Lead Downstream Development

JOB DESCRIPTION

Job Title: Lead Downstream Process Development

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

1. Overall adherence to safe practices and procedures of oneself and the teams reporting in.
2. Contributing to development of procedures, practices and systems that ensures safe operations and compliance to company’s integrity & quality standards.
3. Driving a corporate culture that promotes environment, health, and safety (EHS) mindset and operational discipline at the workplace always.
4. Ensuring safety of self, teams, and labs by adhering to safety protocols and following environment, health, and safety (EHS) requirements always in the workplace.
5. 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.
6. Always Comply to Syngene’s quality standards.
7. Hold self and their teams accountable for the achievement of safety goals.
8. Govern and Review safety metrics from time to time.

Syngene Values

All employees will consistently demonstrate alignment with our core values

•  Excellence
•  Integrity
•  Professionalism

Experience

• Good experience to lead downstream process development specifically with monoclonal antibody purification

Skills and Capabilities

• Working knowledge of downstream purification principles is essential for this role.
• Proficient in operation, maintenance of downstream process equipment like AKTA Pure, AKTA Pilot, TFF systems, column packing, buffer preparation and inventory management.
• Execution of laboratory experiments and documenting them in detail as per Good Documentation Practices
• Compilation of data, Interpretation and preparation of development report, TTD, BPR, SOP, EOP, IOP, and technical presentations.
• Preparation of draft experimental protocol and getting it reviewed by the team lead.
• Experience in scale-up and tech transfer is preferable
• Knowledge on Process characterization, control strategy and PPQ batch is preferable not mandatory.
• Experience in using electronic lab notebook, Electronic Database Management System (EDMS), TrackWise is preferable not mandatory.

Education

• Master’s degree (M. Tech/M.Sc) in Life Science, Chemical Engineering, Biotechnology, or related field.

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.