Manager Downstream Mabs (Biologics)

Manager Downstream Mabs (Biologics)

Bvr People Consulting

Manager Downstream Mabs (Biologics)

Details of the offer

Job description:
The purification team plays a key role in the development of manufacturing processes for biologics. The candidate will be a team lead in the purification team and will be responsible for developing and characterizing purification processes to be scaled - up to the manufacturing facility. This role requires operating in a matrix team environment of process and in - process analytical scientists. The lead will supervise a team working on projects for end to end development, characterization, scale up and validation support.

Key Responsibilities:

1. Managing & Co-ordination of CMC Downstream for a project. Lead a team of scientists and interns.
2. Co- ordination with Senior Management and inter departments ( MSAT, QA & Production group ) for technical updates relative to process development, technology transfer and process improvements.
3. Use DOE approach and past experience to plan experiments for process development, process characterization & process improvement of DSP Operations (Chromatography & filtration).
4. Identify gaps and scope of improvement in the process, workflow; improvements for COGs reduction; Formalize the strategy for advancements.
5. Technical & functional risk analysis and mitigation.
6. Assimilate data from multiple sources and projects to analyze the outcome of experiments.
7. Comparative data evaluation with manufacturing scale batches to define ranges and specifications.
8. Review of critical technical documents supporting regulatory submissions.
9. Identification of intection with external consultants for technical and regulatory advisories.
Education & Experience:

M.Tech/Phd Chemical Engineering, Bioprocess technology, Biochemical Engineering with 5 to 10 Years of Experience in process Development, process characterization and/or scale up of purification processes for biologics.

Technical & soft skills requirements:

1. Comprehensive knowledge of Chromatography and filtration theory and techniques and protein chemistry.
2. Strong communication, Inter- personal, presentation, technical authoring and motivational skills.
3. End to End knowledge in CMC Development.
4. Expertise in DOE and analytical techniques.
Salary: Not Disclosed by Recruiter
Industry: Pharma / Biotech / Clinical Research
Functional Area: Medical, Healthcare, R&D, Pharmaceuticals, Biotechnology
Role Category: R&D
Role: Bio-Technical Research Associate/Scientist
Employment Type: Full Time, Permanent

process development purification processes MABS technology transfer protein chemistry Chemical Engineering Chromatography process improvements filtration CMC Team Leading DOE Downstream

Desired Candidate Profile
Education:UG -B.Tech/B.E. - Bio-Chemistry/Bio-Technology, Biomedical, Chemical
PG - M.Tech - Chemical, Bio-Chemistry/Bio-Technology, Biomedical
Doctorate - Ph.D - Advertising/Mass Communication

Company Profile

BVR People Consulting

BVR people consulting committed to help Organisations to realise and develop their full potential in order to compete in the present day globalised and technology driven business environment. BVRPC invigorates the key components of organizations - The People and The Processes. It is our endeavour to facilitate this process of Rejuvenating Organisations through a variety of customised, innovative and practical solutions that bring about positive attitudinal shifts, while driving organisations to re-assess their true potential. These solutions are designed based on a thorough Diagnosis and Need Audit of the organisation. We work with our clients as partners and a team. Our solutions are tailored for each client's unique needs and business context, and are designed to ensure that clients get the best return on their investment.


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