Shire Process Implementation Lead (Senior Engineer II) in Lexington, Massachusetts

Primary Duties

  • 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.

Responsibilities

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.

Personnel skills

  • 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

Internal:

  • PDTS Upstream and downstream Development group/Competency center

  • PDTS Pilot plant group

  • PDTS Technical Service, Analytical Development, and Life cycle management group

  • Manufacturing team

  • Quality team

  • Equipment and engineering team

External:

  • CMOs

  • 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).

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.