Senior Biotechnologist I

Primary Objectives of this Job

(Provide a brief summary describing the major role, responsibility and purpose of the job. Summarize key areas of accountability and budget responsibility, if applicable.)

With limited 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. Will support engineering and validation activities.

**Responsibilities**:
(Describe the essential daily job functions.)

% of Time

Job Function and Description

70%

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
- Review manufacturing documentation and EBM or PCS alerts real-time to ensure compliance 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 and coordinate 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
- Informing management of events impacting production schedule
- Propose and review document revisions
- Complete required training on time

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

15%

The individual will manage equipment and support facility related projects by
- Act as a Subject Matter Expert SME for improvement projects

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
- Provide technical training for area personnel
- Provide input on training material development
- 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 Takeda’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 and possesses 2 - 4 years of relevant experience in the biotechnology or pharmaceutical industry
- Diploma in Applied Chemistry / Biomedical Sciences / Chemical Engineering / Food Science & Technology / Biologics & Process Technology / Chemical & Pharmaceutical Technology/ Food Science & Nutrition / Molecular Biotechnology / Biotechnology / Chemical & Biomolecular Engineering / Pharmacy Science or related and possess 4 - 6 years of relevant experience in the biotechnology or pharmaceutical industry
- Nitec in Biotechnology / Chemical Process Technology or related with 6 - 8 years of relevant experience in the biotechnology, pharmaceutical industry
- Excellent self-motivated team player with hands-on attitude and good communication skills
- Able to work on rotating shift
- 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.)
- Proficient at following written instructions in the form of Electronic Batch Management (EBM), Batch Records (MBRs, MFRs) and Standard Operating Procedures (SOPs) where applicable
- Possess excellent communication skills
- Possess excellent troubleshooting skills
- Full awareness of current Good Manufacturing Practices (cGMP)
- Proficient documentation and proficient computer skills
- Proficient in aseptic technique where applicable
- Experience as a system us