About the Opportunity
We are looking for a Process Developmet Scientist lll for an innovation-driven, fast-growing oral solid dosage (OSD) CDMO known for its science-first mindset, entrepreneurial culture, and hands-on approach to solving complex drug development challenges. The organization partners with emerging and established biopharma companies to design, develop, and manufacture differentiated oral solid products from early development through commercial launch. Team members operate in a collaborative, curious, and high-accountability environment where advancing therapies and creating value for patients is the core mission.
Core Cultural Values
AUTHENTIC Be vulnerable, build trust
CURIOUS Ask questions, be adaptable, speak up
ACCOUNTABLE Own it, meet commitments, communicate transparently
COLLABORATIVE Engage others, stay open-minded
FLEXIBLE Listen actively, make thoughtful decisions
CARE Be passionate, act with integrity
BLAZE TRAILS Push boundaries, challenge constraints
EXCELLENCE Learn, improve, create value
FOCUS Pay attention to details, deliver exceptional service
How You Will Make an Impact
- Independently lead development activities across client projects from preclinical through Phase III and registration.
- Create phase-appropriate strategies for customer-defined product development programs.
- Execute prototype, scale-up, and process transfer activities including manufacturing, data evaluation, troubleshooting, and risk assessments.
- Write, review, and approve cGMP documentation (batch records, protocols, SOPs, pharm dev reports, investigations, etc.).
- Apply QbD principles, design of experiments, and statistical tools to support drug product development.
- Maintain expert knowledge of equipment and processes relevant to pharmaceutical development.
- Monitor emerging formulation technologies and conduct literature/patent reviews to inform development plans.
- Operate in a GMP environment with diverse compounds (including high-potent and controlled substances).
- Collaborate closely with Analytical Development, QA, Project Management, and Validation groups on cross-functional initiatives.
- Serve as a technical lead on product development project teams and mentor junior scientists.
- Lead continuous process improvements and support scheduling of group activities.
- Demonstrate reliable attendance and professional communication with stakeholders while embodying cultural values.
What You Will Bring
- Bachelors degree in Pharmaceutics, Chemistry, Chemical Engineering, or related field with 8+ years of oral solid dosage formulation/process development experience (Masters with 6+ years acceptable).
- Hands-on expertise in formulation and process development for tablets, capsules, and multiparticulates .
- Strong theoretical foundation in pharmaceutics and physical organic chemistry.
- Proven knowledge of excipient functionality, formulation strategy, and unit operations.
- Experience applying statistical DoE for process optimization.
- Excellent written, verbal, and technical communication skills.
- Familiarity with MS Office and statistical tools such as JMP or Minitab.
- Knowledge of GLP/cGMP and regulatory guidance (FDA, ICH, EMEA) related to oral solid dosage.
Special Conditions
- Some travel required (client meetings, conferences, cross-site collaboration).