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Shire Senior Process Development Engineer I (PPO) in Lexington, Massachusetts
The individual will be a key member within a group responsible for performing large scale upstream operations/development, including the cell expansion, cell culture, and clarification of non-GMP batches to support development timelines and manufacturing support. They will seamlessly collaborate within the framework of cross-functional process development teams including engineers and manufacturing teams. They will be possess excellent problem solving abilities, hold strong coaching and supervisory skills, and communicate well within our multi-disciplinary environment including manufacturing, quality, and manufacturing technical support teams.
Job Function and Description
Lead/Perform non-GMP cell culture campaigns (pilot scale) to support new product development, material supply needs and demonstration runs for multiple programs spanning all phases of biopharmaceutical development. Lead project team to support the transfer of all information including long lead items, batch record development, sample plan building, and on-floor support schedules. Record and trend data in conjunction with key stakeholders.
Actively participate and interact with Process development groups troubleshooting problems, supporting large scale studies, and supporting project goals. Design and develop pilot scale operating procedures and records suitable for use in the production of non-GMP material
Evaluation and implementation of novel large scale technologies that meet a generic platform across multiple processes
Assist in the maintenance of a clean and orderly facility
Mentor junior members of Cell Culture team in developing required skill sets
Education and Experience Requirements
B.S. with 5+ or M.S. with 3+ years of experience in biology, biochemistry, biotechnology, chemical engineering or related field.
Relevant Work Experience Requirements:
Work experience must be in a Process Development or Manufacturing setting.
Must have hands-on experience working with bioreactors/fermenters from bench top to production scale, including process monitoring and process control utilizing a Delta V platform.
Experience with bulk clarification via depth filtration.
Experience with ultrafiltration/infiltration is a plus.
Working knowledge of the Microsoft Office suite is essential.
Key Skills, Abilities, and Competencies
Ideally, the candidate should possess experience and knowledge of activities routinely performed in upstream manufacturing (vial thaw, cell culture expansion, large scale bioreactor setup and control, centrifugation, depth filtration, UF, and media/buffer preparation). Knowledge of downstream purification processing is a plus. The candidate should have process scale-up experience or manufacturing experience.
The candidate must demonstrate excellent written and verbal communication skills and have an ability to independently operate pilot scale equipment, interpret data and maintain an organized lab area. In addition, the individual should be a self starter and be able to communicate effectively with external and internal stakeholders. Candidate must have excellent problem solving skills and be able to work in a fast paced team environment.
Knowledge of Unicorn or Delta V software is required.
Experience with single use bioreactors is preferred.
Excellent leadership skills, documentation skills and troubleshooting abilities. Document development activities accurately in research notebooks and batch records as per corporate guidelines. Provide concise reports and updates to management as required.
Complexity and Problem Solving
The candidate will be expected to effectively complete day to day operations while, managing data and communicating with external stakeholders. The candidate will be expected to work closely with PD operations management, deliver detailed updates and display sense of urgency while completing critical tasks. The candidate will be expected to provide solutions to help trouble shoot pilot scale operations and central service related issues.
Notice to Employment / Recruitment Agents:
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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, gender identity, 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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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.