Sr Scientist, Upstream Processing

Raspa Pharma Pvt. Ltd.; Lucknow; In loco; INR 1.200.000 - 1.800.000; Tempo pieno

Descrizione del lavoro

Raspa Pharma Pvt. Ltd. is seeking 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 laboratory and reports to the CEO.

You will design experiments, transfer processes to pilot and commercial scales, and develop robust SOPs in line with EU-GMP and FDA standards. Strong leadership and cross-functional collaboration are essential.

Competenze

• Master’s or PhD in Biotechnology or Bioprocess Engineering with 4–6 years of experience, or 2–4 years in an industrial track.
• Experience in microbial fermentation/cell culture operations and recovery processes.
• Hands-on experience with glass fermenters, autoclave, analytical HPLC, and tangential flow filtration (TFF).
• Ability to work cross-functionally in fast-paced teams and think critically.

Mansioni

• Design, execute, and analyze experiments for upstream process development and optimization.
• Lead tech transfer and scale-up from lab to pilot and commercial scale.
• Set up SOPs aligned with EU-GMP and FDA standards.
• Guide cross-functional teams in strain improvement and process scale-up.
• Author regulatory sections and maintain critical data for senior management.

Conoscenze

Bioprocess engineering

Cell culture

Fermentation

HPLC

TFF

DOE

SPC

Automation

SOP writing

Team leadership

Formazione

MTech/PhD in Biotechnology

Strumenti

Autoclave

Glass fermenters

HPLC

TFF

Descrizione del lavoro

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