RSSL: Pharmaceutical Development Project Lead

Reading Scientific Services Ltd (RSSL) is a cutting-edge Contract Research Organisation (CRO), providing research, analysis and consultancy to the food and pharmaceutical sectors. Whether we are creating new products, validating medicines or solving investigations, we take pride in being a leader in our field, serving clients from across 60 countries.

In 2019, we’ve been recognised as Enlightened Employer, Women in Business and Thames Valley Tech finalists and in 2018 one of our family earned the Food & Drink Federation’s Scientist of the Year. Enriched by our parent company Mondelēz International, our diverse team includes 23 nationalities from 300 members, creating a family feel as we strive towards our mission of “Science Enhancing Lives”.

In RSSL we are customer focused, science led and results driven. The RSSL Pharmaceutical Development laboratory performs a wide range of analytical analyses for a variety of pharmaceutical and healthcare companies.

This role will involve ensuring that pharmaceutical projects within the Pharmaceutical Development laboratory are performed and supervised effectively and accurately within agreed timescales and to appropriate quality standards. The role will manage a team of scientists, providing technical direction, and will be responsible for reviewing and authorising of certificates of analysis, interpretive scientific reports, method development and validations and authorizing competencies within the area of expertise.

Key Responsibilities:

Technical

. Provide high quality customer service at all times by ensuring effective organisation of assigned workload, integrity of analytical data generated and timely/accurate provision of results.
. Responsible for a portfolio of analytical projects including release testing of pharmaceutical raw materials and finished products, method development and validations, and method transfers.
. Implementation of solutions to technical challenges and support creation of new business opportunities
. Perform data checking and provide interpretation of results for routine and complex testing
. Generate certificate analysis and external interpretive reports.
. Expert user in the use of software packages relevant to the role: Laboratory’s LIMS system, Q-Pulse, Chemwatch, Openlab.
. Provide training and supervise staff in routine activities, methods and interpretation.
. Provide technical direction in area of expertise within and across departments, including maintenance and troubleshooting of laboratory equipment.

Communication & Influence

. Work as part of an efficient analytical team
. To liaise with clients, business development and line management to ensure effective communication of project proposals and results.
. Provide expert advice and lead client and stake holders meetings and audits
. Deliver presentations to clients and stakeholders
. Contribute to both technical and business strategy including influencing senior management

Leadership and supervision

. Manage a team of Scientists and Technicians
. Plan own workload and projects for junior staff
. Train and coach junior members of the team as required.

QEHS

. Work to the highest standards of safety and quality by ensuring that appropriate COSHHs, risk assessments and SOPs are understood and followed.
. To complete, review and approve assigned quality actions on a timely manner.
. Write, approve and review SOPs and Test Methods
. Generation and approval of Risk Assessments and COSHH
. Understand and provide technical regulatory leadership in client audits
. To ensure the maintenance of a clean, tidy and safe working environment for both yourself and members of the team
. To understand and work to the requirements of GMP; including client specific quality requirements and pharmacopoeia requirements.
. Ensure training records are accurate for both yourself and members of the team.

MDLZ

. Know the ethical and legal compliance responsibilities of the position; raise questions and concerns when faced with an ethical or compliance issue; apply integrity in all aspects of professional conduct

Qualifications:

Key Requirements:

Knowledge: including education, qualifications and training:

. Educated to Degree or PhD in a relevant scientific discipline or equivalent relevant experience in a laboratory.
. Excellent understanding of basic lab equipment, HPLC, dissolution and Karl Fischer techniques
. In-depth knowledge of both technical area of expertise & business environment including regulatory requirements
. Good knowledge of laboratory quality and accreditation systems (GMP)

Skills/Leadership Competencies:

. Strong written and spoken communication skills, with the ability to influence, network and manage internal/external relationships.
. Excellent organisational skills including time management and priority setting. Able to lead resource allocation in order to deliver projects to tight timescales.
. Meticulous attention to detail, well organized and strong team working ethos.
. Experienced in managing and mentoring staff
. Technical credibility to develop good working relationships with internal and external clients.
. Ability to solve complex analytical problems
. Computer literate in standard MS office applications

Experience:

. The individual in this position has extensive experience in their discipline (both technical and regulatory) and has a demonstrated track record of applying their knowledge across different business areas.
. Proven experience in Analytical Project Management
. Experience in pharmaceutical laboratory quality systems (GMP
. Experience of working for, or with, a CRO, preferred

Languages:

. Fluent English, written and spoken

We pride ourselves on having a high performing and collaborative culture where we offer support and development to enhance your career and develop your knowledge and skills.

In return for your commitment, drive and enthusiasm, we offer an attractive benefits package within a highly successful International business that offers financial rewards and resources, including bonus scheme, contributory pension, life assurance, generous holiday allowance and a flexible benefits programme.

Application Instructions: 

To apply for this role please visit RSSL's careers pages and select this vacancy: www.rssl.com/careers/current-vacancies

Application Closing Date: 
13 December