Technology Transfer Specialist - Eurofins Cdmo

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 just 30 years, Eurofins has grown from one laboratory in Nantes, France to over 58,000 staff across a network of more than 1000 independent companies in over 54 countries and operating more than 900 laboratories. Eurofins offers a portfolio of over 200,000 analytical methods to evaluate the safety, identity, composition, authenticity, origin, traceability and purity of biological substances and products, as well as providing innovative clinical diagnostic testing services, as one of the leading global emerging players in specialised clinical diagnostics testing._**
**_ In 2021, Eurofins generated total revenues of EUR € 6.7 billion, and has been among the best performing stocks in Europe over the past 20 years._**
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- 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._
**Job Description**:
***:
The Technology Transfer Specialist will support the effective, efficient, and safe transfer of Active Pharmaceutical Ingredient (API) processes from Research and Development to Eurofins CDMO Alphora’s cGMP manufacturing facilities. In addition to this, the Technology Transfer Specialist will manage project deliverables, departmental objectives, and communicate with clients while working in a fast-paced cGMP environment.
**KEY DUTIES AND RESPONSIBILITIES**:
- The preparation of various types of operational documentation such as Master Batch Records, Production Batch Records, Standard Operating Procedures and Environmental, Health and Safety Procedures.
- Plan, coordinate, and manage departmental objectives.
- Coordinate with R&
D, QA and supporting departments to ensure the proper documentation, equipment and resources are available for batch implementation.
- Principle contact for processes introduced to operations including afterhours on-call support
- Evaluate process instructions taking into consideration operator and environmental safety, Current Good Manufacturing Practices (cGMP) requirements and successful completion of the batch.
- Interact with clients as required
- Interact with cGMP auditors or various agencies (e.G. FDA) as required
- Work closely across numerous departments internally including;
Research &
Development, Analytical Services, Operations, Engineering, Quality Assurance, Quality Control
- Participate in technical project meetings and monitor the project process development activities within R&
D. Provide input and advice to the R&
D team regarding production equipment capabilities and limitations and operations.
- Support exception management, process improvement initiatives, and data trending/analysis in a cross-functional role.
**Qualifications**:
- Have a MSc in Chemistry or Chemical Engineering (preferred) or BSc
- Have proficient written and verbal skills
- Be capable of multi-tasking
- Be capable of sound decision-making
- Have a solid chemistry background with process experience being a definite asset
- Have an understanding of (cGMP) manufacturing with prior QA/compliance experience being a definite asset
- Have good interpersonal skills
- Have good time management and project management skills
- 2-5 years’ experience preferred
Additional Information
**_ We thank all applicants within commuting distance of Oakville, Ontario for showing an interest in this position. Only those selected for an interview will be contacted._**
**_ NO AGENCIES, CALLS OR EMAILS PLEASE!_**
Thank you!