Technology Transfer Associate

BioTalent Canada; Mississauga; On-site; CAD 60,000 - 80,000; Full time

Job summary

A leading life sciences company in Canada is seeking a Technology Transfer Associate for a 12-month co-op position. The ideal candidate will be currently enrolled in a Pharmaceutical Regulatory Affairs and Quality Operations program. The job involves reviewing batch records, supporting process improvement initiatives, and applying project management techniques. The approximate hourly co-op salary starts at $22/hr. This role provides valuable experience in a rich and technologically challenging environment.

Qualifications

• Must adhere to current Good Manufacturing Practices (cGMP) and Environmental Health and Safety (EHS).

Responsibilities

• Review Executed Batch Records (EBR’s).
• Daily real-time review of Production Batch Records (PBR’s) while on the production floor.
• Support the EBR correction process closely with Operations.

Education

Currently enrolled in a Pharmaceutical Regulatory Affairs and Quality Operations program

Job description

Eurofins CDMO Alphora is looking for a Technology Transfer Associate– 12-month Co-op

WHO ARE WE?

Eurofins CDMO Alphora Inc. develops and manufactures new therapeutics to improve the lives and health of patients. Eurofins CDMO Alphora provides contract research & development services to global pharmaceutical and biotech companies, developing their processes and manufacturing their bulk drug substances (Active Pharmaceutical Ingredients -“API’s”) as well as finished dosage products (tablets, capsules, suspensions) for supply to clinical trials and commercial requirements. Eurofins CDMO Alphora provides a rich and technologically challenging environment with a continuing flow of interesting projects. Our employees work in close concert with clients throughout the development process to achieve their program objectives. Eurofins CDMO Alphora Inc. is growing its state-of-the-art organization, with continued investments in modern facilities, equipment, and instrumentation while providing a rich environment for employees to develop their technical skills and careers paths.

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.

Eurofins CDMO Alphora is a wholly owned Canadian entity of Eurofins Scientific with over 200 employees. Eurofins Scientific is an international life sciences company, providing a unique range of analytical testing and development 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, pharmaceutical Contract Development and Manufacturing Organization (CDMO) services, advanced material sciences and in the support of clinical studies.

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.