Biocon Biologics Chemistry/Pharmacy Job – Candidates Apply
Biocon Biologics Job. Biocon Biologics is looking for candidates for the Technical Services Lead for CMOs post in the QC bioassay & Molbio Department with experience. Some skills are desired for this post which are mentioned below.
Job Title: Technical Services Lead for CMOs
Location: Bengaluru, Karnataka, India
Qualifications
- A Bachelor’s / Master’s degree preferably in Pharmacy/Chemistry/Biotechnology
- Minimum of 10+ years related work experience in the pharmaceutical industry
- Thorough knowledge of fill finish is mandatory
- Demonstrated record in tech transfer essential
- Knowledge of Regulatory requirements, ICH standards & guidelines, applicable Standard Operating Procedures
- Must possess good interpersonal skills to establish effective working relationships that are critical in a team environment
- Travel to other contract manufacturing sites needed
Responsibilities:
- Manage Technology transfer activities for clinical/validation and commercial products into commercial manufacturing facility
- Develop projects plans that integrates with other scheduling functions within the organization
- Ensure cross functional communication to key stakeholders for any given project/task and that input are received
- Proactively inform Senior management of milestone progress and any potential program delays
- Ensure project execution is performed in compliance to existing procedures
- Ensure deliverables from process leads (e.g., Process Validation reporting) to regulatory filings. Communicate review and approval timelines to management pursue an intensive collaboration with the Pharmaceutical Development and Manufacturing as well as the Pack & Label teams, Technical Integrators, Design Leads and Production Management to ensure production, operation, troubleshooting, non-conformance and change management.
- Coordinates the preparation of the manufacturing site for the manufacture of new products. Communicates as necessary with the various plant departments, other support departments, project team members, and other internal customers.
- Provides information and documentation needed for regulatory submissions or responses as required. Provides technical assessment of changes in manufacturing through appropriate review of documentation and testing resu
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