Development project. Oversees the translation of the needs and customer requirements into technical specifications.


• Leads cross functional teams to assess the commercial viability of new methods, technologies and services.


• Ensures that the necessary technical competencies, infrastructure, equipment and other resources are in place and maintained.


• Directs the development of scientists and RA experts to meet current and future business needs.


• Identifies, authorizes active participation and participates in external task forces and technical meetings that the company engages in.


• Develops and maintains strong relationships with academia, regulatory bodies, industry and research programs.


• Acts as subject matter expert for technical meetings with (prospective) customers.


• Accountable for strategy and execution of technical communications, presentations and (white) papers.


• Develops and promotes a culture of innovation, knowledge leaders, continuous improvement and empowerment, and technological value for the business.


• Compliance to Health & Safety policies and procedures.


• Other duties as assigned

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At Labstat our strength is our people. For over 45 years we are the premier CRO?s in the Kitchener-Waterloo region. Today Labstat International is a member of the Certified group of companies and we are recognized as an international ?Center of Excellence?. We are the world?s largest independent testing laboratory specializing in analytical chemistry, in vitro toxicology and microbiology for the nicotine and cannabis industries. We are a certified GLP laboratory with both SCC and ISO accreditation.

As a result of our continuing growth, Labstat has the following employment opportunity available:

We currently, we have an opening for a Data Analyst, to join our Data Integrity Team.

The Data Analyst II performs duties which include, but are not be limited to, the configuration of LIMS test codes and related LIMS objects, the validation of LIMS calculation blocks, the preparation of method validation reports, the preparation and maintenance of method summaries, and the maintenance of method validation statuses.

Primary responsibilities of the job:

• Member of a team that is responsible for life cycle management of all nicotine, Configuration and maintenance of LIMS test code and related database settings.

• Validation of calculation blocks employed by LIMS

• Preparation of method validation reports either to finalize those prepared by other functions (i.e. Scientist) or from mined data.

• Maintenance of method validation statuses.

• Creation and maintenance of method summaries (standardization of method synopses and validation summary tables) which are used to support Client enquiries and the TPMF filed with FDA.

• Management of the list of limits of detection and quantification values used in reporting (i.e. through mLIMS test code configuration).

• Retrieval and use of data and information from previous studies and projects as necessary.

• The employee shall implement the Laboratory Quality Policy and perform their duties in accordance to existing project specific requirements, current Test Methods, study plans and Standard Operating Procedures (SOP).

• Comply with Health & Safety policies and procedures and wear required Personal Protective equipment at all times

• Other duties as assigned.

Apply for this job with Certified Group

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By clicking the "Apply now" button, you'll be leaving Fazow and going to an external job application page for this company. Please research all companies before applying. When applying for jobs, you should NOT have to pay to apply. Fazow accepts no liability or responsibility as a consequence of any reliance upon information on external sites or in jobs listed on fazow.com.