Sr Research Associate, Technical Services

Paladin Labs Inc.; Hinoba-an; On-site; PHP 600,000 - 900,000; Full time

Job summary

Par Health is seeking a Senior Technical Services Associate to lead technology transfer activities, documentation, and filing support across the product lifecycle. You will coordinate submissions, site transfers, and validation, align cross-functional teams, and ensure timely execution while maintaining cGMP standards.

This role emphasizes meticulous document control and collaboration with QA, regulatory, and manufacturing to enable on-time launches.

Responsibilities

• Coordinate technology transfer submissions and site transfer activities.
• Prepare and finalize documents and processes for site execution.
• Align team members and cross-functional teams to meet timelines.
• Update project details in daily, weekly and monthly meetings.
• Perform risk evaluation and gap analysis to determine batch sizes and prerequisites.
• Review and approve engineering, submission and validation documents; participate in gate reviews.
• Monitor batches according to timelines and market needs.
• Prepare placebo and coordinate QC testing as required.
• Support regulatory filings with required documentation.
• Handle investigations to improve quality documentation and propose next steps.
• Manage CMC queries to support timely product approval and readiness for launch.
• Provide commercial support throughout product lifecycle.

Job description

Job Description Summary Senior Technical Services associate for handling of technology transfer activities of execution, documentation, filing support and other activities as responsible.

Job Description Primary Responsibilities:

Co-ordination, Communication and Smooth Execution for Technology Transfer Activities:

• a) Co-ordination, Communication for the Technology Transfer of Submission, Site transfer, Validation and lifecycle management of products.
• b) Evaluation, preparation, optimization and finalizing the documents & process for successful execution and implementation at site.
• c) Aligning the team members and CFT’s to achieve organizational goals through discussion to meet the timelines.
• d) Participating in updating the project details in daily, weekly and monthly meetings.
• e) Risk evaluation and gap analysis of projects & finalizing the batch sizes to initiate the procurement of prerequisites before commencement of project at site.
• f) Preparation, review and approval of engineering, submission and validation batch documents and preparation and participating in gate meeting and project discussions.
• g) Monitoring of engineering, submission and validation batches as per the timelines and market requirement.
• h) Preparation of placebo and submitting the same to QC for testing as per project requirement.
• i) Support for regulatory filings for the required documentation.
• j) Handling of investigations to make quality documentation and to suggest the way forward .
• k) Handling of CMC queries to get the product approval on time and to make readiness for on time launch.
• l) Commercial support throughout the product lifecycle management.

Other Activities.

• a) Audit compliance.
• b) Ensuring cGMP at site level.
• c) Risk evaluation for Nitrosamine impurities.
• d) Following and implementing the organization values during day-to-day activities.

Secondary Responsibilities:

• a) Awareness of EHS policy, significant environment aspect & impacts associated with workplace and contribution to environment management system.
• b)Supporting to the cross functional team during Audit and performing internal Audits (Qualified auditor).
• c)Responsible to follow and ensure the procedures pertaining to the environmental management system.
• d)Responsible to keep the workplace neat and clean.

Come join us!

At Par Health, we believe great healthcare is built on getting the essentials right. We’re looking for passionate, talented individuals who share our commitment to improving lives. With a global workforce, we lead with pride and purpose—prioritizing quality and safety while fostering a culture of continuous improvement, accountability, and teamwork. Elevating the Essentials isn’t just our tagline, it’s the higher standard we live by every day.