Shire Downstream Development Engineer in Lexington, Massachusetts
The individual will be a member within a group responsible for performing purification process development, including timely completion of small-scale experiments, scale-up, technology transfer and GMP floor support for programs that bring new biopharmaceutical products to pre-clinical, clinical and process validation manufacturing phases. The individual applies basic knowledge form various technical areas, industry practices and standards. Provides quality and productive output that is consistently timely, reliable and reproducible. The candidate must be customer focused, results oriented, science driven and embrace Shire’s values.
≤ 60 %: Experimentation and manufacturing support work related to protein purification, including laboratory and plant scale studies (chromatography and filtration unit operations) to support process development, optimization and characterization. Contributes to the evaluation of novel, generic platform technologies that can be applied across multiple programs. Participates during technology transfer of programs spanning all phases of biopharmaceutical lifecycle, including discussions of scale, equipment design and oversight of GMP, engineering and pre-clinical batches. Interacts with manufacturing operations staff, participates during troubleshooting of issues. Executes IND- and BLA-enabling studies
≤ 25% : Documents data accurately in laboratory notebooks as per established company guidelines and procedures. Drafts technical reports, memos, procedures, technology transfer packages and presentations. Contributes to CMC sections of regulatory submissions. Assists with external abstracts, presentations and publications.
≤ 15% : Organizational support and cross-functional project team participation.
Education and Experience Requirements
MS (0-2 years) or BS (2+ years) in Chemical/Biochemical Engineering or related discipline with relevant industry experience. Product and purification process development experience in the biotechnology/pharmaceutical industry with practical experience around scale-up, technology transfer and manufacturing support of large scale GMP operations is desired. Familiarity with the operation of large scale purification equipment for chromatographic and filtration unit operations is desired. Engineering degree preferred. Keeps current with literature and latest technology developments, particularly in the area of separations.
Key Skills, Abilities, and Competencies
Should have knowledge of experimental design and the ability to assimilate and interpret data collected. Familiarity with cell culture and the analytical characterization of proteins (e.g. SDS PAGE, HPLC, ELISA) is desired. Proficient with standard computer applications. The person will be expected to display sense of urgency while completing critical tasks and effectively manage his/her time. Should be able to work in a fast paced environment with capacity to prioritize accordingly under supervisor’s guidance, in order to meet program timelines.
Complexity and Problem Solving
This person may act as a technical resource within the department to more junior staff during scale-up and technology transfer of purification processes. May lead team members on project assignments. The candidate will be expected to manage basic projects. Applies defined protocols, standard practices and procedures when conducting and designing experiments, under close supervision, to solve a variety of problems of moderate scope and complexity. May provide input during design and development of new processes and techniques that gives Shire competitive advantage.
Internal and External Contacts
The candidate should have good communication, interpersonal and organizational skills (written and verbal). May coordinate information across groups. Individual communicates effectively and frequently with supervisor and peers. Works closely with supervisor for guidance, soundness of technical judgment, result adequacy and accuracy. Presents to department and project team meetings.
She/he interacts with internal stakeholders within BioProcess Development. May act as departmental team leader and interdepartmental project team participant, representing the organization on specific projects. The individual will effectively collaborate and communicate within the framework of cross-functional, multi-disciplinary process development teams including analytical, formulation and the pilot plant. In addition this person will interact effectively with other key partners and customers across the company including research, internal manufacturing, external contract manufacturing, facilities/engineering, supply chain, project management, procurement and quality. Individual may also work with external vendors, including contract manufacturing organizations. Networks externally with industry peers.
Other Job Requirements
This position will be within Shire HGT’s Massachusetts operations (Lexington). The candidate may be asked to travel occasionally (domestically and internationally) for conferences, seminars, and project specific needs.
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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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.