Allergan Sr Mgr, Process Sciences in Liverpool, United States

Sr Mgr, Process Sciences

Liverpool, England, United Kingdom at

Aug 14, 2018Post Date

180863Requisition #

Role Summary

The Senior Manager is a member of the Process Sciences management team in Liverpool. The Process Sciences group develops new drug substances for a range of therapeutic areas within the global Brands R&D group. The role holder leads a team of senior scientists, scientists and scientific associates who perform a wide range of activities associated with the design, development, scale-up, technical transfer, process characterisation, validation and cGMP manufacture of bulk drug substances expressed from mammalian, viral or microbial expression systems. The role holder also has responsibility for the process characterisation and process validation activities associated with the manufacturing process for late stage projects and in support of the regulatory submission. As part of these responsibilities they ensure the scientific studies are conducted and reported in line with regulatory guidance, and that studies have been executed to the right quality, to time, to budget and in compliance with HSE requirements. The role holder is responsible for building and maintaining a motivated and skilled team and ensures technical expertise within their team through on-going professional development of their team members. The role holder may have responsibilities as the Process Sciences responsible lead on the Global CMC team and/or as the Global CMC Team Leader.

General Description of Responsibilities

Responsible for:

  • Leading the process science team to design and optimise the manufacturing process using mammalian, microbial or viral technologies, with the ultimate aim to transfer for clinical and/or commercial manufacture.

  • Defining and getting agreement for the CMC strategy for the manufacturing process stages of the drug substance.

  • Setting objectives and giving performance feedback regularly throughout the year Devising the training and development plan for the team. Coaches and develops staff to meet individual professional development needs and business needs

  • Recruitment, retention and reward of scientific staff within the team

  • Building an effective team through continued development to ensure they are equipped with scientific and technical competences and demonstrate excellence in the development of products

  • Working closely with other Senior Managers and Associate Directors in the Process Science team to develop the new technology platform to ensure competitive advantage in the development of biologics for a range of therapeutic areas

  • Designing and executing process characterisation and process validation activities associated with the manufacturing process for late stage projects and in support of the regulatory submission

  • Ensuring all project work is delivered on time, to budget and to the required levels of technical quality, and that the team generates high quality outputs from experimental programmes, including presentation of results and technical reports.

  • Promote operational excellence and housekeeping within the Process Sciences Laboratories and Facility

  • Ensuring all work is undertaken to the required quality systems, where applicable to cGMP standards and always in compliance with the requirements of the Health and Safety Policy

  • Reviewing and approving experimental programmes and documentation including but not limited to protocols, proformas, lab books and manufacturing instructions.

  • Building project plans and communicating status updates at project meetings

  • Identifying, justifying and gaining support for any CAPEX equipment

  • Making proposals and implementing actions as part of the continuous improvement programme to improve scientific quality, timeliness and efficiencies within the team

  • Maintaining a personal training record and ensuring all staff in the group maintain a personal training record

  • Undertaking due diligence as requested in support of business development

  • Identify, justify and select suitable candidates to deliver work programmes

  • Signing authority up to £5,000 for project related purchases

  • Deputising for the Associate Directors, Process Science when required.

Qualifications, Skills and Experience required

  • Degree (or equivalent) in a relevant science or engineering discipline. A PhD in a relevant subject is preferable. Significant experience in leading the design, optimisation and operation of processes for biologic manufacture within the biotechnology industry.

  • Experience and extensive technical knowledge in the production and scale-up of therapeutics from mammalian, microbial or gene therapy expression systems and knowledge of cGMP is preferable.

  • Clear understanding of the science and a passion for keeping abreast and implementing technological advancements.

  • Experienced people manager, with track record in effectively resourcing, scheduling and delivering development programmes. Demonstrated competency in building effective teams, motivating staff, setting goals, measuring performance and staff development.

  • Leadership qualities

  • Strong organisational skills with a track record of on-time delivery of experimental programmes

  • Strong decision making

  • Excellent interpersonal skills, with ability to influence outcomes

  • Ability to solve complex problems

  • Good oral and written communication skills

  • Strong managerial skills with emphasis on coaching and development

  • Focus on continuous improvement - ability to evaluate systems to improve system functionality and efficiency.

  • Flexible attitude to work - ability to adapt to changing demands and lead people through these changing demands

Behaviours – linked to the Allergan BOLD culture

We Build Bridges with each other, customers and partners

You will use excellent interpersonal skills to build relationships internally and with external partners, such as CROs, CMOs or industry collaborators. You will collaborate across different disciplines to influence outcomes, devise strategies and implement them. You will be adept at communicating to different levels of scientific understanding and promote knowledge sharing and team working.

We Power Ideas that change healthcare

You will challenge “traditional” ways and strive for innovative solutions that deliver timely solutions to meet product development requirements. You will seek new ways to gain optimum process knowledge whilst minimizing the analytical burden. You will solve complex problems with simple solutions. You will mentor and coach team members and promote open science.

We Act Fast to be responsive to customers and business opportunities

You will adapt to changing demands 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 and guide others.

We Drive Results and execute our plans

You will focus on strong planning, risk mitigation strategies and delivery. You will push yourselves and others to deliver and exceed the goals. You will set an example for the team and coach team members. You will demonstrate integrity and trust within the team and be action orientated.

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.