Shire Biotechnologist III in Woodlands, Singapore

With general supervision the individual will perform routine and critical manufacturing operations, including but not limited to work functions in Cell Culture and Purification areas. Operates production equipment according to Standard Operating Procedures (SOPs) for the production of commercial and/or clinical products.

Responsibilities

(Describe the essential daily job functions.) % of Time

Job Function and Description

80%

Primary responsibilities include:

 Execution of routine and critical production operations

 Learn and perform well-defined SOPs

 Pursue on-the-job training through Competency Assessments to increase knowledge and understanding

 Execute instructions and record data in the Electronic Batch Management (EBM) system if applicable

 Execute instructions and record data in the Master Batch Records (MBRs) and Master Formulation Records (MFRs) if applicable

 Attain operating knowledge of the Process Control System (PCS)

 Record data into logbooks and log-sheets

 Review logbooks and log-sheets data

 Perform equipment monitoring

 Perform basic laboratory tasks including but not limited to sampling, pH and conductivity measurements

 Demonstrate aseptic technique in the handling of product and materials if applicable

 Troubleshoot and resolve process related issues

 Initiate and document production events in the Global Event Management System (GEMS) or equivalent system

 Propose document revisions

 Complete required training on time

 Carry out work in a safe manner, notifying management of safety issues and risks

10%

The individual will manage equipment and support facility related projects by

 Perform scheduled cleaning of equipment

 Assist in the assembly and disassembly of process equipment

 Perform standardization of equipment

 Perform basic 5S housekeeping

 Initiate Corrective Work Orders in the C3ME system or equivalent system

 Support change over activities

10%

Staff Technical Training and Development

 Meet and maintain training requirements

 Develop and maintain personal development plan

 Provide annual performance self-assessment on development plan

Responsibility to adhere to any applicable EHS requirements.

Commitment to a fair and respectful relationship to others and behavior in accordance with Shire’s Code of Conduct.

Any other duties as assigned by supervisor.

Education and Experience Requirements

(Include educational requirements or equivalency, required years and type(s) or experience, and necessary licenses or certificates. Specify which are required and which are preferred.)

 Degree in Chemical Engineering / Bioengineering / Chemical & Biomolecular Engineering / Pharmaceutical Engineering or related

 Diploma in Applied Chemistry / Biomedical Sciences / Chemical Engineering / Food Science & Technology / Biologics & Process Technology / Chemical & Pharmaceutical Technology/ Food Science & Nutrition / Molecular Biotech

nology / Biotechnology / Chemical & Biomolecular Engineering / Pharmacy Science or related and possess more than 2 years of relevant experience in the biotechnology or pharmaceutical industry

 Nitec in Biotechnology / Chemical Process Technology or related with more than 5 years of relevant experience in the biotechnology, pharmaceutical industry

 Will work holidays and overtime as required

 May be required to adjust work schedule to meet production demands

Key Skills and Competencies

( Describe critical skills and abilities needed to successfully perform the job, which should be representative of the knowledge, skills, and abilities required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.)

 May be required to perform as a subject matter expert for equipment and/or systems

 Ability to following written instructions in the form of Electronic Batch Management (EBM), Batch Records (MBRs, MFRs) and Standard Operating Procedures (SOPs) where applicable

 Possess good communication skills

 Possess good troubleshooting skills

 Full awareness of current Good Manufacturing Practices (cGMP)

 Proficient documentation and proficient computer skills

 Proficient in aseptic technique where applicable

 Ability to wear personal protective equipment such as safety glasses/goggles, gloves and safety shoes

 Ability to gown and gain entry to biotechnology/pharmaceutical manufacturing areas.

 Ability to work in and out of 2-8 deg C Cold Rooms with appropriate personal protective equipment if required

 Ability to work in confined spaces if required

 Ability to work around chemicals (alcohols, acids & bases)

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.

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.