WHO WE ARE:

At CPL, we are passionate about pharmaceutical product development and contract manufacturing. Our aim is to be the top choice CDMO in the non-sterile liquid and semi-solid pharmaceutical products domain, and ultimately bring benefits to the customers using our manufactured products.
For more than 30 years CPL has partnered with the world’s leading pharmaceutical companies to provide full-service product development and manufacturing, singularly focused on innovation and efficiency.
We recognize our employees are our number one asset and support their career growth. We also offer a benefits program which includes Health/Dental and Vision care, deferred profit-sharing plan, paid time off, employee’s assistance program, work/life balance, employee recognition program, on-site parking, discounted gym membership and wellness program.

JOB SUMMARY:

Product Development group supports all activities required to develop, optimize and scale-up a stable semi-solid (cream, lotion, ointment, gel) / liquid (topical, oral, sub-lingual, nasal spray) formulation to make it suitable for commercial production. Associate Scientist within this group is responsible for the biological and analytical method development, method validation, method transfer to support formulation development and product commercialization. The Associate Scientist assists Principal Scientist, Skin Lab to maintain laboratory operation and ensure that all work is performed in accordance with the applicable SOPs, cGMPs and GLPs.

EDUCATION:

• B.Sc. or M.S. in pharmaceutical sciences or Life Sciences fields

EXPERIENCE:

• 4-5 years of related experience in research and development area of pharmaceutical industry.

KNOWLEDGE, SKILLS, ABILITIES:

• Knowledge of biological and analytical method development, method validation and method transfer.
• Proficient in the use of cell culture, protein, DNA and RNA work.
• Expertise in In-vitro release testing (IVRT) or In-vitro permeability testing (IVPT) will be an asset.
• Working knowledge and application of GMPs/GLPs principles, ICH guidelines and
• compendial methods, in addition to other related and relevant guidelines and
• regulations.
• Demonstrated competencies in CPL’s core values of Integrity, Respect, Trust and
• Fairness.
• Flexible with the ability to adapt, respond quickly and manage change in a fast paced
• environment.
• Strong verbal and written English communication skills. Ability to use computers with familiarity with MS Office.
• At times testing might require long workdays. Ability to work 10-12hou- work days when required needed. Compensatory time-off will be provided.
• Ability to commute between the two campuses when required.

• Responsible for promoting and maintaining safe and healthy working conditions in his /her assigned work area; instructs and enforces compliance with established safe work practices and procedures; ensures assigned trainees receive appropriate training and information necessary to conduct their activities in a safe and healthy manner.
• Promotes and exemplifies the CPL Culture, ensuring the delivery of an exceptional customer experience through demonstrating CPL’s core values.
• Performing biological and analytical method development, method validation, method transfer and sample testing. Preparing biological and analytical method validation/transfer protocol, method validation/transfer report and testing method.
• Developing biology-based services in the lab to be offered to clients.
• Preparing and implementing stability protocol and scheduling. Performing stability testing in accordance with ICH or other regulatory guidelines. Compiling stability testing reports for submission to the customer and/or regulatory agencies.
• Supporting Skin Lab operations and assist drug discovery, product development, optimization, submission to appropriate regulatory agencies, and technical transfer for scale-up, validation and manufacturing within scheduled timeframes.
• Developing and fostering an environment that value troubleshooting skills and root cause analysis expertise.
• Ensures that all work is performed in compliance with the required applicable SOPs, cGMP, GLP and established Safe Work Practices (SWP).
• Support Product Development Team to ensure the timely completion of the project.
• Keeping current on emerging biological and analytical technologies and providing technical resources to support biological and analytical development strategies.
• Responsible for the efficient utilization of resources and supplies to reduce waste and achieve cost containment and Lean objectives.
• Participate evaluation of prospective biological and analytical method, literature, procedures and protocols to determine technical feasibility and project scope.
• Other duties as assigned.