Senior Scientist - Analytical

JOB DESCRIPTION

Job Title: Senior Scientist - Analytical (Bioassay and Physicochemical activities)

Job Location: Bangalore

Job Grade: Level 7

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 to perform the development, validation, and routine testing of bioassay/ELISA for Large Molecules (LMs), especially Monoclonal antibodies (mAbs) and other LMs. 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.

Role Accountabilities:

• Shall develop and validate cell based assays and binding assays (ELISA), Drug content by SEC & Lower molecular weight distribution by Capillary electrophoresis for monoclonal antibodies (mAb). Shall troubleshoot the problems for these methods
• Must have experience in handling of Microplate reader, HPLC, capillary electrophoresis, UPLC (Empower-3 software), UV Visible spectrophotometer balances, Potentiometer, and stability chambers.
• Must have experience in handling PMA instruments (PAMAS, APSS, HIAC…Etc)
• Shall have experience on good documentation/laboratory practices such as ALCOA+
• Broad knowledge on analysis of cell-based assays to derive relative potency software’s (such as Softmax Pro and PLA)
• Basic cell culture technics and hands-on experience in maintaining of mammalian cells. Must have experience in handling various cell lines (adherent and suspension cell lines).
• Preparation of Mammalian cell banks for Bioassays. Experience in handling of primary and continuous cell lines like Revival, maintenance, cell bank preparation, and cryopreservation
• Experience in calibration and qualification of Microplate reader, HPLC, Capillary electrophoresis, UPLC, 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 QMS (such as incidents, Out of Specifications, Deviations, and Change control) through track wise platforms.
• Shall have good experience in handling EDMS activities (such as method development reports, validation protocols, validation reports, stability protocols, stability reprots)
• 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.
• Review of raw data for development, validation, calibration and stability studies.

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

Experience

• Looking for an entry level lateral in Analytical background with exp in Bio assay and Physicochemical activities 

Skills and Capabilities:

• Development, validation, and routine testing of Bioassay /ELISA, SEC, CGE for Monoclonal antibodies (mAbs) and other Large molecules
• Qualification and validation of cell-based bioassays
• Hands-on experience with Microplate reader, HPLC, UPLC/UHPLC, PAMAS, APSS, HIAC, Capillary electrophoresis, UV-Visible spectrophotometer, and QC other analytical instruments
• Good documentation/laboratory practices such as ALCOA+
• Experience in developing and validating SEC, CGE methods for mAbs.
• 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. Tech/ M.Sc. / B.Sc. (Biotechnology) 

Equal Employment Opportunity:

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.