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Manufacturing Manager

  • Job reference: 922070
  • Location: Maidenhead, Berkshire
  • Salary: Negotiable
  • Job type: Contract
  • Sector: Engineering, Manufacturing & Facilities, Life Sciences
  • Date posted: 09/10/2018

OrionGroup are looking for a Manufacturing Manager on behalf of our pharmaceutical client based in Berkshire on an initial 6 to 12-month contract.

Job Outline
To manage and provide oversight to a series of projects associated with currently marketed OTC finished dose products within the manufacturing environment;

Main Responsibilities

Ensure High Product Quality

  • Evaluate the potential impact of proposed changes on quality and efficacy
  • Support the change control process when applicable
  • Participate where necessary in QA-led investigations of process deviations and customer complaints. Support manufacturing trouble shooting activity and propose CAPA where applicable
  • Evaluate manufacturing instructions, specifications and amendment to each.
  • Ensure that current pharmacopeial requirements are met where applicable
  • Perform and support raw material evaluation and qualification
  • Investigate process improvements and oversee the process validation, ensuring adequate documentation is available to support successful registration of projects
  • Support request for information requests which may arise on regulatory variation submission
  • Support request for information requests which may arise on regulatory variation
  • Manage the APR process

Contribute product and Process Engineering Expertise

  • Create pharmaceutical reports.
  • Participate in various cross-disciplinary groups in an expert capacity.
  • Support local manufacturing plant in an expert capacity

Transfer of Products

  • Actively participate in the Tech Transfer Team
  • Contribute expertise on product and process engineering.
  • Support Process and Analytical optimization, development and validation as required

Reformulation of Products

  • Develop product development strategies for current products on market
  • Contribute Expertise on product and process development
  • Actively participate in establishing and developing the process on a production scale
  • Create and/or Review upscaling reports
  • Ensure that adequate documentation is available to support successful registration of products

Product and process improvements

  • Identify and propose
    o product and process improvements
    o cost improvement and business continuity plans
  • Support commercialization of secondary market launches of new product introductions
  • Ensure that adequate documentation is available to support successful registration of projects
  • Management of Third Parties
  • Actively participate in the selection, due diligence and evaluation of Third Party partners
  • Maintain necessary good manufacturing practice (GMP) skills through training, technical review and SOPs

Ideal background and skillset of the successful candidate

  • Educational - Minimum of Bachelors degree with a major in chemistry, chemical engineering or pharmaceutics or equivalent degree.
  • A minimum of 8 years in a pharmaceutical manufacturing or product development environment with a major emphasis on multi-ingredient finished dose formulations.
  • Experience with non-prescription ingredients used in cough, cold & allergy preparations and analgesics is a distinct advantage.
  • Comprehensive understanding of quality compliance knowledge within EU and good understanding of GxP systems
  • A demonstrated business partner and ability to bring together multi-disciplined technical staff in order to problem-solve.
  • Technical writing and documentation review abilities
  • Project management, communication and prioritization skills.
  • Demonstrable experience of working with external manufacturers
  • Maintain necessary good manufacturing practice (GMP) skills through training, technical review and SOPs

Our role in supporting diversity and inclusion
As an international workforce business, we are committed to sourcing personnel that reflects the diversity and values of our client base but also that of Orion Group. We welcome the wide range of experiences and viewpoints that potential workers bring to our business and our clients, including those based on nationality, gender, culture, educational and professional backgrounds, race, ethnicity, sexual orientation, gender identity and expression, disability, and age differences, job classification and religion. In our inclusive workplace, regardless of your employment status as staff or contract, everyone is assured the right of equitable, fair and respectful treatment.