Formulation Scientist - Oral Solid Dosage (Pharma Exp. Required)

Job Description

Job Description

Department

Technical Services

Job Title

Technical Services Associate

FLSA Status

Exempt

Role

N/A

Sub Role (If any)

N/A

Reports To

Director of Operations

1. Role Purpose:

The Technical Services Associate is responsible for department activities in providing technical and proposal writing for the organization. This includes writing Standard Operating Procedures, Technical Transfer Documents, Validation Reports, Manufacturing Batch Records, Protocols, Pre-Development and Pharmaceutical Development Reports, investigations and other various documents. Additionally, the position will assist with the development and delivery of process records for production.

Technical Services role requires preparation of process validation protocols, process validation reports, and commercial batch records preparation.

Manages documentation compliance and change control for R&D. Execute all functions in accordance with current FDA regulations, ICH guide lines, USP methodologies, cGMPs and SOPs. Must perform all work independently with minimal supervision.

Person requires training of staff on technical documents writing in accordance with current FDA regulations. Guides the technical services staff meeting to Organizational Requirements.

2. Key Duties & Responsibilities:

• Develop, write and review/update R&D SOPs, and technical documentation which includes Manufacturing/Packaging batch records.
• Writes Development protocols and reports for R&D.
• Prepares documentation for submission of new ANDA filings.
• Assists in the response to FDA deficiency letters for ANDA filings for answering Pharmaceutics related findings.
• Prepares various summary forms for Pharmaceutics related projects as well as graphs, charts and statistical analysis for establishing product specifications.
• Designs, develops and implements databases to track key project deliverables and resource allocation within Pharmaceutics and updates on an on-going basis.
• Prepares presentations to share project status updates.
• Implements Document Management.
• Handles research and writing projects.
• Implements Change Control management.
• Comply with FDA guidelines/Company Policies of Data Integrity.
• Ensures Technical Services team follows current SOP’s
• Ability to learn new techniques, perform multiple tasks simultaneously, keep accurate records, follow instructions, and comply with company policies.
• Manage the review, tracking, GMP compliance and approval of Change Controls for Production Processes, Facilities and Equipment.
• Provide investigation expertise and technical writing expertise to perform and document process Deviations and Events.
• Implements Change Control management in production and engineering.
• Review and approve documentation associated with cGMP Compliance. Assess and document product quality impact.
• Assist regulatory to provide technical documentation for submission.
• Assists with the development of departmental project timelines and project plans.
• Other duties as delegated

3. Typical Supervisory Responsibility:

N/A

4. Education & Experience:

Education Requirement

Specialization (If any)

B.S in Chemistry preferred or related discipline general pharmaceutical experience or technical writing experience a plus.

Experience Requirement

1+ years working as a Formulation Scientist with knowledge of production required

Number of Years

N/A

5. Technical competencies/ Certifications/ Licenses:

Technical competencies

• Preparation and approval of Standard Operating Procedures .
• Preparation and review of Quality Risk Management for process, area and equipment.
• Experience with quality improvement initiatives as needed .
• Experience with development/writing of SOPs or other quality documents and/or reports as needed.
• Complies with company policies and SOPs.
• Good written and oral communication skills.
• Experience in statistical analysis, process capability reviews with software.
• Ability to act independently.
• Strong organization skills, attention to detail, and the ability to work in a team, fast paced environment.
• Excellent interpersonal, verbal and written communication skills

Certifications

N/A

Licenses

N/A

Other

N/A

6. Physical demand and Work environment:

a. Physical demands:

While performing the duties of this job, the employee is required to walk, sit, and use hands to finger, handle or feel tools or controls, reach with hands and arms, balance, stoop, crouch, bend, talk and hear. The employee must lift and/or move up to 20 pounds. Specific vision abilities required by the job include close vision, distance vision, color vision, peripheral vision, and depth perception.

b. Work environment:

N/A