Job Opening: Apprentice Trainee - Microbiologist (API Industry) Details are Provided below 1. Company: Asence Pharma Pvt 2. Department: Quality Control -Microbiology 3. Location: Ranoli, Vadodara 4. Role Overview: Company is looking for a dedicated and enthusiastic Apprentice Trainee - Microbiologist to join their Quality Control Microbiology team. This role offers a great opportunity to gain hands-on experience in microbial analysis, environmental monitoring, and aseptic techniques in an API manufacturing environment. 5. Eligibility: B.Sc. / M.Sc. in Microbiology or Biotechnology 6. Key Responsibilities: -Perform environmental monitoring (EM) of cleanrooms -Carry out microbiological testing of raw materials, water, and finished products -Maintain proper documentation as per GMP guidelines -Assist in validation and sterility assurance activities -Adhere to safety and quality procedures 7. How to Apply: Send your updated resume to hr@asence.com with the subj...
Johnson & Johnson Requires Senior Scientist, Cell & Gene Therapy API
Job title- Senior Scientist, Cell & Gene Therapy API
Function- Discovery & Pre-Clinical/Clinical Development
Sub function - Biotherapeutics R&D
Category - Senior Scientist, Biotherapeutics R&D (ST6)
Location - Malvern, Pennsylvania, United States
Date posted -
Requisition number - 2406221755W
Description
Johnson & Johnson is currently seeking a Senior Scientist, Cell & Gene Therapy API, to join our team located in Malvern, PA.
The candidate will join the Virology team to involve in and innovative API development activities for Cell & Gene Therapy programs. The role will include all aspects of API development work from platform evaluation, DS process development to viral safety and viral clearance. Working closely with functional teams within J&J Innovative Medicine, this individual is expected to be a key leader for viral safety and viral clearance studies. S/He will be accountable for driving viral safety investigations, virology related health authority quires, evaluate new technologies and platform for API development, and drive scientific excellence for the technical platforms. The candidate should be strongly motivated and dedicated, show initiative, and work independently. Troubleshooting skills are essential. They will demonstrate urgency, be organized, can work well in a team setting, show leadership and be sensitive to timelines. The scientist will effectively and frequently collaborate with colleagues in the API Cell & Gene Therapy function, as well as with multidisciplinary teams at J&J to successfully drive various programs.
Key Responsibilities:
- Oversee viral safety and viral clearance studies for investigations and regulatory requests for Cell & Gene Therapy programs and Biologics.
- Adapt NGS platform for Viral safety studies to meet evolving regulatory guidelines.
- Analysis of Nextgen sequencing data for viral safety evaluation.
- Design and execute complex and scientifically demanding experiments for projects within the framework of a small team. Provide high quality data in a timely fashion, including drafting and executing technical reports.
- Partner effectively with stakeholders & partners for API related activities. Drive initiatives to increase speed and flexibility, as well as efficiency, of development processes through consistent demonstration of scientific rigor and operational excellence.
- Work closely with CRO/CDMO companies to coordinate and manage external studies to advance projects.
- Manage multiple experiments/projects simultaneously.
- Contribute on various projects outside of their own and collaborate with stakeholders from all relevant functions.
- Provides scientific and technical expertise to support process development activities of Cell & Gene Therapy programs. Tech transfers to ensure processes are successfully scaled-up.
- Keep up to date with the literature related to their field. Act as an expert resource in their scientific field and in related disciplines.
Qualifications
Required:
- A PhD in Virology with 4+ years of research experience in Viral vector engineering, Viral safety, Viral clearance, Gene Therapy, Process development of biologics, and Bioinformatics. 3+ years of pharmaceutical industry experience is required.
- CMC experience in drug substance process development, including quality and regulatory filings.
- Hands-on experience in Virology, Cell and Molecular biology techniques (transfections, transductions, qRT-PCR, ELISA, Plaque assays, virus neutralization assays) is required.
- Experience with Next Generation Sequencing platforms and data analysis pipelines
- Critical thinker with excellent time management and delivery focus, able to independently strategize and design/execute and accurately interpret complex scientific experiments and data at a group level across multiple programs is required.
- Highly motivated self-starter, proactive and able to excel within a matrix organization is required.
- Fluent in written and spoken English with excellent communication, interpersonal and collaborative skills is required.
- This role is based in Malvern, PA and may require 10% travel.
Preferred:
- Experience in the regulatory filing and addressing health authority requests
- cGMP knowledge
- Experience in working with cross-functional teams
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