Shire Process Implementation Lead (Senior Engineer II) in Lexington, Massachusetts
Provide process expertise to development programs in various stages and engage in pilot scale production
Have in depth process knowledge and is an expert in understanding manufacturing capabilities and limitation. Familiar with manufacturing process and operations and its quality/compliance requirement.
Tech transfer technical lead for process transfer from development to pilot plant and GMP manufacturing plant (Ph I/II to Ph III). Link development with Manufacturing.
Provide technical support including on floor support during clinical production of biologics/gene therapy products; Main PD point of contact during MFG deviation and GMP investigation;
Contribute actively to manufacturability risk assessments and other QbD initiatives.
Draft regulatory support documents (IND/BLA/BB etc.)
The process implementation lead will interact closely with drug substance process development teams, pilot plant personnel, technical services teams, and manufacturing network to ensure seamless process/knowledge transfer and manufacturing support at all development stages.
30% Providing process expertise for drug substance development programs; SME for manufacturability assessment and other QbD initiatives; providing support to pilot scale production
50% Performing tech transfer from process development to pilot and to GMP MFG plants; Performing GMP manufacturing support (on floor support); Influences the opinion and decision making of others within and out side PDTS
10% Actively drives investigations for dev. programs and contributes to CAPA investigations in the biological pipeline; Identifies and resolves complex technical, operational problems
10% Drafts, reviews and provides input to risk assessment documents and regulatory submission documents; Interacts with QbD, LCM, and RA CMC for risk assessment and CMC submission strategy
Education and Experience Requirements
B.S., M.S., or PhD in biology, biochemistry, biotechnology, chemical engineering or related field. 3-10 years of relevant experience in cell culture process development/pilot plant production and manufacturing is required. Experience in downstream processing is a plus.
Strong interpersonal, problem solving, and communication skills are required as well as ability to work in matrixed environment
Working with multifunctional across facility global teams and projects
Global thinking and strong in translating strategy into operational requirements
Acting in global networks
Organized, structured and goal oriented
Critical thinker with the ability to conceptualize, organize and implement complex research projects
Experience and Expertise
Experience in manufacturing process development and pilot/GMP production
A strong background in upstream-, and/or downstream development techniques (upstream preferred)
Experience with continuous/batch production systems in conventional stainless steel and single use equipment
DoE and QbD concepts
Excellent manufacturing and compliance understanding
Complexity and Problem Solving
Technical lead in tech transfer to internal and external manufacturing network. Experienced in cell culture and fermentation process development, scale-up and technology transfer. Identify and analyze complex technical problems and then find and implement solutions.
Lead or participate in a cross-functional team to develop a robust CMC tech transfer package.
Apply fundamental engineering and biological principles to practical technical challenges.
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 input to the drug substance development group and manufacturing network.
Internal and External Contacts
PDTS Upstream and downstream Development group/Competency center
PDTS Pilot plant group
PDTS Technical Service, Analytical Development, and Life cycle management group
Equipment and engineering team
Equipment companies as needed (Sartorius, Applikon, Millipore etc.)
Other Job Requirements
This position will be based in Shire’s Massachusetts operations (Lexington). The candidate may be asked to travel occasionally (domestically and internationally).
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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 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.