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Scientist III – Product Development

Recro Pharma, Inc.

This is a Full-time position in Gainesville, GA posted June 18, 2021.

Primary Objective of Position

The Scientist III position’s key function is to support research directed toward development of new formulations and/or formulation platforms for a significant PD project or a number of projects with many complex features under minimal supervision using established and novel technology.

This role is responsible for the formulation development and process optimization of challenging pharmaceutical products such as controlled release solid oral dosage forms.

This role will also suggest product development strategies on client projects.

M ajor Duties/Responsibilities
Independently leads development activities for client-based projects, ranging from preclinical to Phase III studies.

This may include creating phase-appropriate strategies for customer-defined product development projects.

Execute prototype, scale-up and process transfer activities including manufacture, data evaluation, trouble-shooting product/process issues, and risk assessments.

Write, review, and approve cGMP documentation including batch records, protocols, SOPS, pharmaceutical development reports, investigation plans, and outcomes for development problems, etc.

Maintain expert knowledge of equipment, instrumentation, and procedures related to product development.

Maintain expert knowledge of equipment, instrumentation, and procedures related to product development.

Maintain and expand knowledge of current and new formulation development technologies and manufacturing processes.

Perform literature and patent searches to provide background basis for development plans.

Attend cGMP training sessions and comply with site-wide and departmental procedures including but not limited to change control, documentation, deviation reporting, cGMP compliance, safety and electronic data security.

Work in a GMP environment with a variety of compounds (potent, DEA controlled substances, etc.).

Work closely with Analytical Development, Quality Assurance, and Validations groups.

Serve as lead for product development activities within cross-departmental project teams.

Provides mentoring to less senior Scientists.

May lead initiatives within the Product Development group.

Assists with scheduling of activities within the group.

Lead or Supervisory Responsibilities: Leads work of others (1-3 individuals) who perform essentially the same work.

May organize, set priorities, schedule and review work, but has no responsibility to hire, terminate, review performance or make pay decisions.

Job Requirements:

Minimum Job Qualifications

Education/Experience: Candidate must possess one of the following combinations to meet the minimum qualifications:
Bachelor’s degree in Pharmaceutics, Physical Organic Chemistry, Pharmaceutical Chemistry, Chemical Engineering or similar with 10 years of relevant work experience; Master’s degree in one of the areas above with 8 years of relevant work experience; or PhD in one of the areas above with 4 years of relevant work experience.

Hands on work experience in formulation or process development is required, especially with solid oral dosage product types.

Experience with QbD, statistical DOE, and formulation and process development from concept through clinical phase III is preferred.

Knowledge/Skills/Abilities
In-depth knowledge of theory and techniques used in pharmaceutics and physical organic chemistry.

Strong knowledge of common pharmaceutical raw materials, their applications, and the principles of formulation development.

Proven experience with statistical design of experiments.

Strong written and oral communication skills.

Working knowledge of MS Office (Word, Excel, PowerPoint, Access, and Outlook), Minitab, JMP or equivalent.

Ability to prepare presentations, speeches, and articles for publication that conform to prescribed style and format.

Ability to apply principles of logical or scientific thinking to a wide range of intellectual and practical problems.

Working knowledge of regulatory requirements, including FDA (GLP/cGMP), EMEA, ICH, and regulations in regards to IID, GRAS, residual solvents, bioequivalence studies, etc for oral formulations.

P h ysical and Mental Demands and Work Environment (The physical and mental demands and work environment described here are representative of those that must be met by an employee to successfully perform the essential functions of the job.

Reasonable accommodations may be made to enable individuals with disabilities to perform essential functions.)

P h ysical Demands
– While performing the duties of this job, the employee is regularly required to stand.

The employee is frequently required to walk, sit, climb or balance and stoop, kneel, crouch or crawl.

The employee is occasionally required to use hands to handle or feel.

The employee must regularly lift and/or move up to 25 pounds, frequently lift and/or move up to 50 pounds, and occasionally lift and/or move more than 50 pounds.

Specific vision abilities required by this job include close vision, distance vision, color vision, peripheral vision, depth perception.


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