Assistant General Manager or Senior Manager- Downstream Processing

Role & responsibilities

• Provide technical leadership for GMP manufacturing of downstream unit operations for purification of monoclonal antibodies (mAbs).
• Have significant understanding in development of mAb purification processes.
• Implementation of efficient downstream purification processes in GMP for monoclonal antibodies derived from mammalian cell cultures, with a focus on biosimilars and novel biotherapeutics.
• Maintain meticulous documentation practices and ensure timely and high-quality record-keeping.
• Collaborate closely with cross-functional teams for smooth functioning,
• Coordinate with upstream process, analytical QC, and QA teams as and when needed.
• Supervise and train junior scientists on various aspects of downstream purification.
• Well experienced in managing unit operations in GMP including assessment of hold time stability of process streams in each purification operation.
• Should be focused on assessing recent technologies for manufacturing of Biologics drugs for purification of mAbs.
• Overseeing and maintenance of all purification skids/columns available GMO facility.
• Should have strong understanding of softwares used for automation of purification operations.
• Must be focused on usage of Continuous manufacturing for biologics drug development.
• Develop and maintain a highly capable and dedicated technical staff. Guide subordinates in carrying out responsibilities and mentor them in their professional development

Core Competencies:

Drive for results

• Highest integrity, committed to ethics and scientific standards.
• Uses an approach to address the task or situation such as delegation, planning, timelines.
• Perseveres to find ways to work through localized challenges or barriers.

Building Effective Teams

• Empowers team members and encourages them to contribute their skills/ideas.
• Gets the right talent mix for the task. Shares credit and celebrates wins.

Process Management

• Strong organizational skills, including the ability to prioritize personal and direct reports workload.
• Abreast with the latest technical innovations and familiarity with Regulatory expectations
• Simplifies complex processes.
• Makes process improvements where value addition is relevant and important.
• Resourceful, uses resources and people wisely.
• Be data driven if providing solutions to challenges also should have the ability to take calculated risks and manage the risks in the most transparent manner.
• Very good understanding and implementation of the best documentation practices including paper and electronic record keeping.
• Sufficient industry experience in handling cross functional interactions.
• Resolving inter departmental challenges through a process of strong rationale while adhering to the expectations of the requirements of different functional groups.

Preferred candidate profile:

• BE in Biochemical Engineering or Chemical Engineering, MTech in Biochemical Engineering/Biological Sciences, Masters in Biochemistry or Biotechnology with 14 to 18 years GMP manufacturing from mammalian cell lines in biopharma/biotech or relevant contract research labs.
• Preference will be for personnel who have prior experience in leading a team in biopharma organizations that focus on mAb downstream unit operations.
• Experience in mammalian downstream unit operations in a GMP setting is highly desirable.
• Experience of leading and managing a team in the bio-pharma industry is very much preferred.
• Should have a strong understanding on in process controls for deriving the mAb of acceptable product quality for human use.
• Technical competence in appropriate scientific discipline or technology will be of great value.
• Cross functional technical knowledge is highly desirable.
• Excellent oral and written communication and interpersonal skills will be desired.