Processing Api Manager

vor 1 Tag

YverdonlesBains, Schweiz MediCrops Holding AG Vollzeit

**(Equal Opportunity Employer)**:

- — Yverdon-les-Bains**Purpose of the Job**:

- The Process API Manager will be responsible for the daily care of processing cannabis plants (Herbal Substance, Cannabis Sativa L.) into Herbal Preparation API (Cannabis Herbal Preparation) in the Processing Area (GMP) from Pre-Processing Decarboxylation (GMP), SFC CO2 Extraction Processing (GMP), Evaporation/Fraction Processing (GMP), Distillation Processing (GMP), Isolation and Chromatography Processing, Formulation and Filling (GMP). Also, Responsible for the Secondary Packaging related to API packaging.
- To ensure the highest quality API, the Process API Manager will excel at leading, coaching and coordinating daily schedules for the grow team.
- The Process API Manager works closely with CTO in defining projects, resource planning, KPI’s, Goals.
- The Process API Manager will monitor and make recommendations to the CTO on Process Lab infrastructure including, process technology and environmental factors to ensure an optimal GMP environment.
- During all step of the processing of the Cannabis Herbal Preparation (API), the Process API Manager will ensure and be responsible of quality care and attention to the process of the API from Pre-Processing Decarboxylation (GMP) to Post-Processing (GMP) which includes Formulation and Filling.
- The Process API Manager will support the CTO for manufacturing development aspects.
- Detailed recordkeeping and strict adherence to the company’s operating procedures (SOP’s and WI’s) and compliance with EU GMP Guidelines Annex 7 and GMP part I and II are essential for this position.

**Main Responsabilities/Duties**:
Processing API Manager tasks:

- Responsible, Manage, Supervise operations, resources, and schedules, daily, throughout the processing API from “Seed-to-Sale”.
- Manage the Daily care of medical cannabis herbal preparation processing in:

- Pre-Process (GMP): Decarboxylation, Terps trap
- Extraction Process (GMP): SFC CO2 Extraction, Winterization/Dewaxing/Filtration,
- Post-Processing (GMP): Evaporation/Fraction, Distillation, Purification, Isolation & Formulation/Filling, including inspecting the API, In Process Control (IPC). _If needed Support the GACP Cultivation Team for the Grinding (GMP) and Primary Packaging (GMP) (Herbal Substance, GMP area only)._
- Responsible of the Continuous systematic cleaning and sanitizing of GMP area and equipment’s; dispose of waste according to strict compliance guidelines and SOP’s and WI’s.
- Accurate tracking and recording of data (Data Integrity) during each phase of the processing/manufacturing of cannabis API herbal preparation. (Track and Trace “Seed-to-Sale”, igWLab)
- Ensure the appropriate information is ALCOA+, clearly in accordance with the state regulations and company Policy, SOP’s, and WI’s. (Data Integrity)
- Effective team management, including assigning work, monitoring progress, training, and developing employees
- Carefully follow directives as provided by the CEO & Chief Tech Ops /Quality Assurance.
- Proactively optimize Processing including Technology, environmental systems, and Methods.
- Provide the best-practices and well-versed in cutting-edge techniques with respect to conformity of EU GMP Guidelines.
- Willingness to continue to learn the best with a strong interest in medical cannabis manufacturing activities.
- In Charge of Processing API Quality Report and Processing/Manufacturing Reporting to CTO/CEO/CFO
- Support in Capex and Opex aspects.
- Not limited to these tasks. (Training Plan Career)

**Requirements**:
Qualifications:

- MUST Hold a degree from University MSc or Degree in a scientific discipline or equivalent; MBA is a plus.
- Lean Six Sigma yellow belt certification or higher (is a +)
- Ideally 5+ years of combined experience working in a research lab and managing lab operations.
- Experience in the medical cannabis industry (is a +)
- In-depth knowledge of Phyto-Extraction management techniques and principles.
- In-depth knowledge of Pre, Extraction and Post Process in Cannabis Medical field (GMP API)
- Good knowledges in EudraLex -the Rules Governing Medicinal Products in the European Union Volume 4 EU Guidelines to Good Manufacturing Practice (GMP) Medicinal Products for Human and Veterinary Use Annex 7 Manufacture of Herbal Medicinal Products, GMP part I & II (API), and ICH- is highly appreciated.
- High level of integrity and a strong work ethic.
- Demonstrated ability to work comfortably and effectively within a diverse, multicultural, multigenerational environment.
- Safety, Quality, Efficacy oriented
- Proficiency and Good communication skills in French, English (must have) and German (would like)
- Analytical root cause mind
- Well organized, pragmatic, and able to define and support CTO
- Strong ability to lead and implement on enterprise level.
- Ability to solve problems is important, as well as to prioritize daily tasks. (Voice of Customer)
- Strong underst

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