Analytical Scientist I

The Analytical Scientist I uses professional knowledge and company's policies and procedures to execute tasks and solve a variety of problems within the Analytical department. The Scientist I executes analytical procedures and ensures compliance with predefined assay acceptance criteria and product specification.

The Scientist I works under the guidance of the Analytical Supervisor to support team efforts to successfully complete analytical activities. She/He interacts with Project Scientists to support method development/transfer/validation activities, as required.

Duties and Responsibilities

• Follow company policies and procedures.
• Perform established laboratory analyses and use the required analytical instrumentation.
• Execute and document Quality Control (QC) testing in a GMP environment.
• Participate in activities related to analytical method development/transfer/optimization/validation.
• Accountable for the accuracy and completeness of the analytical data she/he generates.
• Maintain proactive interactions with Management and Project Scientists to complete tasks timely and efficiently.
• Work closely with the Analytical Supervisor to resolve issues arising during task execution.
• Participate in SOPs writing/review.
• Identify OOS, out of trend (OOT) and atypical results and inform the supervisor or delegate immediately.
• Report quality incidents in accordance with internal procedures.
• Participate in OOS investigations, deviations, and corrective and preventive actions (CAPA) implementation activities as appropriate.
• Practice safe work habits and adheres to company safety procedures and guidelines.
• Analyze and record data in accordance with internal SOPs and Good documentation practices.
• Perform data review according to GLP/GMP requirements.
• Use scientific expertise for troubleshooting, laboratory investigations and problem resolution.
• Perform other related assignments and duties as required or assigned by the supervisor.

The above information has been designed to indicate the general nature and level of work performed by employees within these qualifications. It is not designed to contain or be interpreted as comprehensive inventory of all duties, responsibilities and qualifications required of employees assigned to this job.

Qualifications

• B.Sc. degree in chemistry, biology, biochemistry or related field and a minimum of 5 years related experience (or equivalent combined education with relevant work experience).
• Hands on experience with separation techniques (chromatography HPLC, electrophoresis, etc.) and/or immunological techniques (ELISA, Western Blot) and cell-based assays.
• Understanding of cGMP, USP, EP and ICH regulations.
• Ability to perform laboratory work independently and efficiently.
• Discipline; Detail-oriented; Openness; Creativity; Organization.