Lead Scientist - Biologics CMC

JOB DESCRIPTION

Job Title: Lead Scientist

Job Location: Bangalore

Department: Biopharmaceutical Development

About Syngene:  Syngene (www.syngeneintl.com) is an innovation-led contract research, development and manufacturing organization offering integrated scientific  services from early discovery to commercial supply.

At Syngene, safety is at the heart of everything we do personally and professionally. Syngene has placed safety at par with business performance with shared responsibility and accountability, including following safety guidelines, procedures and SOPs, in letter and spirit

Mandatory expectation for all roles as per Syngene safety guidelines

• Overall adherence to safe practices and procedures of oneself and the teams aligned
• Contributing to development of procedures, practices and systems that ensures safe operations and compliance to company’s integrity & quality standards
• Driving a corporate culture that promotes environment, health, and safety (EHS) mindset and operational discipline at the workplace at all times.
• Ensuring safety of self, teams and lab/plant by adhering to safety protocols and following environment, health, and safety (EHS) requirements at all times in the workplace.
• Ensure all assigned mandatory trainings related to data integrity, health, and safety measures are completed on time by all members of the team including self
• Compliance to Syngene’ s quality standards at all times

Core Purpose of the Role:

• The employee in this role will execute experiments for development, qualification and transfer of analytical methods.
• Documentation: Preparation of DVR (Development report), MQP (method qualification protocol), MQR (method qualification report), MTP (method transfer protocol), MTR (method transfer report) and SAR (sample analysis report).
• Perform instrument calibration/ prepare standard operating procedures.
• Coordination with cross functional teams to complete the assigned work on time and data review.
• Provide the analytical support for process team.
• Will independently conduct experiments with minimum supervision and collect data and draft reports like method development, qualification, and method transfer to Quality control lab/client lab.
• This role will coordinate with QC for method transfer activities and complete the method transfer activity on time.
• Should be a good team player and complete the activity on time within project timelines.
• Coordinate with ENM to complete the instrument/equipment preventive maintenance on time.
• Perform the instrument calibration as per schedule and prepare report.
• Coordination with different supplier and vender as per project requirement.
• Performing any other activities assigned by the department Head or manager.

Role Accountabilities

• Perform activities as assigned by manager.
• Design, plan, review of experiments, prepare documents as assigned.
• Assist during audits and client visits
•  Attend client calls and present the data as needed.

Leadership Capabilities: NA

Syngene Values

All employees will consistently demonstrate alignment with our core values

•  Excellence
•  Integrity
•  Professionalism

Equal Opportunity Employer:

It is the policy of Syngene to provide equal employment opportunity (EEO) to all persons regardless of age, color, national origin, citizenship status, physical or mental disability, race, religion, creed, gender, sex, sexual orientation, gender identity and/or expression, genetic information, marital status, status with regard to public assistance, veteran status, or any other characteristic protected by applicable legislation or local law. In addition, Syngene will provide reasonable accommodations for qualified individuals with disabilities.