Process Development Associate

Emerald Health Therapeutics

Introduction

Join our Team!

We’re passionate about using science to help people. Are you?

The people we serve are looking for solutions. They want to improve their everyday lives, become more productive and enjoy the present moment. That’s where we come in – and where you do, too.

Since 2013, we’ve established a reputation for using science and innovation to help our customers, and we’re proud of our history. Emerald was formed by industry leaders who’ve dedicated themselves to helping people overcome medical conditions so they can live better lives, and we’re always looking for like-minded people to join us in our mission.

Company

Emerald Health Therapeutics (EHT) is a Health Canada Licensed Producer of medical and adult-use cannabis and cannabis derivatives. A seed-to-sale enterprise, Emerald has combined core competencies from decades of experience in pharmaceutical innovation with large-scale agriculture and extraction expertise. Our ambition is to be at the forefront of developing products that provide health and wellness benefits from cannabis for purposeful people. Emerald Health Therapeutics (EHT) is publicly traded on the TSXV (EMH) and the OTCQX (EMHTF). We offer competitive salaries, employer-paid health benefits including acupuncture, naturopathic care and massage; and flexible work hours.

Position

PURPOSE OF JOB:

The Process Development (PD) Associate role is responsible for providing process development support for new product research and development, technology transfers, process validations and Good Production Practices (GPP) manufacturing of cannabis-containing products for commercial sale. The successful candidate will draft and review work instructions, protocols, production procedures, standard operating procedures (SOPs), process development reports and preventative control plans (PCPs). Additionally, they will help to identify critical process parameters and to set appropriate product specifications. As a member of the New Product Development (NPD) team, the PD Associate will work closely with the Quality Assurance (QA) and Production teams to design and scale-up manufacturing processes, manage equipment qualification and cleaning verification, and to support process validation. The PD Associate will take the lead on drafting documentation to support regulatory compliance. A significant component of this role will involve educating and training members of the NPD and Production teams, to ameliorate the standards of documentation and process across these areas of the organization.

This is a new role for a full-time position located in Langley, BC.

Primary duties and responsibilities:  

·        Participate in and influence a cross-functional development team to advance process development and commercial manufacturing activities

·        Design and execute process development studies to develop a thorough understanding of operating and performance parameters

·        Hands-on execution and collaboration on R&D studies to support development, optimization, determination of critical parameters and essential process improvements

·        Draft and review technical documentation from technical Standard Operating Procedures (SOPs), to work instructions, manufacturing batch records, technical reports, summary reports, and preventative control plans (PCPs)

·        Perform process training for Good Production Practices (GPP) production

·        Perform process analysis and trend process performance

·        Perform statistical analysis including design of experiments (DOEs) as appropriate

·        Train colleagues in drafting technical documentation, conducting research, establishing processes and manufacturing to the standards required for a regulated industry

·        Other duties as assigned

Required Skills

Required

·        Experience designing, writing, and implementing equipment, facility, process qualification, validation, and cleaning procedures, and reports in accordance with regulatory and industry standards

·        Solid understanding of a regulatory environment and the requirements to bring regulated products, such as pharmaceuticals, biologics and/or medical devices, to market

·        Practical knowledge of GPP and/or cGMP regulations, including knowing which are applicable and how to apply them

·        Know-how designing and conducting regulated research, including designing R&D processes that can be scaled up and commercialized

·        Experience providing education and training around technical documentation and regulated processes

·        Demonstrated proficiency with technical writing in a cGMP or HC/FDA-regulated manufacturing environment

·        Strong typing and computer skills, including proficiency using Microsoft Office Suite (Word, Excel, PowerPoint), and familiarity with cGMP quality systems

Highly Desirable

·        Familiarity with Health Canada regulations

·        Mastery of scientific and engineering principles

Beneficial

·        Knowledge of the Regulations under the Cannabis Act

·        Familiarity with quality management systems/software, incl. document management systems

PHYSICAL DEMANDS / WORKING CONDITIONS

This role requires safe operation of R&D-scale and pilot-scale production machinery. The employee may be standing for up to 80% of their workday. The employee may have to lift supplies and equipment that way up to 20 kg. The employee may have to wear appropriate protective equipment, such as a mask, gloves, hearing-protection, booties, hairnet etc.

EXPERIENCE:

·        Minimum of three (3) years of process development, technology transfer and cGMP-compliant manufacturing experience in a regulated industry is required

·        Previous experience in a Contract Development and Manufacturing Organization (CDMO) and/or manufacturing in the pharmaceutical, nutraceutical, biotech or the cannabis industry preferred

Education:

·        MSc in Biology, Biochemistry, Biotechnology, Pharmaceutical Sciences, or related discipline strongly preferred

·        BSc with equivalent combination of training and experience working in a process development/manufacturing role will also be considered

COMPETENCIES

·        Ability to work and collaborate effectively in cross functional teams

·        Excellent interpersonal, verbal, and written communication skills

·        Capacity to think critically, combined with practical, common sense

·        Demonstrated troubleshooting and problem-solving skills

·        Ability to work independently and have the initiative and drive to achieve defined objectives and deadlines under tight project timelines

·        Self-motivated, strong sense of responsibility, and willing to accept temporary responsibilities outside of initial job description

·        Comfortable in a fast-paced, dynamic work environment with minimal direction and able to adjust workload based upon changing priorities

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