Shire Senior Engineer II in Lexington, Massachusetts

Primary Duties

As a key member of PI-MST (Process Industrialization – Manufacturing Support team), this individual will be responsible for providing technical and scientific leadership to support downstream processes of commercial productions. The position emphasizes hands-on, lab-based activities to design and execute studies to support process investigations/troubleshooting, process continuous improvement, tech transfer, and life-cycle management. This individual will lead or contribute as a key member of various cross-function teams, who interacts extensively with other groups and departments within Shire, including other PDTS groups, Manufacturing, PTS, QA, QC, Engineering and RA etc.

Responsibilities

Job Function and Description

45%

Provide technical expertise and leadership in identifying opportunities/areas, planning, designing and conducting experiments, analyzing data and documenting results

25%

Lead or participate as cross-function team member and/or represent PDTS-MST in various project teams for process improvements, investigations and manufacturing tech supports

20%

Responsible for high quality of written memos, study proposals, research and development reports

10%

Provide technical expertise and leadership in trouble-shooting and root cause analysis for process discrepancies and quality investigations with extreme complex technical nature

Education and Experience Requirements

This individual will have a minimum of:

  • A Ph.D. in Biochemistry/Protein Chemistry, Chemical Engineering or related disciplines with a minimum of 5 years of relevant experience in a biotechnology/pharmaceutical environment is required; or M.S. in Biochemistry or Chemical Engineering with a minimum of 8 years of relevant experience.

  • Proven record of technical leadership;

  • Proven ability to work in a fast paced environment with demonstrated capacity to juggle multiple tasks and demands

Key Skills, Abilities, and Competencies

The successful candidate must:

  • Have excellent knowledge and experience with protein purification process development and GMP manufacturing support, including protein capture and recovery, chromatography purification, filtration, and UF/DF etc.

  • Have experience in design-of-experiment (DoE) and the ability to analyze and interpret data collected.

  • Demonstrate teamwork/collaboration and the ability to communicate appropriately and effectively

  • Be customer focused, result oriented, science driven and embrace Shire’s values

  • Have the attitude to proactively learn new technologies and manage changes in purification process development and improvement

  • Have experience in GMP working environments

  • This person will have been involved in purification process development or manufacturing support, have technical leadership including the ability to influence, motivate, and drive technical rigor

Complexity and Problem Solving

This individual will be expected to:

  • Lead purification process improvement, trouble-shooting and tech transfer supports. Identify and analyze complex technical problems and then find and implement solutions

  • Apply fundamental scientific and biological principles to practical technical challenges

  • Independently, plan, design and direct experimental studies to be carried out by his/her direct reports and team members while also encouraging team work and career development

  • Work closely with his/her supervisor and coworkers in managing multiple work streams and projects. Make sound and timely decisions based on project priorities. Provide expert input to departmental and senior management towards making strategic and functional decisions

Internal and External Contacts

  • Internally, this individual will represent PI-MST (Process Industrialization – Manufacturing Support Team) in support MFG as customer with close and intensive interactions with internal business partners including PTS, other PDTS groups, QA, QC, RA and Engineering within Shire

  • Externally, this individual will interact with vendors who may supply materials or equipment both used in small-scale development lab and in large-scale MFG.

Other Job Requirements

  • Travel may be required for this position occasionally both domestic and international.

Notice to Employment / Recruitment Agents:

Employment / Recruitment agents may only submit candidates for vacancies only if they have written authorization to do so from Shire’s Talent Acquisition department. Any agency candidate submission may only be submitted to positions opened to the agency through the specific Agency Portal. Shire will only pay a fee for candidates submitted or presented where there is a fully executed contract in place between the Employment / Recruitment agents and Shire and only if the candidate is submitted via the Agency Portal. Candidates submitted or presented by Employment / Recruitment Agents without a fully executed contract or submitted through this site shall not be deemed to form part of any Engagement for which the Agency may claim remuneration.

Equal Employment Opportunity

Shire is an Equal Opportunity Employer committed to a diverse workforce. Shire will not discriminate against any worker or job applicant on the basis of race, color, religion, gender, national origin, ancestry, age, sexual orientation, marital or civil partnership status, pregnancy, gender reassignment, non-job related mental or physical disability, genetic information, veteran status, military service, application for military service, or membership in any other category protected under law.

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Reasonable Accommodations

Shire is committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please call 484-595-8400 and let us know the nature of your request and your contact information.

Shire is the leading global biotechnology company focused on serving people with rare diseases and other highly specialized conditions. We strive to develop best-in-class products, many of which are available in more than 100 countries, across core therapeutic areas including Hematology, Immunology, Neuroscience, Ophthalmics, Lysosomal Storage Disorders, Gastrointestinal/Internal Medicine/Endocrine and Hereditary Angioedema; and a growing franchise in Oncology.

Our employees come to work every day with a shared mission: to develop and deliver breakthrough therapies for the hundreds of millions of people in the world affected by rare diseases and other high-need conditions, and who lack effective therapies to live their lives to the fullest.