Job Description

Company Description

Eurofins Scientific is an international life sciences company, providing a unique range of analytical testing services to clients across multiple industries, to make life and our environment safer, healthier and more sustainable. From the food you eat, to the water you drink, to the medicines you rely on, Eurofins works with the biggest companies in the world to ensure the products they supply are safe, their ingredients are authentic and labelling is accurate. Eurofins believes it is a global leader in food, environmental, pharmaceutical and cosmetics products testing and in agroscience CRO services. It is also one of the global independent market leaders in certain testing and laboratory services for genomics, discovery pharmacology, forensics, CDMO, advanced material sciences and in the support of clinical studies.

In over 35 years, Eurofins has grown from one laboratory in Nantes, France to 61,000 staff across a decentralised and entrepreneurial network of ca. 900 laboratories in 61 countries. Eurofins companies offer a portfolio of over 200,000 analytical methods to evaluate the safety, identity, composition, authenticity, origin, traceability and purity of biological substances and products.

In 2022, Eurofins generated total revenues of EUR 6.7 billion, and has been among the best performing stocks in Europe over the past 20 years.

Eurofins CDMO Alphora Inc. provides a fully integrated suite of services to support drug substance and drug product development from the IND enabling development stage, through to phase II & III supply, and commercial validation and manufacturing for niche APIs. In addition to a continuing flow of interesting and challenging projects for global pharmaceutical and biotech companies, Eurofins CDMO Alphora Inc. is committed to growing its state-of-the-art organization, with continued investments in its people, modern facilities, equipment, and instrumentation.



DUTIES AND RESPONSIBILITIES:

Primary duties:

• Responsibilities will include review of production batch records and provide technical guidance during batch execution. Perform real-time batch records review on a daily basis, and conduct post-batch production document reviews in a timely manner.
• The preparation of various types of operational documentation such as Production Batch Records and batch record supporting documents such as reports for unplanned deviations.
• Work closely with operations teams to ensure neat, accurate and timely record keeping and execution of all required documentation.

Secondary duties:

• Assist in the preparation of Master Batch Records and Standard Operating Procedures and Environmental, Health and Safety Procedures.
• Actively participate in initial and ongoing training for:
• Environmental, Health and Safety Procedures
• WHMIS
• Standard Operating Procedures
• Current Good Manufacturing Practices
• Transportation of Dangerous Goods
• Job related seminars and training sessions * Principle contact for processes introduced to operations. Be available to take calls during off hours to resolve processing problems. Obtain input from R&D and Quality Assurance resources to resolve technical issues.
• Review upcoming batch record instructions with operations on a daily basis for action production batches.
• Evaluate changes in operating instructions taking into consideration operator and environmental safety, cGMP requirements and successful completion of the batch.
• Apply Project Management techniques within the tech transfer role. Maintain project timelines for tech transfer deliverables and communicate project risks to management.

COMMUNICATION AND CONTACTS:

Within the Company

• Interact with all Personnel throughout the CDMO/Alphora division to ensure the timely and safe introduction of processes to operations
• Interact with fellow technology transfer team members, and other department members and managers.
• Interact with Human Resource Department \xe2\x80\x93 attendance and other related issues.

Outside of the Company

• Interact with clients as required
• Interact with cGMP auditors as required
• Interact with various agencies as needed (i.e. environmental compliance, Insurance, WHMIS, HPB/FDA, municipal officials, public utilities, etc.)

Qualifications

Qualifications

• Minimum bachelor level degree in chemistry, chemical engineering or related field
• Minimum 1 year experience working in a GMP environment within the pharmaceutical industry

Your knowledge of cGMP requirements and scale-up equipment is complimented by advanced project management skills and clear, concise and professional communication skills. You have the ability work a rotating on-call schedule as part of a team of Specialists.

Additional Information

At Eurofins we offer excellent full-time benefits including health & dental coverage, life and disability insurance, RRSP with 3% company match, paid holidays, paid time off.

Accommodation: Persons with disabilities who need accommodation in the application process, or those needing job postings in an alternative format, may e-mail a request via the website at .

As a Eurofins employee, you will become part of a company that has received international recognition as a great place to work. To learn more about Eurofins, please explore our website at

We thank all applicants within commuting distance of GTA, Ontario for showing an interest in this position. Only those selected for an interview will be contacted.

NO AGENCIES, CALLS OR EMAILS PLEASE

Eurofins