Analyst-Compounding SM

JOB DESCRIPTION

Job Title: Analytical ChemistryAnalyst

Department : BGRC

Job Location: Bangalore

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
• Hold self and their teams accountable for the achievement of safety goals
• Govern and Review safety metrics from time to time

Core Purpose of the Role:

• The candidate shall be responsible for method development, validation, and stability testing drug substance/drug product. The candidate shall be willing to work in shifts. Hands on experience with complex injectables is an added advantage.

Role Accountabilities:

• Must have strong hands-on experience in development and validation of Assay & related substances methods for drug substance/drug product.
• Must have experience in handling HPLC, UPLC (Empower-3 software), GC, UV Visible spectrophotometer balances, Potentiometer, and stability chambers
• Shall have experience on Good documentation/laboratory practices such as ALCOA+
• Experience in calibration and qualification of HPLC, UPLC, GC, and other QC laboratory instruments
• Shall prepare and review the raw data sheets, instrument operating procedures, and standard operating procedures
• Shall have good experience in handling of QMS (such as incidents, Out of Specifications, Deviations, and Change control)
• Shall be responsible for procurement and inventory maintenance of Pharmacopeial Standards/Chemicals/Reagents/Consumables/Spares etc., required for the projects
• Shall adhere to the procedure of GxP/Safety and as per the procedure defined in the internal standard operation procedure
• Shall operate the MS office (word, excel, ppt), outlook, and other essential tools required for routine activity
• Good communication and e-mail writing skills are required since the candidate needs to communicate to client/external users situated overseas
• Experience in developing and validating SEC, CGE methods is an added advantage especially for monoclonal antibodies (mAb)

Behavioral Skills

• Good Interpersonal skills
• Self-time management
• Good Team player
• Polite/Good Communication skills

Syngene Values

All employees will consistently demonstrate alignment with our core values

•  Excellence
•  Integrity
•  Professionalism

Accountabilities as a Syngene Leader (only for Leadership Hires)

• Champion effective Environment, Occupational Health, Safety and Sustainability (EHSS) practices for the company and oversee compliance with those practices within Biologics business. Play an active leadership role in monitoring and verifying safety performance through Gemba walks and other safety-led activities.
• Foster a corporate culture that promotes an environment, occupational health, safety, and sustainability (EHSS) mindset as well as the highest standards of quality, integrity, and compliance.

• Put people at the heart of our success by providing clear, active leadership defined by the Syngene leadership framework setting high standards of people management, career planning and talent retention as a priority.

Specific requirements for this role

Experience

• 6-8 years

Skills and Capabilities:

• Hands-on HPLC, UPLC/UHPLC, CG, UV-Visible spectrophotometer, Potentiometer, and QC other analytical instruments
• Good documentation/laboratory practices such as ALCOA+
• Particle size determination, Zeta potential and particulate matter analysis techniques is an added advantage
• Experience in developing and validating SEC, CGE methods for mAbs is an added advantage
• Able to follow work instructions and perform the tasks under the supervision of the Team leader
• Preparation and Maintenance of all the documents
• Good knowledge of MS-office (word, excel, ppt)

Education

•           M. Pharm /M. Sc with 3-6 years' experience in R&D under GMP environment (QC)