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