Senior Bioassay Scientist

Piramal Pharma Ltd; Falkirk; On-site; GBP 40,000 - 80,000; Full time

Job summary

An established industry player is seeking a Senior Bioassay Scientist to join their dynamic team. This pivotal role involves leading method development, qualification, and validation studies for biological assays while ensuring compliance with regulatory standards. You will act as an in-house expert, providing training and support to teams, and engaging in projects that enhance laboratory efficiency and safety. If you are passionate about scientific excellence and looking to make a significant impact in the pharmaceutical field, this opportunity is tailored for you.

Benefits

Health insurance

Flexible working hours

Professional development opportunities

Team building activities

Qualifications

• Expertise in bio-analytical methods and techniques.
• Strong background in project management and compliance.

Responsibilities

• Lead method development and validation studies for biological assays.
• Ensure compliance with GMP and regulatory standards.

Skills

Bio-analytical techniques

Project management

Data integrity compliance

Team collaboration

Problem solving

Education

PhD in Life Sciences

Master's in Biotechnology

Tools

Laboratory equipment

SOP documentation

Job description

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Join to apply for the Senior Bioassay Scientist role at Piramal Pharma Ltd

• Establish day-to-day priorities and perform assigned work as agreed with the Bio-Assay Management. Ensure efficient use of time to complete the assigned objectives.
• Act as in-house expert for bio-analytical methods.
• Lead and support projects to deliver method development, qualification and validation studies, routine QC release and stability data for biological assays according to defined SOPs and protocols. In compliance with best cGMP working practices and techniques, ensuring the data and reports are suitable for regulatory filings.
• Maintain laboratory areas, ensuring procedures are complied with to meet client, regulatory GMP and safety requirements. Be accountable for the bioassay laboratories being clean, tidy and well-organised and in a state of continuous inspection readiness.
• Execute calibration of equipment and instruments, informing relevant personnel in a timely manner of any failure of calibration. Carry out general maintenance and housekeeping of equipment.
• Ensure that at any time equipment, facilities and materials used in the area of responsibility comply with defined standards.
• Provide training and troubleshooting support to Development and Quality Control groups as required.
• Check and review data in compliance with Data Integrity requirements.
• Engage in and lead specified compliance and improvement projects, as necessary.
• Ensure economic use of labour, materials, energy and services, proposing and implementing measures for cost reduction and waste minimisation to meet the department and site targets.
• Contribute to the management of the laboratory ensuring effective systems are in place to meet client, regulatory GMP and safety requirements.
• Identify opportunities for improved methods of working to enhance efficiency, cost control and safety/GMP performance.
• Support and provide training of new members of staff.
• Assist Bio-Assay team in the implementation and tracking of measures and targets:
• Release, Stability, Development, technical transfer and validation
• Troubleshooting
• Deviation, change control and commitment tracking close out
• Assist in the introduction of new equipment by supporting IQ/OQ/PQ and comparison studies where applicable
• Be the system owners of Bio-Assay equipment, assisting in equipment periodic reviews, monitoring and maintaining calibration status of equipment within the Bio-Assay department.
  
  

Job Description

KEY ROLES/RESPONSIBILITIES:-

Departmental Operations

• Establish day-to-day priorities and perform assigned work as agreed with the Bio-Assay Management. Ensure efficient use of time to complete the assigned objectives.
• Act as in-house expert for bio-analytical methods.
• Lead and support projects to deliver method development, qualification and validation studies, routine QC release and stability data for biological assays according to defined SOPs and protocols. In compliance with best cGMP working practices and techniques, ensuring the data and reports are suitable for regulatory filings.
• Maintain laboratory areas, ensuring procedures are complied with to meet client, regulatory GMP and safety requirements. Be accountable for the bioassay laboratories being clean, tidy and well-organised and in a state of continuous inspection readiness.
• Execute calibration of equipment and instruments, informing relevant personnel in a timely manner of any failure of calibration. Carry out general maintenance and housekeeping of equipment.
• Ensure that at any time equipment, facilities and materials used in the area of responsibility comply with defined standards.
• Provide training and troubleshooting support to Development and Quality Control groups as required.
• Check and review data in compliance with Data Integrity requirements.
• Engage in and lead specified compliance and improvement projects, as necessary.
• Ensure economic use of labour, materials, energy and services, proposing and implementing measures for cost reduction and waste minimisation to meet the department and site targets.
• Contribute to the management of the laboratory ensuring effective systems are in place to meet client, regulatory GMP and safety requirements.
• Identify opportunities for improved methods of working to enhance efficiency, cost control and safety/GMP performance.
• Support and provide training of new members of staff.
• Assist Bio-Assay team in the implementation and tracking of measures and targets:
• Release, Stability, Development, technical transfer and validation
• Troubleshooting
• Deviation, change control and commitment tracking close out
• Assist in the introduction of new equipment by supporting IQ/OQ/PQ and comparison studies where applicable
• Be the system owners of Bio-Assay equipment, assisting in equipment periodic reviews, monitoring and maintaining calibration status of equipment within the Bio-Assay department.
  
  

Project Delivery

• Responsible planning workload to ensure that assigned projects and deliverables are fully completed on time.
• Lead projects and teams as necessary and in agreement with Bio-Assay Management.
• Lead development, technical transfer, qualification, validation activities and technical support for bio-analytical methods.
• Plan and carry out work, as agreed with Bio-Assay Management, to ensure effective project progression in line with customer requirements.
• Liaise with client technical groups and where necessary provide advice and direction on biological assay requirements.
• Responsible for the QC release testing, stability testing, method development, qualification/validation, technical transfer and troubleshooting related to biological assay test methods.
• Take decisions on scheduling of routine testing including release and stability, development, technical transfer and validation in conjunction with other technical staff to ensure required timelines are met.
• Provide cover for other Bio-assay team members as required.
• Client communication as required, in a professional manner.
  
  

Quality

• Have ownership and ensure timely close out of deviations, investigations, change controls and commitment tracking.
• Immediately escalate any OOS results or deviations to materials, facilities, processes or procedures to bio-assay and QC management.
• Apply best cGMP work-practices and techniques to manage the testing and release bulk drug substance, final products and stability products within specification and in accordance with Data Integrity requirements, Annex 11 Computerised Systems and 21CFRpart11 Good Documentation Practices for Electronic Data
• Uphold cGMP principles and ESH standards, continually seek opportunities to improve and enhance standards, and encourage other staff to do likewise.
• Record all laboratory work in standard official notebooks or analysis sheets as appropriate, and compile results and observations for incorporation into technical reports. Adhere to the relevant procedures.
• Follow all appropriate protocols and procedures as required for the work undertaken.
• Ensure accuracy of raw data and analytical interpretations
• Write and update of SOPs, instructions and protocols and other documentation
• Actively contribute to department and site audit readiness requirements including any continuous improvement initiatives. S:
  
  

Qualifications

KEY COMPETENCIES:

• Technical Expertise – expertise in bio-analytical techniques
• Teamwork -As a team member, the ability and desire to work cooperatively with others on a team
• Communication - The ability to ensure that information is passed on to others who should be kept informed.
• Organisation – The ability to efficiently plan and prioritise across a range of timeframes, making efficient use of time.
• Customer Awareness - The ability to demonstrate concern for satisfying one’s external and/or internal customers.
• Attention to Detail - Ensuring that one’s own and others’ work and information are complete and accurate
• Problem Solving – The ability to accurately assess a situation and derive a positive outcome.
  
  

About Us

In the three decades of its existence, Piramal Group has pursued a twin strategy of both organic and inorganic growth.

Driven by its core values, Piramal Group steadfastly pursues inclusive growth, while adhering to ethical and values-driven practices.

Equal employment opportunity

Piramal Group is proud to be an Equal Employment Opportunity and Affirmative Action employer. We do not discriminate based upon race, ethnicity, religion, color, national origin, gender (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity, gender expression, age, status as a protected veteran, status as an individual with a disability, genetics, or other applicable legally protected characteristics.

We base our employment decisions on merit considering qualifications, skills, performance, and achievements. We endeavor to ensure that all applicants and employees receive equal opportunity in personnel matters, including recruitment, selection, training, placement, promotion, demotion, compensation and benefits, transfers, terminations, and working conditions, including reasonable accommodation for qualified individuals with disabilities as well as individuals with needs related to their religious observance or practice.

About The Team

Piramal Pharma Solutions (PPS) is a Contract Development and Manufacturing Organization (CDMO) offering end-to-end development and manufacturing solutions across the drug life cycle. We serve our customers through a globally integrated network of facilities in North America, Europe, and Asia. This enables us to offer a comprehensive range of services including drug discovery solutions, process & pharmaceutical development services, clinical trial supplies, commercial supply of APIs, and finished dosage forms. We also offer specialized services such as the development and manufacture of highly potent APIs, antibody-drug conjugations, sterile fill/finish, peptide products & services, and potent solid oral drug products. PPS also offers development and manufacturing services for biologics including vaccines, gene therapies, and monoclonal antibodies, made possible through Piramal Pharma Limited’s investment in Yapan Bio Private Limited. Our track record as a trusted service provider with experience across varied technologies makes us a partner of choice for innovators and generic companies worldwide.

Seniority level

• Seniority level

  Mid-Senior level

Employment type

• Employment type

  Full-time

Job function

• Job function

  Research, Analyst, and Information Technology

• Industries

  Pharmaceutical Manufacturing

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