New Jersey Company Seeks Formulation Scientist

Title: Formulation Scientist

Position Type: Full-time

Department: Research and Development

Reports To: Sr. Director of Formulation

Effective Date: Ongoing

Location: New Jersey
Salary: $100K or more based on experience

SEND RESUMES TO

rashmi.marya@altitudestaffing.com

POSITION SUMMARY
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U.S. Citizens, Green Card Holders, and those authorized to work in the U.S. for any employer will be considered.

ESSENTIAL DUTIES & RESPONSIBILITIES

• Develop new technologies, processes and product formulations for solid dosage form of pharmaceuticals. Projects can range from new product development, current product improvement, and ingredient evaluation.

• Design and conduct pre-formulation, formulation development, process development, process optimization, scale up and manufacturing and solve complex problems.

• Represents Formulation Development and acts as subject matter expert with government agencies.

• Write, generate and review protocols, development reports, and master batch records.

• Help and develop the process of the plant and assist in evaluating new equipment.

• Responsible for creating, testing, evaluation, re-evaluation and formatting the product development image to conceptualization.

• Validate processes, procedures and formulations consistent with GMP requirements.

• Source, develop and work with outside laboratories and manufacturing facilities to identify and support innovative products and delivery methods.

• Formulate and modify existing formulas to meet regulatory guidelines, cost parameters and claims.

• Think creatively in prototype preparation and in problem solving.

• Collaborate with other corporate departments to define project scope, timing, product cost

Proprietary 2

• Will maintain working knowledge of industry trends, ie, QbD.

• Will work closely with other members of the R&D team, Operations, Marketing, Regulatory, Quality, Laboratory, etc.

• Other duties may be assigned.

The above statements are intended to describe the general nature and level of work being performed in this job. They are not intended to be construed as an exhaustive list of all responsibilities and skills required for the person doing this job.

QUALIFICATIONS

To perform the job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed here are representative of the knowledge, skill and/or ability required. Reasonable accommodation may be made to enable individuals with disabilities to perform the essential functions.

MINIMUM/PREFERRED REQUIREMENTS

Education

PhD, PharmD, or equivalent qualification and good medical competence in the relevant therapeutic area.

Experience

• Over 5 years relevant experience in drug development including relevant experience in regulatory affairs.

• Experience in working directly on ANDAs and/or 505 B II NDAs.

• Must have experience in solid dosage forms, including sustained release tablets.

• Experience in using design of experiments (QbD) when developing new formulations.

• Experience in formulation development, process development and/or manufacturing.

Language Skills/Licenses/Certifications

Ability to read and interpret documents; ability to write routine reports and documents. Ability to speak and communicate well with team members, colleagues and management.

Additional Skills/Knowledge

• Thorough working knowledge of core processes: discovery, development, and manufacturing.

• Knowledge of FDA regulatory guidance, ICH guidelines and ANDA submissions.

• Solid understanding of pharmaceutical dosage forms.

• Excellent team and interpersonal skills.

• Ability to interact successfully with multiple cultures

Proprietary 3

• Good knowledge of cGMP related to pharmaceutical manufacturing.

• Demonstrated compliance with procedures and policies.

• Strong communication skills both written and verbal.

• Strong attention to detail and ability to multitask and prioritize assignments.

• Ability to work under pressure to meet deadlines · Willingness to work flexible hours.

PHYSICAL DEMANDS/ENVIRONMENTAL CONDITIONS

• Laboratory and office environment’ Ability to sit or stand as required.

• Ability to perform laboratory function associated with position and required in a research lab.

• Standing to perform bench tests, bending, climbing, lifting up to 40 lbs., and ability to wear all required safety equipment as work and environment required.

SEND RESUMES TO

rashmi.marya@altitudestaffing.com

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