Scientist II, Formulation & Process Development

Development of new formulations and manufacturing processes for solids, liquids, and semi-solid dosage forms by selecting the right excipients.

Establish formulation and processes using experimental design for the development of pre-clinical phase III, scale-up, registration, and validation.

Connect with technical leads, supervisors, and cross functional peers (analytical, quality, and project management) onthe progress and timely completion of activities and critical achievements.

Lead client calls and provide scientific justification for the development review and plan cycles.

Essential Functions :

Perform all duties in strict compliance with Standard Operating Procedures, Good Manufacturing Practices, Good Laboratory Practices and Safety guidelines.

Maintains the compliance status required by company and facility standards.

Design, evaluation and development of formulations for pre-clinical studies, clinical trials, process development, and process validation to be commercialized as defined by client requirements.

Represents the organization on formal technical and scientific forums. For example, AAPS, webinars, and CRS.

Actively participates in problem solving for formulations, equipment and processes for assigned projects. For example, assist with the organization of individuals required for a detailed evaluation and investigation of incidents which occur on the manufacturing floor.

Drafts quality batch production records, reports and protocols as needed or to support client regulatory submission to the United States Food & Drug Administration (FDA), European Medicines Agency (EMEA) or other regulatory agencies.

Maintains up to date knowledge of FDA requirements related to OSD development. Ability to navigate the FDA website and corporate guidance’s issued in response to these changes.

Leads with moderate level of supervision, the review and planning of all technical aspects of the project which includes planning and prioritization of multiple projects or task to meet the appropriate timeline achievements.

Highly sufficient knowledge regarding the selection of the individual excipients and the dosage form to support clinical purpose.

Ability to reverse engineer dosage forms and develop basic patent comprehension.

Ability to integrate risk-based approach during the development process and have the appropriate response to the mitigation strategy.

Ability to design experiments to conduct investigations that strive to the true root cause. Ability to formulate statistics in support data or findings.

Review quotes, protocols, results, and reports for all client projects.

Attends and leads project team meetings in most project instances (level of technicality to be considered) to provide information and project status updates.

Ensures the collection and interpretation of process data, as well as, a detailed scientific review in order to substantiate the conclusions / recommendations applied in reports.

Seeks to implement and push innovative ideas and solutions regarding solid oral dosage development

Assist in implementing interpersonal and technical improvements designed to improve the efficiency, reliability, and productivity of operations all conforming to applicable regulatory standards.

Education :

Minimum Bachelor of Science in relevant Engineering or Science field.

Experience :

Typically requires minimum of 4 years of scientific experience.

Equivalency :

Equivalent combinations of education, training, and meaningful work experience may be considered.

Competencies :

Understanding of Good Manufacturing Practices (GMP), Good Laboratory Practices (GLP), and regulatory compliance.

In-depth knowledge of principles and methods in a recognized professional field and solid understanding of other fields.

Communicates and co-operates with team members and customers to meet project and team objectives

Solid knowledge of various aspects or a specialized aspect of a field.

Good knowledge of scientific methodology as related to the pharmaceutical industry.

Strong proficiency in Microsoft Office Suite (Word, Excel, and PowerPoint).

Good critical and logical thinking skills. Effective written, interpersonal, and presentation skills, including managing technical discussions with internal and external customers.

Ability to work on multiple projects simultaneously.

Ability to develop knowledge and skills in pharmaceutical processes, equipment, instrumentation, and procedures. Provide technical solutions.

Physical Requirements :

• Position requires ordinary ambulatory skills and physical coordination sufficient to move about office locations; ability to stand, walk, stoop, kneel, crouch periodically for prolonged periods of time;
• manipulation (lift, carry, move) of light to medium weights of 10-35 pound pounds; arm, hand and finger dexterity, including ability to grasp and type for prolonged periods of time;

visual acuity to use a keyboard, computer monitor, operate equipment, and read materials for prolonged periods of time; ability to sit, reach with hands and arms, talk, and hear for prolonged periods of time.