- Our company is the world leader in delivering therapeutics that provide meaningful advances to patients who live with serious and life-threatening rare genetic diseases. We target diseases that lack effective therapies and affect relatively small numbers of patients, many of whom are children.
- These conditions are often inherited, difficult to diagnose, progressively debilitating and have few, if any, treatment options.
- We will continue to focus on advancing therapies that are the first or best of their kind.
- Our company’s Technical Operations group is responsible for creating our drugs for use in clinical trials and for scaling production of those drugs for the commercial market.
- These engineers, technicians, scientists and support staff build and maintain our company's cutting-edge manufacturing processes and sites, provide quality assurance and quality control to ensure we meet regulatory standards, and procure the needed goods and services to support manufacturing and coordinating the worldwide movement of our drugs to patients.
- Come join our team and make a meaningful impact on patients’ lives.
Rare Opportunities, Personal Impact
- Founded in 1997,our company is a world leader in developing and commercializing innovative bio pharmaceuticals for rare diseases driven by genetic causes. With six products on the market, and a fully-integrated multinational organization in place.
- What makes working here unique? We feel the intense tie between the work we do and the life-changing results it delivers. Our focus on rare disease gives us the rare opportunity to truly impact lives.
- As our company employees, we’re here because we want to be here. We enjoy our work — and each other. Our people are smart. Unassuming. Collaborative. Curious. Interesting. In return, there is development, empowerment and total reward.
- Our company is a high-performing, team based organization, where colleagues are flexible, multi-skilled and empowered to make decisions.
- The individual will be focusing on small-scale cell culture activities in the Manufacturing Sciences and Technology (MSAT) laboratory to support process characterization, trouble-shooting of manufacturing issues, and continuous process improvement activities.
- The candidate must have experience in bio-processing, and more specifically with CHO cell cultures.
- This individual must be competent with analytical techniques typical for a manufacturing sciences lab supporting the manufacturing of recombinant proteins, as well as with analysis and interpretation of data.
- The candidate will be involved in various projects that involve presenting data to collaborators and will assist in writing memos, protocols and reports by organizing data and observations.
- Knowledgeable in protein science, cell culture and protein expression.
- Run the cell culture and harvest operations of a laboratory scale process for a recombinant enzyme active ingredient.
- Test samples from the process for cell viability, cell density, metabolites and titre and additional tests as required by the experimental plan.
- Provide technical support for ongoing cell culture processes at laboratory and manufacturing scale.
- Participate in providing manufacturing with critical information necessary for maintaining consistent product supply, now and in the future.
- Participate in monitoring production processes.
- Participate in the diagnosis and resolution of production problems.
- Participate in maintaining scale-down models of the commercial or clinical process.
- Participate in testing the feasibility of new manufacturing processes.
- Participate in the execution of small-scale validation studies.
- Effective execution of experiments and basic problem solving.
- Thorough documentation of experiments and results.
- Ability to perform data analysis and interpret and present results.
- Ability to solve moderately complex issues independently.
- Excellent verbal and written communications skills.
- Ability to handle multiple tasks with good organizational skills.
- Interface with Process Sciences, Manufacturing, Quality, Validation, Quality Control, and Facilities Services.
- Strong verbal and written communication skills.
- Ability to use computer systems effectively as work requires.
- Ability to work effectively in groups.
- Adhere to all site safety, environmental and industrial hygiene procedures and practices.
- Play an active role in maintaining and enhancing the safety of the workplace and the laboratories.
- May be required to work periodically out of normal business hours
Bachelor's degree in a scientific discipline or biopharmaceutical engineering with 2-5 years relevant cell culture experience in process development or Manufacturing Sciences, or Master's degree with 1-3 years experience.
Minimum of 1 year bio-pharmaceutical experience with CHO cell cultures.
WORK AND PHYSICAL DEMANDS
Laboratory work and manufacturing support activities will require the use or proximity of chemicals, laboratory and manufacturing equipment and instruments, and mechanical moving parts. Noise and vibration may be present.
Periodic week-end laboratory work and/or on call support will be required on a team rotation basis.
We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by law.