Job Title:  Manager - Downstream Processing

ORGANISATIONAL OVERVIEW

We, Lambda Therapeutic Research Limited are a leading global Clinical Research Organization (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 are working across the globe in these facilities.

Lambda offers Full-spectrum clinical trial solutions empowered by more than 20 years of service to the biopharmaceutical and generic industry. At Lambda, our gamut of services under the clinical research domain are executed with comprehensive efforts, to deliver positive results. Led by a management team of highly qualified & experienced industry leaders, we apply innovative technologies, therapeutic expertise, and a commitment 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 promise that we make. That is why, we at Lambda are always looking for qualified and energetic individuals, with a desire for excellence, to join our team.

JOB DETAILS

• Provide technical leadership for DP formulation and lyophilization development and characterization wrt to strategy, designing, executing, and analyzing experiments for Drug substance and Drug product mAb formulation processing within the Process Sciences group.
• Strong understanding of design of formulation studies and selection of appropriate excipients for different dosage forms (liquid/lyo) and stability studies to design and develop suitable formulation in the appropriate container closure and DP dosage form (liquid/lyo) and possessing desired physico-chemical characteristics.
• Independently conduct DOE based screening experiments with high throughput formulation development, analyze experimental data, and optimize formulation compositions.
• Perform forced product degradation studies.
• Responsible for preparing technical documentation, such as protocols and reports, SOPs, and presentations, to support the technology transfer of processes to larger scales.
• Work closely with cross-functional teams to ensure smooth operations.  Coordinate with downstream process, analytical, and QA teams as and when required.
• Strong understanding of DS & DP unit operations like freeze/thaw, filtration, filling, lyophilization.
• Focus on evaluating new technologies to develop cost-effective DP formulation.
• Ensure precise documentation practices and maintain timely, high-quality record-keeping.
• Good collaboration skills with clients.
• Coordinating with suppliers for raw material-related inventories and selection, investigations, raw material changes, and equipment discontinuation/upgradation.
• Responsible for authoring and reviewing technical reports related to drug products and contribute to regulatory submissions and audits with health agencies.
• Ensuring safety of self, teams and lab/plant as per safety requirement and following environment, health, and safety (EHS) requirements always in the workplace
• Any other work assigned by the reporting manager based on experience and expertise.
• To actively participate in the QMS implementation of the FDL & DPM labs.
• To support and attend Internal/External Project Meetings, Client calls as applicable.
• Handling Internal audits, Client audits and Regulatory Audits pertaining to CDMO, Lambda. Review and finalization of Internal/ External Audit Reports.
• Ensuring all time audit readiness and preparation prior to audits.
• Perform an internal self-inspection program to ensure compliance and data integrity is maintained all the time. Conduct internal and external audits to ensure compliance with Good Manufacturing Practices (GMP) and other regulatory requirements. Oversee investigations of non-conformances and deviations.
• Contribute to publications / IP around formulations.
• Ensure all assigned mandatory training related to data integrity, health, and safety measures are completed on time by all members of the team including self.

EXPERIENCE

• Strong understanding of design of formulation studies and appropriate excipients for different dosage forms (liquid/lyo) and stability studies
• Strong understanding of DP unit operations like freeze-thaw, filling, filtration, mixing, lyophilization, container closure integrity testing and packaging operations is desirable.
• Cross functional technical knowledge is highly desirable.
• Excellent oral and written communication and interpersonal skills will be desired.

EDUCATIONAL QUALIFICATION

Masters or Ph.D  in Chemical/Biochemical Engineering or similar disciplines with 5+ years of work experience in drug product formulation development and manufacturing.