Senior Manager – Protein Development

4 days ago

Anantapur, Andhra Pradesh, India beBeeAlbumin Full time ₹ 2,00,00,000 - ₹ 2,50,00,000
About the Job

We are seeking a visionary expert in albumin and immunoglobulin production to lead our biologics manufacturing program into the future.

As a consultant, you will play a key role in designing and scaling manufacturing processes for albumin and immunoglobulins, advising on technology selection and facility setup, ensuring compliance with regulatory guidelines, and implementing quality assurance systems.

This is an exceptional opportunity to shape the direction of our company and contribute to the development of cutting-edge biologics manufacturing solutions.


Responsibilities
  1. Design and scale manufacturing processes for albumin and immunoglobulins.
  2. Advise on technology selection and facility setup.
  3. Ensure compliance with cGMP, FDA, EMA, DCGI, ICH, and WHO guidelines.
  4. Implement quality assurance and quality control systems.

Requirements
  1. Advanced degree (M.Sc./Ph.D. in Biotechnology, Biochemistry, or related field).
  2. 10+ years' experience in biologics manufacturing, with specific expertise in albumin and immunoglobulins.
  3. Proven track record in large-scale plasma fractionation or recombinant protein production.
  4. In-depth knowledge of regulatory frameworks (FDA, EMA, DCGI, ICH, WHO).
  5. Strong leadership qualities with the potential to scale into a director role.

Bonus Skills
  1. Experience engaging with regulatory authorities.
  2. Familiarity with intellectual property, licensing, and compliance in biologics.
  3. Knowledge of market access and global trade regulations.

Location

[on-site/hybrid/remote consulting acceptable initially]


Engagement Terms
  1. Phase 1: Consultant (part-time/flexible, project-based).
  2. Phase 2: Full-time Director of Albumin & Immunoglobulin Production.

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