Scientist, Upstream Processing

Raspa Pharma Pvt. Ltd.; Lucknow; Sur place; INR 1 200 000 - 2 000 000; Plein temps

Résumé du poste

Raspa Pharma Pvt. Ltd. in Uttar Pradesh, Lucknow invites applications for an experienced Upstream Processing Expert to lead development, scale-up, and technical support for cGMP manufacturing of small molecules, proteins, and biosimilars. The role is hands-on in the lab and reports to the CEO.

Ideal candidates will design experiments, transfer technology, set up SOPs per EU-GMP/FDA standards, and guide cross-functional teams in process optimization and sustainability initiatives.

Description du poste

Raspa is a biopharmaceutical company that is committed to reducing the cost of treatment for cancer and other severe diseases. Our diverse and inclusive team is amalgamating technological innovation and automation strategies to make healthcare more accessible, affordable, and sustainable.We are looking for a talented upstream processing expert with proven leadership skills to join our dynamic organization. Qualified individuals will play a leading role in upstream process development; scale up, and technical support of cGMP manufacturing for small molecules, proteins, and biosimilars. This position is expected to be mainly hands on in the laboratory. The person will be reporting directly to the CEO.

You will:

• Design, execute, and analyze experiments targeted towards upstream process development and optimization
• Design experimental work independently or with minimal supervision
• Participate in technology transfer and successful scale-up of processes from lab to pilot to commercial scale. As needed, support process validation, including validation protocol writing, execution and report writing.
• Set-up robust SOPs in line with EU-GMP and FDA standards
• Guide cross functional teams in strain improvement efforts and process scale up
• Develop and implement green processes that optimize recovery rate while promoting the company’s sustainability goals
• Implement Design-of-Experiment & Statistical Process Control principles for efficiently studying response variables and assessing data quality
• Identify and implement new systems and processes to drive quality, efficiency, and cost-savings
• Show proficiency in cell culture, molecular biology, protein expression, and various analytical techniques
• Be responsible for authoring and reviewing of relevant regulatory sections
• Generate, manage, evaluate, and maintain critical data in a highly organized manner. Provide reports for assessment by senior management
• Maintain a functioning bioprocess lab including equipment maintenance and critical supply management

Our ideal candidate will have:

• Master of Technology or PhD degree in Biotechnology, Bio-chemical engineering, Bioprocess Engineering or a related discipline with 4-6 years, or 2-4 years of relevant industrial experience respectively
• Experience in microbial fermentation/cell culture operations and recovery processes, including shake flask expansion, small and large scale fermenter/bioreactor production, scale-up/scale-down, and process transfer
• Hands-on experience in handling equipment such as glass fermenters, autoclave, analytical HPLC, and tangential flow filtration (TFF) systems
• Ability to work and collaborate in cross functional teams such as research, development, and manufacturing in a fast pace and dynamic team setting
• Ability to think critically, demonstrate troubleshooting and problem-solving skills
• Ability to independently make decisions based on data, scientific knowledge, and sound judgement
• A can-do attitude, intellectual curiosity, strong time management skills, a sense of ownership of work, and the ability to be flexible to business needs
• Ability to adapt to a fast-paced environment and able to adjust workload based upon changing priorities
• A clear willingness to “roll up their sleeves” and dive into the details
• Ability to work in shifts
• Ability to lift up to 20 kgs

Nice to have:

• Previous experience of working with flexible schedule
• Knowledge of current process technology trends in the field
• Experience with automation technologies is desired

Raspa is a biopharmaceutical company that is committed to reducing the cost of treatment for cancer and other severe diseases. Our diverse and inclusive team is amalgamating technological innovation and automation strategies to make healthcare more accessible, affordable, and sustainable.We are looking for a talented upstream processing expert with proven leadership skills to join our dynamic organization. Qualified individuals will play a leading role in upstream process development; scale up, and technical support of cGMP manufacturing for small molecules, proteins, and biosimilars. This position is expected to be mainly hands on in the laboratory. The person will be reporting directly to the CEO.

You will:

• Design, execute, and analyze experiments targeted towards upstream process development and optimization
• Design experimental work independently or with minimal supervision
• Participate in technology transfer and successful scale-up of processes from lab to pilot to commercial scale. As needed, support process validation, including validation protocol writing, execution and report writing.
• Set-up robust SOPs in line with EU-GMP and FDA standards
• Guide cross functional teams in strain improvement efforts and process scale up
• Develop and implement green processes that optimize recovery rate while promoting the company’s sustainability goals
• Implement Design-of-Experiment & Statistical Process Control principles for efficiently studying response variables and assessing data quality
• Identify and implement new systems and processes to drive quality, efficiency, and cost-savings
• Show proficiency in cell culture, molecular biology, protein expression, and various analytical techniques
• Be responsible for authoring and reviewing of relevant regulatory sections
• Generate, manage, evaluate, and maintain critical data in a highly organized manner. Provide reports for assessment by senior management
• Maintain a functioning bioprocess lab including equipment maintenance and critical supply management

Our ideal candidate will have:

• Master of Technology or PhD degree in Biotechnology, Bio-chemical engineering, Bioprocess Engineering or a related discipline with 4-6 years, or 2-4 years of relevant industrial experience respectively
• Experience in microbial fermentation/cell culture operations and recovery processes, including shake flask expansion, small and large scale fermenter/bioreactor production, scale-up/scale-down, and process transfer
• Hands-on experience in handling equipment such as glass fermenters, autoclave, analytical HPLC, and tangential flow filtration (TFF) systems
• Ability to work and collaborate in cross functional teams such as research, development, and manufacturing in a fast pace and dynamic team setting
• Ability to think critically, demonstrate troubleshooting and problem-solving skills
• Ability to independently make decisions based on data, scientific knowledge, and sound judgement
• A can-do attitude, intellectual curiosity, strong time management skills, a sense of ownership of work, and the ability to be flexible to business needs
• Ability to adapt to a fast-paced environment and able to adjust workload based upon changing priorities
• A clear willingness to “roll up their sleeves” and dive into the details
• Ability to work in shifts
• Ability to lift up to 20 kgs

Nice to have:

• Previous experience of working with flexible schedule
• Knowledge of current process technology trends in the field
• Experience with automation technologies is desired

We look forward to hearing from you