Shire Head of Process Lab Lexington/Milford in Lexington, Massachusetts

Posting Title Head of Process Lab Lexington/Milford

Job ID 15466BR

Function Technical Operations

Division NA

Employee Type Regular

Level ASSC DIR

Search Location(s) United States - MA - Lexington

Job Category Process and Analytical Development

Job Description Primary Role:

The Head of the Lexington/Milford process lab, part of the PDTS (Process Development and Technical Services) organization, is responsible for providing product lifecycle management and manufacturing support for the global Biologics network. The scope of the experimental work includes studies in support of process improvement ideas that will be implemented globally and are part of the project portfolio plan for the local Lexington/Milford or any other global facility. In addition the scope includes experimental work needed for manufacturing support , like supportive work for CAPA investigations and change control. Responsible for developing, qualifying, and maintaining a scale-down model for specific Biologics processes with at least one scale down factor. This position is in close contact with all the Global Product Support teams and the local head of TS to understand all the PDTS projects and manufacturing issues. This position is the functional and disciplinary head of the local lab teams and works closely with the Global Business Operations manager to support the upkeep, maintenance, and efficient utilization of the lab.

Responsibilities:

30%:

Provide general/technical leadership and management to the Lexington/Milford Process Lab group, leading a team of approx. 20 employees co-located at the site, and managing about 3 direct reports.

Responsible for OpEx and CapEx annual budgeting for the lab. Manage lab cost center to meet OpEx spending goals.

Deliver PDTS lab strategy according to plan

20%:

Plan and coordination of day-to-day activities of the laboratory in conjunction with lab ops management and local or nearby sites. Schedule and prioritize the experiments and utilization of the lab. Maintain equipment and utilities/lab services. Manage laboratory supplies with local and global partners

10%:

Develop, qualify, and maintain scale down models with at least one scale down factor.

Review and approve data from local scale down model (SDM) and assure SDM compliance with SDM qualification handbook

10%:

Apply Lean, Six Sigma and DMAIC methods to improve the manufacturing processes and to determine causes of product failures or process shifts. Promote good experimental design and data analysis techniques.

10%:

Liaise with local Technical Services (TS) teams during investigations to provide study design

Liaise with Process development (PD) for Tech transfer and Development support

Liaise with QC and AD testing support function for data acquisition

Review and approve protocols and final reports written by team members

10%:

Guide and monitor projects/tasks/initiatives and ensure timely issue resolution or implementation of improvements

10%:

Provide an environment for innovation – Industry survey and feasibility to support project proposals

Provide forums to communicate results from experiments and promote the work of the team

Education & Experience Requirements:

Minimum Degree Required: BS in a scientific or engineering discipline

Preferred Degree: PhD in a scientific or engineering discipline

Certificate(s): Lean or Six Sigma certification is preferred

Experience: At least 8 years professional experience in the Biotechnology or Pharmaceutical industry (4 years with a PhD, 6 years with an MS, 8 with BS ). At least 2 of those years should be with supervisory experience. Experience working in a laboratory is a must.

About Shire:

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.

Equal Employment Opportunity

Shire is an equal opportunity employer. Shire evaluates qualified applicants without regard to race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, protected veteran status, disability/handicap status or any other legally protected characteristic.

EEO is the Law at https://www.dol.gov/ofccp/regs/compliance/posters/pdf/eeopost.pdf

EEO is the Law - Supplement at https://www.dol.gov/ofccp/regs/compliance/posters/pdf/OFCCPEEOSupplementFinalJRFQA508c.pdf

Pay Transparency Policy at https://www.dol.gov/ofccp/pdf/EO13665PrescribedNondiscriminationPostingLanguageJRFQA508c.pdf

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.