Eurofins CDMO Alphora is looking for a Technology Transfer Associate – 12-month Co-op
Job Description
The Technology Transfer Associate is accountable to the Technology Transfer Manager or designate, working under close supervision to support the Technology Transfer department. The Technology Transfer Associate must adhere to current Good Manufacturing Practices (cGMP), Environmental Health and Safety (EHS) and Eurofins CDMO Alphora’s practices.
DUTIES AND RESPONSIBILITIES:
- The review of Executed Batch Records (EBR’s).
- Daily real-time review of Production Batch Records (PBR’s) while on the production floor.
- Supporting the EBR correction process working closely with Operations, Technology Transfer, and Quality Assurance
- The revision of various types of documentation such as Standard Operating Procedures and Environmental, Health and Safety Procedures.
- Support the preparation of reports such as deviation reports, Cleaning Study Reports to complete equipment cleaning studies, reports to close protocols (e.g. FDA or HC observations), risk assessments, and other reports as required.
- Including data compilation and analysis
- Support deviation investigations, process improvement initiatives, and data trending/analysis in a cross-functional role.
- Apply Project Management techniques to ensure projects are completed to schedule and communicate project status internally, identifying project risks.
- Support Process Engineering initiatives as required (e.g. cooling curves, distillations, drying rates, temperature ramping, etc.).
- Support the Technology Transfer and Operations Departments with special projects as required.
- Other duties as assigned/required.
Qualifications
The ideal candidate will have:
- Currently enrolled in a Pharmaceutical Regulatory Affairs and Quality Operations program.
The approximate hourly co-op salary for this position starts at $22/hr.
WHO ARE WE?
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.
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.
Additional:
- Follow Environmental, Health and Safety rules/regulations and report any workplace injuries or accidents immediately.
- Adhere to the policies and guidelines set out in the Alphora Employee Handbook
- Work harmoniously with all fellow employees.
COMMUNICATION AND CONTACTS:
Within the Company
- Interact with Operations Leadership and related department personnel for completion of assigned projects.
- Interact with Technology Transfer, Quality Control, Quality Assurance, and Engineering/Maintenance as required.
- Work harmoniously with all fellow employees.
Outside of the Company
- Interacting with Clients, GMP auditors and/or agencies (e.g. HC, FDA, etc.) is not expected in this role.