Formulation Associate

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Formulation Associate

Job Overview:

As a key member of the Mucinex development team, the Formulation Associate will provide active support to key US based Mucinex development programs.

Job Responsibilities:

    - Write technical reports summarizing formulation and process development of target formulations.
    - Prepare documentation for CMC sections of NDAs/CTDs for all new regulatory submissions
    - Oversee the screening of prototype formulations to match target product profiles
    - Ensure the development of stable formulations and robust manufacturing processes for target products.
    - Communicate testing requirements for experimental batches to Analytical team
    - Provide initial development cost estimates and timing to Project Manager and update as required
    - Transfer finalized formulations to Supply for commercialization
    - Prepare regular project updates for presentation to management.
    - Effectively supporting multiple projects with shifting priorities
    - Supporting technology transfer of formulations into remote facilities
    - Develop uniform and robust formulations for multi-API formulations

Job Qualifications:

    - PhD in Pharmaceutics, chemical engineering or related technical discipline with 1-2 years of experience or BS/MS with 3+ years of experience
    - Minimum of 2 years experience in pharmaceutical product development of solid oral dosage forms required. Experience developing and commercializing controlled release products strongly preferred.
    - Proven track record of delivering key milestone of multiple projects simultaneously on expected budget
    - Experience preparing technical reports used in CMC sections US NDA products required
    - Fundamental understanding of key drug development activities and milestones
    - Functional knowledge of common pharmaceutical ingredients and manufacturing equipment
    - Understanding of risk-based experimentation including FMEA analyses
    - Basic understanding of DOE principles and statistical data evaluation. Experience with Minitab a plus.
    - Results oriented, entrepreneurial and self-motivated, with solid organizational capabilities.
    - Excellent communication skills
    - Self-starter capable of delivering independently on objectives with little oversight
    - Strong analytical and problem solving skills
    - Strong intellectual curiosity with an appetite for exploring new and previously uncharted territories and an openness to change and ability to think out of the box
    - Ability to work under pressure and meet deadlines
    - Hands-on scientist with drive and delivery focus
    - Willingness to travel up to 30%

Discover all that's possible with Yoh. Apply now.

Recruiter: Sidra Javed

Yoh is a professional staffing provider with over 70 years of experience in the short and long-term staffing services industry; visit our website to learn more about our company.

Yoh, a Day & Zimmermann company, is an Equal Opportunity Employer, M/F/D/V.

Deadline: Contact employer

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