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Principal Investigator-Process development for oligonucleotide

10.00 to 14.00 Years   Delhi   23 Feb, 2021
Syngene International Limited
Job LocationDelhi
EducationNot Mentioned
SalaryNot Disclosed
IndustryEducation / Training
Functional AreaBio Tech / R&D / Scientist
EmploymentTypeFull-time

Job Description

  • Responsible for Process development for oligonucleotide API/drug substance
Key Responsibilities:
  • Process development for oligonucleotide API/drug substance.
  • Independently handling automated oligo synthesis using solid phase eg. OP100, Mermade etc., 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 oligonucleotide API (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 etc.)
  • Process engineering troubleshooting, data interpretation using advanced software for oligonucleotides.
  • Regulatory knowledge (US FDA, European FDA etc.) for the development of oligonucleotides.
  • 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 of 10-15 persons to develop a new process for oligonucleotides.
  • Manage and develop team through scientific learning and development for oligonucleotides.
  • Communicate seamlessly with the client, provide them with the necessary data, take inputs and drive the project to ensure customer satisfaction.
  • Ability to work with leadership and management team.
  • 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
  • Attend training on environment, health, and safety (EHS) measures imparted company
Educational Qualification: Ph.D. in Organic Chemistry from premier institutes in India or abroad, with post-doctoral experience in US/EU/Japan.Technical/functional Skills:
  • Hands-on experience in protecting/deprotecting group chemistry of nucleosides/nucleotides, phosphoramidites, oligonucleotides etc.
  • Sound knowledge of oligonucleotide synthesis eg. amidite coupling, detritylation, oxidation, thiolation etc., using solid-phase/solution-phase synthesis.
  • Sound knowledge of cleavage and deprotection conditions, purification, lyophilization etc. for oligonucleotides.
  • Strong experience in working with wide-ranging oligo reagents eg. activators, deblocking agents, thiolating/oxidizing reagents, capping reagents, solid support resins etc.
  • Good exposure to various oligonucleotides such as siRNA, antisense, miRNA, aptamers, branching oligonucleotides, oligonucleotide-conjugates eg. GalNac, Vit.E, cholesterol or peptides.
  • Good working knowledge and experience in handling preparative or buffer based HPLC/LPLC.
  • Adequate knowledge of analytical techniques like HPLC, UPLC, GPC etc. for oligonucleotide applications.
  • Good organizational skills and hands on experience.
  • Excellent in computational skills using various software eg. Unicorn, for synthetic oligonucleotides.
  • In-depth knowledge of cGMP or cGXP in oligonucleotides synthesis.
  • Ability to work in an industrial set-up involving cross-functional teams from QC, QA, production etc. in synthetic large molecule area.
  • Excellent technical writing and documentation skills.
  • Excellent communication skills and capable of interacting with multiple clients.
  • Ability to handle a team of scientists, plan the work and progress the project from the technical front.
Experience:10-14 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.
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Keyskills :
researchchemistryclient handlingcompliancecoreequal employment opportunitycontinuous improvement facilitationnucleic acidanimal healthconsumer goods

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