Summary:

The purpose of this position is to carry out assigned advanced laboratory duties which include leading method development and validation studies. The position involves handling multiple tasks and managing own schedule.

Essential Duties & Responsibilities:

The following statements are intended to describe the general nature and level of work being performed by an individual assigned to this job. Other duties may be assigned.

1. Perform methods development and method validation for raw materials and final product testing. Cooperate with Quality Control department in method transfer, as required.
2. Carry out in-process and final product analyses for release and stability studies.
3. Act as a stability coordinator - oversee stability projects including study initiation and sample pulls. Author stability protocols, interim reports, and summaries with data trending.
4. Design and execute feasibility experiments, force degradation and cleaning validation studies.
5. Conduct laboratory tests in compliance with established internal Standard Test Methods (STMs), compendial and vendor/partner supplied methods.
6. Maintain organized records of tests performed and results obtained by following company policies.
7. Author documents such as STMs, method development reports, validation protocols, and SOPs.
8. Provide technical assistance and training to other laboratory personnel.
9. Understand and comply with all company policies, safety procedures, SOPs, cGMP requirements and ICH guidelines.
10. Represent the AD department during internal and external meetings and presentations.
11. Perform preventative maintenance of laboratory equipment, as needed.
12. Apply the knowledge, skills and experience obtained to perform investigations.
13. Assist in maintaining a clean, organized, and equipped laboratory environment.

Supervisory Responsibilities:

This role does not have supervisory responsibilities.

Interaction:

The incumbent works closely with various departments such as Process Development, Manufacturing, Quality Assurance, Quality Control, and Document Control.

Education and Experience:

• Bachelor's degree in relevant field of study (e.g., chemistry or biochemistry) required
• 5 years pharmaceutical industry experience required

Knowledge, Skills, and Abilities:

1. Proficient in method development and validation
2. Strong verbal and written English communication skills (e.g., able to participate in scientific discussions and written interactions)
3. Thorough understanding of the chemical and physical principals upon which formulation, process development and analytical methodology is based
4. Proficient in using and maintaining major laboratory instruments (e.g., HPLC, GC, UV Spec, pH meter, centrifuge, etc.)
5. Strong documentation skills in compliance with cGMP and ICH guidelines
6. Good interpersonal skills (e.g., working with members of other teams to achieve shared goals)
7. Ability to be flexible in adapting work plan to current corporate goals
8. Good organizational and time management skills (e.g., multi-tasking and task prioritization)
9. Good problem solving and troubleshooting skills (e.g., rational progression of investigation)
10. Skilled at organizing and motivating group members
11. Ability to effectively utilize scientific information resources within the assigned area of responsibility
12. Knowledge of mass spectroscopy, pharmacokinetics (PK studies), and solid-state characterization is a plus

Physical Demands:

The physical demands described here are representative of those that must me met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

While performing the duties of this job, the employee is regularly required to sit, talk, move between spaces, reach with hands and arms and stoop. Close vision and the need to focus on computer screen, use of hands, fingers and wrist to type on keyboard and manipulate mouse. Will need to lift and move boxes of paper and binders weighing up to 20 pounds.

Work Environment:

The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodation may be made to enable individuals with disabilities to perform the essential functions.

Typical office setting with a laboratory, offices and cubicles. Employee is required to work in the lab area and in GMP manufacturing areas. Noise level is moderate with consistent printer, telephone ringing and conversation.