Job description: In this role, you will: Engage in activities across multiple cross-functional areas, including production planning, total quality management, systems, manufacturing, equipment and facilities engineering, material management, and process engineering.
Utilize innovative communication tools and techniques to resolve complex issues between teams, foster consensus, and support continuous improvement opportunities and projects.
Perform lab qualification work, provide technical justification for new raw materials, and offer Subject Matter Expert support during major investigations.
Troubleshoot and provide sustainable solutions for root-cause processing and safety problems, support plant process changeovers and clean ups, and ensure alignment between processes, plant, automation, and operators.
Adhere to current Good Manufacturing Practices (cGMP), manage product knowledge during tech transfer and manufacturing campaigns, and foster a culture of Right-First Time through partnerships with Operations and the use of Operational Excellence (OE) principles.
Required profile: Relevant Chemistry or Bachelors degree with 3+ years experience or have a PhD in organic chemistry or related field (or equivalent synthetic chemistry experience).
Demonstrated ability to provide technical solutions for complex problems through extensive product and process knowledge.
Good understanding of process manufacturing and computer systems.
Ability to lead change and exhibit strong collaborative skills.
Excellent mentoring and interpersonal skills.
Strong analytical and problem-solving skills.
Bonus Points If You Have (Preferred Requirements) Relevant pharmaceutical industry experience.
Experience with continuous improvement methodologies such as Lean or Six Sigma.
Familiarity with regulatory requirements and cGMP.
Strong project management skills.
Experience with process optimization and troubleshooting.
Strong organizational skills and attention to detail.
Ability to adapt to changing priorities and work in a fast-paced environment.
Excellent written and verbal communication skills.
Nice to Have Relevant Pharmaceutical industry experience.
Awareness of relevant ICH guidelines and API regulatory requirements.
API process validation experience/knowledge.
Skills: chemistry computer systems chemist