Process R&d-senior Principal Investigator Job in Syngene International Limited

Designation: Process R&D Senior Principal Investigator

Job Location: Bangalore

Department: Chemical Development

About Syngene

Incorporated in 1993, Syngene International Ltd. is an innovation-focused global discovery, development and manufacturing organization providing integrated scientific services to the pharmaceutical, biotechnology, nutrition, animal health, consumer goods and specialty chemical industries around the world. Syngene s clientele includes world leaders such as Bristol-Myers Squibb, Baxter, Amgen, GSK, Merck KGaA and Herbalife. Its innovative culture is driven by the passion of its 4240- strong team of scientists who work with clients from around the world to solve their scientific problems, improve R&D productivity, speed up time to market and lower the cost of innovation.

Job purpose

To develop a process for Oligonucleotide API/drug substance. To ensure smooth Tech transfer activities from lab to plant using sound process engineering principles of oligonucleotides, phosphoramidites, nucleic acid synthesis

Key Responsibilities:

• Lead and mentor a team of approx 10 scientists including Ph.D level team leads.
• Provide scientific and operational leadership, drive project progression, manage resources and infrastructure requirement.
• Nurture creative and innovative solutions to technical problems backed by a sound understanding of fundamental scientific principles in the team.
• Process development for Oligonucleotide API/drug substance
• Independently handling automated oligo synthesis using solid phase eg. OP100, and take responsibility to troubleshoot in case of challenges
• Tech transfer from lab to plant using sound process engineering principles of oligonucleotides, phosphoramidites, nucleic acid synthesis
• Optimization and scale up of oligonucleotides (solid phase synthesis) processing method from Lab scale to manufacturing scale
• Interpretation of HPLC/LCMS analysis of oligonucleotides (ESI, MALDI-TOF, Orbitrap, APCI, Q-TOF, MS/MS tec
• Focus on the deliverable of the project right from initiation to end.
• Evaluate RFPs technically and work with BD to provide proposals to new and existing clients
• Lead and manage a team to develop a new process for oligonucleotides
• Manage and develop team through scientific learning and development for Oligonucleotides,
• Communicate seamlessly with the client and provide them the necessary data, take inputs and drive the project to ensure customer satisfaction
• Ability to work with the leadership and management team
• Regulatory knowledge (US-FDA, European FDA etc.,) for the development of Oligonucleotides
• 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 team

Educational Qualification:

Ph.D. in Organic Chemistry or Chemical Engineering. from premier institutes in India or abroad, with post-doctoral experience in US/EU/Japan.

Technical/functional Skills:

• Industrial experience in the fields of Oligonucleotides, pharmaceuticals, Intermediates and Process R&D. Global exposure is preferred
• Fundamental synthetic organic chemistry and oligonucleotide knowledge with an ability to propose synthetic routes rapidly that is safe and scalable.
• Fundamental process research knowledge including route scouting and evaluation.
• Process optimization and development skills at par with customer/global standards for late phase targets.
• Basic knowledge in process engineering, particularly in unit operations

Experience:

9-12 years of Industrial experience in the fields of custom synthesis, pharmaceuticals, Intermediates and Process R&D, particularly in late phase development. Global exposure is preferred.

Behavioural 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.