Senior Bioassay Scientist

Piramal Group; Falkirk; On-site; GBP 40,000 - 70,000; Full time

Job summary

An established industry player seeks a dedicated professional to join their team in Falkirk. This role focuses on bio-analytical methods and project delivery, ensuring compliance with regulatory standards while optimizing resources. You will lead projects, support teams, and maintain high-quality standards in a collaborative environment. If you are passionate about scientific excellence and thrive in a dynamic setting, this opportunity offers the chance to make a significant impact in the field of pharmaceuticals.

Qualifications

• Expertise in bio-analytical techniques is essential.
• Strong organizational and prioritization skills are required.
• Effective communication skills are necessary for client interactions.

Responsibilities

• Lead and support projects for method development and validation.
• Ensure compliance with SOPs and regulatory standards.
• Manage Bio-Assay equipment and provide training to staff.

Skills

Bio-analytical techniques

Effective communication

Organizational skills

Problem-solving skills

Attention to detail

Job description

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Job Description

KEY ROLES/RESPONSIBILITIES:

Departmental Operations:

• Establish priorities and perform work as agreed with Bio-Assay Management, ensuring efficient completion of objectives.
• Serve as in-house expert for bio-analytical methods.
• Lead and support projects for method development, qualification, validation, routine QC release, and stability data, ensuring compliance with SOPs, protocols, cGMP, and regulatory standards.
• Maintain laboratory areas in compliance with client, GMP, and safety requirements, ensuring cleanliness and inspection readiness.
• Calibrate equipment, perform maintenance, and inform relevant personnel of failures.
• Ensure equipment, facilities, and materials meet defined standards at all times.
• Provide training and troubleshooting support to Development and Quality Control teams.
• Review data for Data Integrity compliance.
• Lead compliance and improvement projects as needed.
• Optimize resource use, propose cost reduction measures, and contribute to safety, GMP, and efficiency improvements.
• Support and train new staff members.
• Assist in tracking measures and targets related to release, stability, development, transfer, validation, troubleshooting, deviations, change control, and commitments.
• Support equipment introduction through IQ/OQ/PQ and comparison studies.
• Manage Bio-Assay equipment, including calibration, reviews, and maintenance.

Project Delivery:

• Plan workloads to ensure timely project completion.
• Lead projects and teams as appropriate.
• Oversee development, transfer, qualification, validation, and technical support for bio-analytical methods.
• Coordinate work to meet customer timelines.
• Communicate with clients and provide technical advice on biological assay requirements.
• Handle QC release testing, stability testing, method development, validation, transfer, and troubleshooting.
• Schedule routine testing to meet deadlines.
• Provide backup for team members and maintain professional client communication.

Quality:

• Own and close deviations, investigations, change controls, and commitments promptly.
• Escalate OOS results or deviations immediately.
• Apply cGMP practices for testing and release of products, ensuring Data Integrity and compliance with regulations.
• Uphold GMP and ESH standards, seeking continuous improvement.
• Document all work accurately and prepare technical reports.
• Follow protocols and procedures diligently.
• Ensure raw data accuracy and proper documentation.
• Update SOPs and related documentation.
• Contribute to audit readiness and continuous improvement initiatives.

Qualifications & Key Competencies:

• Expertise in bio-analytical techniques.
• Ability to work cooperatively in a team.
• Effective communication skills.
• Strong organizational and prioritization skills.
• Customer-focused attitude.
• Attention to detail.
• Problem-solving skills.

About Us

Piramal Group has grown through organic and inorganic strategies, driven by core values of inclusive and ethical growth.

Equal Employment Opportunity

We are committed to diversity and equal opportunity in employment, considering qualifications, skills, and performance without discrimination.

About the Team

Piramal Pharma Solutions (PPS) is a CDMO providing comprehensive development and manufacturing solutions globally, including biologics, APIs, and specialized services, serving innovators and generic companies worldwide.