Technology Transfer Specialist - Eurofins Alphora
Eurofins Alphora Research is an FDA-approved contract research and manufacturing organization focused on process chemistry, Current Good Manufacturing Scale Up (CGMP) scale up, and analytical method development for complex, small molecule Active Pharmaceutical Ingredients (APIs). Our services have supported numerous IND-enabling, clinical, and commercial API technology development programs for our clients for well over a decade. We’re currently staffed by 125+ talented chemists, engineers, operators, business, and support staff and our 50,000 ft² of facilities in Mississauga and Oakville include synthetic organic chemistry laboratories, analytical laboratories, kilo laboratories, pilot plant, warehouse, stability chambers, high potency and cytotoxic laboratories.
Eurofins Alphora staff work together in developing and delivering solutions for our clients that are innovative and efficient while meeting standards for safety and quality that are renowned in the marketplace.
Eurofins Alphora Research is a fast-paced environment that values and respects our employees and encourages their learning and development as we strive to support our clients in improving the health and well-being of people around the world.
The Technology Transfer Specialist Level I – Afternoon Shift will be responsible for the review of production batch records, providing supporting production documents, and the translation of technology into appropriate operational instructions for the Kilo Laboratory and Pilot Plant. The primary focus of this role is technical support of production activities during afternoon shifts. Eurofins Alphora is looking for 2 incumbents for this position: Sunday – Thursday as well as Saturday – Wednesday (either 3pm -11:00pm or 4pm - 12am; weekend shifts are 9am - 5pm).
DUTIES AND RESPONSIBILITIES:
- 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.
- 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
- 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 Alphora 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 – 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.)
- 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.
Submit your resume via email: APPLY NOW!
We respect and value diversity and will accommodate disabilities to the extent possible so please let us know if there is anything that we can to support you during the selection process. Only candidates selected for an interview will be contacted. Thank you!