Upstream Process Development/Senior Research Associate 1

Job Description

The incumbent will be responsible for execution at bench [~50% time] and supervising the cell culture / fermentation development and process transfer in support of in-process early-stage biopharmaceutical development programs - and will work with quality assurance, compliance and regulatory functions to meet project demands and contribute to submissions to regulatory authorities.Key Responsibilities: Primary responsibility for all aspects of mammalian cell culture, including media and buffer preparation, culture initiation, propagation, and cryopreservation of cells while adhering to quality systems.Preparation/planning of resources to meet the demands of multiple concurrent projects that will require flexible work hours working in concert with project scientists.Performance of basic laboratory protocol studies, including basic calculations and data analysis.Accurate and reliable record keeping including database management, batch records, notebooks, and all pertinent documentation.Sterile preparation of laboratory glassware, tools, and reagents.Performance of general laboratory tasks, including maintenance of equipment.Follow Standard Operating Procedures and adhere to all safety and company policiesTo perform in-process testing during experiment.Should be able to troubleshoot in case of any deviation from process/parameter.Assess/investigate the reason for process/equipment failure.Evaluation of incoming technical documents for process understanding.Preparation of documents required for execution and technology transfer.Review and interpretation of data received from analytical functions.To co-ordinate with analytical and other functions on planning of experiments and intimation of samples and tests to be performed.Maintain the laboratory with all necessary requirements and track the inventory to ensure minimum stock is maintained.Responsible for usage and maintenance of trials in SAP.To carry out other responsibilities that may be assigned by the Superior.Possess the knowledge and exposure to environment, health, and safety (EHS) practices Follow environment, health, and safety (EHS) requirements at all times in the workplace ensuring individual and lab/plant safety Ensure environment, health, and safety (EHS) measures are imparted via training and adhered within the teamEducational Qualification: Masters in BiotechnologyTechnical/functional Skills: Candidate must have hands on experience on Upstream process development Thorough knowledge of cell biology, fermentation, cell cultivation methods and associated instrumentation; knowledge of impact of cell culture conditions on protein characteristics. Demonstrated expertise in cell cultivation. Develop models for process scalability analysis for seam-less integration with technology transfer activities. Ability to prioritize and successfully manage complex and competing projects. Excellent communication and organizational skills. Ability to proactively mitigate quality/regulatory risks. Motivated team player with proven leadership abilities. Experience related to Quality-by-design concepts will be considered a strong advantageExperience: 3-6 years post qualificationBehavioural Skills: Should have the capability to work in a team and ability to handle demonstrate a good team spirit. While possessing a good ability to follow instruction should also demonstrate innovative in his/her approach, good communication skills. Should be proactive while working on allotted responsibility.Equal Opportunity Employer: It is the policy of Syngene to provide equal employment opportunity (EEO) to all persons regardless of age, color, national origin, citizenship status, physical or mental disability, race, religion, creed, gender, sex, sexual orientation, gender identity and/or expression, genetic information, marital status, status with regard to public assistance, veteran status, or any other characteristic protected by applicable legislation or local law. In addition, Syngene will provide reasonable accommodations for qualified individuals with disabilities.,

Keyskills :
hplcnmrliteraturestandard operating proceduresresearchequal employment opportunityvalidationmammalian cell culturecontinuous improvement facilitatio