This job is currently Archived,
Posted on : 28 May 2017
- 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.
- Our company 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.
- The basic function of this position focuses on assisting scientists in the development of purification processes for biological drug candidate molecules from mammalian cell culture broths or microbial fermentations.
- It includes the characterization of purified molecules, and the technology transfer of the developed processes to internal and external manufacturing groups. Process validation, protein formulation, and manufacturing support are also part of the job.
- The Research Associate position is composed of multiple levels.
- The successful candidate will be offered a level based on fit with the job description and on their previous accomplishments/experience and education.
- Work on complex processes of diverse scope. Develop and optimize purification processes for pre-clinical and clinical trials and commercial production of biological drug candidate molecules.
- Produce candidate molecules for pre-clinical research. Transfer developed purification processes to manufacturing groups.
- Work includes cross-functional interaction and support for other groups, including Manufacturing, Quality, Validation, Research, Pharmacological Sciences and others.
- Knowledge of protein purification, enzymes, enzyme kinetics a plus.
- Knowledge of protein/enzyme quality attributes, quality indicating assays and assay development a plus.
- Experience with the use of statistical methods to plan and execute multi-variable experiments a plus.
- Use of related methods to evaluate risk a plus.
- Must have ability to follow complex protocols, written and verbal instructions, where appropriate.
- Ability to plan and execute work in an autonomous, or semi-autonomous fashion.
- Ability to provide guidance to other staff. Exercise moderate technical discretion in design and execution of varied experiments and projects.
- Provide quantitative analysis of data and interpretation of results.
- Record experimental data and analysis in lab notebooks. Write protocols.
- Write or contribute to technical reports and other documents (e.g., process validation, batch records).
- Evaluate moderately complex methods and technologies.
- Identify new areas requiring evaluation.
- Evaluate complex lab equipment; recommend vendors.
- Provide assistance to manufacturing start-up, troubleshooting and validation.
- May contribute to scientific publications and regulatory submissions as appropriate.
- Attend external seminars.
- Identify, discuss, and solve problems.
- Provide updates and/or summaries at process development group meetings and at cross-functional meetings.
- Preferred: At least two years previous experience in biological process development or related biopharmaceutical job function desired.
- Less experience will be considered. Position offered will be based in part on relevant experience.
- Basic protein/enzyme skills, including (not limited to)
- Large and small scale purification by chromatography, tangential-flow filtration, and related methods
- Analytical methods for the determination of protein/enzyme quality attributes.
- Knowledge of the basics of analytical assay development and qualification
- Assessment of protein/enzyme stability and knowledge of formulation techniques
- Strong written and verbal communication skills
- Preferred: Master s degree in Biochemistry, Chemical Engineering or related field.
- BA or BS will be considered.
- Position offered will be based in part on educational experience.
- Chromatography columns and controllers at various scales (1 35 cm column i.d.).
- Controllers include Akta bench top units (Akta Pur, Akta Avant, Unicorn software) and larger scale units
- Ultrafiltration/Diafiltration equipment for concentrating and diafiltering various volumes (generally several mL to several L, but occasionally up to 1000 L)
- Fluorescent / UV/Vis plate readers and spectrophotometers
- Liquid handlers
- Compressed gas cylinders/regulators
- Director of Purification Process Development
- VP of Process Sciences
- Scientists and Research Associates in Purification Process Development
- Members of related functional groups
- No direct reports
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.
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