Piramal Pharma Solutions
Job Description
Piramal Pharma Solutions is a leading global CDMO of advanced drug development and manufacturing solutions to the pharmaceutical industry and based in Grangemouth.
Piramal is looking for a Team-leader/Principal Analytical Development Scientist responsible for leading analytical method development, validation, technical transfer and routine Quality Control support. The role will involve both technical and team leadership. The ideal candidate will possess both a strong technical background, and the proven ability (or potential) to lead and develop team of scientists. A track record of delivering project commitments on time is essential.
You will have the opportunity to work with a highly skilled and dedicated team who bring Antibody-Drug Conjugate to patients.. We pride ourselves on serving our customers and patients by developing and manufacturing novel life-saving pharmaceutical products.
We are currently building a new 55 million facility, we a growth of 200 to 300 staff in the next 2 years. Together we offer fantastic opportunities for committed employees to learn and develop their career with us. At Piramal , we research, develop, and supply Biopharma products and services that impact the lives of millions of people each day to make life better, and keep us safer. Your health and well-being matters to us and that’s why we offer you the flexibility to do what’s important to you whether that’s the ability to flex your start and finish times. Where possible, we support a working pattern that suits your lifestyle and helps you reach your ambitions.
Roles/Responsibilities:
Piramal is looking for Principal Scientist/Team Leader in the Analytical Development team. Responsibilities will include:
Lead projects and/or teams to deliver analytical method development, qualification and validation studies and ensuring the data and reports are suitable for regulatory filings.
Provide technical expertise to the team and lead method development, technical transfer, qualification and validation activities.
Provide training and troubleshooting support to the team.
Responsible for planning workload to ensure that assigned projects and deliverables are fully completed on time.
Act as client point of contact for projects, behaving in a professional manner.
Identify opportunities for improved methods of working to enhance efficiency, cost control and safety/GMP performance.
Uphold cGMP principles and ESH standards, continually seek opportunities to improve and enhance standards, and encourage other staff to do likewise.
Lead and ensure timely close out of deviations, change controls and commitment tracking.
Project Scheduling and Delivery
- Responsible for planning workload to ensure that assigned projects and deliverables are fully completed on time.
- Lead projects and teams as necessary and in agreement with the Analytical Development Manager.
- Lead development, technical transfer, qualification, validation and technical support for analytical methods.
- Plan and carry out work, as agreed with the Analytical Development Manager, to ensure effective project progression in line with customer requirements.
- Liaise with client technical groups, and where necessary provide advice and direction on assay requirements.
- Lead method development, technical transfer, qualification and validation activities.
- Act as in-house assay expert, ensuring compliant introduction into the Quality Control production and stability groups – taking decisions on scheduling of development, technical transfer and validation in conjunction with other technical staff.
- Act as client point of contact for projects, behaving in a professional manner.
Technical Leadership
- Provide technical expertise to assist in trouble shooting issues during technical transfer or routine production.
- Ensure reports, documents and CMC regulatory sections are prepared appropriately and can be included in regulatory filings for biologics products.
- Risk Assessment of new products to ensure personnel safety compliance with company requirements for Health and Safety and development expectations.
- As required, lead development, technical transfer, qualification, validation and technical support for departmental projects.
The Person
Proven ability (or potential) to lead and develop team of scientists. A track record of developing high-performing teams and helping team members reach their full potential would be highly advantageous.
Considerable experience in a relevant scientific discipline (e.g. analytical/forensic science) gained through working in a relevant environment.
Qualified to BSc (essential) or PhD (Desirable) in a relevant scientific discipline or equivalent.
Significant experience in the development, validation and application of analytical methods, in-particular ELISA (ID and Potency), in-Vitro Bioassay (CKA, ADCC, ADCP, MOA) with a sound working knowledge of GMP, SHE and Biosafety standards together with highly developed interpersonal and team building skills.
Key competencies
· Team work
· Team Management
· Communication
· Planning and organisational skills
· Technical expertise
· Client Focus
Business Support:
- As required, support for new enquiries via business development and project management
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