Allergan Senior Scientist, Process Sciences in Liverpool, United States

Senior Scientist, Process Sciences

Liverpool, England, United Kingdom at

Jan 09, 2019Post Date

184702Requisition #

Reports to: Sr Manager, Biological Development

Supervisory responsibility: Technical supervision of team members may be required

General Description of Responsibilities

The Senior Scientist is a member of Process Sciences and performs a wide range of activities associated with the design, development, scale-up, technical transfer, process characterisation, validation and cGMP clinical manufacture of bulk drug substances expressed from mammalian, viral or microbial expression systems.

  • The Senior Scientist takes specific responsibilities for leading activities within the group, which could include:

  • Technical lead for project activity and the associated daily planning of the activities

  • Technical lead for the transfer and execution of projects from process development into the production (cleanroom) facility at pilot and clinical scale

  • Technical lead for the cGMP activities to produce clinical drug substance

  • Lead process and facility validation programmes of work

  • Review internal and external process and facility validation reports

  • Coordination of scientists and other senior scientists assigned to their project activity to ensure delivery of the project work

  • Writing protocols, analysing data and authoring reports and reviewing protocols, experimental workbooks, and reports written by other team members and/or authoring, reviewing and approving manufacturing instructions for the cGMP manufacture of batches for non-clinical and clinical use.

  • They may be required to author sections for regulatory documents to support clinical trial applications and marketing authorisation applications

  • Accountability for the delivery of continuous improvement projects within the group

The Senior Scientist will take specific responsibility for leading the delivery of a programme of work within the group including the co-ordination of scientists.

The Senior Scientist is required to support technical transfer from or to partner companies and internally to / from manufacturing teams.

They are required to perform all activities in accordance with regulatory requirements and in compliance with Quality and EHS Policies and Procedures

Leadership Responsibilities

  • Responsibility as technical lead for the design of an experimental or validation programme of work or batch manufacture, ensuring work is designed and delivered in a timely and compliant manner with clear mitigation of risks

  • Prepare resource plans showing requirements to deliver programme of work and negotiate availability with stakeholders. Effectively communicate updates to stakeholders in a timely manner.

  • Prepare daily activity plans to deliver projects and communicate to other senior scientists and scientists working on the project as well as other contributing departments, such as Analytical Sciences, Engineering and QA

  • Organise project activities and manufacturing operations within the laboratory or processing rooms ensuring issues are flagged, solutions proposed and decisions made and acted upon

  • Accountability for the delivery of continuous improvement projects within the group to drive the introduction of new efficiencies or implement technologies that demonstrate positive impact upon compliance and the business

  • Manage lab areas, including supervision of scientists, resolve day to day equipment or technical issues and escalate issues when necessary to Senior Managers

  • Provide coaching and guidance to others

Technical transfer of processes from or to:

  • External partner companies to Allergan Biologics

  • Internally within Allergan Biologics, i.e. development to production pilot/clinical scale

  • Allergan Biologics to other Allergan sites

Lead technical projects in conjunction with QC, QA and AS to assist in:

  • Training

  • Process trouble shooting

  • The generation and review of process and raw material specifications and manufacturing instructions

  • Lead projects within the production area to deliver batches of bulk drug substance, aid troubleshooting and support routine manufacturing operations

Operational Responsibilities

  • Perform all work in accordance with local quality requirements and, where applicable, cGMP standards

  • Champion 5S as a means for continuous improvement to ensure that department goals are achieved and the incidence of non-conformances are reduced

  • Raise and close-out CAPAs, deviations, and change control requests in a timely and compliant manner

  • Maintain an up-to-date and accurate training record to meet all required operating procedures for activities and including ensuring all heath safety and environment training is complete

  • Ensure all documents are completed and approved before execution of tasks or experiments including other scientists working within the project or programme of work

  • Complete all laboratory or batch related documentation in a timely and compliant manner, participating in reviews of the documentation to obtain quality sign off when necessary.

  • Write challenging protocols and proposals to address complex or multi-faceted investigations. Write development operating procedures and reports with minimal corrections on review.

  • Write development, GMP and validation operating procedures, protocols and reports with minimal corrections on review. Ensure that all documentation is delivered in a timely manner

  • Maintain workbooks, logbooks and proformas with minimal corrections on review and reviewing work of colleagues.

  • Deputise for Senior Managers when required

  • Work effectively to a high standard and facilitate team work

  • Identify and raise capex requests including justification of the need, impact assessment upon operations and the business through to successful implementation

  • Training others in techniques, technologies or procedures.

  • To identify the need and provide coaching / mentoring to others in areas of technical expertise relating to process development and/or operations within the facility in order to support biologics development activities.

  • Ownership of equipment or technologies

  • Provide periodic cover outside of normal working hours for essential operations

  • Work across functional areas to support the lifecycle of the project

  • Participate in 3rd party inspections, such as regulatory bodies, as required.

  • To comply with the requirements of the health and safety policies at all times

Qualifications, Skills and Experience

This position specifically requires the following skills and experience:

  • Process Development and GMP Experience with a focus on Upstream Bioreactors

  • Understanding of Scale-Up and Technical Transfer of Upstream processes

  • Cell Culture Optimisation Experience

The job holder must possess a minimum qualification of BSc (or equivalent) in a relevant science or engineering field. They will also hold a PhD and/or have proven industrial experience within the field of bioprocess development, scale-up or cGMP manufacturing. For non-degree qualified individuals, an equivalent combination of experience in an industrial setting and education may be considered.

The job holder must have demonstrable experience of leadership of other staff members, including technical leadership of projects. The job holder must have knowledge and previous experience of mammalian and microbial based processes, in addition to knowledge of current Good Manufacturing Practice.

They must show the following personal attributes:

  • Strong organisational skills

  • Ability to solve complex problems

  • Good oral and written communication skills

  • Commitment to learning and keeping abreast of new technologies within their field

  • Excellent team player and ability to work independently

  • Experience in the use of statistical techniques for the planning and analysis of experiments

  • High attention to detail

  • Excellent interpersonal skills with ability to influence outcomes

Behaviours – linked to the Allergan BOLD culture

We Build Bridges with each other, customers and partners

You will build effective relationships with internal and external parties. You will demonstrate awareness of the impact of your work upon other teams and projects and work to remove barriers. You will be comfortable in your ability to deliver clear communications to both internal and external customers and be aware of your personal impact. You will foster collaboration by promoting knowledge sharing and team working. You will be able to adapt the message and style to suit the audience.

We Power Ideas that change healthcare

You will demonstrate and effectively communicate sound opinion to influence project outcomes. You will question the robustness of your and others work and investigations along with the validity of conclusions drawn. You will demonstrate your initiative on a day to day basis by challenging the status quo, proposing and delivering new solutions to drive continuous improvement and create value for the business. You will see change as an opportunity to develop.

We Act Fast to be responsive to customers and business opportunities

You will adapt to changing demands with agility and be action oriented to overcome challenges. You will apply strong problem solving skills to resolve issues and seek simple solutions. You will make quality decisions on outcomes.

We Drive Results and execute our plans

You will take ownership of your work and others to deliver the programme or project. You will be seen as a valuable influencer of change and demonstrate a positive attitude at all times. You strive to be the best and make a difference every day.

Equal Employment Opportunity Employer

Allergan is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability, or any other protected status.