Pharma Manufacturing Associate: Senior Operations Analyst at Allergan in Campbell, CA

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Description

Allergan plc (NYSE: AGN) is a bold, global pharmaceutical company and a leader in a new industry model - Growth Pharma.Allergan is focused on developing, manufacturing and commercializing branded pharmaceutical, device, biologic, surgical and regenerative medicine products for patients around the world.

Allergan markets a portfolio of leading brands and best-in-class products for the central nervous system, eye care, medical aesthetics and dermatology, gastroenterology, women's health, urology and anti-infectivetherapeutic categories. With commercial operations in approximately 100 countries, Allergan is committed to working with physicians, healthcare providers and patients to deliver innovative and meaningful treatments that help people around the world live longer, healthier lives every day.
Allergan is a company that will inspire you to aim high with your ambition. Where you can build bridges all over the world. Where you can power ideas that drive change. And where you will act fast and drive results for customers and patients. Power your future & join our bold team.

Position Overview
The primary responsibility of the Senior Operations Analyst is to manufacture marketed drug substance, and implementing improvements to the equipment, procedures and systems used in Manufacturing department at our Bioscience Laboratories in Campbell.
Technical expertise should include moderate knowledge of biopharmaceutical manufacturing technology and regulatory requirements, normally acquired through a progressive operation experience in a GMP environment. Especially critical is high level knowledge and hands experience in the areas of microbiology, fermentation, aseptic processing, and protein purification techniques.
Additional responsibilities include support of ongoing clinical products and projects related to new product introduction and technical transfer, which will require occasional support and domestic travel as needed.
Main Areas of Responsibilities
  • Manufacture marketed drug substance in a clean room environment implementing improvements to the equipment, procedures and systems
  • Hands on experience in the areas of microbiology, fermentation, aseptic processing, and protein purification techniques in a GMP environment.
  • Completion and review of Manufacturing documentation. This includes forms, batch production records and any other quality system documentations.
  • Improve the technical capabilities and quality practices within the department. Coordinate activities and resolve issues across the department, other groups, and/or projects.
  • Respond to and/or resolve recurring technical or processing issues. Develop and implement novel approaches to solving non-routine technical problems. Communicate information effectively through updates, reports, and summaries. Lead improvements in processes and methods that reinforce cGMP within the department and/or across the site.
  • Apply systematic thinking processes and technical knowledge to independently address a broad range of non-routine to moderately complex problems. Conduct investigations, demonstrate strong technical and problem-solving skills, and excellent technical writing skills.
  • Assist in providing training and guidance on the staff to meet the goals of the department. When appropriate, assist in providing leadership on project teams.
  • The position will need to be experienced in project management oversight, participating in project teams and execution of team activities.
  • The Associate will also represent the department as the SME and lead multi-disciplinary teams or committees.
  • Provide routine updates on progress, status, and issues associated with campaigns/projects.
  • Provide support and/or direction to junior staff when necessary.
  • Exercise sound judgment when making decisions. Make critical decisions in collaboration with key stakeholders.
  • Demonstrate accountability for personal, departmental, and organizational initiatives.
  • The qualified candidate will possess strong technical and writing skills, organizational, communication skills, and function well as an individual contributor.

Preferred Skills/Qualifications
  • Previous experience with LEAN or Six Sigma is desirable, but not required.
Requirements
  • Minimum 2 years of hands on experience of fermentation, purification or pharmaceutical manufacturing process.
  • Strong technical writing skills.
  • Experience in resolving complex production non-conformances, implementing CAPA is a must.
  • Experience in participating improvement projects, commissioning and validating systems / processes is a must.
  • Previous experience in facility or systems modification / design, as well as specifying equipment, creating systems and Standard Operating Procedures (SOPs) is desired.
  • Strong user of Word, Excel, PowerPoint
  • Familiar with other enterprise systems, for example, SAP, RAM, and SCADA system.
  • Must be able to acquire security background clearance from US Department of Commerce, FBI and CDC.
  • Representative of the Manufacturing department in External audit (for example, FDA, HPRA, CDC) as well as internal audit.
Education

  • Bachelors Degree or Associates Degree with minimum 5 years of relevant experience


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