Development Engineer/Scientist

Summary/Objective 
The Engineer or Scientist is responsible for the technical leadership for large and/or complex manufacturing projects which include development and optimization of formulations and/or manufacturing processes, execution of R&D prototype batches, generation of project documentations, coordination of raw materials and supplies, and manufacturing project supervision. The Engineer/Scientist works closely with Director – Formulation to develop project specific strategies, and support activities to meet company goals.

 ESSENTIAL DUTIES AND RESPONSIBILITIES include the following. Other duties may be assigned.

• Lead formulation and drug product process development activities including but not limiting to formulation development, drug product manufacturing process development, optimization of the process, feasibility/tech transfer, and drug product manufacturing support for R&D and GMP batch manufacturing.
• Responsible for study design, execution, data analysis, and troubleshooting to support client project objectives.
• Author technical documents including protocols, batch records, study reports, specifications, SOPs, and other documents to support Client regulatory filing.
• Participate in client meetings as a technical representative including authoring and giving technical and data focused presentations.
• Work closely with project management, operations, quality, and analytical services to lead and support formulation/process development activities.
• Lead and provide technical expertise to support manufacturing investigations/deviations and CAPA activities, change control activities, assess impact, and provide conclusions.
• Identify, monitor, communicate and resolve issues, scope changes, budget variances or other project objective hurdles that may arise during the project execution. Work with team members, customers, and management to provide mitigation strategies.
• As needed, work with the business development team and provide technical support during the proposal drafting stage.
• Mentor and advise junior engineers and scientists to achieve their respective goals within the department.

ADDITIONAL POSITION REQUIREMENTS 

1. Carries out duties in compliance with all federal and state regulations and guidelines.
2. Complies with all company and site policies and procedures including but not limited to safety, standard operating procedures, and work instructions.
3. Remains current in profession and industry trends.
4. Makes a positive contribution as demonstrated by:
5. making suggestions for improvement
6. learning new skills, procedures, and processes.
7. Is available for other duties as required.
8. Is available for overtime as needed. 

SUPERVISORY RESPONSIBILITIES 

None

QUALIFICATIONS: EDUCATION and/or EXPERIENCE 

Advanced degree in Pharmaceutics, Chemical Engineering, or allied disciplines, Ph.D. with minimum 0-2 years or MS with 3-5 years of pharmaceutical industry experience with thorough understanding of cGMP, regulatory and safety requirements.

Bachelor’s Degree in Engineering is required.

LANGUAGE SKILLS 

1. Read and interpret documents such as standard operating procedures, manuals, batch records, work instructions and specifications. 
2. Legible Handwriting
3. Communicate clearly in writing and orally.

MATHEMATICAL SKILLS

1. Practical experience  with mathematical concepts such as regression analysis, design of experiment (DOE), statistical quality control (SQC), capability analysis, probability and statistical analysis.

OTHER SKILLS, ABILITIES OR QUALIFICATIONS 

1. Scientific understanding: Pharmaceutical Development Process, (Pre-)Formulation Development and/or Process Development and Engineering, Basic Chemistry and Physics, Quality by Design, Technical Transfer and Process Validation, etc.
2. Demonstrate effective collaboration and teamwork.
3. Demonstrate experience managing contract pharmaceutical projects on time and on budget.
4. Demonstrate experience working in a cGMP environment.
5. Familiar with project management tools and technologies such as Microsoft Project.
6. Successfully completes regulatory and job training requirements.
7. Computer skills:
8. Enter data into computer using software applications for data entry, data analysis, statistical analysis, DOE, and word processing.
9. Work and be proficient with e-mail systems
10. Ability to perform repetitive tasks while maintaining speed of work and attention to detail without loss to production.
11. Ability to work with others in a team environment.

WORK ENVIRONMENT

1. This job operates in an office / manufacturing / packaging / warehouse setting. 

PHYSICAL DEMANDS 

1. While performing the duties of this job, the employee is frequently required to stand, walk, use hands to touch, handle or feel, and talk or hear. 
2. The employee is occasionally required to sit and reach with hands and arms. 
3. The employee must be able to lift and/or move up to 50 pounds frequently. 
4. The employee is occasionally required to sit; climb or balance; and stoop, kneel, crouch or crawl.
5. Specific vision abilities required by this job include close vision, distance vision, color vision, peripheral vision, depth perception and ability to adjust focus.

TRAVEL

1. Travel will be required less than 10% of the time, domestic and international

The job demands described here are representative of those that must be met by an employee to successfully perform the functions of this job.  Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.  This job description is not intended and should not be construed to be an exhaustive list of all responsibilities, skills, efforts, or working conditions associated with the job.  It is intended to be a reflection of those principal job elements essential for recruitment and selection, for making fair job evaluations and for establishing performance standards.  The percentage of time spent performing the various job duties is not absolute.  The incumbent shall perform all other functions and/or be cross trained as shall be determined by the sole discretion of management, who has the right to amend, modify, or terminate this job in part or in whole. This document is not a contract for employment.