Junior Analytical Development Scientist

JOB DESCRIPTION

Job Title: Junior Analytical Development Scientist - Injectables

Job Location: Bangalore

Department : Analytical Development - Drug Product

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: Analytical development supporting Formulation development

• Routine analysis of samples
• Method development
• Instrument calibrations
• Documentation
• Report preparation
• Miscellaneous lab responsibilities

Role Accountabilities:

• Candidate should have very good educational and theoretical background.
• Candidate should have knowledge of calibration, method development and troubleshooting using various instruments like Zetasizer, Mastersizer, Osmometer, KF auto titrator, dissolution (I, II & IV), spectroscopic instruments e.g. UV spectrometer, IR and Chromatographic instruments e.g. HPLC/UPLC, GC, Liquid Particulate counter, etc.
• Knowledge of various regulatory guidelines w.r.t. method development, product development and documentation
• Knowledge of method development for injectable formulations w.r.t. tests like assay, degradation products, dissolutions, content uniformity, cleaning method, degradation products of liposomes/microspheres, free and bound API assay, etc.
• Knowledge of specification setting for parenteral dosage forms, in-process specifications as well as finished product specifications
• Knowledge and operating of instruments like LC-MS, GC-MS will be added advantage
• Good understanding of Documentation as per GxP requirements
  • Online Lab notebook writing (ELN or any specific tools)
  • Method development report preparation - Assay, Degradation products, Dissolution, cleaning method, etc.
  • Method of Analysis, Test report, SOP preparation
  • Calibration documentation
  • Review of documents generated by peers or juniors
• Should be able to search scientific literature on-line

Syngene Values

All employees will consistently demonstrate alignment with our core values

• Excellence
• Integrity
• Professionalism

Experience: More than 3 years up to 7 years

Skills and Capabilities:

• Technical/functional Skills:

• Candidate should have good proficiency for MS-office tools
• Should be able to search scientific literature on-line

• Behavioral Skills:

• Strong commitment towards work, and a high level of dedication, enthusiasm, motivation, and persuasive ability in a team.
• Good speaking-listening-writing skills, attention to details, proactive self-starter.
• Ability to work successfully in a dynamic, ambiguous environment.
• Ability to meet tight deadlines and prioritize workloads.
• Ability to develop new ideas and creative solutions.
• Should be able to work in team and flexible for working in shifts.
• Should be a focused employee.

Education: M.Pharm / M.Sc

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.