Senior Manager

Lambda Therapeutic Research Ltd.; Ahmedabad District; On-site; INR 2,800,000 - 3,300,000; Full time

Job summary

Lambda Therapeutic Research Ltd., a leading CRO headquartered in Ahmedabad, India, seeks a senior leader to design, execute, and analyze upstream mAb processes in a Process Sciences group. The role involves leading a team, driving DS development and virus clearance validation, and collaborating with cell culture for seamless transfer to manufacturing.

Strong regulatory knowledge is essential. The candidate should have 10–18 years of experience in mammalian upstream unit operations within

Qualifications

• Experience in mammalian upstream unit operations in a Process Development R&D setting.
• Strong leadership experience in biopharma or CRO environments.
• Familiarity with regulatory expectations and quality systems.

Responsibilities

• Provide technical leadership for upstream unit operations for monoclonal antibodies (mAbs).
• Lead and manage a team for multiple upstream unit operations.
• Drive DS stability and virus clearance validation using QbD approaches.
• Transfer processes with cell culture teams for mAb manufacturing.
• Identify and implement cost-effective newer upstream technologies.

Skills

Mammalian Upstream

Team Leadership

Process Development

QbD Knowledge

Automation software

Education

BE in Biochemical/Chemical Eng

MTech/MSc in Biochemical Eng/Biol Sci with PhD

Job description

Select how often (in days) to receive an alert:

Company: Lambda Therapeutic Research Ltd.

CTC Range (INR): 2800000 - 3300000

ORGANISATIONAL OVERVIEW

We, Lambda Therapeutic Research Limited are a leading global Clinical ResearchOrganization (CRO) headquartered in Ahmedabad – India, with facilities and operations in Mehsana (India),Warsaw (Poland), London (UK), Pittsburgh (USA), Las Vegas (USA) and Fargo (USA). Over 1500 employees areworking across the globe in these facilities.

Lambda offers Full-spectrum clinical trial solutions empowered by more than 20 years of service to thebiopharmaceutical and generic industry. At Lambda, our gamut of services under the clinical research domainare executed with comprehensive efforts, to deliver positive results. Led by a management team of highlyqualified & experienced industry leaders, we apply innovative technologies, therapeutic expertise, and acommitment to quality to help clients develop products safely, effectively, and quickly.
Delivering the best accomplished by hiring the best. Employees are the pillars that hold up every quality promisethat we make. That is why, we at Lambda are always looking for qualified and energetic individuals, with a desirefor excellence, to join our team.

JOB DETAILS

The candidate should play a crucial role in designing, executing, analysing experiments related to development of mAb upstream processing function within the Process Sciences group. The role entails utilization of the prospective candidate’s vast technical experience to lead a team that will be focused on multiple unit operations for upstream monoclonal antibodies for manufacturing of drug substance of clinical grade product quality.

KEY DELIVERABLES

• Provide technical leadership for process development of upstream unit operations for manufacturing of monoclonal antibodies (mAbs).
• Have significant understanding in development of mAb upstream processes.
• To strengthen the capabilities to develop in depth understanding of upstream process development, consistency batches, generation of DS for pre-clinical and clinical studies, virus clearance validation, process improvement, process characterization using QbD approach and process capability studies.
• Well experienced in managing unit operations in GMP including assessment of hold time stability of process streams in each upstream operation.
• Must actively work with the cell culture team in transferring the process for mAb manufacturing.
• Should be focused on assessing recent technologies for development of cost-effective newer technologies for manufacturing of mAbs.
• Should have strong understanding of softwares used for automation of upstream operations.

ALLIED RESPONSIBILITIES

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

EXPERIENCE

• Experience in mammalian upstream unit operations in a Process Development R&D 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.
• Should have conceptual understanding on defining critical product quality attributes and its relevance to DS stability.
• Significant experience in upstream process of different mAbs. Working knowledge of upstream process of receptor fusions etc. will be valued.
• 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.

EDUCATIONAL QUALIFICATION

• BE in Biochemical Engineering or Chemical Engineering, MTech/M.Sc. with PhD in Biochemical Engineering/Biological Sciences with 10 to 18 years developing mAb upstream processes from mammalian cell lines in biopharma/biotech or relevant contract research labs.
• Preference will be for personnel having prior experience in leading a team in biopharma organizations that focus on mAb upstream unit operations.